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 […]
Category: Medicines
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 – […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. From: Department of Health and Social Care Published 31 January 2020 Last updated 27 May 2021 — See all updates Contents Quality […]
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 […]
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 […]
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. […]
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 […]
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 […]
Pharmacovigilance Procedures UK No-Deal Guidance
Guidance Guidance on pharmacovigilance procedures Published 31 December 2020 Contents 1.1. General Approach to the operation of pharmacovigilance 2.2. Actions for submitting and receiving ICSRs 3.3. Signal detection 4.4. Risk Management Plans (RMPs) 5.5. Periodic Safety Update Reports (PSURs) 6.6. Post Authorisation Safety Studies (PASS) 7.7. Safety Referrals 8.8. Major Safety Reviews 9.9. Post-authorisation Measures […]
Medical Packaging UK Post-Deal Guidance
Guidance Registering new packaging information for medicines How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Actions to take once you have been issued an MA Multi-language packs Submission and best practice Contact Print […]
Medicines Marketing Authorisations UK Post-Deal Guidance
Guidance Rolling review for marketing authorisation applications How the rolling review process for marketing authorisation applications will work, and how to apply. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Rolling review Final phase (for marketing authorisation application) Print this page Rolling review The rolling review is a new route for […]
Medicines Authorisations UK Post-Deal 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 Last updated 29 December 2020 — see all updates From: Medicines and Healthcare products Regulatory Agency Brexit transition: new rules for 2021 The UK has agreed a deal […]
NI Medicines CMAs UK Post-Deal Guidance
Guidance Procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations from 1 January 2021 Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021. Published 29 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Marketing Authorisations granted before 31 December 2020 Marketing […]
NSAI Electrical Equipment
Healthcare and Medical [UK]
Healthcare and medical: international trade regulations Import and export regulations for the healthcare sector, market trends and drivers, and the UK Trade Tariff and classification of goods. Published 9 October 2012 Last updated 24 April 2015 — see all updates From: Department for International Trade and Department of Health and Social Care Contents Introduction Export regulations Export goods […]
Drug Precursors UK No Deal Notes
Purpose If the UK leaves the EU in March 2019 without a deal, find out how this would affect you if you are handling and trading in drug precursor chemicals. Drug precursors are chemicals that can be used in the illicit manufacture of narcotic drugs. They also have legitimate commercial uses and are legally used […]
Pharmacovigilance UK No Deal Notes
Purpose The purpose of this notice is to explain future arrangements for nominated persons (‘authorised representatives’ and ‘responsible persons’) in relation to manufactured goods. These arrangements will apply in the unlikely event that the UK exits the EU without a deal in March 2019. This notice does not cover the following areas: The role of […]
Investigational Medicines
Guidance on importation of investigational medicinal products from approval countries How the management and oversight of the import of investigational medicinal products from listed countries will work in a no deal scenario. Published 11 March 2019 From: Medicines and Healthcare products Regulatory Agency Documents Importing Investigational Medicinal Products (IMP) from EEA to UK HTML List […]
Air Freight of Medicines
Guidance on air freight as part of the contingency planning for the UK’s departure from the EU Published 11 March 2019 Contents 1.Introduction to air transport 2.GDP Principles of transportation 3.Risk control measure 4.Air cargo security checks 5.Containers, packaging and labelling 6.Medicines regarding special conditions Leaving the EU with a deal remains the Government’s top priority. This […]
Importing Medicines
Importing medicines from an EEA State which is on an approved country for import list Published 11 March 2019 Contents 1.Importing medicines from an EEA State which is on an approved country for import list 2.Importing UK authorised human medicines from a country on the list for use in the UK 3.Importing human medicines from […]
Approved Countries Human Medicines
List of approved countries for authorised human medicines on exit day Published 11 March 2019 Contents 1.List of exit day 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 1. List of exit day approved countries If the […]
Veterinary Sector
