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How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
How the MHRA processes variations to Marketing Authorisations (MAs)
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
If you're advertising or marketing, including direct marketing, you must be accurate and honest and follow the advertising codes of practice
Pharmacovigilance system requirements
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Declaration for approval under Commission Regulation 1019/2002.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
Use this form to notify the IPO of marketing authorisation for a medicinal or plant protection product, granted after your application for an SPC for that product.
Submission dates and how the submissions using the EC decision reliance procedure work.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Apply for a public health exemption from the sunset clause.
The actions to take for sourcing medicines in different circumstances.
How to renew marketing authorisations for products granted through different routes and at different times.
Quality and labelling rules for growing, packing, distributing, importing and selling fresh fruit and vegetables.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines.
Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021.
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