Derogation from certain obligations concerning investigational medicinal products made available in the United Kingdom with respect to Northern Ireland as well as in Cyprus, Ireland and Malta
Amending Regulation (EU) No 536/2014 as regards a derogation from certain obligations concerning investigational medicinal products made available in the United Kingdom with respect to Northern Ireland as well as in Cyprus, Ireland and Malta
- Stage
- In force, reached 20 Apr 2022
- In force
- In force since 31 Jan 2022 · CELEX 32022R0641
- Procedure
- Ordinary legislative procedure
- Rapporteur
- Pascal Canfin (Renew)
- Lead DG
- DG SANTE
- Last activity
- 14 Jun 2022
Where it stands
Latest: Discussions within the Council or its preparatory bodies, 14 Jun 2022.
ShowHide the earlier record: 5 dates, 17 Dec 2021 to 9 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
- 9 Mar 2022
- Discussions within the Council or its preparatory bodies
- 16 Mar 2022
- Feedback on adopted proposal closed: derogations concerning investigational medicinal products in NI IE CY and MT, 1 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)0998Parliament
- Text adopted · OJ L 118 20.04.2022, p. 0001Commission
- Text adopted · Regulation 2022/0641Commission
- Text adopted · SP(2022)281Parliament
- Text adopted · T9-0117/2022Parliament
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 |
|---|---|---|
| 16 Mar 2022 | 1 |
Summary
GeneratedThis regulation temporarily exempts clinical trial sponsors from specific EU labelling and packaging requirements for investigational medicinal products supplied from the UK to Northern Ireland, and to Cyprus, Ireland, and Malta. It primarily affects pharmaceutical companies and research organizations conducting multinational trials to prevent supply disruptions.
What the workspace adds on this file
Everything above is the public record. Subscribers see this page with their own layer on top.
Why it matters to you
What moved
Your contacts on it
A first draft
Sources: EP Legislative Observatory · EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.
Request access
See this file with your own layer on top: why it matters to you, your contacts on it and a first draft. We’ll schedule a 20-minute walkthrough.
EU-hosted · GDPR-compliant · Trust Center →
By submitting, you agree to our privacy policy.