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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.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Following MHRA approval of a clinical trial, a study on Nuwiq, a recombinant FVIII therapy for the treatment of haemophilia A, can proceed.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
Information for patients, healthcare professionals and developers of new medicines
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (7 March 2024) approved the medicine ganaxolone (Ztalmy) as the first anti-seizure medication in the UK to treat cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).
How the MHRA makes decisions on what is a medicinal product (borderline products).
You must get permission to export certain drugs and medicines.
How veterinary medicines can be advertised.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Following its Phase 1 investigation, the CMA has found that Theramex's proposed purchase of Femoston and Duphaston could reduce competition and choice for hormone replacement therapy treatments.
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