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Who in the pharmaceutical industry can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
If you're advertising or marketing, including direct marketing, you must be accurate and honest and follow the advertising codes of practice
All marketing and advertising must be: an accurate description of the…
Advertising to consumers The Consumer Protection from Unfair Trading…
There are 2 advertising codes of practice that describe how businesses…
You must describe your product accurately. This means if you make a claim…
You must check if customers want to be contacted by fax, phone, post or…
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
The seeds which must be certified before you can market them, how to get them certified and how to get a licence for your seed business.
Find out what makes a person an enabler of tax avoidance, and what to do about legally privileged communications.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
How the MHRA processes variations to Marketing Authorisations (MAs)
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
Guidance for the pharmaceutical industry on how to apply for an authorisation to place a veterinary medicine on the UK market or part of, or to expire one.
Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the EU and UK markets before 1 January 2021 and the evidence you may need to provide.
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