To provide more specific information for applications for authorisation with a request for application of the procedure according to Art. 13 TPA (consideration of review by regulatory authorities in countries with comparable medicinal product control), two new forms have been created from the existing one.
For relevant applications for authorisation of veterinary medicinal products (VMP/TAM), the form FO Information for application Art. 13 TPA VMP now applies, while for human medicinal products (HAM), the form FO Information for application Art. 13 TPA HAM applies.
The VMP form has been valid since July 2024. All relevant documents must now be entered chronologically and without omissions according to sections 11.1 and 11.2 of the Guidance document Authorisation veterinary medicinal product under Art. 13 TPA.
The HAM form enters into force in revised form from 1 January 2025. The content of the information to be provided is unchanged.