Application for marketing authorisation
Updated 10 April 2025
Application guidelines
Guidelines for applicants for marketing authorisations for medicines
Bioequivalence and labelling of medicinal products with regard to generic substitution
Guidance to manufacturers outside the EU/EEA area
Guidelines for marketing authorisation for vitamin and mineral products
Forms
Information about completion of applicant, contact person and representative in the application form
The EU application form for a marketing authorisation of a homeopathic medicinal product (human use)