Sittings · Document

DRAFT OPINION (COM(2025)0102 – C100048/2025 – 2025/0102(COD)) 2025-09-03

On the proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795

Committee on the Internal Market and Consumer Protection · Rapporteur: Marion Walsmann

PA_Legam

SHORT JUSTIFICATION

The Critical Medicines Act is an important step towards ensuring the availability and security of critical medicinal products and other medicinal products of common interest throughout the EU. Its objectives are ambitious yet essential: ensuring timely access for patients, enhancing the resilience of supply chains, and reducing vulnerabilities in the European pharmaceutical system.

Against this background, the rapporteur welcomes the Commission's proposal as a solid and pragmatic foundation. However, further targeted improvements are necessary to ensure that the Regulation can deliver on its objectives and be implemented effectively. The proposed amendments in this opinion focus on four key priorities to reinforce resilience, improve coherence, and strengthen legal certainty.

A first priority is the reform of procurement practices. The current framework places excessive emphasis on the lowest price, which undermines resilience and availability. To safeguard equal and timely access for patients throughout the Union, procurement procedures must prioritise security of supply, stability of deliveries and fair competition. However, flexibility is also crucial: multi-winner procedures can reduce dependency on single suppliers, and carefully designed exemptions are necessary in specific market segments, such as orphan medicines, where diversification is not feasible.

The second area of focus is strengthening joint procurement initiatives at the Union level. These mechanisms are particularly beneficial for smaller Member States, embodying the principle of solidarity within the internal market. However, to ensure they provide genuine added value, the provisions must be streamlined to avoid duplication and ensure they are coherent with existing tools.

The third objective is to clarify the role of sustainability criteria in procurement. While environmental and social considerations are important in many policy areas, they must not conflict with this Regulation's primary aim of safeguarding the security of supply of critical medicinal products. The inconsistent application of such criteria could unintentionally restrict availability. Therefore, a systematic assessment of possible interactions is required to ensure that sustainability goals complement, rather than undermine, resilience.

Finally, the rapporteur supports the establishment of a European preference system, as proposed by the Commission. This instrument must be carefully designed to remain compatible with international obligations and avoid protectionist tendencies. A flexible, incentive-based approach is essential to strengthen European production capacities while maintaining WTO compliance.

Taken together, the proposed changes enhance the Commission's proposal in a balanced way. They provide a more resilient and secure supply of critical medicines, ensure clearer and more coherent rules, and support the successful implementation of the Critical Medicines Act, benefiting patients across Europe.

AMENDMENT

The Committee on the Internal Market and Consumer Protection submits the following to the Committee on Public Health, as the committee responsible:

Amendment 1

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) To avoid unnecessary delays and the creation of additional administrative layers, the verification of whether a project fulfils the strategic project criteria should be performed by any Member State authority requested to provide advantages offered in this Regulation. A designated authority should, when solicited, verify whether a given project is a strategic project. In order to accelerate and facilitate their deployment, strategic projects should benefit from streamlined administrative processes, priority status in the context of permit granting procedures and related dispute resolution procedures, as well as, be offered targeted regulatory support. In this context, the Member States should give particular attention to small and medium sized enterprises (SMEs) which should have a fair chance to initiate strategic projects.

(18) To avoid unnecessary delays and the creation of additional administrative layers, the verification of whether a project fulfils the strategic project criteria should be performed by any Member State authority requested to provide advantages offered in this Regulation. A designated authority should, when solicited, verify whether a given project is a strategic project. In order to accelerate and facilitate their deployment, strategic projects should benefit from streamlined administrative processes, priority status in the context of permit granting procedures and related dispute resolution procedures, as well as, be offered targeted regulatory support. In this context, the Member States should give particular attention to small and medium sized enterprises (SMEs) as well as small mid-cap enterprises as defined in Commission Recommendation (EU) 2025/1099, which should have a fair chance to initiate strategic projects.

Or. en

Justification

In the pharmaceutical industry in particular, mid-caps often play a key role in drug production, especially for generic preparations and supply-relevant active ingredients. These companies are typically not only not part of large group structures, but also lack the administrative resources of large pharmaceutical companies to handle complex regulatory requirements completely independently.

