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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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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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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  Share this article

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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  Share this article

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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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