Applicants and marketing authorisation holders can now also access the new version (1.28.0.0) of the Marketing Authorisation Application Form for national, mutual recognition and decentralised procedures.
The new version of the Marketing Authorisation Application Form (eAF) is now available, allowing applicants and MAHs to familiarise themselves with the upcoming changes.
The main purpose of this update is to align product data in the application form with the ISO Identification of Medicinal Products (IDMP) model. For veterinary medicinal products, the update also reflects changes related to the New Veterinary Regulation 2019/6 (NVR).
Human medicinal products
For human medicinal products, the new version of the eAF can be used for new marketing authorisation applications submitted to national competent authorities (NCAs) under:
- national procedures (NPs) ;
- mutual recognition procedures (MRPs) ;
- decentralised procedures (DCPs).
The updated form may be used from 1 September 2026 and will become mandatory for all new submissions from 1 January 2027.
Veterinary medicinal products
For veterinary medicinal products, the new version of the eAF can be used for new marketing authorisation applications submitted to NCAs under:
- NPs;
- MRPs;
- subsequent Recognition Procedures (SRP);
- DCPs.
The updated form may be used from 1 September 2026 and will become mandatory for all new submissions from 1 January 2027.
Important reminder
Applicants are reminded that the version of the application form must not be changed during an ongoing procedure. The same version should be used throughout the entire lifecycle of a procedure.
Applicants and MAHs are encouraged to review the updated form and prepare for the transition ahead of its mandatory implementation.
Excerpt from the official page. The original is authoritative.