Nomenclature, excipients, abbreviated indications

The regulations related to the labelling and package leaflets of pharmaceutical products is set out in Directive 2001/83/EC of the European Commission and in the Medicines Act.

The following documents are also relevant when drafting a good SmPC, package leaflet or labelling text:

Please contact the secretariat of the Pharmacotherapeutic group under which your product falls for specific dossier related questions and questions of a more technical nature.