Amendment 2

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include stockholding obligations, efficient and effective monitoring of supply chains for potential supply bottlenecks, their transparency to the contracting authority, contract performance clauses on timely delivery and measures in case of non-timely delivery or the number of diversified suppliers. Supply chain structures vary significantly between market segments. While supplier diversification is often feasible for widely used generics, niche medicines, complex biopharmaceuticals or critical medicinal products with low sales, including so-called orphan medicinal products, might have only one or two manufacturers worldwide. In such cases, rigid diversification requirements risk undermining supply. Procurement obligations should therefore be applied proportionately and adapted to the specific market conditions. Where diversification of supply chains is de facto not possible or not economically feasible, targeted exemptions from certain award criteria may be granted. At the same time, alternative measures such as stockpiling or reinforced risk management plans could help to ensure the continued availability of these medicinal products.

Or. en

Justification

The application of supply chain diversification as an award criterion, as set out in Article 18 (1) of this Regulation, must reflect market realities. In specific cases, such as those involving low-demand critical medicines or orphan drugs, diversification is often not feasible. Requiring more than a single qualified supplier could be disproportionate and may even lead to market withdrawal. This is why the possibility of targeted exemptions may be essential to safeguard supply and ensure practical feasibility.

Amendment 3

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) To ensure a high level of health protection and security of supply, it is necessary to procure in a way that promotes diversification of suppliers where dependency on a single or a limited number of third countries, threatening the security of supply, has been established through a vulnerability evaluation. In such situations, contracting authorities in the Member States should introduce procurement requirements that favour suppliers of critical medicinal products that manufacture a significant portion of these products in the EU. Moreover, the contracting authorities in the Member States, when justified by market analysis and public health considerations, may apply procurement requirements that favour suppliers of medicinal products of common interest that manufacture a significant portion of these medicinal products in the EU. These measures should be designed and applied in line with the Union's international obligations including the principles of non-discrimination and proportionality. To safeguard the Union’s strategic autonomy and reduce critical dependencies, a significant proportion of the production of critical medicinal products, medicinal products of common interest, or their active pharmaceutical ingredients intended for the Union market should be located within the Union, as defined in this Regulation. While trusted international cooperation and strategic partnerships remain important, ensuring resilience and security of supply means that production capacity needs to meet that threshold on Union territory. The assessment of whether this threshold is met should be carried out by the Commission or, where appropriate, by the competent authorities of the Member States, taking into account product-specific characteristics, market conditions, and risk-related considerations. This approach will ensure that the Union retains the capacity to respond effectively to public health needs and future crises.

Or. en

Amendment 4

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

(35) To ensure that the collaborative procurement initiatives contribute to the achievement of the objectives of this Regulation, while fully respecting the principle of subsidiarity, the Commission’s involvement in joint procurement and procurement on behalf, or in the name of the Member States, should be limited to defined cases. For this reason the Commission should assess the proportionality of any collaborative procurement request, taking into account factors such as the necessity and scale of the procurement, the ability of Member States to act individually or collectively, and the potential impact on the internal market, and derogations from Article 168 (2) and (3) of Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council12 should be provided.

__________________

12 Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union (OJ L, 2024/2509, 26.9.2024, ELI: http://data.europa.eu/eli/reg/2024/2509/oj).

Or. en

Amendment 5

Proposal for a regulation

Recital 37 a (new)

Text proposed by the Commission

Amendment

(37a) Ensuring a reliable supply of critical medicinal products requires coherent coordination between pharmaceutical policy and Union policies on environmental protection and climate change. To identify and mitigate potential conflicts of interest early on, the Critical Medicines Coordination Group should also assess the impact of existing and forthcoming environmental policy regulations on the availability of medicinal products and submit corresponding recommendations to the Commission.

Or. en

Justification

The coordination group should be empowered to recognise potential interactions between environmental and climate protection measures, and the supply of medicinal products, at an early stage. Increasing regulatory pressure, for instance through industry emissions regulations or sustainability reporting requirements, can have unintended consequences for the production and supply of medicinal products, as well as their availability. A systematic assessment of these impacts is essential to ensure security of supply and system resilience.

Amendment 6

Proposal for a regulation

Article 3 – paragraph 1 – point 18 a (new)

Text proposed by the Commission

Amendment

(18a) 'significant proportion' means that the Commission or, where appropriate, the competent authority of the Member States concerned, has assessed that at least 25% of the annual production volume of a critical medicinal product, a medicinal product of common interest, or their active pharmaceutical ingredient (API), intended for the Union market, is manufactured within the Union , taking into account product-specific characteristics, market conditions, and risk-related considerations.

