European Medicines Agency
A reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
- Stage
- In force, reached 31 Jan 2022
- In force
- In force since 1 Feb 2022 · CELEX 32022R0123
- Procedure
- Ordinary legislative procedure
- Rapporteur
- Nicolás González Casares (S&D)
- Lead DG
- DG SANTE
- Last activity
- 1 Feb 2023
Where it stands
Latest: Plenary sitting, 1 Feb 2023.
ShowHide the earlier record: 18 dates, 12 Nov 2020 to 8 Jul 2021
- 12 Nov 2020
- Adoption by Commission
- 16 Nov 2020
- Discussions within the Council or its preparatory bodies
- 14 Dec 2020
- Plenary sitting
- Referred to committee
- 2 Feb 2021
- Feedback on adopted proposal closed: Proposal for a Regulation on a Union framework addressing public health emergencies (EMA), 36 responses · Commission
- 24 Feb 2021
- Discussions within the Council or its preparatory bodies
- 1 Mar 2021
- Discussions within the Council or its preparatory bodies
- 2 Mar 2021
- Discussions within the Council or its preparatory bodies
- 10 Mar 2021
- Discussions within the Council or its preparatory bodies
- 30 Mar 2021
- Discussions within the Council or its preparatory bodies
- 4 May 2021
- Discussions within the Council or its preparatory bodies
- 5 May 2021
- Discussions within the Council or its preparatory bodies
- 19 May 2021
- Discussions within the Council or its preparatory bodies
- 26 May 2021
- Discussions within the Council or its preparatory bodies
- 3 Jun 2021
- Discussions within the Council or its preparatory bodies
- 16 Jun 2021
- Discussions within the Council or its preparatory bodies
- 5 Jul 2021
- Plenary sitting
- 7 Jul 2021
- Plenary sitting
- Debate in plenary
- 8 Jul 2021
- EP decision on amendments to the legislative proposal
- Plenary vote
- Plenary sitting
- Plenary amended the proposal
- Referred back to committee for interinstitutional negotiations
- 10 Nov 2021
- Discussions within the Council or its preparatory bodies
- 19 Jan 2022
- Plenary vote results
- Plenary sitting
- 20 Jan 2022
- EP position at first reading
- Plenary amended the proposal
- Plenary vote
- 21 Jan 2022
- Discussions within the Council or its preparatory bodies
- 25 Jan 2022
- Approval of the EP's first reading position by the Council (adoption of the legislative act)
- Signed
- 31 Jan 2022
- Published in the Official Journal
- 14 Feb 2022
- Plenary sitting
- 1 Feb 2023
- Plenary sitting
Who is on it
The Parliament's rapporteurs, shadow rapporteurs and opinion rapporteurs currently on this file.
| Role | Name | Group | Country | Committee |
|---|---|---|---|---|
| Rapporteur | Nicolás González Casares | S&D | ES | ENVI |
| Shadow rapporteur | Cristian-Silviu Buşoi | EPP | RO | ENVI |
| Shadow rapporteur | Frédérique Ries | Renew | BE | ENVI |
| Shadow rapporteur | Joanna Kopcińska | ECR | PL | ENVI |
| Shadow rapporteur | Joëlle Mélin | PfE | FR | ENVI |
| Shadow rapporteur | Kateřina Konečná | The Left | CZ | ENVI |
| Shadow rapporteur | Tilly Metz | Greens/EFA | LU | ENVI |
| Rapporteur for opinion | Joëlle Mélin | PfE | FR | ITRE |
Amendments
Tabled between 30 Jun 2021 and 13 Jan 2022. The texts are in the amendment documents below.
By committee
- ENVI152
Covers 152 of the 156 amendments.
By author
- Pascal Canfin1
Amendments each member tabled or co-signed. The record names an author on 1 of the 156 amendments.
By article
- Article 12 a (new)2
- Article 1 – paragraph 1 – point a1
- Article 1 – paragraph 1 – point b1
- Article 1 – paragraph 1 – point b a (new)1
- Article 10 – paragraph 21
- Article 10 – paragraph 41
- Article 10 – paragraph 51
- Article 10 – paragraph 6 a (new)1
- Article 10 – paragraph 6 – point c1
- Article 11 – paragraph 1 – introductory part1
ShowHide 20 more provisions
- Article 11 – paragraph 21
- Article 11 – paragraph 4 a (new)1
- Article 12 – paragraph 1 – point a a (new)1
- Article 12 – paragraph 1 – point b1
- Article 12 – paragraph 1 – point f1
- Article 13 – paragraph 11
- Article 13 – paragraph 1 a (new)1
- Article 14 – paragraph 11
- Article 14 – paragraph 2 – point f1
- Article 14 – paragraph 31
- Article 14 – paragraph 51
- Article 14 – paragraph 81
- Article 15 a (new)1
- Article 15 – paragraph 31
- Article 15 – paragraph 51
- Article 16 – paragraph 11
- Article 16 – paragraph 21
- Article 16 – paragraph 71
- Article 17 – paragraph 11
- Article 17 – paragraph 1 a (new)1
Covers 31 of the 156 amendments.
Documents
Newest first. Each opens at its source.
- Report · A9-0216/2021Parliament
- Proposal · COM(2020)0725Parliament
- Text adopted · Corrigendum to final act 32022R0123R(03)Commission
- Text adopted · OJ L 020 31.01.2022, p. 0001Commission
- Text adopted · OJ L 071 09.03.2023, p. 0037Commission
- Report · PE680.818Parliament
- Committee opinion · PE689.565Parliament
- Proposal · PE691.143Parliament
- Amendments · PE691.443Parliament
- Text adopted · Regulation 2022/0123Commission
- Text adopted · SP(2022)66Parliament
- Text adopted · T9-0006/2022Parliament
- Text adopted · T9-0351/2021Parliament
Consultations on it
The Commission's Have Your Say consultations linked to this file. Where we publish the positions filed, the title opens them here.
| Consultation | Feedback deadline | Feedback received |
|---|---|---|
| 2 Feb 2021 | 36 |
Summary
GeneratedRegulation (EU) 2022/123 strengthens the European Medicines Agency's role in crisis preparedness and management for medicinal products and medical devices. It applies from 1 March 2022, with Chapter IV on medical devices applying from 2 February 2023.
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Sources: EP Legislative Observatory · EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.
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