BlueReg Group Market Specific Services Brexit Brexit The United Kingdom (UK) formally left the European Union (EU) on the 31st January 2020 and became a third country to the EU. The Brexit transition period began on the 1st February 2020 and ended on the 31st December 2020. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is now the stand-alone medicines and medical devices regulator for the UK. The Northern Ireland (NI) Protocol became applicable on 1st January 2021, and was designed as a practical solution to avoid a hard border on the island of Ireland, whilst ensuring that the UK, including NI, could leave the EU as a whole. The initial period of application of the protocol is four years. In accordance with the protocol, NI align with all relevant EU rules relating to the placing on the market of manufactured goods. As such, NI is assimilated to a Member State. BlueReg can help navigate you through the implications for this, with respect to medicinal products. BlueReg experts can assist with all aspects of MHRA Brexit related guidance and activities, including the new routes for obtaining a Marketing Authorisation (MA), clinical trials, paediatrics, pharmacovigilance, orphan drugs and life cycle maintenance. BlueReg can also guide you through the requirements for products approved via the Centralised Procedure (CP), Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP) and the steps that are required as a consequence of Brexit. Our experts BlueReg valuable expertise, in this fast moving regulatory environment, can assist you with anticipating the aspects which could be problematic for the different submissions and procedural requirements so that delays are mitigated and submissions progress smoothly and in a timely manner. Claire Ray Paula Buffery Previous Associated services BlueReg assists companies to plan and submit any necessary changes to existing marketing authorizations 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. Next Associated news UK BREXIT – eCTD BASELINE for Converting CAPs into UK MAs From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s stand-alone... Learn more 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... Learn more 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... Learn more Contact our experts today Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any area of product development, commercialisation and early access programs, and life cycle management Make an enquiry About us Welcome to BlueReg, an international consulting company for the pharmaceutical industry, specializing in development, regulatory affairs, economic affairs, quality and pharmacovigilance. We have built long-term partnerships with many clients by offering them “tailor-made” services guaranteeing expert advice and efficient solutions, thus supporting their projects towards success. Our links Affiliations Careers Terms of use Privacy Policy GDPR Get in touch with us here: contact@blue-reg.com Manage Cookies This site uses cookies and gives you control over what you want to activate OK, accept all Deny all cookies Personalize