With the imminent move of the EMA to Amsterdam, the Agency has issued a progress update, a booklet giving advice for visitors to the EMA and further advice to industry.
EMA Brexit updates from January and February 2019
- The EMA has published an overview of the work it will be carrying out – other than the ‘category 1’ highest priority activities - as the relocation to Amsterdam gets underway (Link). A press release detailing the stages of the relocation has also been published (Link).
- After the relocation of the EMA to Amsterdam, visitors to the Agency may find the information in the booklet just published by the EMA helpful. Transport to the building, accommodation, and where to go on arrival are covered in the orientation guide (Link).
- Following a multi-stakeholder workshop held in November 2018, the HMA and EMA have jointly released a report highlighting key considerations regarding availability of human and veterinary medicines, particularly in light of impacts foreseen from Brexit (Link).
- The EMA has published a revised guidance document to assist Applicants and MAHs of Centrally Authorised Products (human and veterinary) with changes relating to Brexit. Variations, transfers, PV, changes of contact persons and rapporteurships, and compliance issues are all addressed in the document, which is available on the EMA website (Link). The related Q&A document, issued in conjunction with the European Commission, has also been updated (Link).