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Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
A form of IP that extends the protection of patented active ingredients present in pharmaceutical or plant protection products.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
You must get permission to export certain drugs and medicines.
How the MHRA makes decisions on what is a medicinal product (borderline products).
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
The process for the simultaneous review of veterinary medicine submissions by New Zealand’s Ministry for Primary Industries (MPI) and the UK's Veterinary Medicines Directorate.
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