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Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
A guide to collecting data about your packaging. This is for UK organisations affected by extended producer responsibility (EPR) for packaging.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
How the MHRA processes variations to marketing authorisations.
Who in the pharmaceutical industry can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
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