United Kingdom

Our market specific services for the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK regulatory authority. This agency is responsible for regulating all medicines and medical devices in the UK 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.

Our services

Specific services provided by our team in the UK include:

 

  • Advice and interpretation of UK regulations
  • Interaction and meetings with MHRA
  • 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 scientific advice meetings
  • Pharmacovigilance support

Associated services

Brexit

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.

Associated services

Looking for help and support in entering the UK? Our UK based consultants can provide support and advice for all your project requirements in relation to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Associated services

Looking for help and support in entering the UK? Our UK based consultants can provide support and advice for all your project requirements in relation to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Associated services

Looking for help and support in entering the UK? Our UK based consultants can provide support and advice for all your project requirements in relation to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Associated News

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...

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EMA GUIDANCE – COVID-19

Given the support given to our clients in interactions with health authorities all around the...

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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...

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