Importing Unlicensed Medicines From Canada Into the UK: What an Importer Must Hold
For UK importers and specials pharmacies: the regulation 167 exemption, WDA(H) and MHRA import notification, why Canadian DIN products are a practical source, and the document pack Nexara Health supplies.
The UK route
A medicine without a UK marketing authorisation may be supplied to meet the special clinical needs of an individual patient — a "special" — under the exemption in the Human Medicines Regulations 2012 [1]. Imported unlicensed medicines must come through an importer holding an MHRA wholesale dealer's licence (WDA(H)) that covers this activity, and the importer must notify the MHRA before each import; the MHRA can object within 28 days [2].
What the importer must do
- Hold a WDA(H) with the relevant unlicensed-medicine import authorisation [2].
- Submit the MHRA import notification for the product, source and quantity [2].
- Keep records that allow the product to be traced to the patient-specific need, and report adverse reactions [1].
Why Canada as a source
Canadian products carry a Health Canada DIN, bilingual labelling, and come from Health Canada-licensed establishments; the Canadian Drug Product Database gives the UK importer an authoritative record to cite in the notification [3]. Where a molecule is short in the UK but marketed in Canada with several generics, Canada is often the quickest regulated source.
Documents Nexara Health supplies to a UK importer
Health Canada DPD record for the DIN; Certificate of Analysis; batch and expiry; the Canadian DEL of the exporter (DEL #3-002896); a validated temperature record for cold-chain goods; and a commercial invoice in the importer's name. Notification is filed by the UK importer; Nexara Health does not supply directly to UK pharmacies or patients.
Related data
Check the UK price and availability context on the molecule's [supply graph](/molecule/adalimumab/suppliers) and the destination rules on the [UK import route page](/import).
Sources
[1] Human Medicines Regulations 2012, regulation 167 (supply to fulfil special patient needs) — https://www.legislation.gov.uk/uksi/2012/1916/regulation/167
[2] MHRA, Import a medicine that does not have a UK licence (unlicensed medicines: importer notification) — https://www.gov.uk/guidance/import-a-human-medicine
[3] Health Canada, Drug Product Database — https://health-products.canada.ca/dpd-bdpp/