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From · Plenary report · 2024-01-31 A-9-2024-0019 on the proposal for a regulation of the European Parliament and of the Council on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
To · act followup · 2024-07-08 SP-2024-270-TA-9-2024-0097 Follow up to T9-0097/2024
+8 added · −236 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 the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013

(First reading without prior interinstitutional negotiations)

(COM(2023)0222 – C90148/2023 – 2023/0127(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 unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013

(Ordinary legislative procedure: first reading)

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

The European Parliament,

2. Reference numbers: 2023/0127 (COD) / A9-0019/2024 / P9_TA(2024)0097

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0222),

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

– having regard to Article4. 294(2)Legal andbasis: Article 118, first paragraph,paragraph of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90148/2023),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 Rule 59 of its Rules of Procedure,

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 report of the Committee on Legal Affairs (A9-0019/2024),

1. Adopts its position at first reading hereinafter set out;

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 1

Amendment 2

Proposal for a regulation

Recital 2 a (new)

Amendment 3

Proposal for a regulation

Recital 14 a (new)

Amendment 4

Proposal for a regulation

Recital 16

Amendment 5

Proposal for a regulation

Recital 17

Amendment 6

Proposal for a regulation

Recital 20 a (new)

Amendment 7

Proposal for a regulation

Recital 21

Amendment 8

Proposal for a regulation

Recital 21 a (new)

Amendment 9

Proposal for a regulation

Recital 22

Amendment 10

Proposal for a regulation

Recital 22 a (new)

Amendment 11

Proposal for a regulation

Recital 26

Amendment 12

Proposal for a regulation

Recital 26 a (new)

Amendment 13

Proposal for a regulation

Recital 29

Amendment 14

Proposal for a regulation

Recital 30

Amendment 15

Proposal for a regulation

Recital 31

Amendment 16

Proposal for a regulation

Recital 33

Amendment 17

Proposal for a regulation

Recital 35

Amendment 18

Proposal for a regulation

Article 2 – paragraph 1 – point 9 a (new)

Amendment 19

Proposal for a regulation

Article 3 – paragraph 1 – point b

Amendment 20

Proposal for a regulation

Article 3 – paragraph 2 – subparagraph 2

Amendment 21

Proposal for a regulation

Article 5 – paragraph 3 – introductory part

Amendment 22

Proposal for a regulation

Article 5 – paragraph 3 – point a – point i

Amendment 23

Proposal for a regulation

Article 5 – paragraph 3 – point a – point ii

Amendment 24

Proposal for a regulation

Article 5 – paragraph 3 – point a – point iii

Amendment 25

Proposal for a regulation

Article 5 – paragraph 3 – point a – point iv

Amendment 26

Proposal for a regulation

Article 8 – paragraph 4 a (new)

Amendment 27

Proposal for a regulation

Article 9 – paragraph 1 – point a – point iv a (new)

Amendment 28

Proposal for a regulation

Article 9 – paragraph 1 – point d a (new)

Amendment 29

Proposal for a regulation

Article 10 – paragraph 1

Amendment 30

Proposal for a regulation

Article 12 – paragraph 1

Amendment 31

Proposal for a regulation

Article 13 – paragraph 1

Amendment 32

Proposal for a regulation

Article 13 – paragraph 2

Amendment 33

Proposal for a regulation

Article 13 – paragraph 3

Amendment 34

Proposal for a regulation

Article 13 – paragraph 4

Amendment 35

Proposal for a regulation

Article 13 – paragraph 5

Amendment 36

Proposal for a regulation

Article 13 – paragraph 5 a (new)

Amendment 37

Proposal for a regulation

Article 14 – paragraph 1

Amendment 38

Proposal for a regulation

Article 14 – paragraph 3 – subparagraph 2 (new)

Amendment 39

Proposal for a regulation

Article 14 – paragraph 4

Amendment 40

Proposal for a regulation

Article 15 – paragraph 4 – point c a (new)

Amendment 41

Proposal for a regulation

Article 15 – paragraph 6

Amendment 42

Proposal for a regulation

Article 15 – paragraph 9 a (new)

Amendment 43

Proposal for a regulation

Article 15 – paragraph 10

Amendment 44

Proposal for a regulation

Article 15 – paragraph 12

Amendment 45

Proposal for a regulation

Article 15 – paragraph 12 a (new)

Amendment 46

Proposal for a regulation

Article 15 – paragraph 12 b (new)

Amendment 47

Proposal for a regulation

Article 16 – paragraph 1

Amendment 48

Proposal for a regulation

Article 17 – paragraph 3 – point a

Amendment 49

Proposal for a regulation

Article 17 – paragraph 3 – point a a (new)

Amendment 50

Proposal for a regulation

Article 17 – paragraph 3 – point c

Amendment 51

Proposal for a regulation

Article 18 – paragraph 1

Amendment 52

Proposal for a regulation

Article 18 – paragraph 1 a (new)

Amendment 53

Proposal for a regulation

Article 19 – paragraph 2

Amendment 54

Proposal for a regulation

Article 22 – paragraph 1 – point a

Amendment 55

Proposal for a regulation

Article 23 – paragraph 3

Amendment 56

Proposal for a regulation

Article 28 – paragraph 3

Amendment 57

Proposal for a regulation

Article 28 – paragraph 5

Amendment 58

Proposal for a regulation

Article 29 – paragraph 4

Amendment 59

Proposal for a regulation

Article 29 – paragraph 4 a (new)

Amendment 60

Proposal for a regulation

Article 32 – paragraph 1 a (new)

Amendment 61

Proposal for a regulation

Article 34 – paragraph 1

Amendment 62

Proposal for a regulation

Article 35 – paragraph 1 – point i a (new)

Amendment 63

Proposal for a regulation

Article 35 – paragraph 1 – point j

Amendment 64

Proposal for a regulation

Article 35 – paragraph 1 – point m

Amendment 65

Proposal for a regulation

Article 35 – paragraph 1 – point n

Amendment 66

Proposal for a regulation

Article 35 – paragraph 8 a (new)

Amendment 67

Proposal for a regulation

Article 40 – paragraph 1

Amendment 68

Proposal for a regulation

Article 40 – paragraph 3

Amendment 69

Proposal for a regulation

Article 41 – paragraph 2

Amendment 70

Proposal for a regulation

Article 41 – paragraph 3

Amendment 71

Proposal for a regulation

Article 42 – paragraph 3

Amendment 72

Proposal for a regulation

Article 46 – paragraph 2

Amendment 73

Proposal for a regulation

Article 56 – paragraph 1

ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he has received input from the following entities or persons in the preparation of the report, until the adoption thereof in committee:

The list above is drawn up under the exclusive responsibility of the rapporteur.

PROCEDURE – COMMITTEE RESPONSIBLE

FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE