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Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines.
Letting people know your services are available on the Digital Marketplace.
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.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
Guidance on applying to renew a marketing authorisation (MA) for a veterinary medicine.
How to renew marketing authorisations for products granted through different routes and at different times.
Guidance for the pharmaceutical industry on who can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Pharmacovigilance system requirements
Guidance for suppliers of cloud technology, digital outcomes, user research studios and user research participants.
Find out how to apply VAT to charges for postage, delivery services and how to treat direct marketing services involving distribution of printed matter.
This playbook explains how we use social media at GDS. In it, we share our best practice, what we've learned and what we're planning to do.
Submissions related to human medicines need to be submitted directly to the MHRA.
How to apply for marketing authorisation via this new procedure.
Marking, labelling and marketing standards you must follow to import and export plant seeds, food and manufactured goods.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
The UK government's design principles and examples of how they've been used.
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.
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