The Medicines and Healthcare products Regulatory Agency (MHRA) has provided an update for pharmaceutical companies on preparations for exiting the European Union (EU). The MHRA has stated that there will be no sudden changes to the United Kingdom’s (UK) regulatory framework when it leaves the EU in March 2019.
On 15th December 2017 the European Council agreed to advance Brexit negotiations to the second stage and adopted guidelines for that second phase. This followed the publication of a joint report on progress during the first phase. The joint report makes it clear that goods placed on the market under Union law before the UK’s withdrawal should be able to remain on the markets of the UK and the Union with no need for product modifications or re-labelling.
The EU guidelines 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 implementation period. The EU is expected to adopt additional negotiating directives on transitional arrangements in January 2018.
The MHRA states that the UK is fully committed to continuing the close working relationship with its European partners. However, there is concern over a no-deal scenario with the European Medicines Agency (EMA). Should there not be an implementation period, the MHRA has said their approach would be in line with the following principles:
- The EU (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.
- Adopt a pragmatic approach in establishing UK regulatory requirements. The MHRA would give adequate notice and ensure that companies had sufficient time to implement any changes in requirements.
- Where possible, make use of the information the MHRA already has to complete administrative tasks for continuity of work and licences.
- Ensure the minimum disruption and burden on companies as the UK exits the EU, while building on the existing relationship between MHRA and firms.
For now the UK is still an EU member state and the MHRA is working “to ensure business continuity where procedures are likely to run beyond” March 2019, when the UK will officially leave the EU.
To read more on the MHRA update to pharmaceutical companies on Brexit, please click here.