As of the end of the transition period, an orphan designation holder currently located in the United Kingdom has to change the place of establishment…
The qualified person responsible for pharmacovigilance must reside and carry out his/her tasks in a Member State of the EU.
Parallel trade of medicinal products in the internal market is possible because of the rules in the internal market for the exhaustion of trademark…
As of the end of the transition period, UK authorities will no longer undertake the role of a supervisory authority.
MAH- As of the end of the transition period, a marketing authorisation holder established in the United Kingdom has to have…
From 1 January 2021, Northern Ireland will continue to participate in referrals under Article 29.
The UK will no longer participate in ASMF work-sharing procedures with EU Member States.
From 1 January 2021 the fees listed in the Veterinary Medicines Regulations will continue to apply for each GB Marketing Authorisation (MAs), NI MA…
A Written confirmation confirms that, for a third country exporting Active Substances to the EEA, the standards of Good Manufacturing Practice (GMP)…
The procedures detailed under the Chapter IIa of Variations Regulation (EC) No 1234/2008 will be incorporated into UK law from 11pm on 31 December…