MEPs will quiz the Commission on recently proposed derogations to ensure continued supply of medicines to Northern Ireland, as well as to Cyprus, Ireland and Malta.
On Thursday, Andrzej Rys, Commission Director for Health systems, medical products and innovation, will brief Members of the Environment, Public Health and Food Safety (ENVI) Committee on the recent proposals to allow medicines from Great Britain to be supplied to Northern Ireland and to address outstanding supply concerns in Cyprus, Ireland and Malta.
When: Thursday 13 January 2022, estimated starting time 9:30 CET
Where: European Parliament in Brussels, room Antall 4Q2 and videoconference
You can watch the debate live here.
Background
In line with the package of solutions for Northern Ireland tabled on 13 October 2021, the Commission adopted on 17 December 2021 a series of proposals aiming to ensure the supply of medicines to Northern Ireland, as well as to Cyprus, Ireland and Malta.
The proposed exceptional provisions would allow medicines authorised in the UK to be supplied to Northern Ireland temporarily and until the European Medicines Agency grants a marketing authorisation in the EU. Specific conditions would be in place to ensure that UK-authorised medicines do not enter the EU single market. In this context, marketing authorisation holders may be established and/or located in parts of the UK other than Northern Ireland and batch testing may be carried out in parts of the UK other than Northern Ireland. Additionally, authorisation to manufacture and import investigational medicinal products would not be required for products imported into Cyprus, Ireland, Malta and Northern Ireland from parts of the UK other than Northern Ireland, provided that certain conditions are fulfilled.
The Commission proposes that these derogations apply indefinitely to Northern Ireland, while for Cyprus, Ireland and Malta the derogations would be temporary for a period of three years, as these markets are expected to gradually be supplied through member states.
An additional Commission Notice bridges the gap between 31 December 2021 (deadline for application of previous guidance provided by the Commission) and the entry into force of the recently proposed legislative measures.
Further information
- Proposal for a Directive of the European Parliament and of the Council amending Directives 2001/20/EC and 2001/83/EC
- Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) No 536/2014
- Commission Delegated Regulation (EU) of 17.12.2021 amending Delegated Regulation (EU) 2016/161
- Commission Notice – Application of EU’s pharmaceutical acquis in markets historically dependent on medicines supply from or through parts of the UK other than Northern Ireland
- Committee on the Environment, Public Health and Food Safety