Importing Medicines to UK

Guidance Sourcing medicines for the UK Market The actions to take for sourcing medicines in different circumstances. From: Medicines and Healthcare products Regulatory Agency Published 31 December 2020 Last updated 22 December 2021 — See all updates Contents 1. Importing medicines from an EEA State which is on an approved country for import list 2. Importing […]

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Converting to UK Authorisation

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. From: Medicines and Healthcare products Regulatory Agency Published 31 December 2020 Last updated 15 October 2021 — See all updates Contents General approach to grandfathering of CAPs Actions […]

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Safety of Human Organs etc.

Guidance Quality and safety of human organs, tissues and cells Guidance for hospitals, tissue establishments and fertility clinics for ensuring the quality and safety of human organs, tissues and cells (including reproductive cells). From: Department of Health and Social Care Published 31 December 2020 Last updated 28 September 2021 — See all updates Contents Quality and […]

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Marketing Authorisation Applications UK 2021 Guidance

Guidance Marketing Authorisation Application submission dates for 150-days national and European Commission decision reliance procedures Submission dates and how the submissions using the EC decision reliance procedure work. From: Medicines and Healthcare products Regulatory Agency Published 1 February 2021 Last updated 23 August 2021 — See all updates Contents Submission dates for 150-days assessment procedure for […]

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Medical Devices Regulations

EXPLANATORY MEMORANDUM TO THE MEDICAL DEVICES (AMENDMENT) (EU EXIT) REGULATIONS 2021 2021 No. [XXXX] 1. Introduction 1.1 This Explanatory Memorandum has been prepared by the Department of Health and Social Care and is laid before Parliament by Act. 1.2 This memorandum contains information for the Sifting Committees. 2. Purpose of the instrument 2.1 This instrument is […]

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Biological Product Licensing

Guidance on licensing biosimilars, ATMPs and PMFs The way you apply to licence biological products has changed From: Medicines and Healthcare products Regulatory Agency Published 31 December 2020 Last updated 10 May 2021 — See all updates Contents Guidance for Great Britain (England, Wales and Scotland) Marketing Authorisation Applications for similar biological products (biosimilars) Guidance for […]

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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 3 August 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 from Great Britain into Northern Ireland works. From: Medicines and Healthcare products Regulatory Agency Published: 5 January 2021 Last updated: 5 March 2021, see all updates Contents Overview Conformity marking Additional importer requirements Customs requirements Further information Print this page […]

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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. From: Medicines and Healthcare products Regulatory Agency Published 31 December 2020 Last updated 1 January 2022 — See all updates Contents Overview Legislation that applies in Great Britain […]

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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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