Legal provisions of COM(2021)998 - Amendment of Regulation as regards derogations from obligations concerning medicinal products made available in the UK (in respect of Northern Ireland), Cyprus, Ireland, Malta - Main contents
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| dossier | COM(2021)998 - Amendment of Regulation as regards derogations from obligations concerning medicinal products made available in the UK (in ... |
|---|---|
| document | COM(2021)998  |
| date | April 12, 2022 |
Article 1
In Article 61(1) of Regulation (EU) No 536/2014, the following subparagraph is added:
‘However, the import of investigational medicinal products from other parts of the United Kingdom into Northern Ireland and, until 31 December 2024, into Cyprus, Ireland and Malta shall not be subject to the holding of such an authorisation provided that all of the following conditions are fulfilled:
| (a) | the investigational medicinal products have undergone certification of batch release either in the Union or in parts of the United Kingdom other than Northern Ireland to verify compliance with the requirements set out in Article 63(1); |
| (b) | the investigational medicinal products are only made available to subjects in the Member State into which those investigational medicinal products are imported or, if imported into Northern Ireland, are only made available to subjects in Northern Ireland.’ |
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
It shall apply from 31 January 2022.
This Regulation shall be binding in its entirety and directly applicable in all Member States.