The United Kingdom formally left the European Union (EU) on the 31st January 2020. A transition period commenced on the 1st February 2020, which is due to end on the 31st December 2020. During the transition period EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ remains applicable to the UK.
Medicines and Healthcare products Regulatory Agency (MHRA)
As the withdrawal negotiations progress the MHRA will issue updated guidance on how they will regulate and any steps to be taken for existing authorisations, ongoing procedures, clinical trials etc..
Should you wish to be added to the BlueReg communication and distribution list for notification of MHRA Brexit guidance as they are issued please contact us below.
European Medicines Agency (EMA)
Guidance for centrally authorised products and the consequences of Brexit, are maintained by the EMA and European Commission. To access the guidance please click here.
Medicinal products for human use approved via the mutual recognition procedure (MRP)/ decentralized procedure (DCP), and those EU nationally approved
As EU pharmaceutical law remains valid for the UK during the transition period, pharmaceutical companies can continue to carry out activities in the UK until the 31 st December 2020. Marketing authorisation holders, Qualified Persons for Pharmacovigilance (QPPVs) and pharmacovigilance system master files (PSMFs), as well as manufacturing/quality control testing/batch release sites, can be based in the UK until the end of 2020.
BlueReg is happy to assist companies to plan and submit any necessary changes to their authorised medicines before the end of the transition period in order to comply with EU law.
United Kingdom and Ireland
Looking for help and support in entering the UK or Irish markets? Unclear how Brexit will impact on the UK position within medicines regulation in Europe? Our UK based consultants can provide support and advice for all your project requirements in relation to the UK Medicines and Healthcare products Regulatory Agency (MHRA) or Republic of Ireland Health Products Regulatory Authority (HPRA).
UK Medicines and Medical Devices Bill begins passage through Parliament
The purpose of the Bill is to replace the EU Human Medicines Directive, which will...
News - 20 February 2020
Paul Kuiken : General Manager UK and Vice President Global Geographic Expansion
BlueReg Group is pleased to announce that Paul Kuiken has joined the company today as...
News - 23 May 2019