EMA, HMA and HPRA post updates regarding Brexit related variations, batch control testing in the UK and CESP submissions

European Medicines Agency (EMA)

The EMA’s dedicated web page (Link) giving Brexit-related information for companies has been further updated in February. Some guidance documents have been updated, and a new notice from the Commission regarding interim measures for changes to batch testing sites has also been published (Link).

The EMA has published specific procedural guidance for companies in regard to Brexit-related variations (Link). A pre-notification checklist is made available to MAHs to help reduce errors in their dossiers, inclusion of administrative changes is discouraged, and there is the possibility to flag the application as Brexit-related via the user interface when creating the delivery file.

Batch control testing of medicines in the UK

A template document has been made available for companies requesting extensions for batch testing arrangements involving sites in the UK. The template can be found on this page of the HMA website. The Irish agency HPRA has issued further useful information regarding batch control testing in the UK (Link).

Common European Submission Portal (CESP)

Working on the premise that the UK will leave the EU on 30^th March 2019, an announcement on CESP informs applicants that the UK agencies will not be able to access submissions made through this platform after that date. Delivery files generated after that date that include the UK will not be functional.  See the notice on CESP here (Link).