EMA and the European Commission have published a document in support of the pharmaceutical industries in tackling UK's exit from the European Union. In the form of questions and answers, the document refers to medicinal products for human and veterinary use, in the form of questionnaire replies and answers. veterinary. Nine points to clarify administrative and regulatory issues, in case the company's operational headquarters is in British territory.
Among the topics considered centralized procedures, the request for authorization for trade and for the assignment of the status of orphan drug, pharmacovigilance, production and release of lots.
The document follows a note addressed to the MAHs of centrally authorized medicinal products for human and veterinary use published on 2 May.
Ema is preparing a number of other papers to be published on the Agency website. Companies are advised to periodically check the website dedicated to the consequences of Brexit.
See Attachment
