Easing Barriers for Medicines

ANNEX TBT-2: MEDICINAL PRODUCTS Article 1: Definitions 1. For the purposes of this Annex: (a) “authority” means an authority of a Party as listed in Appendix A; (b) “Good Manufacturing Practice” or “GMP” means that part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate […]

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Life Sciences Guidance

The life sciences sector and preparing for EU Exit If the UK leaves the EU without a deal, there may be changes that affect your business. Published 28 February 2019 From: Department for Business, Energy & Industrial Strategy Contents Regulation and standards Importing and exporting Your employees Personal data Trade associations Your business may need […]

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Life Sciences

Description of sector This Sectoral Report reflects 3 of the 58 listed sectors; ‘Pharmaceuticals’, ‘MedicalDevices’ and ‘Life Sciences’. Life Sciences refers to the application of biology and technology to health improvement, including biopharmaceuticals, medical technology, genomics, diagnostics and digital health. This report does not cover all health related issues; issues relating to animal and plant health […]

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Medicines

December 2018 Medicines fAs part of a whole of Government response to Brexit, the Department of Health is working to ensure a comprehensive and coordinated set of preparations to ensure continuity of health services and supply of medical products in a no deal Brexit. This work involves the Department and its key agencies including the […]

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Medicines UK No Deal Notes

Batch testing medicines Purpose This notice updates businesses on the arrangements that will come into force in the unlikely event that the UK leaves the EU on 29 March 2019 (may also apply to new exit date on 31 December 2020) with no agreement in place for the regulation of human medicines. This notice only covers arrangements with reference to: batch testing, by manufacturers, of human […]

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Exporting Active Substances

Guidance Written Confirmations for export to EEA and Northern Ireland of Active Substances manufactured in Great Britain Updated 2 February 2021 Contents 1.Purpose of the Written Confirmation 2.‘Third Country’ status for Great Britain (England, Wales and Scotland) manufacturers of Active Substances 3.Generation of Written Confirmations for Active Substances manufactures in the UK 4.Obtaining Written Confirmations […]

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Qualified Person Pharmacovigilance UK Post Deal Guidance

Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) Pharmacovigilance system requirements Published 31 December 2020 Last updated 1 February 2021 — see all updates From: Medicines and Healthcare products Regulatory Agency Contents Guidance on the QPPV for UK authorised products Guidance on the PSMF for UK authorised products Guidance for […]

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Vet Medicines Regulation UK No Deal Notes

Purpose The purpose of this notice is to outline the arrangements that would come into force to regulate veterinary medicines in the unlikely event the UK leaves the EU on 29 March 2019 (may also apply to new exit date on 31 December 2020) with no agreement in place, with specific reference to: Marketing Authorisation Holder (MAH) – legal presence requirements Veterinary ‘Generic’ Marketing Authorisations – […]

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Animal Medicine IT Systems UK No Deal Notes

Purpose The purpose of this notice is to inform key stakeholders of the actions they will need to undertake to continue to submit regulatory and notification information to the UK, via the Veterinary Medicines Directorate (VMD), in the event that the UK leaves the EU in March 2019 with no agreement in place. Before 29 […]

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Medical Devices NI UK Post-Deal Guidance

Guidance Guidance for retailers: supplying medical devices to Northern Ireland How the supply of medical devices into Northern Ireland works. Published 5 January 2021 From: Medicines and Healthcare products Regulatory Agency Contents Conformity marking Additional importer requirements Further information Print this page A key part of the agreement on the UK withdrawal from the European […]

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OTC Medicines NI UK Post-Deal Guidance

Guidance Guidance for retailers: supplying over-the-counter medicines to Northern Ireland How the supply of medicines into Northern Ireland works. Published 5 January 2021 From: Medicines and Healthcare products Regulatory Agency Contents What you need to do to supply authorised medicines from Great Britain to Northern Ireland Alternative supply chain options Glossary of terms Further information […]

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Medicines Authorisation Rely EU Approval

Guidance European Commission (EC) Decision Reliance Procedure How to apply for marketing authorisation via this new procedure. Published 4 January 2021 From: Medicines and Healthcare products Regulatory Agency Contents How to apply Fees Assessment procedure If Major Objections are raised Print this page For a period of two years from 1 January 2021, when determining […]

