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How to apply for marketing authorisation via this new procedure.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
How to market forest reproductive material (FRM) for forestry purposes, including regulations, registration, master certificates and licences.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
What you need to do to comply with regulations on manufactured goods you place on the Northern Ireland market.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Find out if you need to use the UKCA (UK Conformity Assessed) marking on products you manufacture or handle.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
How the MHRA processes variations to Marketing Authorisations (MAs)
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
How to renew marketing authorisations for products granted through different routes and at different times.
Lists of standards that businesses can use to show their products, services or processes comply with essential requirements of legislation.
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
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