Medicines: get scientific advice from the MHRA
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Official website: gov.uk00
Requirements
You need to send the MHRA a list of questions you need advice on before we can give advice. Your final questions list should focus on the future development, variation or risk management plan for your medicinal product. Questions should focus on specific scientific issues such as: quality aspects, for example, chemical, pharmaceutical and biological testing to show the quality of a medicinal product non-clinical aspects, for example, toxicological and pharmacological testing to show the safety of a medicinal product clinical aspects, for example, endpoints, trial duration, target population, choice of comparator pharmacovigilance plans and post-authorisation safety study protocols applications for variations or renewals advice before publishing advertisements for a medicinal product changes to labelling or packaging leaflets for medicinal products or a product range
Fees
UK-based small and medium-sized enterprises ( SMEs ) with approved SME status do not have to pay for scientific advice. This is according to the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020. SMEs must apply for SME status from the MHRA to be eligible for this fee waiver.
Official source
Medicines: get scientific advice from the MHRA
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