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How to renew marketing authorisations for products granted through different routes and at different times.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
How to apply for marketing authorisation via this new procedure.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
How to market forest reproductive material (FRM) for forestry purposes, including regulations, registration, master certificates and licences.
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
The way you apply to licence biological products has changed
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
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 guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
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 how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Marking, labelling and marketing standards you must follow to import and export plant seeds, food and manufactured goods.
Use this form to transfer a product licence, also known as a marketing authorisation, to a different owner.
Marketing standards for poultry meat producers, manufacturers, retailers and distributors.
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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