Category: Medicines

Guidance Registering to make submissions to the MHRA from 1 January 2021 Submissions related to human medicines would need to be submitted directly to the MHRA. Published 1 September 2020 Last updated 23 December 2020 — see all updates From: Medicines and Healthcare products Regulatory Agency Brexit transition: new rules for 2021 The UK has left […]

GuidanceGuidance on submitting clinical trial safety reports from 1 January 2021 How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs). Published 18 December 2020 From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, and the transition […]

Guidance Guidance on MAH and QPPV location The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV) From: Medicines and Healthcare products Regulatory Agency Published 31 December 2020 Last updated 22 December 2021 — See all updates Contents Qualified Person responsible for Pharmacovigilance (QPPV): UK requirements regarding legal presence Establishment […]

Guidance Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, ‘grandfathering’ and managing lifecycle changes This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products. Published 1 September 2020 Last updated 30 November 2020 — see all updates From: Medicines and Healthcare products Regulatory Agency New rules for January […]

Guidance Register as a manufacturer to sell medical devices from 1 January 2021 How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland from 1 January 2021 Published 7 December 2020 Last updated 8 December 2020 — see all updates From: Medicines […]

Guidance Veterinary medicinal products placed on the EU and NI markets before 1 January 2021 Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the EU and UK markets before 1 January 2021 and the evidence you may need to provide. Published 28 October 2020 From: Veterinary […]

Guidance Guidance on pharmacovigilance procedures This guidance summarises our approach to pharmacovigilance From: Medicines and Healthcare products Regulatory Agency Published 31 December 2020 Last updated 14 October 2021 — See all updates Documents Guidance on pharmacovigilance procedures HTML Details See Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply to UK MAHs […]

Guidance Renewing Marketing Authorisations for medicines How to renew marketing authorisations for products granted through different routes and at different times. From: Medicines and Healthcare products Regulatory Agency Published 31 December 2020 Last updated 15 July 2021 — See all updates Contents Renewals for converted Centrally Authorised Products (CAPS) Renewals submitted for MAs granted through mutual […]

Guidance Guidance note on new assessment routes from 1 January 2021 New routes for assessment including an accelerated procedure and rolling review. Published 27 October 2020 From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, and the transition period after Brexit comes to an end this […]

Guidance Variations to Marketing Authorisations (MAs) from 1 January 2021 How the MHRA will process variations to Marketing Authorisations (MAs) from 1 January 2021. Published 27 October 2020 From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, and the transition period after Brexit comes to an […]

Guidance Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing Authorisations (MAs) Published 26 October 2020 New rules for January 2021 The UK has left the EU, and the transition period after Brexit comes to an end this year. This page tells you what you’ll need to do from 1 January 2021. It will […]

Guidance Centrally Authorised Products conversion explainer Guidance for the veterinary pharmaceutical industry on how to convert a Centrally Authorised Product (CAP) to a national GB Marketing Authorisation. Published 23 October 2020 From: Veterinary Medicines Directorate Contents Centrally authorised products and the Northern Ireland Protocol Automatic conversion to a GB Marketing Authorisation MA Certification and Vm […]

Guidance 1 January 2021 Adverse Event Reporting, Periodic Safety Update Reports and concerns Guidance for the veterinary pharmaceutical industry on Pharmacovigilance reporting. This guidance will be updated with more information as it becomes available. Published 7 October 2020 Last updated 23 October 2020 — see all updates From: Veterinary Medicines Directorate Contents National Competent Authority Adverse […]

Guidance Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021 Pharmacovigilance system requirements from 1 January 2021 Published 4 September 2020 Last updated 23 October 2020 — see all updates From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the […]

Guidance Supplying medicines to Northern Ireland from 1 January 2021 What you need to do to supply authorised medicines from Great Britain to Northern Ireland. Published 1 October 2020 Last updated 20 October 2020 — see all updates From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, […]

