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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.
When you can use a designated UK-based conformity assessment body (CAB) to test your goods against the importing market’s regulations.
Submission dates and how the submissions using the EC decision reliance procedure work.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines.
If you're advertising or marketing, including direct marketing, you must be accurate and honest and follow the advertising codes of practice
This playbook explains how we use social media at GDS. In it, we share our best practice, what we've learned and what we're planning to do.
From 13 May 2024 we are introducing a change to the procedure for new Marketing Authorisation (MA) applications, where a joint assessment of labels is requested.
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.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
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
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How to apply for marketing authorisation via this new procedure.
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.
Find out how to apply VAT to charges for postage, delivery services and how to treat direct marketing services involving distribution of printed matter.
How to renew marketing authorisations for products granted through different routes and at different times.
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