Or. en

Justification

Including a clear definition of “significant proportion” would strengthen the Regulation by providing legal certainty and ensuring a resilient supply of critical medicinal products. Setting the threshold at 25% strikes a balanced compromise: it is high enough to incentivise meaningful production within the Union and reduce external dependencies, yet not so high as to impose disproportionate burdens on manufacturers or risk shortages. This level thus safeguards both supply security and market availability while remaining realistic and achievable for the industry.

Amendment 7

Proposal for a regulation

Article 18 – paragraph 1

Text proposed by the Commission

Amendment

1. For award procedures of critical medicinal products falling within the scope of Directive 2014/24/EU of the European Parliament and of the Council, contracting authorities in the Member States shall apply procurement requirements other than price-only award criteria such as procurement requirements that promote the resilience of supply in the Union. Where appropriate, contracting authorities may apply multi-winner procurements. The procurement requirements shall be defined in accordance with Directive 2014/24/EU and may relate to stockholding obligations, monitoring of supply chains for potential supply bottlenecks, their transparency upon request of the contracting authority and, subject to safeguarding the confidentiality of trade secrets, contract performance clauses on timely delivery or the number of diversified suppliers. In particular with regard to supplier diversification, procurement requirements shall be proportionate and adapted to the specific characteristics of the relevant market segment. Where diversification of supply chains is not technically possible or not economically feasible, targeted exemptions from certain criteria may be granted, so as not to jeopardise the availability of critical medicinal products on the market.

Or. en

Justification

Multi-winner procurements can ensure the security of the supply of critical medicinal products by reducing dependency on a single supplier and lowering the risk of shortages. They can also foster competition while maintaining resilience. Furthermore, in accordance with Article 18(1) CMA, the possible consideration of supply chain diversification as an award criterion should be carried out in a differentiated manner with regard to different market conditions. In specific segments, such as those involving critical medicinal products in low demand or so-called “orphan drugs”, actual diversification is often not feasible. In these cases, the contractual obligation of a single qualified provider can pose a challenge in itself. Such an obligation could be disproportionate and have counterproductive effects, such as market withdrawals. Therefore, targeted exemptions are necessary in order to avoid jeopardising the supply of such products and to take account of the practical realities of supply.

Amendment 8

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

2. Contracting authorities shall apply procurement requirements for critical medicinal products that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union, in order to ensure security of supply, and, when feasible, shall apply multi-winner procurements. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Justification

In order to achieve the objectives of this regulation, it is crucial to promote and strengthen the production of critical medicinal products within the European Union while adhering to the Union’s international obligations. In this context, ensuring supply security must be a central priority. Therefore, the criteria should apply to all products within the CMA’s remit, not just particularly vulnerable medicinal products with a high dependency on third countries, in order to prevent them from becoming vulnerable in the first place. With this in mind, strong preference should be given to suppliers that manufacture a significant proportion of all products within the CMA’s remit within the EU, thereby safeguarding the highest possible level of supply security.

Amendment 9

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities may apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

3. With regard to medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities shall apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 10

Proposal for a regulation

Article 18 – paragraph 4

Text proposed by the Commission

Amendment

4. This Article shall not preclude contracting authorities from using additional qualitative requirements, including in relation to environmental sustainability and social rights.

4. This Article shall not preclude contracting authorities from using additional qualitative requirements that aim to contribute to improving supply chain security and the availability of critical medicinal products or medicinal products of common interest.

Or. en

Justification

The application of qualitative requirements in relation to environmental sustainability and social rights by contracting authorities, does not help to achieve the overarching goal of a strengthened security of supply and availability of critical medicinal products or medicinal products of common interest within the Union as set out in Article 1 (1) of this regulation.

Amendment 11

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3, on the basis of a market analysis or where they can demonstrate that the application of these provisions would lead to a disproportionately high price in the procurement concerned. This derogation shall be clearly justified in writing and specify the circumstances relied upon. It may be subject to ex-post review by the supervisory authority designated by the Member State.

Or. en

Justification

In exceptional cases, it may be necessary to derogate from the designated criteria if their strict application would place an excessive burden on those responsible for procurement or prevent potential bidders from participating. However, exemptions should only be granted in exceptional circumstances and must allow for review by the relevant authorities.

Amendment 12

Proposal for a regulation

Article 22 – title

Text proposed by the Commission

Amendment

Commission procurement on behalf of or in the name of Member States

deleted

Or. en

Justification

Merged with Article 23.

