UK and Ireland Overview 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
Our experts
Our team can also support you through the entire application process from development, to registration and post-approval management
Associated news
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...