Guidance Sourcing medicines for the Great Britain market from an approved country for import or Northern Ireland from 1 January 2021 The actions to take for sourcing medicines in different circumstances. Published 1 September 2020 Last updated 20 October 2020 — see all updates From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 […]

Guidance Importing investigational medicinal products into Great Britain from approved countries Importing investigational medicinal products for use in clinical trials From: Medicines and Healthcare products Regulatory Agency Published 31 December 2020 Last updated 7 July 2021 — See all updates Documents Importing Investigational Medicinal Products (IMP) from countries on a list to Great Britain HTML List […]

Guidance Acting as a Responsible Person (import) A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’ From: Medicines and Healthcare products Regulatory Agency Published 31 December 2020 Last updated 22 December 2021 — See all updates Contents 1. […]

Guidance Trading in drug precursors from 1 January 2021 Published 14 October 2020 New rules for January 2021 The UK has left the EU, and the transition period after Brexit comes to an end this year. This page tells you what you’ll need to do from 1 January 2021. It will be updated if anything […]

Guidance Supplying medicines to Northern Ireland from 1 January 2021 What you need to do to supply authorised medicines from Great Britain to Northern Ireland. Published 1 October 2020 From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, and the transition period after Brexit comes to […]

Guidance List of approved countries Updated 22 December 2021 Contents 1.List of approved countries 2. Approved country for import list 3. List of countries approved for Batch testing 4. List of countries with equivalent regulatory standards for the manufacture of active substances Print this page 1. List of approved countries The Human Medicines Regulations 2012 refers to lists of […]

Written Confirmations for export to EEA and Northern Ireland of Active Substances manufactured in Great Britain Published 1 September 2020 New rules for January 2021 The UK has left the EU, and the transition period after Brexit comes to an end this year. This page tells you what you’ll need to do from 1 January […]

Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021 Pharmacovigilance system requirements from 1 January 2021 Published 4 September 2020 From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, and the transition period after Brexit comes to […]

Overview From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system. This guidance provides information on how the UK system will operate, including for: Getting your device certified Conformity marking your device Registering your […]

Guidance for Great Britain (England, Wales and Scotland) Marketing Authorisation Applications for similar biological products (biosimilars) from 1 January 2021 The guidance is written on the basis of Reg 53 of The Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019. It is our intention to update these Regulations […]

Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021 The process to convert Parallel Distribution Notices (PDNs) into Parallel Import Licences (PILs) from 1 January 2021. Published 1 September 2020 From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, and […]

Guidance for Great Britain Conditional Marketing Authorisation Applications The MHRA will introduce a national Conditional Marketing Authorisation (CMA) scheme for new medicinal products in Great Britain from 1 January 2021. Great Britain is England, Wales and Scotland. In Northern Ireland Marketing Authorisation applications for products which fall within mandatory scope of the Centrally Authorised Procedure as laid […]

Registering new packaging information for medicines from 1 January 2021 How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued Published 1 September 2020 From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, and the transition period after […]

1. General Approach to the operation of pharmacovigilance This document outlines the submission requirements for pharmacovigilance data from 1 January 2021. The MHRA will retain responsibility for Pharmacovigilance across the UK from 1 January 2021. There will be some different requirements for products placed on the market in the UK with respect to Great Britain and Northern Ireland. […]

Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, ‘grandfathering’ and managing lifecycle changes This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products. Published 1 September 2020 From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, and the […]

Importing blood or blood components If you import blood or blood components into the UK from the EU, Norway, Iceland or Liechtenstein you must: make sure that each imported unit of blood or blood component is prepared in accordance with Directive 2005/62/EC make sure that each imported unit of blood or blood component meets the quality […]

Guidance Registering to make submissions to the MHRA from 1 January 2021 Submissions related to human medicines would need to be submitted directly to the MHRA. Published 1 September 2020 From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, and the transition period after Brexit comes […]

Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021 Importing investigational medicinal products for use in clinical trials from 1 January 2021 Published 1 September 2020 From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, and the transition period after Brexit […]