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Unlicensed Medicines

Unlicensed Medicines. 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

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Unlicensed Medicines

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  1. Unlicensed Medicines Kate Fox Commercial Manager BCM Specials Ltd

  2. 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 MEDICINES WHERE TO START ?

  3. So what is a Special ? • 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

  4. Hierarchy of Unlicensed Medicines

  5. Supplier Responsibility • 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

  6. So Where Does Pharmacy Fit In? • 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

  7. Record Keeping 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

  8. Documentation • Unlicensed Imports • Translated PIL • Over Label • Manufactured Specials • Batched Manufactured Specials – Certificate of Analysis • Bespoke Manufactured Specials – Certificate of Conformity

  9. NHS Changes • 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

  10. Question Time ! ! Any Questions ?

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