The British Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use (CBPMs), known as “specials”. Amongst others, the MHRA will require a valid GMP certificate for the site of manufacture.
What are “Specials”?
According to the MHRA, “Specials” are products which have been specially manufactured or imported for the treatment of an individual patient after being ordered by adoctor, dentist, nurse / pharmacist (independent prescriber) or supplementary prescriber.
Persons authorized to procure unlicensed CBPMs in the UK are:
- Doctors on the GMC Specialist Register,
- Special Importers,
- Registered pharmacies,
- Licensed wholesalers.
The MHRA published two related documents for the supply of unlicensed
- medicinal products ‘specials’, MHRA guidance note 14, and
- cannabis-based products for medicinal use in humans.
According to MHRA Guidance Note 14, “the requirement for a “special need” relates to the special clinical needs of an individual patient. It does not include reasons of cost, convenience or operational needs“.
Is a QP required?
The cannabis product has to be procured from a manufacturer / importer with a GMP certificate authorized by the Licensing Authority. The manufacturing / assembly site will be inspected for GMP compliance. This requires that manufacture or assembly is carried out under the supervision of appropriately qualified staff, including a named quality controller and a production manager, who are acceptable to the Licensing Authority. However, a Qualified Person (QP) is not required to be named on a Manufacturer’s (Specials) Licence for release of a finished unlicensed product. The release of “specials” should be performed by the quality controller or a nominated deputy. The product should, in particular, comply with the relevant requirements and monographs of the British Pharmacopoeia (BP).
According to the agency, in addition to confirming GMP compliance during inspections, a GMP Inspector will also take account of
- Product specifications,
- Stability data and justification for expiry dating,
- Evidence to support GACP compliance (Good Agricultural and Collection Practice).
Furthermore, the document for cannabis-based products includes 4 Annexes providing:
- A Flowchart on the process for prescribing, supplying & importing cannabis-based medicinal products,
- Guidance on the hierarchy for the use of unlicensed medicines,
- Packaging requirements: specific provisions for the dispensing label,
- A Supply Chain Checklist (e.g. valid GMP certificate for the site of manufacture / from the importer; valid Certificate of Analysis (CoA); record keeping; reporting of adverse reactions; dispensing label).
Please find more detailed information in the Guidance on the Supply of unlicensed medicinal products (specials) available at GOV.UK.