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From · report parliamentary committee draft · 2023-10-13 JURI-PR-753704 on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)
To · act followup · 2024-07-08 SP-2024-270-TA-9-2024-0099 Follow up to T9-0099/2024
+8 added · −191 removed · 1 modified paragraphs

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

ORDINARY LEGISLATIVE procedure

on the proposal for a regulation of the European Parliament and of the Council on thesupplementary protection certificate for medicinal products (recast)

(First reading without prior interinstitutional negotiations)

(COM(2023)0231 – C90146/2023 – 2023/0130(COD))

Follow up to the European Parliament legislative resolution on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)

(Ordinary legislative procedure – recast)

1. Rapporteur: Tiemo WÖLKEN (S&D / DE)

The European Parliament,

2. Reference numbers: 2023/0130 (COD) / A9-0022/2024 / P9_TA(2024)0099

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0231),

3. Date of adoption of the resolution: 28 February 2024

– having regard to Article4. 294(2)Legal andbasis: Article 114(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90146/2023),Union

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

5. Competent Parliamentary Committee: Committee on Legal Affairs (JURI)

– having regard to the opinion of the European Economic and Social Committee of 27 September 2023,

6. Commission's position: takes note of the amendments proposed by the European Parliament, while reserving its detailed position on these until the opening of interinstitutional negotiations.

– having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts,

– having regard to Rules 110 and 59 of its Rules of Procedure,

– having regard to the report of the Committee on Legal Affairs (A90000/2023),

A. whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the Commission proposal does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;

1. Adopts its position at first reading hereinafter set out, taking into account the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment 1

Proposal for a regulation

Recital 2

Or. en

Amendment 2

Proposal for a regulation

Recital 3

Or. en

Amendment 3

Proposal for a regulation

Recital 5

Or. en

Amendment 4

Proposal for a regulation

Recital 13

Or. en

Amendment 5

Proposal for a regulation

Recital 24

Or. en

Amendment 6

Proposal for a regulation

Recital 41 a (new)

Or. en

Amendment 7

Proposal for a regulation

Recital 45

Or. en

Amendment 8

Proposal for a regulation

Recital 60

Or. en

Amendment 9

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Or. en

Amendment 10

Proposal for a regulation

Article 2 – paragraph 1 – point 12 a (new)

Or. en

Amendment 11

Proposal for a regulation

Article 5 – paragraph 1

Or. en

Amendment 12

Proposal for a regulation

Article 5 – paragraph 2 – introductory part

Or. en

Amendment 13

Proposal for a regulation

Article 5 – paragraph 2 – point a – point i

Or. en

Amendment 14

Proposal for a regulation

Article 5 – paragraph 2 – point a – point ii

Or. en

Amendment 15

Proposal for a regulation

Article 5 – paragraph 2 – point a – point iii

Or. en

Amendment 16

Proposal for a regulation

Article 5 – paragraph 2 – point a – point iv

Or. en

Amendment 17

Proposal for a regulation

Article 5 – paragraph 2 – point a – point iv a (new)

Or. en

Amendment 18

Proposal for a regulation

Article 7 – paragraph 4 a (new)

Or. en

Amendment 19

Proposal for a regulation

Article 8 – paragraph 1 – point d a (new)

Or. en

Amendment 20

Proposal for a regulation

Article 8 – paragraph 1 – point d b (new)

Or. en

Amendment 21

Proposal for a regulation

Article 11 – paragraph 1 – introductory part

Or. en

Amendment 22

Proposal for a regulation

Article 11 – paragraph 1 – point f a (new)

Or. en

Amendment 23

Proposal for a regulation

Article 15 – paragraph 1 – point c a (new)

Or. en

Amendment 24

Proposal for a regulation

Article 20 – paragraph 1

Or. en

Amendment 25

Proposal for a regulation

Article 24 – paragraph 1

Or. en

Amendment 26

Proposal for a regulation

Article 24 – paragraph 2

Or. en

Amendment 27

Proposal for a regulation

Article 24 – paragraph 3

Or. en

Amendment 28

Proposal for a regulation

Article 26 – paragraph 4 – point c a (new)

Or. en

Amendment 29

Proposal for a regulation

Article 26 – paragraph 6

Or. en

Amendment 30

Proposal for a regulation

Article 26 – paragraph 9

Or. en

Amendment 31

Proposal for a regulation

Article 26 – paragraph 9 a (new)

Or. en

Amendment 32

Proposal for a regulation

Article 26 – paragraph 10

Or. en

Amendment 33

Proposal for a regulation

Article 28 – paragraph 3 – point a

Or. en

Amendment 34

Proposal for a regulation

Article 28 – paragraph 3 – point c

Or. en

Amendment 35

Proposal for a regulation

Article 29 – paragraph 3

Or. en

Amendment 36

Proposal for a regulation

Article 29 – paragraph 5

Or. en

Amendment 37

Proposal for a regulation

Article 32 – paragraph 5 a (new)

Or. en

Amendment 38

Proposal for a regulation

Article 33 – paragraph 4

Or. en

Amendment 39

Proposal for a regulation

Article 35 – paragraph 2 – point j a (new)

Or. en

Amendment 40

Proposal for a regulation

Article 35 – paragraph 2 – point n

Or. en

Amendment 41

Proposal for a regulation

Article 35 – paragraph 2 – point o

Or. en

Amendment 42

Proposal for a regulation

Article 35 – paragraph 11 a (new)

Or. en

Amendment 43

Proposal for a regulation

Article 45 – paragraph 3

Or. en

Amendment 44

Proposal for a regulation

Article 57 – paragraph 2

Or. en