Sittings · Document

Draft report (COM(2023)0193 – C9-0144/2023 – 2023/0131(COD)) 2023-11-21

Laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

Committee on the Environment, Public Health and Food Safety

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AM_Com_LegReport

Amendment 1277

Tomislav Sokol, Pernille Weiss

Proposal for a regulation

Article 72 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. An orphan medicinal product which benefits from the prolongation of market exclusivity as referred to in paragraph 3, shall not benefit from the rewards referred to in Article 86 [of revised Directive 2001/83/EC].

Or. en

Amendment 1278

Tomislav Sokol, Pernille Weiss

Proposal for a regulation

Article 72 – paragraph 4 b (new)

Text proposed by the Commission

Amendment

4 b. The holder of an orphan marketing authorisation shall be entitled to a total maximum period of 14 years of orphan marketing exclusivity from the time the orphan medicinal product in question first obtains an authorization as defined in Article 69.

Or. en

Amendment 1279

Andrey Slabakov

Proposal for a regulation

Article 72 a (new)

Text proposed by the Commission

Amendment

Article72a

Improving accessibility of Orphan Medicinal Products placed on the Union markets

1. An applicant for marketing authorisation for an orphan medicinal product benefitting from a period of market exclusivity shall demonstrate as part of its application process, that it has fulfilled the following measures to ensure improved access to the orphan medicinal product within the Union:

(a) it has developed a detailed roadmap for entering into a partnership with relevant European Reference Networks, working on the orphan medical conditions for which the orphan medicinal product holds an indication;

(b) it has established, without prejudice to proprietary data and trade secrets, an in-depth communication strategy regarding the orphan medicinal product, its indications, its method of action, expected effects on the relevant patient population; this information shall be communicated to clinicians in the Union working with the relevant patient populations, with the cooperation of the Member States, as well as patient and professional organisations;

2. Member States shall adopt appropriate and adequate measures within their national legislation to improve patient access to orphan medicinal products authorised for placement on the Union markets by adopting national Action Plans for Rare Diseases that include at least the following elements:

(a) fully transposing Directive 2011/24/EU and guaranteeing the fulfillment of patients' rights to cross-border healthcare in every Member State; where necessary, set up the appropriate pathways for patients suffering from rare diseases to benefit from Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems, in order to access orphan medicinal products available in other Member States;

(b) establishing, individually or through voluntary cooperation with other Member States, Centres of Excellence for the management and care of patients with rare diseases;

(c) putting in place, in cooperation with the Agency, the necessary infrastructure to ensure a high level of uptake by clinicians and other medical professionals of information regarding the latest orphan medicinal products, authorised to be placed on the Union market;

(d) ensuring a sufficient level of financial support for existing and future Europan Reference Networks, guaranteeing their capability to generate, collect and analyse real-world data; setting up robust frameworks for partnerships between ERNs, national regulators and marketing authorisation holders for orphan medicinal products, for the purpose of data collection and analysis;

Or. en

Amendment 1280

Alessandra Moretti

Proposal for a regulation

Article 73 a (new)

Text proposed by the Commission

Amendment

Article73a

Reporting of research and development costs from the marketing authorisation holder

1. Where the marketing authorisation holder benefits from the incentives outlined in Article 71 paragraph 2, it shall:

(a) upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an report with detailed information on their actual costs and expenditure in research and development activities related to the medicinal product.

(b) make the report available within 30 days from the receipt of the request;

(c) publish a summary of the report on the same webpage where the information described in Article 57 of revised Directive 2001/83/EC will be published. The link should be communicated to the Agency.

(d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor.

2. The Commission shall adopt implementing acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.

Or. en

Amendment 1281

Kateřina Konečná

Proposal for a regulation

Article 73 a (new)

Text proposed by the Commission

Amendment

Article73a

Reporting of research and development costs from the marketing authorisation holder

1. Where the marketing authorisation holder benefits from the incentives outlined in Article 71 paragraph 2, it shall:

(a)upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their expenditure in research and development activities related to the medicinal product;

(b) make the report available within 30 days from the receipt of the request;

(c) publish a summary of the report on the same webpage where the information described in Article 57 of revised Directive 2001/83/EC will be published. The link should be communicated to the Agency;

(d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor.

2. The Commission shall adopt implementing acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.

Or. en

Amendment 1282

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen, Dacian Cioloş

Proposal for a regulation

Article 73 a (new)

Text proposed by the Commission

Amendment

Article 73a

European Framework for Rare Diseases

By (OP: 24 months after the date of entry into force of this Regulation), the Commission shall, following appropriate consultation with the Member States, patient organisations and, where relevant, other interested parties, propose a needs driven and goals based European Framework for Rare Diseases with a view to bridge relevant Union legislation, policies and programmes, and support national strategies to better meet the unmet needs of people living with rare diseases, and their carers.

Or. en

Amendment 1283

Kateřina Konečná

Proposal for a regulation

Article 73 b (new)

Text proposed by the Commission

Amendment

Article73b

Joint procurement of orphans, drugs against cancer and advanced therapy medicinal products

1. Upon request from the Member States, the Commission shall facilitate joint procurement of orphans, drugs against cancer and advanced therapy medicinal products at the EU level on Member States' behalf going beyond the emergency situations under the Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU.

2. The Commission is empowered to establish the EU Pharmaceutical Fund. Each Member State may contribute to the EU Pharmaceutical Fund by paying, for each unit used within the Member State, a given amount, which is defined considering the Member State's ability to pay based on GDP per-capita.To ensure financial sustainability of the EU Pharmaceutical Fund, country-specific contributions shall be such as to ensure balance between the total expected amount to be paid to the manufacturer and the expected total amount of contributions made by Member States.

3. The Commission is empowered to adopt delegated act in accordance with this Article to supplement this Regulation by further defining the scheme, conditions of participation of Member States in joint procurements of orphans, drugs against cancer and advanced therapy medicinal products at the EU level and funding of EU Pharmaceutical Fund.

Or. en

Justification

Joint procurement of medicines can be a successful form of increased cooperation to improve affordability as well as access to medicines and security of supply. This has been demonstrated by the joint procurement of COVID-19 therapeutics and monkeypox vaccines. However, the potential of the EU joint procurements reaches beyond vaccines and treatments for communicable cross-border health threats. New STOA paper on Improving access to medicines and promoting pharmaceutical innovation choose joint procurements as the Policy Option 1 (p. 61-62) for Improving access to medicine of EU patients.

Amendment 1284

Andrey Slabakov

Proposal for a regulation

Article 74 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) when the active substance concerned is not yet authorised in any medicinal product in the EU and is intended to treat a novel paediatric condition;

(a) when the active substance concerned is not yet authorised in any medicinal product in the EU and is intended to treat, diagnose or prevent a paediatric condition;

Or. en

Amendment 1285

Margarita de la Pisa Carrión

Proposal for a regulation

Article 74 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) when the active substance concerned is not yet authorised in any medicinal product in the EU and is intended to treat a novel paediatric condition;

(a) when the active substance concerned is the first of its kind intended to treat, diagnose or prevent a paediatric condition;

Or. en

Amendment 1286

Margarita de la Pisa Carrión

Proposal for a regulation

Article 75 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless when the product is directed at a molecular target that on the basis of existing scientific data, is responsible for a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population;

(b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless on the basis of existing scientific data, there is medical plausibility that the product, due to its mechanism of action, could address an unmet medical need in a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population. Where that is the case, the applicant shall be required to conduct one paediatric investigation plan based on the product’s mechanism of action in a single disease or condition for which there is such an unmet medical need, and no more than one such paediatric investigation plan for any given active substance;

Or. en

Amendment 1287

Andrey Slabakov

Proposal for a regulation

Article 75 – paragraph 1 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1288

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher

Proposal for a regulation

Article 75 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless there is medical plausibility that the product, due to its mechanism of action and on the basis of existing scientific data, could address an unmet medical need in a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population;

Or. en

Amendment 1289

Tomislav Sokol

Proposal for a regulation

Article 75 – paragraph 1 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1290

Tomislav Sokol

Proposal for a regulation

Article 75 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing treatments for paediatric patients.

(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing methods of diagnosis, prevention or treatments for paediatric patients, including when clinical studies are not feasible.

Or. en

Amendment 1291

Margarita de la Pisa Carrión

Proposal for a regulation

Article 75 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing treatments for paediatric patients.

Or. en

Amendment 1292

Andrey Slabakov

Proposal for a regulation

Article 75 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing treatments for paediatric patients.

(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing methods of diagnosis, prevention or treatments for paediatric patients.

Or. en

Amendment 1293

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen, Dacian Cioloş

Proposal for a regulation

Article 75 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing treatments for paediatric patients.

(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing methods of diagnosis, prevention or treatment for paediatric patients.

Or. en

Amendment 1294

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 75 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The Agency shall, after consultation with the Commission and relevant interested parties, draw up guidelines for the application of this Article.

