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.
The BlueReg team have a highly successful track record of delivering all French market specific services, from the simple to the complex providing expert advice as well as hands-on operational support..
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
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).
Looking for help with regulatory activities in the United States? BlueReg can help to navigate the Food and Drug Administration (FDA) regulations and provide support and advice for all your project requirements.
Looking for support in marketing your product in France? PharmaBlue, a BlueReg company, is a partner “Exploitant” of pharmaceutical companies for the marketing in France of their medicinal products which have been granted a temporary use authorization (ATU) or a marketing authorisation (MA).
Product Quality Review
BlueReg has an experienced team for Product Quality Review (PQR) writing including CMC, Quality and Regulatory Affairs consultants dedicated to supporting your company through PQR reviews for your medicinal products.
Market Access France
BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices) in France.
BlueReg assists companies to plan and submit any necessary changes to existing marketing authorisations before the end of the Brexit transition period in order to comply with EU law. Please contact us or follow our BlueReg LinkedIn page to be kept up to date with the Medicines and Healthcare products Regulatory Agency (MHRA) Brexit guidance as they are issued.
BlueReg will help you make pharmacovigilance a more streamlined process through ongoing support and tailored feedback. We offer expert advice and bespoke consultancy to assist you with a complete range of pharmacovigilance services.
BlueReg can assist with all your audit requirements and can provide a complete audit preparation package which we can tailor to your needs.
Specific Services for Europe
BlueReg has a dedicated team who cover the whole development process from concept to approval, on centralized or multi-national projects. Our consultants have diverse experience ranging from regulatory strategy to operational execution and full project management support will be provided.
Early Access Programmes (ATU)
Looking to reach market earlier ? You can rely on the experience and expertise of our consultants at BlueReg for providing advice and efficient implementation of your Early Access Programs (ATU) projects (nominative and cohort) in France .
Pricing and reimbursement (Drugs and Medical devices)
BlueReg consultants can provide pricing and reimbursement insight and support you prior to the launch of your products in France. BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices).
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