EFPIA Proposal for discussion points
(5 February 2021)
- Governance
o Platforms for engagement for the industry with DG Sante on issues related to
the NIP and regulatory issues in general.
o Set-up of the Medicines WG.
- Regulatory issues
o Unnecessary deletion of UK batch release sites during 12-month phase-in
period: member states implementation of the Commission Notice (2021/C
27/08).
o Location of MAH for Marketing Authorisations which include Northern Ireland
within their scope: clarification needed on implementation by end of 2020 in
order to avoid delays in applications and subsequent supply of medicines.
o Lack of MHRA access to EMA Common Repository and CESP: duplication of
effort/resources.
- Organisation and set-up of paral el trade
- Import licence to bring goods from UK into EU (different requirements in MSs)
(Specifics related to the necessary import licence differ from one MS to another,
making it difficult for companies to comply.)