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

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...

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

Conversion of centrally authorized products into national UK Marketing authorisations in case of No Deal Brexit

MHRA has sent to Marketing Authorization Holder (MAH) a guidance outlining requirements for submitting baseline...

Learn more

Line - Organism