December 11, 2017
In March of 2017, the United Kingdom submitted its withdrawal from the European Union. The EMA (European Medicine Agency) and the European Commission will help pharmaceutical companies to prepare for the UK’s withdrawal from the EU. The following Questions and Answers concerns information regarding the location of establishment for certain companies specifically centralised procedures and certain activities these companies may encounter.
5 key points to remember from this article:
- If you are a marketing authorisation holder established in the UK, you must be established in the Union. However, for centrally authorised products the marketing authorisation holder will need to transfer its marketing authorisation to a holder established in the Union (EEA).
- Applicants who are established in the UK will need to change to a non-UK applicant established in the Union (EEA) before the 30th of March 2019.
- If your Qualified Person for Pharmacovigilance (QPPV) resides and carries out his/ her task in the UK, he/ she must reside and carry out his/ her task in a Member State of the Union (EEA).
- The Pharmacovigilance System Master File (PSMF) must be located in the UK. Otherwise, the marketing authorisation holder will need to change the location of the PSMF to a Member State within the Union (EEA).
- If your batch release site is located in the UK, the qualified person of the manufacturing and importation authorisation holder is responsible. He/ she will certify that each batch of medicinal product intended to be placed on the EEA market was manufactured in accordance with EU GMP (Good Manufacturing Practice) requirements and the marketing authorisation.