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Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
How the MHRA processes variations to marketing authorisations.
How we review the information landlords are required to send to us
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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