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Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to apply for marketing authorisation via this new procedure.
Guidance for prescribing vets on the use of the cascade.
Reported problems with the supply of an animal medicine and the date when the issue is expected to be resolved.
Check the tariff classification for a defined daily dose of active substances.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
Submission dates and how the submissions using the EC decision reliance procedure work.
Guidance for manufacturers and distributors of premixtures and feedingstuffs containing veterinary medicines or specified feed additives.
Your rights and security searches, body scans and privacy rules if you're disabled or taking medication aboard aircraft
When entering the UK, you need to prove your medicine is prescribed to you if it contains a controlled drug - find out what proof you need to get.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
Data on the real-world efficacy of the COVID-19 vaccines.
Dose of nicotine delivered & uptake and consistency of dose.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Guidance for industry on flexible approaches we are taking on good distribution practices.
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
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