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Submission dates and how the submissions using the EC decision reliance procedure work.
How the MHRA processes variations to Marketing Authorisations (MAs)
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
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.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines.
How to renew marketing authorisations for products granted through different routes and at different times.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021.
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.
This strategy sets out Public Health England's 3-year strategic framework.
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.
This strategy sets out Public Health England's 3-year strategic framework and planned calendar of activity from 2014 to 2017.
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.
If you're advertising or marketing, including direct marketing, you must be accurate and honest and follow the advertising codes of practice
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Don’t include personal or financial information like your National Insurance number or credit card details.
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