Dossier requirements

A company has to submit a dossier for the evaluation of a medicinal product. This dossier, which has to meet current European requirements concerning content and layout, consists of five modules.

  • Module 1 contains administrative data, including the Summary of Product Characteristics, the package leaflet and the labelling text. In European jargon ‘SmPC’ is mostly used as abbreviation for ‘Summary of Product Characteristics’. This documents holds the most important scientific data about the medicinal product for doctors and pharmacists.
  • Module 2 includes the summaries of the chemical-pharmaceutical, pharmacological-toxicological and the clinical-pharmacological dossier.
  • Module 3 consists of the chemical-pharmaceutical data, i.e. all data about the composition and preparation as well as quality control of a medicinal product.
  • Module 4 consists of pharmacological toxicological data. This includes all data about a medicinal product collected from animals (animal experiments) relating to toxicity and the mechanism of action of a medicinal product.
  • In Module 5 the clinical-pharmacological data are gathered. The data on the efficacy and safety of the product in humans appear in this part of the dossier.