Belgium
Starting 1 June 2025, the Federal Agency for Medicines and Health Products (FAMHP) will require companies to use a new contact form for inquiries regarding variations and renewals of marketing authorisations for human medicinal products. This form will replace the current email address (postlicensing@fagg-afmps.be), and its use will be mandatory. After submission, users will receive confirmation, and the follow-up process will be partially automated to improve efficiency.
The contact point handles questions about submissions, procedures, approvals, fees, and document corrections related to variations, renewals, and parallel import authorisations, excluding centrally authorised products. Questions about the status of files, publication errors, and the sunset clause are also included.
Response times will vary depending on the topic, ranging from 5 to 30 working days. Detailed instructions and required information are available on the FAMHP website to ensure accurate and timely responses.
Source: New contact form for questions on variations and renewals from 1 June 2025 | FAMHP