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There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Information for patients, healthcare professionals and developers of new medicines
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
Guidance on using non-investigational medicinal products in a clinical trial.
The epidemiology, symptoms, diagnosis and management of human T-cell lymphotropic virus types 1 and 2 (HTLV-1 and HTLV-2).
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Explains changes to drug driving law and the guidance available for healthcare professionals and users of prescription medicine.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Information on taking, submitting and processing samples which potentially contain MPXV.
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