2021/0432(COD)
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
Basic information
2021/0432(COD)
COD - Ordinary legislative procedure (ex-codecision procedure)
Regulation
Amending Regulation 2014/536 2012/0192(COD)
Subject
4.20.02 Medical research
4.20.02.06 Clinical practice and experiments
4.20.04 Pharmaceutical products and industry
Geographical area
Cyprus
Ireland
Malta
United Kingdom
Status
Procedure completed
Key players
-
European Parliament
Committee responsible Rapporteur Appointed CANFIN Pascal (Renew)
02/02/2022
-
European Commission
Commission DG Commissioner Health and Food Safety KYRIAKIDES Stella
Key events
| Date | Event | Reference | Summary |
|---|---|---|---|
| 17/12/2021 | Legislative proposal published | COM(2021)0998 | |
| 20/01/2022 | Committee referral announced in Parliament, 1st reading | ||
| 07/04/2022 | Decision by Parliament, 1st reading | T9-0117/2022 | |
| 07/04/2022 | Results of vote in Parliament | ||
| 12/04/2022 | Act adopted by Council after Parliament's 1st reading | ||
| 12/04/2022 | Final act signed | ||
| 20/04/2022 | Final act published in Official Journal |
Technical information
| Procedure | Information |
|---|---|
| Procedure reference | 2021/0432(COD) |
| Procedure type | COD - Ordinary legislative procedure (ex-codecision procedure) |
| Nature of procedure | Legislation |
| Legislative instrument | Regulation |
| Amending Regulation 2014/536 2012/0192(COD) | |
| Legal basis | Rules of Procedure EP 170 Treaty on the Functioning of the EU TFEU 168-p4 Treaty on the Functioning of the EU TFEU 114 |
| Mandatory consultation of other institutions | European Economic and Social Committee European Committee of the Regions |
| Stage reached in procedure | Procedure completed |
| Committee dossier |
ENVI/9/08019
|
Documentation gateway
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Document type Committee Reference Date Summary Text adopted by Parliament, 1st reading/single reading T9-0117/2022 07/04/2022 -
Document type Reference Date Summary Draft final act 00007/2022/LEX 12/04/2022 -
Document type Reference Date Summary Legislative proposal COM(2021)0998 17/12/2021 Commission response to text adopted in plenary SP(2022)281 01/06/2022 -
Institution/body Document type Reference Date Summary ESC Economic and Social Committee: opinion, report CES0378/2022 23/02/2022