Amendment 13

Proposal for a regulation

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where nine or more Member States jointly request the Commission to procure on their behalf, or in their name, the Commission may initiate a procurement procedure under the conditions set out in this Article when the procurement relates to medicinal products belonging to one of the following categories below;

deleted

(a) critical medicinal products for which a vulnerability evaluation has identified a vulnerability in the supply chains or for which the MSSG has recommended a common procurement initiative;

(b) medicinal products of common interest, for which a joint clinical assessment report has been published pursuant to Article 12(4) Regulation (EU) 2021/2282 of the European Parliament and the Council29 , or which have undergone a clinical assessment carried out under the voluntary cooperation among Member States as per Article 23(1) point (e) of that Regulation.

__________________

29 Regulation (EU) 2021/2282 of the European Parliament and the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, ELI: http://data.europa.eu/eli/reg/2021/2282/oj)

Or. en

Amendment 14

Proposal for a regulation

Article 22 – paragraph 2

Text proposed by the Commission

Amendment

2. The joint request referred to in paragraph 1 shall only be made where the medicinal product concerned fulfils one of the criteria set out in that paragraph and if the requested procurement procedure will help to improve the security of supply and availability of critical medicinal products in the Union or ensure the availability and accessibility of medicinal products of common interest, as applicable.

deleted

Or. en

Amendment 15

Proposal for a regulation

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

3. The participation in the procurement procedure shall be open to all Member States. The Commission shall inform all Member States of the request, through the Critical Medicines Group, and invite them to join the procedure.

deleted

Or. en

Amendment 16

Proposal for a regulation

Article 22 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall assess the utility, necessity and proportionality of the request and whether the request is justified in light of the objectives of this Regulation. The Commission shall in particular verify whether the procurement could constitute discrimination or restriction to trade or a distortion to competition.

deleted

Or. en

Amendment 17

Proposal for a regulation

Article 22 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission shall inform the interested Member States within one month of the request of its decision and state its reasons in case of a refusal.

deleted

Or. en

Amendment 18

Proposal for a regulation

Article 22 – paragraph 6

Text proposed by the Commission

Amendment

6. If in light of the Commission assessment, it is necessary, in order to achieve the objectives of this Regulation, to conduct the procurement as exclusive for the Member States or to agree to minimum binding quantities, the Commission agreement to pursue the procedure may be conditioned upon acceptance of these conditions by interested Member States.

deleted

Or. en

Amendment 19

Proposal for a regulation

Article 22 – paragraph 7

Text proposed by the Commission

Amendment

7. Except for the derogations provided for in this Regulation, the procurement referred to in this Article shall be carried out in accordance with Article 168 (3) of Regulation (EU, Euratom) 2024/250930 .

deleted

__________________

30 Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union (recast) (OJ L, 26.9.2024, p. 1, ELI: http://data.europa.eu/eli/reg/2024/2509/oj).

Or. en

Amendment 20

Proposal for a regulation

Article 23 – title

Text proposed by the Commission

Amendment

Joint Procurement

Joint Procurement and procurement on behalf of Member States

Or. en

Justification

Some of the objectives of Article 22 and 23, as defined in the Commission proposal, seem to overlap and their respective scope is unclear. To be more coherent and improve legal certainty, it seems necessary to merge them in an expedient way.

Amendment 21

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

1. Under conditions laid down in this Article and by way of derogation from Article 168(2) of Regulation (EU, Euratom) 2024/2509, if a contract is necessary for the implementation of the joint action between the Commission and Member States, the Commission and at least nine Member States may engage, as contracting parties, in a joint procurement procedure.

1. Under the conditions laid down in this Article and by way of derogation from Article 168(2) and (3) of Regulation (EU, Euratom) 2024/2509, if a contract is necessary for the implementation of the joint action between the Commission and Member States, the Commission and at least nine Member States may engage, as contracting parties, in a joint procurement procedure, or the Commission may procure, on behalf of, or in the name of Member States, in accordance with paragraphs 2 to 8 of this Article.

Or. en

Amendment 22

Proposal for a regulation

Article 23 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. A joint procurement procedure may be organised following a request by the Member States or at the Commission’s initiative when the procurement relates to medicinal products belonging to one of the categories below:

2. A procurement procedure referred to in paragraph 1 may be organised following a request by the Member States or at the Commission’s initiative, provided that, when the procurement relates to medicinal products belonging to one of the categories below:

Or. en

Amendment 23

Proposal for a regulation

Article 23 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) medicinal products of common interest, for which a joint clinical assessment report has been published pursuant to Article 12(4) Regulation (EU) 2021/2282 of the European Parliament and the Council31 , or which have undergone a clinical assessment carried out under the voluntary cooperation among Member States as per Article 23(1) point (e) of that Regulation.

