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Before making a submission to the Scottish Medicines Consortium (SMC), the Marketing Authorisation Holder should initially consult the Guidance to Manufacturers on Medicines outwith SMC Remit.
A generic medicine is considered to be outwith SMC remit.
A branded generic medicine (or combination product) is considered to be outwith SMC remit:
- if an equivalent generic medicine is already available in the UK for the same indication and via the same route of administration
- if the branded generic costs the same or less than the originator product which has previously been accepted by SMC for the same indication (or was licensed in the UK prior to January 2002).
Generic medicine: a pharmaceutical product that is produced when the patent on the original (reference) medicinal product has expired within a Member State of the European Union (EU) and is labelled with an approved name. It is bioequivalent to the reference product and contains the same active ingredient at the same strength, in the same pharmaceutical form and is used to treat the same disease. A generic medicine may have different non-active ingredients and may differ in shape or size. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly with regard to safety and/or efficacy. A generic application can be submitted in a Member State where the reference medicinal product has never been authorised.
Branded generic medicine: a generic medicine that has been given a brand name.
Reference medicinal product: a product which is approved in the EU by the licensing authority based on a full dossier of quality, safety and efficacy data and against which the generic is compared.