Regulatory News - September 2020

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Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA Suite of Post-Brexit Transition Guidance

The MHRA have released a suite of documents on their website titled ‘MHRA post-transition period information’. The collection of documents provides guidance for industry and organisations to follow from 1st January 2021, at which point the MHRA will be the UK’s standalone medicines and medical devices regulator.

The collection covers clinical trials, devices, licensing, importing and exporting, IT systems, pharmacovigilance and paediatrics. The guidance may be subject to future updates as required and will be developed further in due course.

See here for the collection of guidance.

MHRA EU Exit and Post Transition Guidance Webinar Series

To supplement the collection of guidance published on their website, which will apply following the end of the transition period (from 1st January 2021), the agency is running a series of free webinars. These webinars will help stakeholders understand the detail of the guidance and provide them with the opportunity to ask any questions.

The webinars will cover the following topics:

  • Guidance for manufacturers of biological medicines - independent batch release in the United Kingdom from 1 January 2021 (held by The National Institute for Biological Standards and Controls);
  • UK supply chain regulation from 1 January 2021;
  • Clinical Trials;
  • Regulation of medical devices from 1 January 2021;
  • Post EU Transition: Pharmacovigilance requirements for UK authorised products;
  • UK marketing authorisation and variation procedures from 1 January 2021;
  • Conversion of Community Authorisations to Great Britain MAs and handling of applications that are pending in the centralised and MRDC procedures at the end of Transition;
  • PLPI – the legal framework of parallel imports;
  • UK paediatric requirements from 1 January 2021.

Further information on the webinar series can be found here.

Public Consultations

There are currently no public consultations ongoing.