(b) medicinal products of common interest, for which a joint clinical assessment report has been published pursuant to Article 12(4) of Regulation (EU) 2021/2282 of the European Parliament and the Council31 , or which have undergone a clinical assessment carried out under the voluntary cooperation among Member States as per Article 23(1) point (e) of that Regulation.

__________________

31 Regulation (EU) 2021/2282 of the European Parliament and the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, ELI: http://data.europa.eu/eli/reg/2021/2282/oj)

Or. en

Amendment 24

Proposal for a regulation

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission may decide to conduct the joint procurement procedure if the procurement procedure helps to improve the security of supply and availability of critical medicinal products in the Union or ensure the availability and accessibility of medicinal products of common interest, as applicable.

3. The Commission may only launch the procurement procedure referred to in paragraph 1 if it assesses that the procedure demonstrably contributes to improving the security of supply and availability of critical medicinal products in the Union or ensuring the availability and accessibility of medicinal products of common interest, as applicable. This assessment shall be based on objective criteria, including market conditions, risk assessments, and product-specific characteristics.

Or. en

Amendment 25

Proposal for a regulation

Article 23 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission shall assess the necessity of a joint action and whether the request is justified in light of the objectives of this Regulation. The Commission shall in particular verify whether the procurement could constitute discrimination or restriction to trade or a distortion to competition.

5. The Commission shall assess the utility, necessity and proportionality of the procurement procedure referred to in paragraph 1 and whether it is justified in light of the objectives of this Regulation. The Commission shall in particular verify whether the procurement could constitute discrimination or restriction to trade or a distortion to competition.

Or. en

Amendment 26

Proposal for a regulation

Article 23 – paragraph 6

Text proposed by the Commission

Amendment

6. If, in light of the Commission assessments referred to in paragraphs 3 and 5, it is necessary, in order to achieve the objectives of this Regulation, the procurement procedure may be conditioned upon interested Member States accepting specific requirements, including conducting the procurement as exclusive to those Member States or agreeing to minimum binding quantities.

Or. en

Amendment 27

Proposal for a regulation

Article 23 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7a. The Commission shall ensure that any procurement procedure under this Article applies, to the greatest extent possible, the award criteria and requirements referred to in Article 18(1) to (4), in order to promote supply chain resilience, availability, and diversification.

Or. en

Amendment 28

Proposal for a regulation

Article 23 – paragraph 8

Text proposed by the Commission

Amendment

8. Except for the derogations provided for in this Regulation, the joint procurement procedure shall be carried out by the Commission in accordance with Article 168 (2) of Regulation (EU, Euratom) 2024/2509.

8. Except for the derogations provided for in this Regulation, the joint procurement procedure shall be carried out by the Commission in accordance with Article 168 (2) and (3) of Regulation (EU, Euratom) 2024/2509.

Or. en

Amendment 29

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

1. The Critical Medicines Group shall facilitate coordination in the implementation of this Regulation and, where appropriate, advise the Commission, so as to maximise the impact of the measures envisaged and to avoid any unintended effects on the internal market.

1. The Critical Medicines Group shall facilitate coordination in the implementation of this Regulation and, where appropriate, advise the Commission, including with regard to the assessment of the impact of other Union legal acts on the availability of critical medicines and the development of appropriate countermeasures, so as to maximise the impact of the measures envisaged and to avoid any unintended effects on the internal market.

Or. en

Justification

The coordination group should also be enabled to examine the impact of other regulations (such as environmental legislation) on security of supply and propose appropriate countermeasures.

Amendment 30

Proposal for a regulation

Article 26 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(da) assess the impact of existing and forthcoming environmental, climate or sustainability legislation on the availability and security of supply of critical medicinal products in the Union, including the potential impact on production sites, supply chains and market availability, including issuing opinions and making recommendations to the Commission.

Or. en

Justification

This addition would allow an early examination of the conflicting objectives between environmental policy and security of supply without fundamentally jeopardising the environmental objectives.

Amendment 31

Proposal for a regulation

Article 26 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. The Critical Medicines Group may provide recommendations to the Commission on regulatory exemptions that are necessary for the short-term redistribution of critical medicinal products, such as modifications to packaging, language or labelling requirements.

Or. en

Justification

This addition could allow a certain degree of regulatory flexibility (e.g. multi-country packs) in the event of supply bottlenecks.