Or. en

Amendment 1295

Andrey Slabakov

Proposal for a regulation

Article 75 – paragraph 3

Text proposed by the Commission

Amendment

3. On the basis of the experience acquired as a result of the operation of this Article or of scientific knowledge the Commission is empowered to adopt delegated acts in accordance with Article 175 to amend the grounds for granting a waiver detailed in paragraph 1.

deleted

Or. en

Amendment 1296

Margarita de la Pisa Carrión

Proposal for a regulation

Article 75 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. In consultation with the Commission and with interested parties, the Agency shall draw up guidelines for the application of this Article.

Or. en

Amendment 1297

Andrey Slabakov

Proposal for a regulation

Article 75 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Agency shall, in consultation with the Commission and with all interested parties, draw up guidelines for the application of this Article.

Or. en

Amendment 1298

Tomislav Sokol

Proposal for a regulation

Article 75 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. In consultation with the Commission and with interested parties, the Agency shall draw up guidelines for the application of this Article.

Or. en

Amendment 1299

Andrey Slabakov

Proposal for a regulation

Article 76 – paragraph 1

Text proposed by the Commission

Amendment

1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of safety and efficacy clinical studies so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.

1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of confirmatory safety and efficacy clinical studies in adults or children so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.

Or. en

Amendment 1300

Tomislav Sokol

Proposal for a regulation

Article 76 – paragraph 1

Text proposed by the Commission

Amendment

1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation confirmatory of safety and efficacy clinical studies in adults or children so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.

Or. en

Amendment 1301

Margarita de la Pisa Carrión

Proposal for a regulation

Article 76 – paragraph 1

Text proposed by the Commission

Amendment

1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of confirmatory safety and efficacy clinical studies in adults or children so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.

Or. en

Amendment 1302

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 76 – paragraph 1

Text proposed by the Commission

Amendment

1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of confirmatory safety and efficacy clinical studies so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.

Or. en

Amendment 1303

Sunčana Glavak

Proposal for a regulation

Article 76 – paragraph 4

Text proposed by the Commission

Amendment

4. In consultation with the Commission and with interested parties, the Agency shall draw up and publish guidelines for the practical application of this Article.

4. In consultation with the Commission and with interested parties, and with the CPOMP, the Agency shall draw up and publish guidelines for the practical application of this Article.

Or. en

Amendment 1304

Maria Angela Danzì

Proposal for a regulation

Article 77 – paragraph 1

Text proposed by the Commission

Amendment

1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 90 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.

1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1), which is valid in accordance with the provisions of Article 76(2), the Agency shall, after receiving the opinion of its paediatric working party, adopt within 90 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.

Or. it

Justification

The paediatric working party's opinion should be taken into consideration on account of its scientific competence in supporting the development of the Agency's regulatory experience

Amendment 1305

Tomislav Sokol

Proposal for a regulation

Article 77 – paragraph 1

Text proposed by the Commission

Amendment

1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 80 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.

Or. en

Amendment 1306

Sunčana Glavak

Proposal for a regulation

Article 77 – paragraph 1

Text proposed by the Commission

Amendment

1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 70 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.

Or. en

Amendment 1307

Andrey Slabakov

Proposal for a regulation

Article 77 – paragraph 2

Text proposed by the Commission

Amendment

2. After the validation of the proposed initial paediatric investigation plan prepared in accordance with the adapted procedure referred to in Article 74(2) first subparagraph, which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt a decision within 70 days as to whether or not the paediatric investigation plan is expected to ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies envisaged.

deleted

Or. en

Amendment 1308

Andrey Slabakov

Proposal for a regulation

Article 77 – paragraph 3

Text proposed by the Commission

Amendment

3. After receiving an updated version of the paediatric investigation plan referred to in Article 74(2), third subparagraph, the Agency shall review it within 30 days.

deleted

After the timeframe laid down in the first subparagraph, without any request from the Agency in accordance with paragraph 5, the updated version of the paediatric investigation plan shall be considered as agreed.

Or. en

Amendment 1309

Andrey Slabakov

Proposal for a regulation

Article 77 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

After receiving an updated version of the paediatric investigation plan referred to in Article 74(2), third subparagraph, the Agency shall review it within 30 days.

deleted

Or. en

Amendment 1310

Maria Angela Danzì

Proposal for a regulation

Article 77 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

After receiving an updated version of the paediatric investigation plan referred to in Article 74(2), third subparagraph, the Agency shall review it within 30 days.

After receiving an updated version of the paediatric investigation plan referred to in Article 74(2), third subparagraph, the Agency shall, after receiving the input of the paediatric working party, review it within 30 days.

Or. it

Justification

The paediatric working party's opinion should be taken into consideration on account of its scientific competence in supporting the development of the Agency's regulatory experience

Amendment 1311

Andrey Slabakov

Proposal for a regulation

Article 77 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1312

Andrey Slabakov

Proposal for a regulation

Article 77 – paragraph 4

Text proposed by the Commission

Amendment

4. When the final paediatric investigation plan referred to in Article 74(2), third subparagraph, is received, the Agency shall adopt within 60 days a decision on the paediatric investigation plan considering all the updated reviews eventually conducted and of the initial decision in accordance with paragraphs 2 and 3.

deleted

Or. en

Amendment 1313

Andrey Slabakov

Proposal for a regulation

Article 77 – paragraph 5

Text proposed by the Commission

Amendment

5. Within time periods referred to in paragraphs 1, 2, 3 or 4 the Agency may request the applicant to propose modifications to the plan or ask for additional information, in which case the time-limits referred to in paragraphs 1, 2, 3 and 4 shall be extended for a maximum of the same number of days. These time-limits shall be suspended until the supplementary information requested has been provided.

5. Within the time period referred to in paragraph 1, the Agency may request the applicant to propose modifications to the plan or ask for additional information, in which case the time-limit shall be extended for a maximum of the same number of days. This time-limit shall be suspended until the supplementary information requested has been provided.

Or. en

Amendment 1314

Maria Angela Danzì

Proposal for a regulation

Article 78 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

Following the receipt of a valid application in accordance with the provisions of Article 76(2), the Agency shall within 90 days adopt a decision as to whether or not a product-specific waiver shall be granted.

Following the receipt of a valid application in accordance with the provisions of Article 76(2), the Agency shall, after receiving the input of its paediatric working party, within 90 days adopt a decision as to whether or not a product-specific waiver shall be granted.

Or. it

Justification

The paediatric working party should also be involved in the granting of product-specific derogations.

Amendment 1315

Maria Angela Danzì

Proposal for a regulation

Article 78 – paragraph 3

Text proposed by the Commission

Amendment

3. When appropriate, the Agency may of its own motion adopt decisions, on the basis of the grounds set out in Article 75(1), to the effect that a class or a product-specific waiver, as referred to in Article 75(2), should be granted.

3. When appropriate, the Agency may, either of its own motion or acting upon the recommendations of the paediatric working party, adopt decisions on the basis of the grounds set out in Article 75(1), to the effect that a class or a product-specific waiver, as referred to in Article 75(2), should be granted.

Or. it

Justification

The paediatric working party should also be involved in the granting of product-specific derogations.

Amendment 1316

Maria Angela Danzì

Proposal for a regulation

Article 78 – paragraph 7

Text proposed by the Commission

Amendment

7. In consultation with the Commission and with interested parties, the Agency shall draw up and publish guidelines for the practical application of this Article.

7. In consultation with the Commission and with interested parties, the Agency and its paediatric working party shall draw up and publish guidelines for the practical application of this Article.

Or. it

Justification

The paediatric working party should also be involved in the granting of product-specific derogations.

Amendment 1317

Sunčana Glavak

Proposal for a regulation

Article 78 – paragraph 7

Text proposed by the Commission

Amendment

7. In consultation with the Commission and with interested parties, the Agency shall draw up and publish guidelines for the practical application of this Article.

7. In consultation with the Commission and with interested parties, and with the CPOMP, the Agency shall draw up and publish guidelines for the practical application of this Article.

Or. en

Amendment 1318

Andrey Slabakov

Proposal for a regulation

Article 80 – paragraph 1

Text proposed by the Commission

Amendment

If, having considered a paediatric investigation plan, the Agency concludes that Article 75(1), points (a), (b) or (c), applies to the medicinal product concerned, it shall adopt negative a decision under Article 77, paragraphs 1, 2 or 4.

Or. en

Amendment 1319

Andrey Slabakov

Proposal for a regulation

Article 81 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall adopt a decision on the request referred to in paragraph 1 and inform the applicant thereof. The Agency shall adopt such decision at the same time as the adoption of the positive decision under Article 77, paragraphs 1 or 2.

Or. en

Amendment 1320

Maria Angela Danzì

Proposal for a regulation

Article 81 – paragraph 3

Text proposed by the Commission

Amendment

3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years.

3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years and should ensure that the PIP is completed no more than two years after the marketing authorisation for other populations is granted.

Or. it

Justification

Reducing the length of the deferral may not be sufficient to reduce the significant backlog in approving paediatric medicinal products; the duration of the PIP shall not exceed two years after the granting of the marketing authorisation for medicinal products for other populations.

Amendment 1321

Susana Solís Pérez

Proposal for a regulation

Article 81 – paragraph 3

Text proposed by the Commission

Amendment

3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years.

