Category Archives: Health
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 ...
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 ...
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 ...
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 ...
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. ...
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 ...
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 ...
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 ...
Written Confirmations for export to EEA and Northern Ireland of Active Substances manufactured in Great Britain Published 1 September 2020 New rules for January 2021 The UK has left the EU, and the transition period ...
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021 Pharmacovigilance system requirements from 1 January 2021 Published 4 ...
Overview From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system. ...
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 ...
Responsible Person From 1 January 2021, a wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by the ...
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 ...
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 ...
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 ...
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 ...
Guidance Registering to make submissions to the MHRA from 1 January 2021 Submissions related to human medicines would need to be submitted directly to the MHRA. Published 1 September 2020 From: Medicines and ...
Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021 Importing investigational medicinal products for use in clinical trials from 1 January 2021 Published 1 ...
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