MHRA updates pharmaceutical companies on Brexit preparations
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published an official update to pharmaceutical companies on preparations for Brexit.
The MHRA says a UK and EU negotiation joint report has made clear that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the EU with no need for product modifications or re-labelling; be put into service where provided in Union law; and that the goods concerned should be subject to continued oversight.”
The EU guidelines also acknowledge the proposal put forward by the UK for a time-limited implementation period, based on the existing structure of EU rules and regulations. The aim is for access to one another’s markets to continue on current terms throughout this period and for it to be based on the existing structure of EU rules and regulations.
No sudden changes to UK regulatory framework
However, if there is no implementation period, the MHRA’s approach would be in line with the following principles:
- the European Union (Withdrawal) Bill will convert the existing EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework;
- it would be pragmatic in establishing UK regulatory requirements, giving adequate notice and ensuring that companies had sufficient time to implement any changed requirements; and
- where possible, it would make use of the information it already has to complete administrative tasks for continuity of work and licences.