3. The length of the deferral shall be specified in a decision of the Agency and shall be substantiated by scientific and technical reasoning or by considerations pertaining to public health.

Or. en

Amendment 1322

Tomislav Sokol

Proposal for a regulation

Article 81 – paragraph 3

Text proposed by the Commission

Amendment

3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years.

3. The length of the deferral shall be specified in a decision of the Agency and shall be justified on scientific and technical grounds or on grounds relating to public health.

Or. en

Amendment 1323

Andrey Slabakov

Proposal for a regulation

Article 81 – paragraph 3

Text proposed by the Commission

Amendment

3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years.

3. The length of the deferral shall be specified in a decision of the Agency.

Or. en

Amendment 1324

Andrey Slabakov

Proposal for a regulation

Article 82 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

In duly justified cases, a request for a prolongation of the deferral, may be submitted, at least 6 months before the expiry of the deferral period. A prolongation of the derogation shall not exceed the duration of the deferral period given under Article 81(3).

In duly justified cases, a request for a prolongation of the deferral may be submitted.

Or. en

Amendment 1325

Tomislav Sokol

Proposal for a regulation

Article 82 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

In duly justified cases, a request for a prolongation of the deferral, may be submitted, at least 12 months before the expiry of the deferral period. A prolongation of the derogation shall not exceed the duration of the deferral period given under Article 81(3).

Or. en

Amendment 1326

Sunčana Glavak

Proposal for a regulation

Article 82 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. In case of the product that has already been authorized for use in adults in accordance with the provision of this Regulation, and if the cause for deferral of the PIP was a failure to timely complete clinical studies in children, before granting another deferral, the Agency may consider the evidence obtained from extrapolation and from the appropriately designed post-marketing long-term studies for monitoring safety and efficacy as specified in Article 138, paragraph 1, subparagraph 2, point za a(new)

Or. en

Amendment 1327

Margarita de la Pisa Carrión

Proposal for a regulation

Article 84 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The procedure foreseen in paragraph 1 shall also apply when the applicant updates the elements of an initial paediatric investigation plan submitted in accordance with Article 74(2).

Or. en

Amendment 1328

Andrey Slabakov

Proposal for a regulation

Article 84 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The procedure foreseen in paragraph 1 shall also apply when the applicant updates the elements of an initial paediatric investigation plan submitted in accordance with Article 74(2).

Or. en

Amendment 1329

Margarita de la Pisa Carrión

Proposal for a regulation

Article 84 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

If, following the decision agreeing the paediatric investigation plan referred to in Article 77, paragraphs 1, 2 and 4, or on the basis of the updated paediatric investigation plan received in accordance with Article 77(3), the Agency, on the base of new scientific information available, considers that the agreed plan or any of its elements are no longer appropriate, it shall request the applicant to propose changes to the paediatric investigation plan.

If, following the decision agreeing the paediatric investigation plan referred to in Article 77, paragraph 1, the Agency, on the base of new scientific information available, considers that the agreed plan or any of its elements are no longer appropriate, it shall request based on detailed scientific grounds, that the to applicant proposes changes to the paediatric investigation plan. The applicant shall submit a response to the request for changes within 60 days. Within 30 days, the Agency shall review the applicant’s response and adopt a decision on its refusal or acceptance.

Or. en

Amendment 1330

Andrey Slabakov

Proposal for a regulation

Article 84 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1331

Andrey Slabakov

Proposal for a regulation

Article 84 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The applicant shall submit the changes requested within 60 days.

The applicant shall submit a response to the request for changes within 60 days.

Or. en

Amendment 1332

Margarita de la Pisa Carrión

Proposal for a regulation

Article 84 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The applicant shall submit the changes requested within 60 days.

The applicant shall submit a response to the request for changes within 90 days.

Or. en

Amendment 1333

Tomislav Sokol

Proposal for a regulation

Article 84 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The applicant shall submit the changes requested within 60 days.

The applicant shall submit the changes requested within 90 days.

Or. en

Amendment 1334

Maria Angela Danzì

Proposal for a regulation

Article 84 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

Within 30 days, the Agency shall review these changes and adopt a decision on their refusal or acceptance.

Within 30 days, and after receiving the opinion of its paediatric working party, the Agency shall review these changes and adopt a decision on their refusal or acceptance.

Or. it

Justification

The paediatric working party should also be involved in the granting of product-specific derogations.

Amendment 1335

Andrey Slabakov

Proposal for a regulation

Article 84 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

Within 30 days, the Agency shall review these changes and adopt a decision on their refusal or acceptance.

Within 30 days, the Agency shall review the applicant’s response and adopt a decision on its refusal or acceptance.

Or. en

Amendment 1336

Margarita de la Pisa Carrión

Proposal for a regulation

Article 84 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

Within 30 days, the Agency shall review these changes and adopt a decision on their refusal or acceptance.

Within 30 days, the Agency shall review the applicant’s response and adopt a decision on its refusal or acceptance.

Or. en

Amendment 1337

Sunčana Glavak

Proposal for a regulation

Article 85 – paragraph 1

Text proposed by the Commission

Amendment

1. In consultation with the Member States, the Commission and interested parties, the Agency shall draw up the detailed arrangements concerning the format and content which applications for agreement or modification of a paediatric investigation plan, and requests for waivers or deferrals are to follow in order to be considered valid and concerning the operation of the compliance check referred to in Articles 48, 49(2), 86 and 90(2) of [revised Directive 2001/83/EC].

1. In consultation with the Member States, the Commission, and interested parties, the Agency and its relevant Committee (CPOMP) shall draw up the detailed arrangements concerning the format and content which applications for agreement or modification of a paediatric investigation plan, and requests for waivers or deferrals are to follow in order to be considered valid and concerning the operation of the compliance check referred to in Articles 48, 49(2), 86 and 90(2) of [revised Directive 2001/83/EC].

Or. en

Amendment 1338

Maria Angela Danzì

Proposal for a regulation

Article 86 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The paediatric experts who are taking part in the CHMP's working parties shall contribute to the conformity assessment.

Or. it

Justification

For this action it is necessary to those involve paediatric experts who have been working with the CHMP.

Amendment 1339

Maria Angela Danzì

Proposal for a regulation

Article 87 – paragraph 1

Text proposed by the Commission

Amendment

1. Decisions referred to in Articles 77, 78, 80, 81, 82 and 84 adopted by the Agency shall be supported by scientific conclusions which shall be annexed to the decision.

1. Decisions referred to in Articles 77, 78, 80, 81, 82 and 84 adopted by the Agency shall be supported by scientific conclusions, which should incorporate the opinion expressed by the paediatric working party and which shall be annexed to the decision.

Or. it

Justification

All the activities linked in these articles have been assigned to the disbanded PDCO. It must be made clear that the scientific conclusions must be delivered by scientists who are expert in paediatric matters and who are part of one of the Agencies' paediatric working parties.

Amendment 1340

Maria Angela Danzì

Proposal for a regulation

Article 87 – paragraph 2

Text proposed by the Commission

Amendment

2. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when preparing the above mentioned scientific conclusions. The outcome of such consultations shall be annexed to the decision.

2. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use and other appropriate working parties when preparing the above mentioned scientific conclusions. The outcome of such consultations shall be annexed to the decision.

Or. it

Amendment 1341

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 87 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Within the timelines for adoption of a decision foreseen in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant.

Or. en

Amendment 1342

Andrey Slabakov

Proposal for a regulation

Article 87 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Within the timelines for adoption of a decision foreseen in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant.

Or. en

Amendment 1343

Tomislav Sokol

Proposal for a regulation

Article 87 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Within the timelines for adoption of a decision foreseen in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant.

Or. en

Amendment 1344

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 87 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. Within 20 days following receipt of the scientific conclusions, the applicant may submit to the Agency a written request, citing detailed grounds, for a re-examination.

Within 30 days following receipt of a request for re-examination pursuant to paragraph 2b, the Agency shall confirm or revise its previous scientific conclusions.The Agency shall be able to question the applicant directly.The applicant may also offer to be questioned.Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions.

If, within the 15-day period referred to in paragraph 4, the applicant does not request re-examination, the scientific conclusions shall become definitive.

The Agency shall adopt a decision within a period not exceeding 15 days following the date on which the scientific conclusions have become definitive. This decision shall be communicated to the applicant in writing and shall annex the final scientific conclusions.

Or. en

Amendment 1345

Tomislav Sokol

Proposal for a regulation

Article 87 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. Within 30 days following receipt of the scientific conclusions, the applicant may submit to the Agency a written request, citing detailed grounds, for a re-examination.

Or. en

Amendment 1346

Andrey Slabakov

Proposal for a regulation

Article 87 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. Within 30 days following receipt of the scientific conclusions, the applicant may submit to the Agency a written request, citing detailed grounds, for a re-examination.

Or. en

Amendment 1347

Andrey Slabakov

Proposal for a regulation

Article 87 – paragraph 2 c (new)

Text proposed by the Commission

Amendment

2 c. Within 30 days following receipt of a request for re-examination pursuant to paragraph 2b, the Agency shall confirm or revise its previous scientific conclusions. The Agency shall be able to question the applicant directly. The applicant may also offer to be questioned. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions.

