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Who in the pharmaceutical industry can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
If you're advertising or marketing, including direct marketing, you must be accurate and honest and follow the advertising codes of practice
All marketing and advertising must be: an accurate description of the…
Advertising to consumers The Consumer Protection from Unfair Trading…
There are 2 advertising codes of practice that describe how businesses…
You must describe your product accurately. This means if you make a claim…
You must check if customers want to be contacted by fax, phone, post or…
Submission dates and how the submissions using the EC decision reliance procedure work.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
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.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
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.
Quality and labelling rules for growing, packing, distributing, importing and selling fresh fruit and vegetables.
Marketing authorisations granted in 2024
Find out how to apply VAT to charges for postage, delivery services and how to treat direct marketing services involving distribution of printed matter.
Placing a veterinary medicine on the market, including non-medicinal products, medicinal words and phrases, how to obtain advice, report non-compliance.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
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.
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.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Submissions related to human medicines need to be submitted directly to the MHRA.
Don’t include personal or financial information like your National Insurance number or credit card details.
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