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What changed
DRAFT 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)
(COM(2023)0231 – C90146/2023 – 2023/0130(COD))
(Ordinary legislative procedure – recast)
The European Parliament,
– having regard to the Commission proposal to Parliament and the Council (COM(2023)0231),
– having regard to Article 294(2) and 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),
– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,
– having regard to the opinion of the European Economic and Social Committee of 27 September 2023,
– 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 (A9-0022/2024),
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
Amendment 2
Proposal for a regulation
Recital 3
Amendment 3
Proposal for a regulation
Recital 8
Amendment 4
Proposal for a regulation
Recital 9
Amendment 5
Proposal for a regulation
Recital 13
Amendment 6
Proposal for a regulation
Recital 24
Amendment 7
Proposal for a regulation
Recital 30
Amendment 8
Proposal for a regulation
Recital 32 a (new)
Amendment 9
Proposal for a regulation
Recital 33
Amendment 10
Proposal for a regulation
Recital 38
Amendment 11
Proposal for a regulation
Recital 39
Amendment 12
Proposal for a regulation
Recital 41 a (new)
Amendment 13
Proposal for a regulation
Recital 45
Amendment 14
Proposal for a regulation
Recital 60
Amendment 15
Proposal for a regulation
Article 2 – paragraph 1 – point 12 a (new)
Amendment 16
Proposal for a regulation
Article 3 – paragraph 1 – point b
Amendment 17
Proposal for a regulation
Article 3 – paragraph 3
Amendment 18
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Amendment 19
Proposal for a regulation
Article 5 – paragraph 2 – point a – point i
Amendment 20
Proposal for a regulation
Article 5 – paragraph 2 – point a – point ii
Amendment 21
Proposal for a regulation
Article 5 – paragraph 2 – point a – point iii
Amendment 22
Proposal for a regulation
Article 5 – paragraph 2 – point a – point iv
Amendment 23
Proposal for a regulation
Article 8 – paragraph 1 – point d a (new)
Amendment 24
Proposal for a regulation
Article 8 – paragraph 1 – point d b (new)
Amendment 25
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Amendment 26
Proposal for a regulation
Article 11 – paragraph 1 – point f a (new)
Amendment 27
Proposal for a regulation
Article 15 – paragraph 1 – point a
Amendment 28
Proposal for a regulation
Article 16 – paragraph 2
Amendment 29
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Amendment 30
Proposal for a regulation
Article 20 – paragraph 1
Amendment 31
Proposal for a regulation
Article 23 – paragraph 1
Amendment 32
Proposal for a regulation
Article 24 – paragraph 1
Amendment 33
Proposal for a regulation
Article 24 – paragraph 2
Amendment 34
Proposal for a regulation
Article 24 – paragraph 3
Amendment 35
Proposal for a regulation
Article 24 – paragraph 5 a (new)
Amendment 36
Proposal for a regulation
Article 25 – paragraph 3 a (new)
Amendment 37
Proposal for a regulation
Article 26 – paragraph 2
Amendment 38
Proposal for a regulation
Article 26 – paragraph 4 – point c a (new)
Amendment 39
Proposal for a regulation
Article 26 – paragraph 6
Amendment 40
Proposal for a regulation
Article 26 – paragraph 9
Amendment 41
Proposal for a regulation
Article 26 – paragraph 9 a (new)
Amendment 42
Proposal for a regulation
Article 26 – paragraph 10
Amendment 43
Proposal for a regulation
Article 26 – paragraph 12 a (new)
Amendment 44
Proposal for a regulation
Article 27 – paragraph 1
Amendment 45
Proposal for a regulation
Article 28 – paragraph 3 – point a
Amendment 46
Proposal for a regulation
Article 28 – paragraph 3 – point a a (new)
Amendment 47
Proposal for a regulation
Article 28 – paragraph 3 – point c
Amendment 48
Proposal for a regulation
Article 29 – paragraph 3
Amendment 49
Proposal for a regulation
Article 29 – paragraph 3 a (new)
Amendment 50
Proposal for a regulation
Article 29 – paragraph 5
Amendment 51
Proposal for a regulation
Article 30 – paragraph 4
Amendment 52
Proposal for a regulation
Article 30 – paragraph 4 a (new)
Amendment 53
Proposal for a regulation
Article 32 – paragraph 1 – subparagraph 1 a (new)
Amendment 54
Proposal for a regulation
Article 32 – paragraph 5 a (new)
Amendment 55
Proposal for a regulation
Article 33 – paragraph 4
Amendment 56
Proposal for a regulation
Article 35 – paragraph 1
Amendment 57
Proposal for a regulation
Article 35 – paragraph 2 – point j a (new)
Amendment 58
Proposal for a regulation
Article 35 – paragraph 2 – point k
Amendment 59
Proposal for a regulation
Article 35 – paragraph 2 – point n
Amendment 60
Proposal for a regulation
Article 35 – paragraph 2 – point o
Amendment 61
Proposal for a regulation
Article 35 – paragraph 11 a (new)
Amendment 62
Proposal for a regulation
Article 44 – paragraph 2
Amendment 63
Proposal for a regulation
Article 44 – paragraph 3
Amendment 64
Proposal for a regulation
Article 45 – paragraph 3
Amendment 65
Proposal for a regulation
Article 57 – paragraph 2
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.
9.11.2023
LETTER OF THE COMMITTEE ON LEGAL AFFAIRS
Mr Adrián Vázquez Lázara
Jurisconsult Jurisconsult Director-General
PROCEDURE – COMMITTEE RESPONSIBLE
FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE