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Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
Guidance on transitional arrangements for the Clinical Trials Regulations.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
An overview of the process to get a marketing authorisation (MA), including submitting, fast-tracking an application, naming your medicine and paying fees.
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
How to get access to MHRA submissions portals, how to use them, where to go for help.
Guidance on using non-investigational medicinal products in a clinical trial.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Guidance on clinical trials that are categorised as ‘notifiable’.
Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'
Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal products in clinical trials.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
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