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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…
Find out the rules from 1 January 2018 if you promote or use arrangements that are meant to give someone a VAT or other indirect tax saving or a tax deferral.
Submission dates and how the submissions using the EC decision reliance procedure work.
How the MHRA processes variations to Marketing Authorisations (MAs)
Pharmacovigilance system requirements
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
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.
How to renew marketing authorisations for products granted through different routes and at different times.
Placing a veterinary medicine on the market, including non-medicinal products, medicinal words and phrases, how to obtain advice, report non-compliance.
How to contact MHRA for specific services or enquiries.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
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 Marketing Authorisations for veterinary medicines in the UK.
How to market, trial and release GMOs.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Marketing authorisations (MAs) granted since January 2014.
Submissions related to human medicines need to be submitted directly to the MHRA.
How a marketing authorisation holder should report a defect with a veterinary medicine.
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