Child Protection EU

Fighting child sexual abuse Directive 2011/93/EU — combating sexual abuse and sexual exploitation of children and child pornography It aims at improving the protection of children from sexual abuse and exploitation. To achieve this, it obliges EU countries to: adopt prevention measures; protect child victims; investigate and prosecute offenders. Key Points To facilitate the prosecution […]

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Falsified Medicines Directive

Guidance Implementing the Falsified Medicines Directive: Safety Features How to prepare for implementation and compliance of the Safety Features Regulation. From: Medicines and Healthcare products Regulatory Agency Published 24 October 2018 Last updated 22 December 2021 — See all updates Contents Introduction How the Falsified Medicines Directive works Guidance and useful resources Print this page Introduction […]

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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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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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NHS Migrants’ Guide

NHS entitlements: migrant health guide Advice and guidance for healthcare practitioners on the health needs of migrant patients. From: Public Health England Published 31 July 2014 Last updated 28 June 2021 — See all updates Contents What this guidance is for NHS entitlements animation Summary of changes after the Brexit transition period COVID-19 testing, treatment and […]

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EU Withdrawal Note Substance Human Origin

Brussels, 23 January 2018 NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF SUBSTANCES OF HUMAN ORIGIN (BLOOD, TISSUES AND CELLS, AND ORGANS) 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 […]

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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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Migrants & NHS UK Post Deal Guidance

Guidance NHS entitlements: migrant health guide Advice and guidance for healthcare practitioners on the health needs of migrant patients. From: Public Health England Published: 31 July 2014 Last updated: 1 March 2021, see all updates Contents What this guidance is for Summary of changes after the Brexit transition period COVID-19 testing, treatment and vaccination Free services […]

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NHS + Migrants UK Post-Deal Guidance

Published 31 July 2014 Last updated 21 January 2021 — see all updates From: Public Health England Contents What this guidance is for Summary of changes after the Brexit transition period COVID-19 testing and treatment Free services GP services Immigration health surcharge Hospital treatment Dental treatment Special groups Data sharing Resources Print this page What this […]

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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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Healthcare EU Citizens UK Post-Deal Guidance

Guidance Healthcare for visitors to the UK from the EU Information on accessing healthcare for visitors to the UK from EU countries, Norway, Iceland, Liechtenstein and Switzerland. From: Department of Health and Social Care Published: 19 March 2019 Last updated: 9 March 2021, see all updates Contents Coronavirus (COVID-19) testing and treatment What you 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. From: Department of Health and Social Care Published 31 January 2020 Last updated 27 May 2021 — See all updates Contents Quality […]

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VAT Health Sector UK Post-Deal Guidance

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 31 December 2020 — see all updates From: HM Revenue & Customs Contents 1. Overview 2. Medical services provided by registered […]

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UK Healthcare EU Citizens UK Post-Deal Guidance

Guidance Healthcare for EU citizens living in or moving to the UK Information on accessing healthcare for citizens from EU countries, Norway, Iceland, Liechtenstein and Switzerland living in or moving to the UK. Published 19 March 2019 Last updated 31 December 2020 — see all updates From: Department of Health and Social Care Contents What you […]

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Health UK Citizens in Ireland UK Post-Deal Guidance

Guidance Healthcare for UK nationals living in Ireland How to get state healthcare if you’re living, working or studying in Ireland. From: Department of Health and Social Care, Foreign & Commonwealth Office, and Foreign, Commonwealth & Development Office Published 28 August 2019 Last updated 21 October 2021 — See all updates Contents Stay up to date Ways to […]

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EU Health Programme UK Post-Deal Guidance

Guidance EU Third Health Programme (Health for Growth) funding Information for UK and EU organisations about existing and future funding. Published 31 December 2020 From: Department of Health and Social Care Print this page This guidance is for UK organisations such as universities and businesses that currently receive Third Health Programme funding. It is also […]

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Health Care Qualifications Regs HL Report

European Qualifications (Health and Social Care Professions) (EFTA States) (Amendment etc.) (EU Exit) Regulations 2020 In Focus Published Friday, 13 November, 2020 In Focus Brexit & the EU Health Emily Haves There is currently a system for mutual recognition of health and social care qualifications within and between European Economic Area states and Switzerland. The UK […]

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Healthcare for UK Visitors in EU UK Post-Deal Guidance

Guidance Healthcare for UK nationals visiting the EU How to get state healthcare when you’re on holiday or travelling to a country in the EU, Iceland, Liechtenstein, Norway or Switzerland. From: Department of Health and Social Care and Foreign, Commonwealth & Development Office Published 28 January 2019 Last updated 1 November 2021 — See all updates Contents Coronavirus […]

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Healthcare for EU Visitors UK Post-Deal Guidance