Or. en

Amendment 1348

Tomislav Sokol

Proposal for a regulation

Article 87 – paragraph 2 c (new)

Text proposed by the Commission

Amendment

2 c. Within 30 days following receipt of a request for re-examination pursuant to paragraph 4, the Agency shall confirm or revise its previous scientific conclusions. The Agency shall be able to question the applicant directly. The applicant may also offer to be questioned. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions.

Or. en

Amendment 1349

Andrey Slabakov

Proposal for a regulation

Article 87 – paragraph 2 d (new)

Text proposed by the Commission

Amendment

2 d. If, within the 30-day period referred to in paragraph 2b, the applicant does not request re-examination, the scientific conclusions shall become definitive.

Or. en

Amendment 1350

Tomislav Sokol

Proposal for a regulation

Article 87 – paragraph 2 d (new)

Text proposed by the Commission

Amendment

2 d. If, within the 30-day period referred to in paragraph 4, the applicant does not request re-examination, the scientific conclusions shall become definitive.

Or. en

Amendment 1351

Tomislav Sokol

Proposal for a regulation

Article 87 – paragraph 2 e (new)

Text proposed by the Commission

Amendment

2 e. The Agency shall adopt a decision within a period not exceeding 10 days following the date on which the scientific conclusions have become definitive. This decision shall be communicated to the applicant in writing and shall annex the final scientific conclusions.

Or. en

Amendment 1352

Andrey Slabakov

Proposal for a regulation

Article 87 – paragraph 2 e (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1353

Andrey Slabakov

Proposal for a regulation

Article 88 – paragraph 1

Text proposed by the Commission

Amendment

Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4, is discontinued, the applicant shall notify the Agency of its intention to discontinue the conduct of the paediatric investigation plan and provide the reasons for such discontinuation as soon as possible and no less than six months before the discontinuation. In cases where such a time-frame is not possible, the applicant shall notify the Agency no later than 6 months of its decision to discontinue the investigation plan.

Or. en

Amendment 1354

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 88 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1355

Sunčana Glavak, Tomislav Sokol

Proposal for a regulation

Article 88 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4 could not be completed due to failure of timely completion of pediatric studies, for the product that has already been authorized for use in adults in accordance with the provision of this Regulation, the Agency should consider evidence from the pediatric studies as specified in Article 138, paragraph 1, subparagraph 2, point za a(new)

Or. en

Amendment 1356

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 91 – paragraph 1

Text proposed by the Commission

Amendment

1. Any clinical study which involves the use in the paediatric population of a medicinal product covered by a marketing authorisation and is sponsored by the marketing authorisation holder, whether or not it is conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the Agency or to the Member States which have previously authorised the medicinal product concerned within six months of completion of the studies concerned.

Or. en

Amendment 1357

Tilly Metz

Proposal for a regulation

Article 91 – paragraph 3

Text proposed by the Commission

Amendment

3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly.

Or. en

Amendment 1358

Maria Angela Danzì

Proposal for a regulation

Article 91 – paragraph 3

Text proposed by the Commission

Amendment

3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, including the accurate dosage, and may vary the marketing authorisation accordingly.

Or. it

Justification

Paediatric medicinal products should be placed on the market in packaging that is fit for paediatric use, safe and suitable to use and that includes adapted leaflets and, to reduce medication errors, particular care should be taken to ensure that its dosages are accurate.

Amendment 1359

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 91 – paragraph 3

Text proposed by the Commission

Amendment

3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, including dosage accuracy, and may vary the marketing authorisation accordingly.

Or. en

Amendment 1360

Tiemo Wölken

Proposal for a regulation

Article 91 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. By way of derogation of Article 91, paragraph 1, marketing authorisation holders of vaccines, any clinical study which involves the use in the paediatric population of a vaccine covered by a marketing authorisation and is sponsored by the marketing authorisation holder, whether or not it is conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the Agency or to the Member States which have previously authorised the medicinal product concerned within twelve months of completion of the studies concerned.

Or. en

Amendment 1361

Sunčana Glavak, Tomislav Sokol

Proposal for a regulation

Article 91 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Where a medicinal product is covered by a marketing authorization for adults, and the paediatric authorisation could not be completed due to the inability to timely complete the pediatric clinical studies, instead of granting deferrals, the Agency should consider evidence from the pediatric studies defined in Article 138, paragraph 1, subparagraph 2, point za a(new)

Or. en

Amendment 1362

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 94 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

Irrespective of the outcome of a clinical trial within 6 months from the end of the trial the clinical trial sponsor, the addressee of the Agency's decision on a paediatric investigation plan or the marketing authorisation holder as appropriate, shall submit to the EU database a summary of the results of the trial shall be uploaded in the database.

Irrespective of the outcome of a clinical trial within 12 months from the end of the trial the clinical trial sponsor, the addressee of the Agency's decision on a paediatric investigation plan or the marketing authorisation holder as appropriate, shall submit to the EU database a summary of the results of the trial shall be uploaded in the database.

Or. en

Amendment 1363

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 94 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

If for justified scientific reasons it is not possible to submit the summary of the result of the trial within 6 months it shall be submitted to the EU database at the latest within twelve months after the trial has ended. The justification for the delay needs also to be submitted in the EU database.

deleted

Or. en

Amendment 1364

Sunčana Glavak, Tomislav Sokol

Proposal for a regulation

Article 95 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Within the European network, the Agency shall, together with the proposed members of the network, develop a platform study concept for paediatric patients. The objectives of the platform study concept are to create active paediatric patients’ master files open for future authorizations of the same molecules or molecules with the same mechanism of action, and/or to share the same pool of patients for joined clinical trials of industry and academia within the same administrative process.

Or. en

Amendment 1365

Maria Angela Danzì

Proposal for a regulation

Article 96 – paragraph 1

Text proposed by the Commission

Amendment

Paediatric medicinal products shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, paediatric medicinal products.

These incentives will be granted by means of specific calls for research proposals encompassing the product's entire development phase, from discovery to post-marketing, as outlined in the annual paediatric research plans, which are part of the EU's research programmes concerning health and health products.

Or. it

Justification

A great deal of EU funding has been allocated to R&D programmes concerning health products in the field of paediatrics.

Amendment 1366

Andrey Slabakov

Proposal for a regulation

Article 98 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) the renewals of the deferrals beyond five years and the detailed reasons provided as mentioned in Article 82;

deleted

Or. en

Amendment 1367

Stelios Kympouropoulos

Proposal for a regulation

Article 101 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.

The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including errors of medication, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.

Or. en

Amendment 1368

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 101 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.

Or. en

Amendment 1369

István Ujhelyi

Proposal for a regulation

Article 101 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure

Or. en

Amendment 1370

Tiemo Wölken

Proposal for a regulation

Article 101 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.

Or. en

Amendment 1371

Tilly Metz

Proposal for a regulation

Article 101 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation and medication errors, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.

Or. en

Amendment 1372

Marian-Jean Marinescu

Proposal for a regulation

Article 101 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure

Or. en

Justification

This will allow more data on the number of medication errors that occur in Europe to be collected. The availability of consistent, reliable, data will support research and analysis on the root causes of medication errors which will contribute to evidence-based policy making on how to prevent medication harm in healthcare settings.

Amendment 1373

Tiemo Wölken

Proposal for a regulation

Article 101 – paragraph 2 – subparagraph 5

Text proposed by the Commission

Amendment

The Agency shall ensure that healthcare professionals and the public have appropriate levels of access to the Eudravigilance database, and that personal data is protected. The Agency shall work together with all stakeholders, including research institutions, healthcare professionals, and patient and consumer organisations, in order to define the ‘appropriate level of access’ for healthcare professionals and the public to the Eudravigilance database.

The Agency shall ensure that healthcare professionals and the public have appropriate levels of access to the Eudravigilance database, and that personal data is protected in line with the EU data protection and privacy legislation. The Agency shall work together with all stakeholders, including research institutions, healthcare professionals, and patient and consumer organisations, in order to define the ‘appropriate level of access’ for healthcare professionals and the public to the Eudravigilance database.

Or. en

Amendment 1374

Tiemo Wölken

Proposal for a regulation

Article 101 – paragraph 2 – subparagraph 6

Text proposed by the Commission

Amendment

The data held on the Eudravigilance database shall be made publicly available in an aggregated format together with an explanation of how to interpret the data.

The data held on the Eudravigilance database shall be made publicly available in an aggregated and anonymised format together with an explanation of how to interpret the data. Where anonymization is not possible, the data shall be pseudonymised.

Or. en

Amendment 1375

Tiemo Wölken

Proposal for a regulation

Article 101 – paragraph 2 – subparagraph 6 a (new)

Text proposed by the Commission

Amendment

The Commission is empowered to adopt an implementing act to further specify the categories of personal data processed in the Eudravigilance database after consulting with and duly integrating the opinion of the European Data Protection Supervisor. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 17.

Or. en

Amendment 1376

Tilly Metz

Proposal for a regulation

Article 103 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

The periodic safety update reports shall, in addition, be made publicly available in the web-portal referred to in Article 135(1)(n).

