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 Manufacturers 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 its 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 ?