To the attention of Marketing Authorisation Holders
UK withdrawal from the European Unit
On the 31st December 2020, the transitional period in which the EU pharmaceutical legislation stipulated in the ‘Community Acquis’ continued to be applicable in the United Kingdom has come to an end.
Marketing Authorisation Holders (MAHs) are kindly reminded that batch release and testing sites located in the UK should have been removed from medicinal product authorisation dossiers by the 31st of December 2020, through related variations.
The European Commission, the EMA and the CMDh have developed regulatory guidelines and procedures for situations arising from transition of the UK to the third country status.
MAHs are asked to consult the published and constantly updated documents, in order to apply the pharmaceutical legislation in a correct and timely manner. See also “Practical Guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP Q/A 37” posted on the HMA website, under the Brexit section (https://www.hma.eu/535.html).
Consequently, MAHs should implement the required actions as soon as possible so that marketing authorisations (MAs) are compliant with the ‘Community Acquis’ and should immediately submit the required variations for removal / replacement / addition.
Failure to meet these conditions could have consequences such as MA suspension (until the situation is remedied) or withdrawal, as appropriate.
Please check the following links on the EMA websites as well: Brexit: the United Kingdom’s withdrawal from the European Union | European Medicines Agency (europa.eu) (https://www.ema.europa.eu/en/about-us/brexit-united-kingdoms-withdrawal-european-union) and HMA, the ‘Brexit’ section: Heads of Medicines Agencies: BREXIT (hma.eu) (https://www.hma.eu/542.html?&L=0).
Moreover, given the dynamics of the information, you are advised to weekly check the National Agency for Medicines and Medical Devices of Romania (NAMMDR) website (https://www.anm.ro/en/) for procedural updates.