Or. en

Amendment 1377

Andrey Slabakov

Proposal for a regulation

Article 104 – paragraph 1 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 1378

Tilly Metz

Proposal for a regulation

Article 104 – paragraph 1 – subparagraph 1 – point h

Text proposed by the Commission

Amendment

(h) the initiation of the procedure provided for in Article 41(2), and Articles 114, 115 and 116 of [revised Directive 2001/83/EC], the active substances or medicinal products concerned and the issue being addressed, any public hearings pursuant to that procedure and information on how to submit information and to participate in public hearings;

(h) the initiation of the procedure provided for in Articles 114, 115 and 116 of [revised Directive 2001/83/EC], the active substances or medicinal products concerned and the issue being addressed, any public hearings pursuant to that procedure and information on how to submit information and to participate in public hearings;

Or. en

Amendment 1379

Tilly Metz

Proposal for a regulation

Article 104 – paragraph 1 – subparagraph 1 – point i

Text proposed by the Commission

Amendment

(i) conclusions of assessments, recommendations, opinions, approvals and decisions taken by the Agency and its Committees under this Regulation and [revised Directive 2001/83/EC], unless it is required that this information is made public by the Agency by other means;

(i) conclusions of assessments, obligations for post-marketing studies, recommendations, opinions, approvals and decisions taken by the Agency and its Committees under this Regulation and [revised Directive 2001/83/EC].

Or. en

Amendment 1380

Maria Angela Danzì

Proposal for a regulation

Article 104 – paragraph 1 – subparagraph 1 – point j

Text proposed by the Commission

Amendment

(j) conclusions of assessments, recommendations, opinions, approvals and decisions taken by the coordination group, the competent authorities of the Member States and the Commission in the framework of the procedures set out in Articles 16, 106, 107 and 108 of this Regulation and of Chapter IX, Sections 3 and 7 of [revised Directive 2001/83/EC].

(j) conclusions of assessments, recommendations, opinions, approvals, obligations deriving from the conditional marketing authorisation and decisions taken by the coordination group, the competent authorities of the Member States and the Commission in the framework of the procedures set out in Articles 16, 106, 107 and 108 of this Regulation and of Chapter IX, Sections 3 and 7 of [revised Directive 2001/83/EC].

Or. it

Justification

In order to ensure complete transparency and scrutiny, information relating to the obligations deriving from the conditional marketing authorisation shall be made public not only in the summary of product characteristics and in the package leaflet (Article 19), but also on the web portal managed by the Agency. All information concerning terms and conditions shall also be made public.

Amendment 1381

Andrey Slabakov

Proposal for a regulation

Article 104 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The summaries referred to in point (c) shall include a description of any additional risk minimisation measures.

The risk management plans referred to in point (c) shall include a description of any additional risk minimisation measures and distribution/implementation plans.

Or. en

Amendment 1382

Tilly Metz

Proposal for a regulation

Article 104 – paragraph 2

Text proposed by the Commission

Amendment

2. In the development and review of the web portal, the Agency shall consult relevant stakeholders, including patient and consumer groups, healthcare professionals and industry representatives.

2. In the development and review of the web portal, the Agency shall consult relevant stakeholders, including patient and consumer groups, healthcare professionals, non-profit research entities and industry representatives.

Or. en

Amendment 1383

Tilly Metz

Proposal for a regulation

Article 104 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a register of environmental risk assessment studies conducted for the purpose of supporting an environmental risk assessment for medicinal products authorised in the Union, unless such information is made public in the Union by different means.

Or. en

Justification

It is very important that there is a one stop shop for those studies to avoid duplication of research

Amendment 1384

Cyrus Engerer

Proposal for a regulation

Article 104 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

Information in such register shall be publicly available, unless restrictions are necessary to protect commercially confidential information. For the purpose of setting up such register, the Agency may request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation].

Information in such register shall be publicly available and includes as a minimum the information reported in Annex II - Section 1.6 of [revised Directive 2001/83/EC], unless restrictions are necessary to protect commercially confidential information. For the purpose of setting up such register, the Agency may request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation].

Or. en

Amendment 1385

Tilly Metz

Proposal for a regulation

Article 104 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

Information in the register shall be publicly available . For the purpose of setting up such register, the Agency shall request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation].

Or. en

Justification

Aarhus convention should be an overriding force here and all environment-related data must be made publicly available

Amendment 1386

Tilly Metz

Proposal for a regulation

Article 109 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency and the European Monitoring Centre for Drugs and Drug Addiction shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs.

2. The Agency and the European Drugs Agency shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs.

Or. en

Amendment 1387

István Ujhelyi

Proposal for a regulation

Article 111 – paragraph 1

Text proposed by the Commission

Amendment

The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union.

The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, including those that record adverse events including medication errors, processes and standards for medication safety, and implement digital technologies in healthcare settings, capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union.

Or. en

Amendment 1388

Tiemo Wölken

Proposal for a regulation

Article 111 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1389

Marian-Jean Marinescu

Proposal for a regulation

Article 111 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

To close gaps in the current EU pharmacovigilance policy and legislation tackling the downstream determinants of harm to better protect the health of European citizens from medication hazards in healthcare settings is required

Amendment 1390

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 111 – paragraph 1

Text proposed by the Commission

Amendment

The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, including those that record adverse reactions including medication errors, processes and standards for medication safety, and implement digital technologies, with a view to achieve high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union.

Or. en

Amendment 1391

Stelios Kympouropoulos, Pernille Weiss

Proposal for a regulation

Article 111 – paragraph 1

Text proposed by the Commission

Amendment

The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, and implement digital technologies in healthcare proceedings, capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union.

Or. en

Amendment 1392

Dolors Montserrat

Proposal for a regulation

Article 112 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Medicinal products subject to additional monitoring.

1.The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring.That list shall include the names and active substances of:

(a) medicinal products authorised in the Union that contain a new active substance which was not contained in any medicinal product authorised in the Union;

(b) any biological medicinal product not covered by point (a) that was authorised after [date of implementation];

(c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113;

(d) medicinal products authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (b) and (c) of Article 44(1), Article 45 or point (a) of the first subparagraph of Article 87(1) thereof.

At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in points (d), (e) or (g) of Article 12(4), point (b) of Article 20(1) or Article 46(2), may also be included in the list referred to in paragraph 1 of this Article.At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (a), (d), (e) or (f) of Article 44(1), point (b) of Article 87(1) or Article 100(2) thereof may also be included in the list referred to in paragraph 1 of this Article.

2.The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan.

5. The Agency, in cooperation with the competent authorities, shall develop and carry out awareness-raising campaigns on the promotion of information on medicinal products subject to additional monitoring. These campaigns shall aim to raise awareness among healthcare professionals, patients, consumers and the general public about the pharmacovigilance system and the additional monitoring of medicinal products.

Or. es

Justification

La modificación propuesta mantiene los requisitos relativos a los medicamentos sometidos a vigilancia adicional reflejados en el artículo 23 del Reglamento n.º 726/2004. También incluye la necesidad de mantener el triángulo negro invertido en consonancia con el Reglamento de Ejecución (UE) nº 198/2013 de la Comisión, de 7 de marzo de 2013, relativo a la selección de un símbolo a efectos de identificación de los medicamentos de uso humano sujetos a seguimiento adicional.La legislación revisada debe mantener el concepto de "seguimiento adicional", ya que puede ayudar a identificar mejor los posibles efectos secundarios de los medicamentos aprobados recientemente y a aplicar medidas de mitigación de riesgos. Asimismo, los prospectos deben incluir el símbolo del triángulo negro invertido, fácil de identificar y acompañado de una nota que explique el concepto de seguimiento adicional de forma sencilla pero al mismo tiempo suficientemente exhaustiva.En la enmienda se propone mantener el ámbito actual de los "medicamentos sometidos a un seguimiento adicional", ya que incluye las sustancias activas nuevas, los productos biológicos, los medicamentos aprobados mediante sistemas de acceso temprano y los medicamentos para los que existen obligaciones específicas de seguridad post comercialización.

Amendment 1393

Margarita de la Pisa Carrión

Proposal for a regulation

Article 112 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Medicinal products subject to additional surveillance

1.The Agency, in cooperation with the Member States, shall establish, maintain and make public a list of medicinal products subject to additional monitoring.

That list shall include the names and active substances of:

(a) medicinal products authorised in the Union containing a new active substance not contained in any medicinal product authorised in the Union;

(b) any biological medicinal product not referred to in point (a) authorised after [date of application];

(c) medicinal products authorised under this Regulation, under the conditions laid down in Article 12, paragraph 4, point f), Article 20, paragraph 1, point a), or Articles 18, 19, 30 or 113.

(d) medicinal products authorized under [Directive 2001/83/EC as revised] under the conditions referred to in Article 44, first paragraph b) and c) or in Article 45 or a) of the first paragraph of Article 87 thereof.

