Monthly Archives: February 2014

Feb 4

Linguistic review of SmPCs, Labels and PILs in the marketing authorisation process

What comprises regulatory documentation All pharmaceutical products which receive marketing authorisation in the EU are to be accompanied by specific regulatory documentation. This includes summaries of product characteristics (SmPCs), patient information leaflets (PILs) and labels. SmPCs are official descriptions of drugs. They include information such as: pharmaceutical form, indications, method of administration, pharmacological properties, etc. […]

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