UK MHRA-Specific Services
A SPECIFIC REGULATORY SYSTEM
The United Kingdom market operates independently from the European Union. This means that the UK’s Biotech, Pharmaceutical, and MedTech sectors have their own regulatory framework, regulatory authority, and payers.
As of January 2021, the UK Medicines Healthcare Products Regulatory Agency (MHRA) serves as the standalone regulator for medicines and medical devices.
SPECIFIC COMPREHENSIVE SOLUTIONS
RPN solutions for non-UK companies accessing the UK market include:
- Advice in interpreting UK regulations.
- Facilitating interactions and meetings with the MHRA.
- Providing regulatory support for clinical trials.
- Assisting with Marketing Authorization Application (MAA) submissions and life cycle management submissions.
- Ensuring compliance with the Association of the British Pharmaceutical Industry (ABPI) Code of Practice.
- Acting as ABPI signatory for copy approval of promotional materials.
- Advising marketing teams on product claims.
- Assisting with applications for Wholesaler Dealers License (WDL) or Manufacturer/Importer License (MIA).
- Guidance on setting up supply chains and meeting distribution requirements.
- Attending MHRA scientific advice meetings.
- Pharmacovigilance support.