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Access for NI Medicines UK Post-Deal Guidance

Guidance Unfettered Access Procedure for marketing authorisations approved in Northern Ireland How to apply for the Unfettered Access Procedure (UAP). Published 4 January 2021 From: Medicines and Healthcare products Regulatory Agency Contents How to apply Fees Assessment procedure If Major Objections are raised Print this page Marketing Authorisation Holders (MAHs) may seek recognition in Great […]

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Vitimins Register UK Post-Deal Guidance

Guidance Great Britain register on the addition of vitamins and minerals and of certain other substances to foods Published 31 December 2020 Contents 1.Section A: vitamins and minerals that may be added to foods 2.Section B: vitamin formulations and mineral substances that may be added to foods 3.Section C: maximum and minimum amounts of vitamins […]

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Investigational Medicines NI UK Post-Deal Guidance

Guidance Supplying investigational medicinal products to Northern Ireland What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Supply of investigational medicinal products until 31 December 2021 Supply of investigational medicinal products from 1 January 2022 […]

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Supplying Medicines NI UK Post-Deal Guidance

Guidance Supplying authorised medicines to Northern Ireland What you need to do to supply authorised medicines from Great Britain to Northern Ireland. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents 1. Supply of authorised medicines until 31 December 2021 2. Supply of authorised medicines from 1 January 2022 3. Supply of […]

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Medical Devices Reg UK Post-Deal Guidance

Guidance Regulating medical devices in the UK What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Overview Legislation that applies in Great Britain The role of the MHRA Requirements for those […]

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Med Devices UK Approved Bodies Post-Deal Guidance

Guidance Medical devices: UK approved bodies UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Published 1 January 2021 Last updated 1 January 2021 — see all updates From: Medicines and Healthcare products Regulatory Agency Documents UK approved bodies for medical devices HTML BSI Assurance UK Ltd Medical Devices […]

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Orphan Medicines UK Post-Deal Guidance

Guidance Orphan medicinal products in Great Britain The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Application process How to apply Market exclusivity period Paediatric indications Variation applications (section 4.1 of the Summary […]

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Converting Marketing Authorisations UK Post-Deal Guidance

Guidance Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), ‘grandfathering’ and managing lifecycle changes This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents General approach to grandfathering of CAPs Actions that holders of converted EU MAs need to […]

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Blood & Blood Products UK Post-Deal Guidance

Guidance Quality and safety of human blood and blood products What blood establishments, blood banks and manufacturers of blood products need to do to ensure the safety and quality of blood and blood products. Published 31 January 2020 Last updated 31 December 2020 — see all updates From: Department of Health and Social Care Contents Quality […]

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MHRA Procedures UK Post-Deal Guidance

Guidance Register to make submissions to the MHRA Submissions related to human medicines need to be submitted directly to the MHRA. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Gaining Access to MHRA Submissions Registering to use the vigilance systems: MHRA Gateway and ICSR Submissions Print this page For applications that […]

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Clinical Trials UK Post-Deal Guidance

Guidance Registration of clinical trials for investigational medicinal products and publication of summary results This guidance contains information about registration of clinical trials, publishing trial results and requirements. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Registration of your clinical trial Publishing trial results Future requirements Contact Print this page Registration […]

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Varying Marketing Authorisation UK Post-Deal Guidance

Guidance Variations to Marketing Authorisations (MAs) How the MHRA processes variations to Marketing Authorisations (MAs) Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Update to this guidance on 29 December 2020 1. Variations Procedure 2. Variation of a UK marketing authorisation Products authorised under EU Decentralised or Mutual Recognition Procedures 3. […]

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NI EU Medicines Authorisations UK Post-Deal Guidance

Guidance Procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Marketing Authorisations granted before 31 December 2020 Marketing Authorisation Applications submitted or […]

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Medicines Marketing Authorisations UK Post-Deal Guidance

Guidance Renewing Marketing Authorisations for medicines How to renew marketing authorisations for products granted through different routes and at different times. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Renewals for converted Centrally Authorised Products (CAPS) Renewals submitted for MAs granted through mutual recognition (MR) or decentralised (DC) procedures Renewals submitted […]

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