Medicines and Healthcare Products Regulatory Agency (MHRA)

The MHRA is an executive agency of the Department of Health and Social Care, regulating medicines, medical devices and blood components in the United Kingdom. It grants marketing authorisations, inspects manufacturers, classifies products for supply and runs safety surveillance through the Yellow Card scheme. Supply classification under the Human Medicines Regulations 2012 runs in three tiers: prescription-only, pharmacy medicine sold under a pharmacist's supervision, and general sale. Therapeutic peptides sit in the first.

Its position changed after the United Kingdom left the European Union. From 2021 it became a standalone national regulator rather than part of the EU centralised system, first running reliance routes on EU decisions and later replacing them with the International Recognition Procedure, which shortens assessment where a trusted reference regulator has already approved it. Northern Ireland was subsequently brought under UK-wide licensing. These routes have been revised more than once, so the procedure applying to any given product should be checked on the MHRA's own pages.

For a reader the MHRA is a second independent read on the same molecule. Its assessment reports sit alongside FDA and EMA documents, and where the three diverge on an indication, a population restriction or a warning, the reasoning is usually visible in them. Yellow Card, open to patients as well as professionals, captures a different slice of safety data.

The claim to check is MHRA approved. Devices are registered rather than licensed on efficacy grounds, food supplements are not MHRA products at all, and a site manufacturing licence says nothing about any particular product. The British National Formulary is likewise cited as regulatory authority; it is a professional reference, not a licensing document.