Category Archives: UK Post-Exit Guidance Notes [2020]
Guidance for Great Britain (England, Wales and Scotland) Marketing Authorisation Applications for similar biological products (biosimilars) from 1 January 2021 The guidance is written on the basis of Reg 53 of The ...
Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021 The process to convert Parallel Distribution Notices (PDNs) into Parallel Import Licences (PILs) from 1 ...
Guidance for Great Britain Conditional Marketing Authorisation Applications The MHRA will introduce a national Conditional Marketing Authorisation (CMA) scheme for new medicinal products in Great Britain from 1 ...
Registering new packaging information for medicines from 1 January 2021 How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued Published 1 ...
1. General Approach to the operation of pharmacovigilance This document outlines the submission requirements for pharmacovigilance data from 1 January 2021. The MHRA will retain responsibility for Pharmacovigilance ...
Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, ‘grandfathering’ and managing lifecycle changes This guidance covers ‘grandfathering’ and managing ...
Import from a non-EU country You’ll no longer have access to the EU’s import system TRACES (Trade Control and Expert System) from 1 January 2021. You’ll need to use the UK’s new Import of Products, Animals, Food and ...
Pet Travel This guidance applies to people travelling to the EU with their pet cats, ferrets or dogs, including assistance dogs. Great Britain (England, Scotland and Wales) will become a third country from 1 January ...
Existing UK trade agreements with non-EU countries Trade agreements until 31 December 2020 The UK has left the EU. The Withdrawal Agreement sets out how the UK is able to continue to be covered by EU-third country ...
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 ...
Importing blood or blood components If you import blood or blood components into the UK from the EU, Norway, Iceland or Liechtenstein you must: make sure that each imported unit of blood or blood component is ...
The UK trades in rough diamonds is regulated by the Kimberley Process (KP) Certification Scheme. The EU is a participant of the KP acts on behalf of the UK. 1. Until 31 December 2020 The EU will treat the UK as a ...
ontents Actions for UK satellite broadcasters Broadcast of works transmitted into the UK The EU Satellite and Cable Directive provides a country-of-origin principle for licensing of copyright material in cross-border ...
1. UK-qualified lawyers with businesses in the EU, Norway, Iceland or Liechtenstein If you are a UK lawyer with ownership interests in the EU, Norway, Iceland or Liechtenstein (EEA-EFTA) you need to contact the local ...
Animals, semen and embryos covered by Balai Follow this guidance if you’re moving the following from 1 January 2021: simian primates, monkeys and apes prosimian primates, for example lemurs, bushbabies, lorises, aye ...
Importing and exporting hops and hops products during the transition period Hops marketed in the EU (including the UK) must meet rules on marketing standards. This includes hops extracts, hop cones and ground, ...
Contents Exports from the UK to the EU Exports to non-EU countries (third countries) from the UK Border and customs offices EU listing of the UK and its establishments Documents for transporters Other export ...
Importing and exporting To continue importing and exporting products between the UK and EU you must: Get a UK Economic Operator Registration and Identification (EORI) number. Decide if you want to hire an ...
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 ...
UK residents who want to travel to the EU with their firearms or shotguns will no longer be able to apply for a European Firearms Pass (EFP) from 1 January 2021. Instead, you should check the firearms licensing ...
You will be eligible for broadly the same support as students from the EU member state you are studying in, as long as you are living there by 31 December 2020. UK nationals studying in the Republic of Ireland will ...
Contents The Network and Information Systems (NIS) Directive provides legal measures to boost the overall level of network and information system security in the EU. The UK implemented the NIS Directive through the ...
Rules from 1 January 2021 From 1 January 2021 there will be new arrangements for the movement of waste between the UK and the EU. Notified waste shipments from the UK to the EU from 1 January 2021 The UK is a party ...
Recognition of hallmarks From 1 January 2021, the UK’s obligations to recognise EU hallmarks will end and EU members’ obligations to recognise UK hallmarks will also end. Any product already on the market before ...
Contents Importing through Eurotunnel Exporting through Eurotunnel Contact Border Force The UK will continue to comply with the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). ...
Contents This guidance sets out the actions you should take to prepare for 1 January 2021, to plan for and help manage any potential service disruption to adult social care. This guidance is for adult social care ...
Contents If you import fish to the UK from the EU you’ll need a validated catch certificate from the exporter. If the fish you’re importing has been stored or processed, you may also may need additional documents, ...
Changes to export rules for identifying livestock You currently use the country code ‘UK’ on ear tags on livestock. To export livestock to the EU from 1 January 2021, you’ll need to make sure your livestock are also ...
What counts as a composite food product Composite food products are for human consumption only. They contain a mix of: processed products of animal origin (POAO) plant products used as a main ingredient – not ...
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