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Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
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 processes variations to Marketing Authorisations (MAs)
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
These published standards relate to a number of KPIs in the VMD Deliverables and KPI document.
Who in the pharmaceutical industry can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
How to apply for marketing authorisation via this new procedure.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
How to change the ownership from one marketing authorisation (MA) holder to another.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Guidance for the pharmaceutical industry on how to apply for an authorisation to place a veterinary medicine on the UK market or part of, or to expire one.
The Veterinary Medicines Directorate may suspend or expire a licence to market an animal medicine if it fails to comply with the regulations.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Submission dates and how the submissions using the EC decision reliance procedure work.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
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