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.
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
Regulating medical devices from 1 January 2021
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
Registering to make submissions to the MHRA from 1 January 2021
Webinars: preparing to make submissions to the MHRA from 1 January 2021
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
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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