At the request of the Commission, after consulting the Pharmacovigilance Risk Assessment Committee, medicinal products authorized under this Regulation under the conditions referred to in Article 12, paragraph d), e) or g), Article 20.1 b) or 46.2 may also be included in the list referred to in paragraph 1 of this Article.At the request of a competent national authority, after consulting the Pharmacovigilance Risk Assessment Committee, medicinal products authorised under [Directive 2001/83/EC revised] under the conditions referred to in the first paragraph of Article 44 a), d) or f), in the first subparagraph of Article 87 b), or in paragraph 2 of Article 100, may also be included in the list referred to in paragraph 1 of this Article.

2.The list referred to in paragraph 1 shall include an electronic link to the product information and the summary of the risk management plan.

3.In the cases referred to in paragraphs a) and b) of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in paragraph 5 of Article 108 of [Revised Directive 2001/83/EC] In the cases referred to in points c) and d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been met.

4.For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement "This medicinal product is subject to additional monitoring".The declaration shall be preceded by an inverted black triangle and followed by a standard explanatory phrase.

Or. en

Amendment 1394

Tiemo Wölken

Proposal for a regulation

Article 112 a (new)

Text proposed by the Commission

Amendment

Article 112a

Medicines under additional monitoring

1. The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring.

That list shall include the names and active substances of:

(a) medicinal products authorised in the Union that contain a new active substance which was not contained in any medicinal product authorised in the Union;

(b) any biological medicinal product not covered by point

(a) that was authorised after [date of implementation];

(c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113.

(d) medicinal products that are authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (b) and (c) of the first paragraph of Article 44, Article 45, or point (a) of the first subparagraph of Article 87(1) thereof.

(e) medicinal products undergoing the safety-related referrals described in this Regulation and in [revised Directive 2001/83/EC].

At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to [revised Directive 2001/83/EC] subject to the conditions referred to in points (a), (d) or (f) of the first paragraph of Article 44, point (b) of the first subparagraph of Article 87 or Article 100(2) thereof, may also be included in the list referred to in paragraph 1 of this Article.

2. The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan.

In the cases referred to in points (c) and (d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled.

In the cases referred to in point (e) of paragraph 1 of this Article, the medicinal product shall remain in the list for the duration of the procedure, and thereafter depending on the outcome of the referral.

4. For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement ‘This medicinal product is subject to additional monitoring’. The statement shall be preceded by a symbol which shall be selected by the Commission, following a recommendation of the Pharmacovigilance Risk Assessment Committee, and shall be followed by a standardised explanatory sentence that is appropriate and easy to understand by users. The Commission and the Agency shall ensure that consumers and patients are consulted in this process.

Or. en

Amendment 1395

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 112 a (new)

Text proposed by the Commission

Amendment

Article 112a

Medicinal products subject to additional monitoring

1. The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. That list shall include the names and active substances of:

medicinal products authorised in the Union that contain a new active substance which, was not contained in any medicinal product authorised in the Union.

(b) any biological medicinal product not covered by point (a) that was authorised after [date of implementation];

(c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113;

At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (a), (d) or (f) of Article 44(1), point (b) of Article 87(1) or Article 100(2) thereof, may also be included in the list referred to in paragraph 1 of this Article. 2.

The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan.

3. In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 108(5) of [revised Directive 2001/83/EC]. In the cases referred to in points (c) and (d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled. 4. For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement ‘This medicinal product is subject to additional monitoring’.

That statement shall be preceded by an inverted black triangle and followed by a standardised explanatory sentence.

Or. fr

Justification

This article is equivalent to Article 23 of existing Regulation No 726/2004. Only paragraph (5) is new.

Amendment 1396

Tilly Metz

Proposal for a regulation

Chapter IX – title

Text proposed by the Commission

Amendment

IX REGULATORY SANDBOX

IX deleted

Or. en

Justification

As drafted it seems like a "carte blanche"; questionable if this is needed as we previously had ATMPs and other products marketed without this tool; in addition, Article 28 of the Directive could be used as an avenue to put non-traditional products on the market, hence sandboxes here are not needed

Amendment 1397

Tilly Metz

Proposal for a regulation

Article 113

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 1398

Maria Angela Danzì

Proposal for a regulation

Article 113 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;

(a) it is not possible to develop the medicinal product, even if medical devices or in-vitro diagnostic are used as combined products, or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;

Or. it

Justification

The regulatory sandboxes' scope of application must be as wide as possible so as to favour technological developments, including improvements to drug-device combination products.

Amendment 1399

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 113 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it is not possible to adequately develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;

Or. en

Amendment 1400

Tomislav Sokol

Proposal for a regulation

Article 113 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it is not possible to adequately develop the medicinal product or category of products in compliance with the requirements applicable to such medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;

Or. en

Amendment 1401

Fulvio Martusciello

Proposal for a regulation

Article 113 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1402

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 113 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it is not possible to satisfactorily develop the medicinal product or category of products in compliance with the requirements applicable to such products due to scientific or regulatory challenges arising from characteristics or methods related to the product;

Or. en

Amendment 1403

Peter Liese

Proposal for a regulation

Article 113 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it is not possible to effectively develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;

Or. en

Amendment 1404

Susana Solís Pérez, Catherine Amalric, Frédérique Ries

Proposal for a regulation

Article 113 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The creation of a regulatory sandbox is intended to fulfill the following objectives:

a) enabling competent authorities to offer advice to potential marketing authorization applicants to ensure adherence to this Regulation, or other pertinent EU legislation as applicable:

b) assisting prospective marketing authorization applicants in the experimentation and advancement of innovative medicinal products or product categories;

c) facilitating regulatory learning within a managed setting.

Or. en

Amendment 1405

Pernille Weiss

Proposal for a regulation

Article 113 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 or other relevant Union legislation under the conditions set out in Article 114. By [OP please insert the date = 12 months after the date of entering into force of this Regulation], the Commission shall make an assessment of other relevant Union legislation, and where appropriate draw up a list for which this Article shall apply.

Or. en

Amendment 1406

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 113 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 or other applicable Union legislation under the conditions set out in Article 114. By [OP please insert the date =18 months after the date of entering into force of this Regulation], the Commission shall draw up a list of applicable Union legislation for the application of this Article.

Or. en

Amendment 1407

Stelios Kympouropoulos

Proposal for a regulation

Article 113 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114, while balancing innovation in regulatory procedures with patient safety.

Or. en

Amendment 1408

Ondřej Knotek, Catherine Amalric, Billy Kelleher

Proposal for a regulation

Article 113 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114, while balancing patient safety and innovation in regulatory process.

Or. en

Amendment 1409

Tomislav Sokol

Proposal for a regulation

Article 113 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1410

Peter Liese

Proposal for a regulation

Article 113 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1411

Fulvio Martusciello

Proposal for a regulation

Article 113 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1412

Tomislav Sokol

Proposal for a regulation

Article 113 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall monitor the field of emerging medicinal products and shall request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and shall engage with them in preliminary discussions, where relevant by invoking the mechanism of consultation of Article 162. The Agency may set up consultation mechanism with other Union and non-Union regulatory agencies to facilitate its monitoring. The Agency shall draw up and regularly update a list of emerging medicinal or health products for which a regulatory sandbox may be established.

Or. en

Amendment 1413

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 113 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions. The Agency may establish a dialogue framework with regulatory bodies both within and outside the Union to aid in its oversight role. Additionally, the Agency is tasked with creating and routinely revising a roster of nascent medicinal or health products that could be considered for a regulatory sandbox environment.

Or. en

Amendment 1414

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 113 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall monitor the field of emerging medicinal products and shall request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and shall engage with them in preliminary discussions. The Agency may set up consultation mechanism with other Union and non-Union regulatory agencies to facilitate its monitoring. The Agency shall draw up and regularly update a list of emerging medicinal or health products for which a regulatory sandbox may be established.

Or. en

Amendment 1415

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 113 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1416

Fulvio Martusciello

Proposal for a regulation

Article 113 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1417

Stelios Kympouropoulos

Proposal for a regulation

Article 113 – paragraph 3

Text proposed by the Commission

Amendment

3. Taking into account HTA expertise, the Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions.

Or. en

Amendment 1418

Ondřej Knotek, Catherine Amalric, Billy Kelleher

Proposal for a regulation

Article 113 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1419

Stelios Kympouropoulos, Pernille Weiss

Proposal for a regulation

Article 113 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The regulatory sandbox may also cover the exploration and application of medical devices, in-vitro diagnostics, in silico methods, AI and machine learning technologies in the developement, manifacturing, quality control, and administration of medicinal products, as their use can significanlty add to the efficiency, safety, and effectiveness of the life cycle of medicinal products.

Or. en

Amendment 1420

Fulvio Martusciello

Proposal for a regulation

Article 113 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.

Where the Agency considers it appropriate to set up a regulatory sandbox for products which might be regulated as medicinal products (including advanced therapy medicinal products), medical devices, in-vitro diagnostics, substances of human origin, , it shall provide a recommendation to the Commission, where relevant after invoking the mechanism of consultation of Article 162. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.

Or. en

Amendment 1421

Tomislav Sokol

Proposal for a regulation

Article 113 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Where the Agency considers it appropriate to set up a regulatory sandbox for products which might be regulated as medicinal products (including advanced therapy medicinal products), medical devices, in-vitro diagnostics, substances of human origin, it shall provide a recommendation to the Commission, where relevant after invoking the mechanism of consultation of Article 162. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.

