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Detailed guidance, regulations and rules
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Data, Freedom of Information releases and corporate reports
Guidance for the pharmaceutical industry on who can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
Submission dates and how the submissions using the EC decision reliance procedure work.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
If you're advertising or marketing, including direct marketing, you must be accurate and honest and follow the advertising codes of practice
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
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.
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.
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.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
If you import, manufacture, process, distribute or sell plant protection products (PPPs) for professional use in Great Britain, register to comply with regulations.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Steps to help grow your business - finding finance, mentors, increasing sales and developing products and services
Marketing authorisations (MAs) granted since January 2014.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How to renew marketing authorisations for products granted through different routes and at different times.
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