Summary of product characteristics
From Ganfyd
The summary of product characteristics (SPC) is part of the package that makes up a licensed drug or medicine. It is, thus, a regulatory requirement that a licensed drug or medicine should have an SPC. The SPC lists the doses and the recognised indications and adverse effects of the product.
SPCs (Summaries of Product Characteristics) are the legally approved summary of a medicine with UK marketing authorisation. Any use of a product outside its indications in the current SPC is legally unlicensed use. However it is more commonly termed out of license or off license use as liability for harm is commonly shared and indeed is unlikely to be found with respect to the medical practitioner where there is a body of reasonable medical opinion that supports such use.
In the USA presently the PiLs has the role of the sole legal medicines information leaflet but in Australasia and Europe simplified information is available to the patient as in Patient Information Leaflets (PILs).
External links
- electronic Data Sheets, Summaries of Product Characteristics (SPCs) and Patient Information Leaflets (PILs) are available from the electronic Medicines Compendium.
- EU regulations EMEA web site
