Medicines Healthcare Products Regulatory Agency
January 29
09:01
2025
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This Medicines and Healthcare products Regulatory Agency (MHRA) guidance is for those who want to manufacture, import, distribute or supply unlicensed medicines for human use (also known as specials), includingCBPMs.
Specials are products which have been specially manufactured or imported for the treatment of an individual patient after being ordered by a:
- doctor
- dentist
- nurse independent prescriber
- pharmacist independent prescriber
- supplementary prescriber
Persons authorised to procure unlicensedCBPMsin the UK are:
- doctors on the GMC Specialist Register
- specialist Importers with a Home Office import and Domestic licence and MHRA licence
- registered pharmacies or retail pharmacy businesses (with Home Office Domestic licences, where appropriate)
- licensed wholesale dealers for supply to the order of any of the above