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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.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
You must get permission to export certain drugs and medicines.
The CMU is part of the Medicine, Pharmacy and Industry Group of DHSC which looks at supply and procurement in hospitals.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
How to use PharmaQC to access pharmaceutical suppliers, Quality Control (QC) pharmacists and Commercial Medicines Unit (CMU) buyers.
Information for patients, healthcare professionals and developers of new medicines
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
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