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What is an SPC?
An SPC is a legal document containing factual information about a medicinal product, based on data generated during the development of the product. It forms an integral part of the marketing authorisation.* European Union (EU) law requires that an SPC is available for every licensed medicine (including generics) marketed in a member state. 1 The availability of an SPC is therefore a marker of a licensed medicine. There is a separate SPC for each form and strength of a medicine; 2 however, for convenience and for presenting the information to healthcare professionals, a drug company may amalgamate SPCs for a range of strengths and formulations. 2 After a medicine has been licensed, the SPC is updated from time to time as more becomes known about the product.
What's in an SPC?
The information in an SPC is presented in standard numbered sections and subsections (see box on page 57). The broad contents are determined by EU law, 1 but advice on the detailed presentation of the information in SPCs is set out in European Commission (EC) guidance (last updated in October 2005, and currently being revised). 2 At the end of the SPC, there is a statement of the legal category of the medicine in the UK (i.e. whether prescription-only medicine [POM], pharmacy [P] or general sales list [GSL]).
A black triangle printed next to the name of a medicine on an SPC in the UK indicates that the Medicines and Healthcare products Regulatory Agency (MHRA) is closely monitoring the product to increase understanding of its safety and to identify rapidly any previously unrecognised unwanted effects. 3 A black triangle signals to the healthcare professional that the medicine is being intensively monitored, and that all adverse events suspected to be associated with the medicine, regardless of severity, should be reported. Most SPCs for medicines identified in the scheme do include a black triangle, but its inclusion is not a legal requirement, and there have been recorded instances of omission of the symbol. 3
Who writes the SPC?
The company applying for authorisation to market the medicine drafts the SPC but the wording must be approved by the regulatory authority (the European Medicines Agency [EMEA] or the MHRA in the UK)....