Marketing authorisation dossier (CTD format)

The marketing authorisation dossier is the body of administrative, pharmaceutical, preclinical and clinical data that the applicant submits to the authority to demonstrate the quality, safety and efficacy of its medicinal product. Its content is laid down by Directive 2001/83/EC and its Annex I. It is presented in the format of the Common Technical Document, or CTD, harmonised within the International Council for Harmonisation and used in particular in the Union, the United States and Japan.

The five-module structure

• Module 1 contains the region-specific administrative information, including the application form, the proposed summary of product characteristics, the labelling and the package leaflet.
• Module 2 contains the summaries and critical overviews of the quality, non-clinical and clinical data.
• Module 3 describes quality, that is to say the composition, manufacturing process, controls and stability of the active substance and of the finished product.
• Module 4 contains the reports of the non-clinical pharmacology and toxicology studies.
• Module 5 contains the clinical study reports.

In the Union, the dossier is in principle filed electronically, in eCTD format, for European and national procedures alike.

The abridged dossier for abbreviated applications

An applicant for a generic authorisation need not provide the results of preclinical tests and clinical trials. For Modules 4 and 5, it refers to the dossier of the reference medicinal product and provides its own quality data together with bioequivalence studies. This option is available only once the period of data protection for the reference medicinal product has expired. Data exclusivity thus protects the non-clinical and clinical modules, not the quality module, which each applicant must compile for its own product.

The dossier as evidence in litigation

Module 3 of a competitor’s dossier describes the formulation and the manufacturing process with a precision rarely matched elsewhere. It is therefore the document sought first in a saisie-contrefaçon based on a process or formulation patent, and the court may order its production. Its disclosure raises trade secret issues, which the court resolves by arranging access to the exhibits, for example through a confidentiality club.

Key points

The authorisation dossier follows the CTD format in five modules, of which Module 3 describes quality and Modules 4 and 5 the non-clinical and clinical studies. A generic is exempted from Modules 4 and 5 once data protection has expired, but must compile its own quality module. In a dispute over a formulation or process patent, the competitor’s Module 3 is often the decisive evidence. That document should be expressly targeted in the application for a saisie-contrefaçon order, and the confidentiality measures that will govern its disclosure should be anticipated.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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