On 1 January 2025, the Royal Decree of 22 September 2024 on advertising of medicinal products for veterinary use will come into force. That Decree describes the mandatory notification procedure prior to the distribution of any advertisement for a medicinal product for veterinary use to the general public.
Since Article 47/1 of the Law of 5 May 2022 on medicinal products for veterinary use came into force, a notification is required for advertising of medicinal products for veterinary use to the public.
On 1 January 2025 the Royal Decree of 22 September 2024 on the advertising of medicinal products for veterinary use will come into force, the procedure to be followed for notification and the legal deadlines will be clearly defined in the Royal Decree (section 1 of chapter 3).
Notification procedure
• Notification of an advertisement must be submitted to the Federal Agency for Medicines and Health Products (FAMHP) no later than 30 days before the advertisement is published.
• The notification dossier must be submitted electronically to advertising@fagg-afmps.be. It must contain at least the following elements: the draft advertisement, the completed submission form and the model of the packaging of the medicinal product.
• The FAMHP will confirm (or not) the admissibility of the dossier by e-mail.
• Within 30 days following confirmation of the admissibility of the notification file, the FAMHP will send the applicant any comments it may have on the advertisement. The applicant will then have 60 days to respond to these comments. If no response is received within this period, the notification dossier will be closed.
• The notification procedure and the other specified legal deadlines are defined in article 5 of the Royal Decree of 22 September 2024.
The submission of a notification dossier will be subject to the payment of a fee, the amount of which can be consulted on this page.
Validity of an advertisement and renewal
A notified advertisement is valid for two years. It begins 30 days after the FAMHP confirms the admissibility of the notification dossier. Once the validity period has expired, the advertisement can no longer be published.
However, the validity of an advertisement can be extended by submitting a renewal dossierno later than 45 days before the end of the advertisement's validity.
The submission of a renewal application will be subject to the payment of a fee, the amount of which can be consulted on this page.
Advertisements still running on 1 January 2025
As stipulated in Article 20 of the Royal Decree of 22 September 2024, advertisements still running when the Royal Decree comes into force on 1 January 2025 must be notified to the FAMHP, in accordance with the provisions of the Royal Decree, by 1 April 2025 at the latest.
Among these, advertisements already notified to the FAMHP following the entry into force of Article 47/1 of the Law of 5 May 2022 must be renotified in accordance with the procedure described in the Royal Decree of 22 September 2024. However, they will not be subject to the payment of the fee.
The various possible scenarios on 1 January 2025 are described in the table below.
| 1. Advertisements dated before Article 47/1 of the Law of 5 May 2022 and still being broadcast on 1 January 2025 | These advertisements must be notified to the FAMHP by 1 April 2025. | À partir du 01.01.2025, ces publicités seront soumises au paiement de la redevance. |
| 2. Advertisements already notified to the FAMHP after Article 47/1 of the Law of 5 May 2022 came into force. | These advertisements were already notified to the FAMHP before 1 January 2025. However, they must be resubmitted in accordance with article 5 §2 of the Royal Decree of 22 September 2024, by 1 April 2025 at the latest. Please indicate clearly in your e-mail that this is a resubmission in order to avoid any confusion. | As these advertisements were notified to the FAMHP before 1 January 2025, no fees need to be paid. |
| 3. New advertisements from 1 January 2025 | These advertisements must be notified to the FAMHP in accordance with article 5 § 2 of the Royal Decree of 22 September 2024, no later than 30 days before they are broadcast. | These advertisements will be subject to the payment of the fee. |
Contact
advertising@fagg-afmps.be