Notification procedure
Holders of a marketing authorisation (MA), a registration, an authorisation for parallel import or a temporary authorisation for use and parallel distributors are legally required to report , are legally required to notify the FAMHP via PharmaStatus of any information regarding:
- the marketing (start of commercialisation);
- the permanent discontinuation of marketing (stop of commercialisation);
- the temporary discontinuation of marketing (temporary unavailability).
They are also legally obliged to apply for the export of certain medicines.
Please refer to the frequently asked questions and the PharmaStatus manual for more information.
1. Notification of the start of commercialisation
The marketing authorisation holder or parallel distributor must notify the commercialisation of a medicinal product as soon as the effective commercialisation date is known. To keep the commercialisation status up to date, it is essential to notify the commercialisation at least fifteen working days before the effective commercialisation date.
2. Notification of permanent discontinuation of commercialisation
The marketing authorisation holder or parallel distributor must notify the permanent discontinuation of commercialisation at least six months before the effective date of discontinuation.
Please note
The provisions of article 6 section 1 of the law of 25 March 1964 (Sunset clause) remain applicable to marketing authorisations/registrations of medicinal products granted by the Belgian authorities.
3. Notification of temporary unavailability
When the marketing authorisation holder or parallel distributor expects that not all orders can be fully fulfilled within three working days, this must be reported to the FAMHP as soon as possible and no later than at the start of the unavailability.
4. Notification of the end date of temporary unavailability
The marketing authorisation holder or parallel distributor must report the estimated end date as well as the actual end date as soon as the medicinal product becomes available again.
5. Applications for authorisation to export medicinal products
For certain medicinal products for which a shortage is imminent or already exists, export authorisation must be requested. This can be done by the wholesaler using this form. The FAMHP has published all relevant information on the webpage Authorisation to export medicinal products.
Legal framework
- Article 6, section 1e, paragraphs one and two of the law of 25 March 1964 on medicines.
- Articles 113, section 3, and 238, section 3, of the Royal Decree of 14 December 2006, part 1 and part 2 on medicines for human and veterinary use.
- Articles 2, 4 and 5 of the law of 20 December 2019 amending various laws concerning shortages of medicines.
- The Royal Decree of 19 January 2023 implementing article 12septies, second paragraph, of the law of 25 March 1964 on medicinal products.
Publication
If certain medicinal products are no longer available in Belgium, either temporarily or permanently, this may pose a risk to public health. The FAMHP publishes relevant information for healthcare professionals and patients on the webpage Availability of medicines and on PharmaStatus.
The various lists are also available at the links below.
- List of unavailable medicines (human use)
- List of unavailable medicines (veterinary use)
- List of re-available medicines (human use)
- List of re-available medicines (veterinary use)
- List of medicines new on the market (human use)
- List of medicines new on the market (veterinary use)
The medicinal products for which export authorisation must be requested, are published in the Belgian Official Gazette and can also be found in this list.