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Information on good laboratory, manufacturing and distribution practice, good pharmacovigilance practice (GPvP), out-of-specification investigations, inspection metrics and fees.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Legal requirements and good practice guidance for Veterinary Practice Premises Inspections.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Guidance on what pharmacovigilance is and compliance issues from previous inspections.
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.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Comply with good pharmacovigilance practice and prepare for an inspection.
News and guidance on veterinary medicines issues affected by coronavirus (COVID-19).
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.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Guidance for industry on flexible approaches we are taking on good distribution practices.
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
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 an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
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