From 1 June 2025, the Federal Agency for Medicines and Health Products (FAMHP) will introduce a new contact form for firms that have questions around their files of variations and renewals for medicinal products for human use.
What does this mean for you
The new contact form will replace the email address postlicensing@fagg-afmps.be for asking questions. The use of this form will be mandatory from 1 June 2025.
After completing the contact form, you will receive a confirmation stating the details provided. The follow-up process is partially automated, ensuring streamlined processing of questions and increased efficiency. It is important to read the information on the website carefully before filling in the form.
What questions are handled?
The variations and renewals point of contact handles questions on:
- The submission, procedure or approval of a variation or renewal of a marketing authorisation (except for products authorised through the centralised procedure);
- The submission, procedure, approval of an application for a new authorisation, variation or renewal of a parallel import authorisation;
- The withdrawal of a marketing authorisation;
- The withdrawal of an ongoing procedure;
- The resending of automatic emails;
- Information about the status of a file;
- Concrete questions about fees to be paid for submitting variations, renewals or authorisations for parallel imports;
- Questions about correction of approved documents;
- The reporting of errors in publication of approved documents or published data in the medicinal products database;
- Questions about the approved data of an authorised medicinal product;
- Questions on how to apply the sunset clause and to ensure its follow-up.
How to ask a question?
Fill in the contact form and make sure you provide all the required information. This will help us answer your question quickly and accurately. For specific questions about files, automatic emails, licensed products, fees, document corrections and the sunset clause, please provide detailed information as described on the website.
Processing times
To ensure the smooth processing of questions, we will work with priority levels. Processing times vary depending on the type of question:
- Reporting errors in publication of approved documents or data in the medicinal products database: 5 working days
- Automatic emails: 10 working days
- Status of a submitted file; question relating to the withdrawal of a product: 15 working days
- Question relating to variation, renewal, parallel import authorisation, fees, correction of approved documents and approved dates of a medicinal product: 20 working days
- Question relating to the withdrawal of an ongoing procedure and sunset clause: 30 working days
More information
Questions and answers on the point of contact Marketing Authorisation (variations and renewals)