The veterinary sector and preparing for EU Exit If the UK leaves the EU on 29 March without a deal, there may be changes that affect private, official or abattoir veterinarians. Published 7 March 2019 From: Department for Environment, Food & Rural Affairs Contents Importing and exporting Changes to pet travel Veterinary medicines Your employees […]
MHRA Applications
Making submissions to the MHRA in a no deal scenario If the UK leaves the EU without a deal, submissions related to human medicines would need to be submitted directly to the MHRA. Published 4 March 2019 Last updated 11 March 2019 — see all updates From: Medicines and Healthcare products Regulatory Agency Contents Gaining Access […]
UK Conformity Assessment Cert Guidance
Using the UKCA marking if the UK leaves the EU without a deal Published 2 February 2019 Contents When to use the UKCA marking Using the UKCA marking Using the CE marking Further information The UKCA (UK Conformity Assessed) marking is the new UK product marking that will be used, subject to parliamentary approval, for certain goods […]
Organs Tissues & Cells Guidance
Quality and safety of human organs, tissues and cells if the UK leaves the EU without a deal What you need to do to ensure continued use of human organs, tissues and cells (including reproductive cells) if the UK leaves the EU on 29 March 2019 (may also apply to new exit date on 31 December 2020) without a deal. Published 15 February 2019 From: Department […]
Medical Devices Guidance
Regulating medical devices in the event of a no deal scenario What you need to know about the regulation of medical devices in the UK if we leave the EU with no deal. Published 26 February 2019 From: Medicines and Healthcare products Regulatory Agency Contents Details The legislation The role of the MHRA Role of […]
Further Medicines / Devices Guidance
Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal Updated 26 February 2019 Contents 1.Medicines 2.Medical Devices 3.Clinical Trials of investigational medicinal products 1. Medicines 1.1 How medicines are currently regulated Under the terms of the UK’s membership of the EU, the UK is a full member of […]
Medicines, Medical Devices, Trials (No Deal)
Guidance How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal Updated 3 January 2019 Contents Purpose Before 29 March 2019 (may also apply to new exit date on 31 December 2020) After 29 March 2019 (may also apply to new exit date on 31 December 2020) if there’s no deal Implications More information © Crown copyright 2019 This publication is licensed under the terms of the Open Government Licence v3.0 […]
Medicines and Medical Devices
Businesses supplying medicines and medical devices Updated 21 December 2018 Contents Medical devices and clinical consumables Medical radio-isotopes Batch testing and clinical trials Manufacturer’s Authorisation licences Actions you can take now If the UK leaves the EU without a deal, people should be reassured and have confidence in the government’s plans for continuity of medicines […]
Working in Organs Tissues and Cells
UK licensed establishments working with organs, tissues and cells Updated 21 December 2018 Contents How processes will change Actions you can take now If the UK leaves the EU without any deal on 29 March 2019 (may also apply to new exit date on 31 December 2020), the UK can still import and export organs, tissues and cells from and to EU countries. If you’re a […]
Traders in Drug Precursors
Traders in drug precursor chemicals Updated 21 December 2018 Contents How processes will change How to register and apply for licences Actions you can take now If the UK leaves the EU without any deal on 29 March 2019 (may also apply to new exit date on 31 December 2020), EU regulations on trading in drug precursor chemicals would no longer apply to the UK. The […]
UK Lords Note Medicines
Important Notice- See the Disclaimer Below Brexit Legal, McMahon Legal and Paul McMahon have no liability arising from reliance on anything contained in this article nor on this website Contact McMahon Legal
Pharmacovigilance Qualified Person
Guidance Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) Pharmacovigilance system requirements From: Medicines and Healthcare products Regulatory Agency Published 31 December 2020 Last updated 30 November 2021 — See all updates Contents Guidance on the QPPV for UK authorised products Guidance on the PSMF for UK authorised products Guidance […]
Medicines Regulation UK Parliament
Important Notice- See the Disclaimer Below Brexit Legal, McMahon Legal and Paul McMahon have no liability arising from reliance on anything contained in this article nor on this website Contact McMahon Legal
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 […]
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 […]
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 […]
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 […]
MHRA Approach Recognition Approval 2021 UK Guidance
Guidance Guidance on handling of Decentralised and Mutual Recognition Procedures approved or pending on 1 January 2021 The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP). Published 24 December 2020 From: Medicines and Healthcare products Regulatory Agency Brexit transition: new rules for 2021 […]