Kate Fox
Commercial Manager
BCM Specials Ltd
Conditions of manufacture and supply of unlicensed medicinal products
• Bona fide unsolicited order
• Product formulated to the requirement of the prescriber and is
used for their individual patients on their direct responsibility
• Special manufacturer must hold MHRA Manufacturer’s Specials
License
• A special may not be advertised or supplied if an equivalent
licensed product is available
• Essential records must be kept and serious adverse drug
reactions reported to the MHRA

Unlicensed imported Medicine
◦ Product with a license in it’s country of origin
◦ A non UK made unlicensed medicine or food
supplement

Special Manufacture
◦ Manufactured under a Specials License issued by
the MHRA
◦ Manufactured under the Medicines Act Section 10 –
by a pharmacy itself or a supplier known as
extemporaneous dispensing
UK Licensed
Medicine
Off Label Use of
UK Licensed
Medicine
Imported Product Licensed
in the Country of Origin
UK Manufactured ‘Special’ made under
an MHRA Specials License
An extemporaneously dispensed medicine
(under section 10)
An Imported Product not licensed in the country of origin
A non-UK made unlicensed medicine or food supplement

Licensed Medicine
◦ Used in compliance with the license and SPC then
manufacturer assumes responsibility

Unlicensed Medicine
◦ No SPC so prescriber takes full responsibility in law
for any adverse effect caused by the medicine
unless if can be demonstrated that the medicine
was faulty

Pharmacy who orders the medicine has a
responsibility to ensure
◦ Medicine supplied meets prescribers requirements
◦ Medicine is fit for patient use
◦ Responsible for formulation, bioavailability and
stability of product
◦ Record keeping – correct documentation supplied
with product
Any person supplying unlicensed medicines
must keep the following records for 5 years
Source of the special – manufacturer /supplier
Quantity and date which supplied
Patient details
Batch Number
C of A / C of C (manufactured special only)
Details of any adverse drug reaction

Unlicensed Imports
◦ Translated PIL
◦ Over Label

Manufactured Specials
◦ Batched Manufactured Specials – Certificate of
Analysis
◦ Bespoke Manufactured Specials – Certificate of
Conformity

MHRA Review of Unlicensed Medicines
◦ introduced over label of imported medicines as
standard (not legal requirement)

NHS Tenders
◦ Driving quality assurance for trusts
◦ Reducing work loads for trusts / suppliers
◦ Ensuring value for money for the NHS
Any Questions ?