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This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
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.
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.
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Find out how to apply VAT to charges for postage, delivery services and how to treat direct marketing services involving distribution of printed matter.
Form for a business to register seed marketing operations.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
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.
Guidance on applying to renew a marketing authorisation (MA) for a veterinary medicine.
How to set up a public service mutual and 'spin out' of a public service organisation.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
Steps to help grow your business - finding finance, mentors, increasing sales and developing products and services
Information for people who wish to apply to release a vaccine or a blood product to market in the UK.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
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