Category Archives: Medicines
Guidance From 1 January 2021 Application and Authorisation Process explainer Guidance for the pharmaceutical industry on how to apply for and manage an authorisation to place a veterinary medicine on the UK market ...
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 Veterinary medicinal products placed on the EU and NI markets before 1 January 2021 Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the ...
Guidance Updated guidance on pharmacovigilance procedures Updated 27 October 2020 New rules for January 2021 The UK has left the EU, and the transition period after Brexit comes to an end this year. This page tells ...
Guidance Renewing Marketing Authorisations for medicines from 1 January 2021 The way Marketing Authorisations (MAs) are processed will change from 1 January 2021. Published 1 September 2020 Last updated 27 October ...
Guidance Guidance note on new assessment routes from 1 January 2021 New routes for assessment including an accelerated procedure and rolling review. Published 27 October 2020 From: Medicines and Healthcare products ...
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 From: Medicines and ...
Guidance Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing Authorisations (MAs) Published 26 October 2020 New rules for January 2021 The UK has left the EU, and the transition period ...
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 1 January 2021 Adverse Event Reporting, Periodic Safety Update Reports and concerns Guidance for the veterinary pharmaceutical industry on Pharmacovigilance reporting. This guidance will be updated with more ...
Guidance 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 ...
Guidance Supplying medicines to Northern Ireland from 1 January 2021 What you need to do to supply authorised medicines from Great Britain to Northern Ireland. Published 1 October 2020 Last updated 20 October 2020 ...
Guidance Sourcing medicines for the Great Britain market from an approved country for import or Northern Ireland from 1 January 2021 The actions to take for sourcing medicines in different circumstances. Published 1 ...
Guidance Importing Investigational Medicinal Products (IMP) from countries on a list to Great Britain Updated 20 October 2020 New rules for January 2021 The UK has left the EU, and the transition period after Brexit ...
Guidance Acting as a Responsible Person (import) from 1 January 2021 From 1 January 2021, a wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain ...
Guidance Trading in drug precursors from 1 January 2021 Published 14 October 2020 New rules for January 2021 The UK has left the EU, and the transition period after Brexit comes to an end this year. This page tells ...
Guidance Supplying medicines to Northern Ireland from 1 January 2021 What you need to do to supply authorised medicines from Great Britain to Northern Ireland. Published 1 October 2020 From: Medicines and Healthcare ...
Guidance List of approved countries from 1 January 2021 Updated 25 September 2020 New rules for January 2021 The UK has left the EU, and the transition period after Brexit comes to an end this year. This page tells ...
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