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Data, Freedom of Information releases and corporate reports
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 who 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.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Letters sent by the Competition and Markets Authority (CMA) to companies about their non-compliance with market investigation orders and undertakings.
How to apply for marketing authorisation via this new procedure.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
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.
Submissions related to human medicines need to be submitted directly to the MHRA.
Decision for applicant Oracle International Corporation against registration number 15156394, applicant successful.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
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.
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.
Quality and labelling rules for growing, packing, distributing, importing and selling fresh fruit and vegetables.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
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