EU Withdrawal Notes Medicinces

Rev 01, published on 23 January 2018 Notice to marketing authorisation holders of centrally authorised Medicinal products for human and veterinary use The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means that unless a […]

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Bioequivalence Studies UK 2021 Guidance

Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021 This guidance provides further information on comparator products used in studies supporting abridged marketing authorisation applications 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 […]

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Health Care Providers 2021 UK Guidance

Guidance How healthcare providers can prepare for 1 January 2021 Supply of medical products Read about the government’s plan to introduce import controls on EU goods after 31 December 2020. The government has already announced it will implement new border controls in 3 stages leading up to full implementation in July 2021. Details are set out in the Border […]

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Laboratory Practice EU Guidance 2021

EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Brussels, 19 June 2020 REV1 – replaces the notice dated 28 June 2019 NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF GOOD LABORATORY PRACTICE (GLP) Since 1 February 2020, the United Kingdom has withdrawn from the European Union […]

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CAP Vet Products Conversion 2021 UK Guidance

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 Last updated 10 November 2020 — see all updates From: Veterinary Medicines Directorate Contents Centrally authorised products and the Northern Ireland Protocol Automatic conversion to […]

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VAT Pharma and Medical

Guidance Health professionals and pharmaceutical products (VAT Notice 701/57) How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists. Published 28 July 2014 Last updated 1 November 2020 — see all updates From: HM Revenue & Customs Contents 1. Overview 2. Medical services provided by registered […]

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Veterinary Product Export 2021 UK Guidance

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 […]

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Pharmocovigilence 2021 UK Guidance

Guidance Updated guidance on pharmacovigilance procedures Updated 27 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 changes. For current […]

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Renewing Medicine Authorisation 2021 UK Guidance

Guidance Renewing Marketing Authorisations for medicines from 1 January 2021 The way Marketing Authorisations (MAs) are processed will change from 1 January 2021. Published 1 September 2020 Last updated 27 October 2020 — see all updates From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left the EU, and the […]

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New Medicines Authorisations 2021 UK Guidance

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 […]

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Marketing Authorisations Variations 2021 UK Guidance

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 […]

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Medicines Authorisations Conversion 2021 UK Guidance

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 […]

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Veterinary Products Conversion 2021 UK Guidance

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 […]

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Adverse Events +Reports 2021 UK Guidance

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 […]

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Pharmacovigilence 2021 UK Guidance

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 […]

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Importing Medicines to NI 2021 UK Guidance

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, […]

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Importing Medicines to GB 2021 UK Guidance

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 […]

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Investigational Medicines 2021 UK Guidance

Guidance Importing Investigational Medicinal Products (IMP) from countries on a list to Great Britain Updated 20 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 […]

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Responsible Person Medicines 2021 UK Guidance

Guidance Acting as a Responsible Person (import) from 1 January 2021 From 1 January 2021, 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)’ Published 1 September 2020 Last updated 20 October 2020 — see all updates From: […]

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Trading Drug Precursors 2021 UK Guidance

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 […]

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Medicines GB to NI 2021 UK Guidance

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 […]

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Approved Countries Medicines 2021 UK Guidance

Guidance List of approved countries from 1 January 2021 Updated 25 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 2021. It will be updated if anything […]

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Exporting Active Substances

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 […]

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Pharmacovigilance

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 […]

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Medical Products 2021 UK Guidance

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 […]

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Misc. Medicines Licences 2021 UK Guidance

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 […]

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