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:
- Guideline on the excipients in the label and the package leaflet of medicinal products for human use (MEB 8)
- Statement of ‘abbreviated indications’ on OTC medicinal product packaging (MEB 21)
- Nomenclature of pharmaceutical products (MEB 13)
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.