MHRA Post-Transition Period Information

Last Updated on 05/10/2020 by Millie York

Guidance for industry and organisations to follow from 1st January 2021.

From 1st January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.

Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.

Stakeholders need to get ready for new rules from 1st January 2021.

Contacting us about the post-transition period

For enquiries relating to the Agency’s planning and procedures around the post-transition period, see our Contact Us page.

Guidance from NIBSC

As well as the below guidance, the National Institute for Biological Standards and Control (NIBSC), one of the three centres of the MHRA, has published on information for manufacturers of biological medicines.

Clinical trials

Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021

Guidance on substantial amendments to a clinical trial from 1 January 2021

Devices

Regulating medical devices from 1 January 2021

Licensing

Supplying medicines to Northern Ireland from 1 January 2021

How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB)

Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021

Registering new packaging information for medicines from 1 January 2021

Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021

How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021

Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021

Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021

Reference Medicinal Products (RMPs) from 1 January 2021

Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, ‘grandfathering’ and managing lifecycle changes

Renewing Marketing Authorisations for medicines from 1 January 2021

Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021

Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021

Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021

Importing and exporting

Importing medicines on an approved country for import list from 1 January 2021

Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021

Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021

List of approved countries for authorised human medicines from 1 January 2021

Acting as a Responsible Person (import) from 1 January 2021

IT systems

Registering to make submissions to the MHRA from 1 January 2021

Webinars: preparing to make submissions to the MHRA from 1 January 2021

Pharmacovigilance

Guidance on pharmacovigilance procedures from 1 January 2021

Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021

Paediatrics

Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021

Completed Paediatric Studies – submission, processing and assessment from 1 January 2021

Format and content of applications for agreement or modification of a Paediatric Investigation Plan and requests for waivers or deferrals and concerning the operation of the compliance check from 1 January 2021

Published: 1st October 2020

Source: GOV UK, Medicines and Healthcare products Regulatory Agency

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