Derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland, as well as in Cyprus, Ireland and Malta
Amending Directives 2001/20/EC and 2001/83/EC as regards derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland, as well as in Cyprus, Ireland and Malta
- Stage
- In force, reached 20 Apr 2022
- In force
- In force since 20 Apr 2022 · CELEX 32022L0642
- Transposition deadline
- 1 Jan 2022
- Procedure
- Ordinary legislative procedure
- Rapporteur
- Pascal Canfin (Renew)
- Last activity
- 14 Jun 2022
Where it stands
Latest: Discussions within the Council or its preparatory bodies, 14 Jun 2022.
ShowHide the earlier record: 4 dates, 17 Dec 2021 to 1 Mar 2022
- 17 Dec 2021
- Adoption by Commission
- 20 Dec 2021
- Discussions within the Council or its preparatory bodies
- 20 Jan 2022
- Plenary sitting
- Referred to committee
- 1 Mar 2022
- Discussions within the Council or its preparatory bodies
- 18 Mar 2022
- Feedback on adopted proposal closed: Solutions to ensure continuity of supply of human medicines to Northern Ireland, Ireland, Cyprus and Malta, 5 responses · Commission
- 4 Apr 2022
- Plenary sitting
- 5 Apr 2022
- Plenary vote
- 7 Apr 2022
- Discussions within the Council or its preparatory bodies
- EP position at first reading
- Plenary amended the proposal
- Plenary vote
- 12 Apr 2022
- Approval of the EP's first reading position by the Council (adoption of the legislative act)
- Signed
- 20 Apr 2022
- Published in the Official Journal
- 2 May 2022
- Plenary sitting
- 14 Jun 2022
- Discussions within the Council or its preparatory bodies
Who is on it
The Parliament's rapporteurs, shadow rapporteurs and opinion rapporteurs currently on this file.
| Role | Name | Group | Country | Committee |
|---|---|---|---|---|
| Rapporteur | Pascal Canfin | Renew | FR | ENVI |
| Shadow rapporteur | Bas Eickhout | Greens/EFA | NL | ENVI |
| Shadow rapporteur | Cyrus Engerer | S&D | MT | ENVI |
| Shadow rapporteur | Deirdre Clune | EPP | IE | ENVI |
| Shadow rapporteur | Idoia Villanueva Ruiz | The Left | ES | ENVI |
Documents
Newest first. Each opens at its source.
- Proposal · COM(2021)0997Parliament
- Text adopted · Directive 2022/0642Commission
- Text adopted · OJ L 118 20.04.2022, p. 0004Commission
- Text adopted · SP(2022)281Parliament
- Text adopted · T9-0116/2022Parliament
Consultations on it
The Commission's Have Your Say consultations linked to this file. Each title opens on the Commission's portal.
| Consultation | Feedback deadline | Feedback received |
|---|---|---|
| 18 Mar 2022 | 5 |
Summary
GeneratedThis regulation creates temporary derogations from certain EU obligations for human medicinal products licensed in the UK, allowing continued supply in Northern Ireland, Cyprus, Ireland, and Malta to prevent shortages. It affects pharmaceutical companies, national health authorities, and patients in those markets. The act was signed in April 2022 and is now in force.
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A first draft
Sources: EP Legislative Observatory · EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.
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