Or. en

Amendment 1422

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 113 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Where the Agency considers it appropriate to set up a regulatory sandbox for products, which might be regulated as medicinal products (including advanced therapy medicines), medical equipment, in-vitro diagnostics, substances of human origin, it shall provide a recommendation to the Commission, where appropriate after invoking the consultation mechanism of Article 162. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.

Or. en

Amendment 1423

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 113 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which may be classified as a medicinal product or other categories of products falling under the scope of legislation referred to in paragraph 1, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.

Or. en

Amendment 1424

Stelios Kympouropoulos

Proposal for a regulation

Article 113 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products (inlcuding ATMPs), or medical devices and other technologies, which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.

Or. en

Amendment 1425

Kateřina Konečná

Proposal for a regulation

Article 113 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Where the Committee on Human Medicinal Products considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.

Or. en

Amendment 1426

Pernille Weiss, Stelios Kympouropoulos

Proposal for a regulation

Article 113 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Where the Agency considers it appropriate to set up a regulatory sandbox for products which are likely to fall under the scope of this Regulation or other relevant Union legislation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.

Or. en

Amendment 1427

Peter Liese

Proposal for a regulation

Article 113 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products, medical devices and in-vitro diagnostics, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.

Or. en

Justification

The regulatory sandboxes are restricted to pharmaceuticals, yet today's innovative products often merge with medical devices, diagnostics, and digital tools, each under distinct regulations. An expanded scope will keep the sandbox relevant and effective in addressing the regulatory needs of these integrated solutions.

Amendment 1428

Pernille Weiss, Stelios Kympouropoulos

Proposal for a regulation

Article 113 – paragraph 5

Text proposed by the Commission

Amendment

5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.

5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations including, where relevant, with academia, HTA bodies, patients and their caregivers, healthcare professionals, sponsors, or developers. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other relevant Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.

Or. en

Amendment 1429

Stelios Kympouropoulos

Proposal for a regulation

Article 113 – paragraph 5

Text proposed by the Commission

Amendment

5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations, by where relevant, HTA bodies, healthcare professionals, patients and their caregivers, and other relevant stakeholders. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.

Or. en

Amendment 1430

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 113 – paragraph 5

Text proposed by the Commission

Amendment

5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations, including, where relevant, of HTA bodies, patients and their caregivers, clinicians, sponsors, developers and academia. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.

Or. en

Amendment 1431

Susana Solís Pérez, Catherine Amalric, Ondřej Knotek

Proposal for a regulation

Article 113 – paragraph 5

Text proposed by the Commission

Amendment

5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations including, where relevant, HTA bodies, patients and their caregivers, clinicians, sponsors, developers and academia . The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.

Or. en

Amendment 1432

Fulvio Martusciello

Proposal for a regulation

Article 113 – paragraph 5

Text proposed by the Commission

Amendment

5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] , Regulation (EC) 1394/2007 and other applicable Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.

Or. en

Amendment 1433

Peter Liese

Proposal for a regulation

Article 113 – paragraph 5

Text proposed by the Commission

Amendment

5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other applicable Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.

Or. en

Amendment 1434

Tomislav Sokol

Proposal for a regulation

Article 113 – paragraph 5

Text proposed by the Commission

Amendment

5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other applicable Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.

Or. en

Amendment 1435

Kateřina Konečná

Proposal for a regulation

Article 113 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall, by means of implementing acts, take a decision on the set up of a regulatory sandbox taking into account the recommendation of the Agency and the sandbox plan pursuant to paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

6. The Commission shall, by means of delegated acts, take a decision on the set up of a regulatory sandbox taking into account the recommendation of the Agency and the sandbox plan pursuant to paragraph 4. Those delegated acts shall be adopted in accordance with the examination procedure referred to in Article 175.

Or. en

Amendment 1436

Fulvio Martusciello

Proposal for a regulation

Article 113 – paragraph 7 – point c

Text proposed by the Commission

Amendment

(c) include as part of the sandbox plan the requirements of this Regulation and of [revised Directive 2001/83/EC] that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment.

(c) include as part of the sandbox plan the requirements of this Regulation of [revised Directive 2001/83/EC], of Regulation (EC) 1394/2007 and of other applicable Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment.

Or. en

Amendment 1437

Tomislav Sokol

Proposal for a regulation

Article 113 – paragraph 7 – point c

Text proposed by the Commission

Amendment

(c) include as part of the sandbox plan the requirements of this Regulation, [revised Directive 2001/83/EC], of Regulation (EC) 1394/2007 and of other applicable Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment.

Or. en

Amendment 1438

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 113 – paragraph 7 – point c

Text proposed by the Commission

Amendment

(c) include as part of the sandbox plan the requirements of this Regulation, and of [revised Directive 2001/83/EC], and other applicable Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment.

Or. en

Amendment 1439

Peter Liese

Proposal for a regulation

Article 113 – paragraph 7 – point c

Text proposed by the Commission

Amendment

(c) include as part of the sandbox plan the requirements of this Regulation, of [revised Directive 2001/83/EC] and other applicable Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment.

Or. en

Amendment 1440

Pernille Weiss, Stelios Kympouropoulos

Proposal for a regulation

Article 113 – paragraph 7 – point c

Text proposed by the Commission

Amendment

(c) include as part of the sandbox plan the requirements of this Regulation, of [revised Directive 2001/83/EC] or of other relevant Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment.

Or. en

Amendment 1441

Kateřina Konečná

Proposal for a regulation

Article 113 – paragraph 8 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission may, by means of implementing acts, suspend or revoke a regulatory sandbox at any time. in any of the following cases:

The Commission may, by means of delegated acts, suspend or revoke a regulatory sandbox at any time. in any of the following cases:

Or. en

Amendment 1442

Stanislav Polčák

Proposal for a regulation

Article 113 – paragraph 8 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) it is appropriate to protect public health.

(b) it is appropriate to protect public health or the environment.

Or. cs

Amendment 1443

Kateřina Konečná

Proposal for a regulation

Article 113 – paragraph 8 – subparagraph 2

Text proposed by the Commission

Amendment

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Those delegated acts shall be adopted in accordance with the examination procedure referred to in Article 175.

Or. en

Amendment 1444

Fulvio Martusciello

Proposal for a regulation

Article 113 – paragraph 9

Text proposed by the Commission

Amendment

9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoption of supplementary conditions, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by adapting the applicable requirements and conditions laid down in paragraphs 6 and 7, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Or. en

Amendment 1445

Tomislav Sokol

Proposal for a regulation

Article 113 – paragraph 9

Text proposed by the Commission

Amendment

Or. en

Amendment 1446

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 113 – paragraph 9

Text proposed by the Commission

Amendment

9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated adapting the relevant requirements and conditions set out in paragraphs 6 and 7, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Or. en

Amendment 1447

Kateřina Konečná

Proposal for a regulation

Article 113 – paragraph 9

Text proposed by the Commission

Amendment

9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoption of supplementary conditions, the Commission may, after consultation of the Agency, amend its decision by means of delegated acts. The Commission may also prolong the duration of a regulatory sandbox by means of delegated acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 175.

Or. en

Amendment 1448

Kateřina Konečná

Proposal for a regulation

Article 113 – paragraph 10

Text proposed by the Commission

Amendment

10. This Article shall not exclude the setting up of time limited pilot projects to test different ways of implementing the applicable legislation.

10. This Article shall not exclude the setting up of time limited pilot projects to test different ways of implementing the applicable legislation through delegated acts.

Or. en

Amendment 1449

Tilly Metz

Proposal for a regulation

Article 114

Text proposed by the Commission

Amendment

Article 114

deleted

Products developed under a sandbox

1. When authorising a clinical trial application for products covered by a regulatory sandbox, Member States shall take the sandbox plan referred to in Article 113(1) into consideration.

2. A medicinal product developed as part of a regulatory sandbox may be placed on the market only when authorised in accordance with this Regulation. The initial validity of such authorisation shall not exceed the duration of the regulatory sandbox. The authorisation may be prolonged at the request of the marketing authorisation holder.

3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.

4. For medicinal products developed as part of a regulatory sandbox for which a marketing authorisation has been granted in accordance with paragraph 2 and where appropriate paragraph 3, the summary of product characteristics and the package leaflet shall indicate that the medicinal product has been developed as part of a regulatory sandbox.

5. Without prejudice to Article 195 of [revised Directive 2001/83/EC], the Commission shall suspend a marketing authorisation granted in accordance with paragraph 2, where the regulatory sandbox has been suspended or revoked in accordance with Article 113(7).

6. The Commission shall immediately vary the marketing authorisation to take account of the mitigation measures taken in accordance with Article 115.

Or. en

Amendment 1450

Kateřina Konečná

Proposal for a regulation

Article 114 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1451

Fulvio Martusciello

Proposal for a regulation

Article 114 – paragraph 3

Text proposed by the Commission

Amendment

3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and of other applicable Union legislation. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.

Or. en

Amendment 1452

Tomislav Sokol

Proposal for a regulation

Article 114 – paragraph 3

Text proposed by the Commission

Amendment

3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation,[revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and of other applicable Union legislation. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.

