UK and Ireland
Our market specific services for the UK and Ireland
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK regulatory authority, the Health Products Regulatory Authority (HPRA) is the Republic of Ireland regulatory authority. These agencies are responsible for regulating all medicines and medical devices in the UK and Ireland by ensuring they are efficacious and have an acceptable safety/risk profile.
Our UK based consultants can provide support and advice for all your project requirements. Specific services provided by our team in the UK include:
- Advice and interpretation of UK and Ireland regulations
- Interaction and meetings with MHRA and HPRA
- Regulatory support for clinical trials
- Regulatory support for Marketing Authorisation Application (MAA) submissions and life cycle management submissions
- Compliance with the Association of the British Pharmaceutical Industry (ABPI) Code of Practice
- ABPI signatory (copy approval) for promotional materials
- Providing advice to marketing teams on product claims
- Wholesaler dealers licence applications (WDL) / Manufacturer/importer licence (MIA)
- Advice on setting up supply chains and distribution requirements
- Attendance at MHRA and HPRA scientific advice meetings
- Pharmacovigilance support
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.
Scientific Advice and Interaction with Health Regulatory Agencies
BlueReg has extensive experience in scientific advice with the European Medicines Agency (EMA) and many national competent authorities. BlueReg can assist with all competent authority meetings.
Advertising & Promotional Material Review
BlueReg is the strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance.
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