Brexit Guideline from CMDh updated

The Heads of Medicines Agencies (HMA) consists of the heads of the National Competent (EU) Authorities who are responsible for the regulation of medicinal products in the EU. The Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) of the HMA has updated a recently published Guideline on Brexit.

The "Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP" is a Q&A Document and intended to answer important questions regarding the consequences of Brexit. The Guide constists of 37 questions and and anwers. The answers to the following questions have been changed.

Question 30: Can I still place my product on the market when the MAH, batch release site, batch control site, local representative, QPPV or PSMF will still be located in the UK after the end of the transition period?

Question 31: What will happen to my ongoing DCP marketing authorisation applications when the applicant, future MAH, batch release site, batch control site, local representative, QPPV or PSMF will still be located in the UK after the end of the transition period?

Questions 37: For existing authorisations, if I still have UK sites mentioned in the dossier after the end of the transition period in addition to EU sites, e.g. alternative batch release or batch control sites, should I remove these?

Regarding the Question 31 the HMA clarifies: "Unless all UK sites/activities (applicant, future MAH, local representative, QPPV, PSMF) and/or UK(GB) sites (batch release site, batch control site) have been removed/replaced by Day 210, the procedure will be closed negatively as the application is not compliant with the EU legislation".

Here you find the full Document: Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

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