Or. en

Amendment 1453

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 114 – paragraph 3

Text proposed by the Commission

Amendment

3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other relevant Union legislation . These derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.

Or. en

Amendment 1454

Peter Liese

Proposal for a regulation

Article 114 – paragraph 3

Text proposed by the Commission

Amendment

3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation, [revised Directive 2001/83/EC] and other applicable Union legislation . Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.

Or. en

Amendment 1455

Anders Vistisen

on behalf of the ID Group

Proposal for a regulation

Article 114 – paragraph 3

Text proposed by the Commission

Amendment

3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC], and Regulation (EC) 1394/2007. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.

Or. en

Amendment 1456

Tilly Metz

Proposal for a regulation

Article 115

Text proposed by the Commission

Amendment

Article 115

deleted

General sandbox provisions

The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2).

Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without delay until an effective mitigation takes place.

2. Participants in the regulatory sandbox, in particular the marketing authorisation holder of the medicinal product concerned, shall remain liable under applicable Union and Member States liability legislation for any harm inflicted on third parties as a result from the testing taking place in the sandbox. They shall inform the Agency without undue delay of any information which might entail the amendment of the regulatory sandbox or concerns the quality, safety or efficacy of products developed as part of a regulatory sandbox.

3. The modalities and the conditions of the operation of the regulatory sandboxes, including the eligibility criteria and the procedure for the application, selection, participation and exiting from the sandbox, and the rights and obligations of the participants shall be set out in implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

4. The Agency with input from Member States shall submit annual reports to the Commission on the results from the implementation of a regulatory sandbox, including good practices, lessons learnt and recommendations on their setup and, where relevant, on the application of this Regulation and other Union legal acts supervised within the sandbox. These reports shall be made publicly available by the Commission.

5. The Commission shall review the reports and put forward, as appropriate, legislative proposals with a view to update the regulatory framework referred to in Article 113(2) or delegated acts in accordance with Article 28 of [revised Directive 2001/83/EC].

Or. en

Amendment 1457

Sirpa Pietikäinen

Proposal for a regulation

Article 115 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or environment or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2).

Or. en

Amendment 1458

Tomislav Sokol

Proposal for a regulation

Article 115 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to stop or restrict their use and inform the Commission in accordance with Article 113(2).

Or. en

Amendment 1459

Fulvio Martusciello

Proposal for a regulation

Article 115 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to stop or restrict their use and inform the Commission in accordance with Article 113(2).

Or. en

Amendment 1460

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 115 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to end or restrict their use and inform the Commission in accordance with Article 113(2).

Or. en

Amendment 1461

Tomislav Sokol

Proposal for a regulation

Article 115 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without delay until an effective mitigation takes place.

Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without any delay until an effective mitigation takes place.

Or. en

Amendment 1462

Fulvio Martusciello

Proposal for a regulation

Article 115 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without delay until an effective mitigation takes place.

Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without any delay until an effective mitigation takes place.

Or. en

Amendment 1463

Marian-Jean Marinescu

Proposal for a regulation

Article 116 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The marketing authorisation holder of a medicinal product in possession of a centralised marketing authorisation or a national marketing authorisation (‘the marketing authorisation holder’) shall notify the competent authority of the Member State where the medicinal product has been placed on the market and, in addition, the Agency for a medicinal product covered by a centralised marketing authorisation (these are referred to in this Chapter as ‘the competent authority concerned’) of the following:

1. The marketing authorisation holder of a medicinal product in possession of a centralised marketing authorisation or a national marketing authorisation (‘the marketing authorisation holder’) shall notify and explain the reasons for the competent authority of the Member State where the medicinal product has been placed on the market and, in addition, the Agency for a medicinal product covered by a centralised marketing authorisation (these are referred to in this Chapter as ‘the competent authority concerned’) of the following:

Or. en

Justification

Prevention of lack of access to medicines

Amendment 1464

István Ujhelyi

Proposal for a regulation

Article 116 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than twelve months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;

(a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than four months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;

Or. en

Amendment 1465

Dolors Montserrat

Proposal for a regulation

Article 116 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than six months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;

Or. en

Amendment 1466

Andrey Slabakov, Elisabetta De Blasis

Proposal for a regulation

Article 116 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1467

István Ujhelyi

Proposal for a regulation

Article 116 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than twelve months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;

(b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than four months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;

Or. en

Amendment 1468

Andrey Slabakov, Elisabetta De Blasis

Proposal for a regulation

Article 116 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than six months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;

Or. en

Amendment 1469

Dolors Montserrat

Proposal for a regulation

Article 116 – paragraph 1 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1470

Andrey Slabakov

Proposal for a regulation

Article 116 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than six months before the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;

(c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than three months before, and in all cases at the earliest possible time, the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder, unless such suspension is triggered by a relevant competent authority;

Or. en

Amendment 1471

István Ujhelyi

Proposal for a regulation

Article 116 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than two months before the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;

Or. en

Amendment 1472

Dolors Montserrat

Proposal for a regulation

Article 116 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 1473

Andrey Slabakov

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1474

Andreas Glück

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder immediately as soon as they become aware of such temporary disruption which may include substantial concerns about the possibility of a temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

Or. en

Justification

Most shortages would be preventable six months ahead. Marketing authorisation holders should report the a shortage as soon as they become aware of it which may include alerts in the case of substantial concerns regarding the possible disruption in supply.

Amendment 1475

Dolors Montserrat

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than two months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption. The temporary disruption in supply of a medicinal product for which another pack size of that same product is available shall not need to be notified. The Agency shall make available the information to the concerned Member State, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

Or. en

Amendment 1476

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than two months before the start of such temporary disruption of supply, four months if the medicinal product is on the Union list of critical medicinal products established by Article 131 or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

Or. fr

Amendment 1477

István Ujhelyi

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

Or. en

Amendment 1478

Margarita de la Pisa Carrión

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

Or. en

Amendment 1479

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

Or. en

Amendment 1480

Fulvio Martusciello

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

Or. en

Amendment 1481

Tomislav Sokol, Pernille Weiss

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

Or. en

Amendment 1482

Stelios Kympouropoulos

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

Or. en

Amendment 1483

Maria Angela Danzì

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder and of the public authorities no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

Or. it

Justification

Pharmaceutical companies' demand forecasts should not be the only warning sign of an expected shortage. Often, pharmaceutical companies use internal forecasts to show that they are ready to change demand. It is a fact that nobody can check such internal documents and determine their quality.

Amendment 1484

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected and forecasted duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

Or. en

Amendment 1485

Kateřina Konečná

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) a temporary disruption in supply of a medicinal product in a given Member State based on the demand forecast of the marketing authorisation holder and, where available, of national competent authorities in the Union, no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

Or. en

Amendment 1486

Tilly Metz

Proposal for a regulation

Article 116 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) a temporary disruption in supply of a medicinal product in a given Member State, based on the demand forecast of the marketing authorisation holder and public authorities, where available, no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

Or. en

Amendment 1487

Andrey Slabakov, Elisabetta De Blasis

Proposal for a regulation

Article 116 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The marketing authorisation holder of a medicinal product in possession of a centralised marketing or a national marketing authorisation shall notify the Agency of a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than three months before the start of such temporary disruption of supply or, if this is not possible, as soon as they become aware of such temporary disruption.The temporary disruption in supply of a medicinal product for which another pack size of that same product is available shall not need to be notified.

The Agency shall make available the information to the concerned Member States to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

Or. en

Amendment 1488

Frédérique Ries

Proposal for a regulation

Article 116 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission is empowered to adopt delegated acts, in accordance with Article 175 in order to amend Annex IV as regards the information to be provided in case of a temporary disruption of supply, information to be provided in case of a suspension or cessation of marketing of a medicinal product or withdrawal of the marketing authorisation of a medicinal product, or the content of the shortage prevention plan referred to in Article 117.

3. The Commission is empowered to adopt delegated acts, after consultation with marketing authorisation holders and other relevant stakeholders, and in accordance with Article 175 in order to amend Annex IV as regards the information to be provided in case of a temporary disruption of supply, information to be provided in case of a suspension or cessation of marketing of a medicinal product or withdrawal of the marketing authorisation of a medicinal product, or the content of the shortage prevention plan referred to in Article 117.

Or. en

Amendment 1489

Kateřina Konečná

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

The marketing authorisation holder shall submit the prevention plan of a critical medicinal product with the concerned competent authority, following paragraph 9 of Article 127. In addition, and following the provisions of paragraph 1 of Article 132, the prevention plans of those medicinal products included in the Union list of critical medicinal products shall be shared with the Agency. The marketing authorisation holder shall comply with any binding recommendations issued by the competent authority of the Member State and by the MSSG, and take in due consideration any other recommendation.

Or. en

Amendment 1490

Margarita de la Pisa Carrión

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1491

Tomislav Sokol, Pernille Weiss

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the Union list of critical medicinal products referred to in Article 131. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by determining medicinal products for which a shortage prevention plan shall be maintained and kept up to date, including due to the lack of availability of alternatives. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Or. en