Guidance Healthcare for visitors to the UK from the EU Information on accessing healthcare for visitors to the UK from EU countries, Norway, Iceland, Liechtenstein and Switzerland. From: Department of Health and Social Care Published 19 March 2019 Last updated 1 November 2021 — See all updates Contents Coronavirus (COVID-19) testing and treatment What you need […]

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Healthcare for EU Citizens UK Post-Deal Guidance

Guidance Healthcare for EU citizens living in or moving to the UK Information on accessing healthcare for citizens from EU countries, Norway, Iceland, Liechtenstein and Switzerland living in or moving to the UK. From: Department of Health and Social Care Published 19 March 2019 Last updated 1 November 2021 — See all updates Contents What you […]

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UK Commons Committee Pharma Sector

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 

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UK Commons Committee Medicine

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UK Commons Committee Health Social Care

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Children’s Services

Brexit: no deal preparations for local authority children’s services in England Advice to local authority children’s services in England on how to prepare in the event that the UK leaves the EU without a deal. Published 15 March 2019 Last updated 19 August 2019 — see all updates From: Department for Education Applies to: England […]

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Health Sector Impact

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 

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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 […]

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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 

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UK Lords Note NHS and Trade Deals

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UK Lords Note Health and Welfare

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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 

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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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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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NHS Charges Overseas Visitors 2021 UK Guidance

Guidance How the NHS charges overseas visitors for NHS hospital care Updated 10 February 2020 Contents Visitors to the UK from the EEA/Switzerland People living in the EU whose healthcare costs are funded by the UK EEA and Swiss citizens resident in or moving to the UK People living outside the EEA and Switzerland Health […]

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Substances Human Origin EU Guidance 2021

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Brussels, 8 June 2020 REV2 – replaces the notice (REV1) dated 23 January 2018 NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF SUBSTANCES OF HUMAN ORIGIN (BLOOD, TISSUES AND CELLS, ORGANS) Since 1 February 2020, the United Kingdom has withdrawn […]

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Tobacco Products EU Guidance 2021

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Brussels, 8 May 2020 REV1 – replaces the notice dated 7 October 2019 NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES ON TOBACCO AND RELATED PRODUCTS Since 1 February 2020, the United Kingdom has withdrawn from the European Union and has become a “third […]

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Clinical Trials EU Guidance 2021

EUROPEAN COMMISSION Directorate-General for Health and Food Safety Brussels, 7 May 2020 REV1 – replaces the notice dated 6 September 2018 NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF CLINICAL TRIALS Since 1 February 2020, the United Kingdom has withdrawn from the European Union and has become a […]

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Healthcare EU Citizens in UK 2021 UK Guidance

Guidance Healthcare for EU citizens living in or moving to the UK from 1 January 2021 Information on accessing healthcare for citizens from EU countries, Norway, Iceland, Liechtenstein and Switzerland living in or moving to the UK from 1 January 2021. Published 17 December 2020 From: Department of Health and Social Care New rules for […]

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Medical Devices Registration 2021 UK Guidance

Guidance Register medical devices to place on the market 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 11 December 2020 From: Medicines and Healthcare products Regulatory Agency New rules for […]

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EU Health Professionals 2021 UK Guidance

Guidance EEA-qualified and Swiss healthcare professionals practising in the UK from 1 January 2021 Guidance for European Economic Area (EEA)-qualified and Swiss healthcare professionals practising in the UK after the end of the transition period on 31 December 2020. Published 26 November 2020 From: Department of Health and Social Care New rules for January 2021 […]

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E-Cigarettes

Guidance Placing an e-cigarette on the market from 1 January 2021 From 1 January 2021, new rules mean notifications from Great Britain and Northern Ireland will need to be sent to different routes Published 24 November 2020 From: Medicines and Healthcare products Regulatory Agency Contents Guidance on the submission and content of notifications for Great […]

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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 Health Care Medicines 2021 UK Guidance

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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Medical Devices 2021 UK Guidance

Guidance Regulating medical devices from 1 January 2021 What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets from 1 January 2021. Published 1 September 2020 Last updated 21 October 2020 — see all updates From: Medicines and Healthcare products Regulatory Agency New rules for […]

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Orphan Medical Products 2021 UK Guidance

How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB) The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application. Published 1 October 2020 From: Medicines and Healthcare products Regulatory Agency New rules for January 2021 The UK has left […]

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Healthcare Providers 2021 UK Guidance

Contents This guidance sets out the actions that healthcare providers should take to prepare for 1 January 2021. Doing this will help to plan for and manage potential service disruption to healthcare. This guidance is for commissioners and healthcare providers, including hospitals, care homes, GP practices and community pharmacies. You can also see guidance for adult […]

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Drug Precursors Trade 2021 UK Guidance

Overview Drug precursor chemicals are controlled by the Home Office because they can be used to produce illicit drugs. They can also have legitimate commercial uses. You’ll need to apply for an import and/or export licence when trading with EU countries in certain categories of drug precursor chemicals from 1 January 2021. Current rules for […]

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