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From · report parliamentary committee draft · 2023-10-13 JURI-PR-753703 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 · 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
+49 added · −73 removed · 50 modified paragraphs

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

– having regard to Rule 59 of its Rules of Procedure,

– having regard to the report of the Committee on Legal Affairs (A90000/2023),(A9-0019/2024),

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

Recital 1

Or. en

Amendment 2

Proposal for a regulation

Recital 142 a (new)

Or. en

Amendment 3

Proposal for a regulation

Recital 21

Recital 14 a (new)

Or. en

Amendment 4

Proposal for a regulation

Recital 21 a (new)

Recital 16

Or. en

Amendment 5

Proposal for a regulation

Recital 2217

Or. en

Amendment 6

Proposal for a regulation

Recital 2220 a (new)

Or. en

Amendment 7

Proposal for a regulation

Recital 2621

Or. en

Amendment 8

Proposal for a regulation

Recital 31

Recital 21 a (new)

Or. en

Amendment 9

Proposal for a regulation

Recital 3322

Or. en

Amendment 10

Proposal for a regulation

Recital 35

Recital 22 a (new)

Or. en

Amendment 11

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Recital 26

Or. en

Amendment 12

Proposal for a regulation

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

Recital 26 a (new)

Or. en

Amendment 13

Proposal for a regulation

Article 3 – paragraph 1 – point b

Recital 29

Or. en

Amendment 14

Proposal for a regulation

Article 5 – paragraph 3 – introductory part

Recital 30

Or. en

Amendment 15

Proposal for a regulation

Article 5 – paragraph 3 – point a – point i

Recital 31

Or. en

Amendment 16

Proposal for a regulation

Article 5 – paragraph 3 – point a – point ii

Recital 33

Or. en

Amendment 17

Proposal for a regulation

Article 5 – paragraph 3 – point a – point iii

Recital 35

Or. en

Amendment 18

Proposal for a regulation

Article 52 – paragraph 31 – point a –9 pointa iv(new)

Or. en

Amendment 19

Proposal for a regulation

Article 5 – paragraph 3 – pointparagraph a1 – point iv a (new)b

Or. en

Amendment 20

Proposal for a regulation

Article 83 – paragraph 42 a– (new)subparagraph 2

Or. en

Amendment 21

Proposal for a regulation

Article 85 – paragraph 43 b– (new)introductory part

Or. en

Amendment 22

Proposal for a regulation

Article 95 – paragraph 13 – point d a (new)– point i

Or. en

Amendment 23

Proposal for a regulation

Article 95 – paragraph 13 – point da b– (new)point ii

Or. en

Amendment 24

Proposal for a regulation

Article 105 – paragraph 13 – point a – point iii

Or. en

Amendment 25

Proposal for a regulation

Article 105 – paragraph 13 – point a (new)– point iv

Or. en

Amendment 26

Proposal for a regulation

Article 128 – paragraph 14 a (new)

Or. en

Amendment 27

Proposal for a regulation

Article 139 – paragraph 1 – point a – point iv a (new)

Or. en

Amendment 28

Proposal for a regulation

Article 139 – paragraph 21 – point d a (new)

Or. en

Amendment 29

Proposal for a regulation

Article 1310 – paragraph 31

Or. en

Amendment 30

Proposal for a regulation

Article 1312 – paragraph 51

Or. en

Amendment 31

Proposal for a regulation

Article 1413 – paragraph 1

Or. en

Amendment 32

Proposal for a regulation

Article 1413 – paragraph 42

Or. en

Amendment 33

Proposal for a regulation

Article 1513 – paragraph 4 – point c a (new)3

Or. en

Amendment 34

Proposal for a regulation

Article 1513 – paragraph 64

Or. en

Amendment 35

Proposal for a regulation

Article 1513 – paragraph 9 a (new)5

Or. en

Amendment 36

Proposal for a regulation

Article 1513 – paragraph 105 a (new)

Or. en

Amendment 37

Proposal for a regulation

Article 1514 – paragraph 13 a (new)1

Or. en

Amendment 38

Proposal for a regulation

Article 1614 – paragraph 13 a– subparagraph 2 (new)

Or. en

Amendment 39

Proposal for a regulation

Article 1714 – paragraph 3 – point a4

Or. en

Amendment 40

Proposal for a regulation

Article 1715 – paragraph 34 – point c a (new)

Or. en

Amendment 41

Proposal for a regulation

Article 1815 – paragraph 1 – introductory part6

Or. en

Amendment 42

Proposal for a regulation

Article 1815 – paragraph 19 a (new)

Or. en

Amendment 43

Proposal for a regulation

Article 1915 – paragraph 210

Or. en

Amendment 44

Proposal for a regulation

Article 2215 – paragraph 1 – point c a (new)12

Or. en

Amendment 45

Proposal for a regulation

Article 2215 – paragraph 1 – point c12 ba (new)

Or. en

Amendment 46

Proposal for a regulation

Article 2315 – paragraph 312 b (new)

Or. en

Amendment 47

Proposal for a regulation

Article 2816 – paragraph 31

Or. en

Amendment 48

Proposal for a regulation

Article 2817 – paragraph 53 – point a

Or. en

Amendment 49

Proposal for a regulation

Article 2917 – paragraph 43 – point a a (new)

Or. en

Amendment 50

Proposal for a regulation

Article 3217 – paragraph 13 a– (new)point c

Or. en

Amendment 51

Proposal for a regulation

Article 3218 – paragraph 1 b (new)

Or. en

Amendment 52

Proposal for a regulation

Article 3418 – paragraph 1 a (new)

Or. en

Amendment 53

Proposal for a regulation

Article 3519 – paragraph 1 – point i a (new)2

Or. en

Amendment 54

Proposal for a regulation

Article 3522 – paragraph 1 – point ma

Or. en

Amendment 55

Proposal for a regulation

Article 3523 – paragraph 1 – point n3

Or. en

Amendment 56

Proposal for a regulation

Article 3528 – paragraph 8 a (new)3

Or. en

Amendment 57

Proposal for a regulation

Article 3628 – paragraph 2 a (new)5

Or. en

Amendment 58

Proposal for a regulation

Article 4029 – paragraph 14

Or. en

Amendment 59

Proposal for a regulation

Article 4029 – paragraph 34 a (new)

Or. en

Amendment 60

Proposal for a regulation

Article 4232 – paragraph 31 a (new)

Or. en

Amendment 61

Proposal for a regulation

Article 4634 – paragraph 21

Or. en

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

Or. en

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