UK exits the EU (third country status)

I posted several times regarding EU Notices and Notices from EU regulatory agencies. These remind that the UK will be a third country (as respects the EU) on exit at 12pm CET 29th March 2019. If you have not already done so, please read these Notices.

Any Transition Period that is agreed is in the context of the EU-UK Withdrawal Treaty, and will continue certain EU arrangements only.

One of the aspects is UK membership of EU regulatory agencies (third countries are not members of EU regulatory agencies).

On 11th April 2018, the European Medicines Agency (EMA) confirmed that the EU27 member states and the EMA had completed the task of redistribution of the UK portfolio of centrally authorised medicine and veterinary products. The UK will not be a member of the EMA on its exit. Arrangements were already in place to relocate the EMA (from the UK) to an EU27 member state.

Please read the information that is published about this redistribution here.

UK exits the EU (medicines and veterinary products)

On 2nd May 2017 the European Commission and the European Medicines Agency (currently based in London) issued a Q&A document. This first list of questions and answers addresses the establishment requirements (within the EEA), and will be updated.

The document is here. From 30th March 2019 00:00 hrs (CET) the UK will be a (EEA) third country, and the following provisions will apply :

(1) marketing authorisation holders must be established in the EEA (this includes Norway, Iceland and Liechtenstein),

(2) Qualified Persons for Pharmacovigilance (QPPV) must reside and carry out their tasks within the EEA,

(3) the Pharmacovigilance System Master File (PSMF) must be located within the EEA,

(4) active substances manufactured in the UK will be considered imported active substances, 

(5) medicinal products manufactured in the UK will be considered imported medicinal products, 

(6) batch release sites (for certification) must be located in the EEA.