On 24th November, the European Medicines Agency (EMA) released guidance to Marketing Authorisation Holders (MAHs) of centrally authorised medicines, along with its updated Q&A document:
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure
The document reiterates that, as things stand, the UK will become a ‘third country’ as of 00:00h (CET) on 30th March 2019. The key points are:
- All MAHs of centrally approved medicines must be based in the European Economic Area (EEA) and must complete the transfer before 30th March 2019. Any applicant that is expected to receive a decision after 29th March 2019 will need to change to a non-UK applicant in the EEA before 30th March 2019.
- Confirmation that the five year period of validity for Minor Use Minor Species (MUMS/ limited market classification for (veterinary medicines) is not affected by the transfer of classification.
- Brexit-related variations can be grouped, as long as this does not cause delay in implementation of changes required before 30th March 2019.
- Qualified Person for batch release must be located in the EEA. Variation categories for manufacturing, batch release etc. have been provided.
- Guidance for the transfer of products (practicalities, cost, mock-up inclusion etc), including orphan designation status, is provided.
- Changes to the person responsible for scientific services, batch recall and quality defects should be notified exclusively in writing on the provided template.
- No changes to the previously given PV guidance that the Qualified Person for Pharmacovigilance (QPPV) Pharmacovigilance System Master File (PSMF) must be located in the EEA. Changes to both will need to be notified to the Article 57 database.
As Brexit activities gather pace Quanticate will continue to offer guidance to proactively manage the transition. Our EEA based QPPV and Article 57 database expertise position us to seamlessly negotiate the post-Brexit pharmacovigilance landscape.
Related Links:
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/11/WC500239369.pdf
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500228739.pdf
