Directorate General
POST AUTHORISATION
competent for all activities following approval of the first marketing authorisation for a medicine or health product
Marketing Authorisation Division (variations and renewals)
Applications for variations and renewals of marketing authorisations
5 760
files submitted
5 048
files closed
Closed marketing authorisations for parallel import
Contact centre
1 541
questions answered
Vigilance Division
Medicinal products for human use
8 017
notifications received
Notifications of adverse reactions for medicinal products for human use
Trend
The number of notifications decreased compared to 2022 due to a lower number of notifications linked to the COVID-19 vaccination but remained higher than before the COVID crisis. The number of updated safety reports increased slightly.
Annual safety reports
1 138
annual safety reports
SaMS
Change in the number of active substances for which Belgium is responsible for assessing safety data (SaMS), including the assessment of suspected serious and unexpected adverse reactions and annual safety reports.
Trend
In 2023, there was a sharp increase due to the gradual allocation of active substances to EU countries under the new European Regulation.
Medicines for veterinary use
461
adverse reactions received
Notification of adverse reactions for medicinal products for veterinary use
New
Vigilance is now shared between several departments.
Veterinary pharmacovigilance is now managed by the Assessors Division of DG PRE authorisation, and materiovigilance by the Health Products Division.
Human Body Material Unit
Haemovigilance (blood and labile blood components)
1 196
reports of incidents and serious adverse events received
Biovigilance (cells and tissues)
including
Reports of serious adverse reactions and events
including
substitute cells and tissues: 3
haematopoietic stem cells: 3
all types of cells and tissues: 1
New
2023 saw a decrease compared with 2022 (-24 %). The number of notifications received in 2023 compared with 2019 (pre-COVID period) still showed a significant increase (26 %).
Trend
Biovigilance:
In 2023 there was a further increase of approximately 9 % in the number of notifications (303 notifications), after a decrease in 2022 (280 notifications) compared to 2020 (327 notifications) and 2021 (334 notifications).
Health Products Division
Medical devices
1 837
free sale certificates of medical devices
1 999
applications for marketing authorisations for class I in vitro diagnostic medical devices received
1 654 215
reports of the implantation and explanation of medical devices in the central traceability register (CTR)
Implants and invasive medical devices notified to the FAMHP
5 733
vigilance notifications for medical devices
New
2023 saw another significant increase of over 25 % in the number of serious incidents, following a smaller increase in 2022 (10 %).
Proper Use Division
Information about medicinal products and medical devices
Database
1 152
new authorisations for medicinal products in Belgium (in the Medicinal Product Management database)
Availability of medicinal products for human use
Unavailability notifications for medicinal products for human use
Impact of new temporary unavailabilities
1 713
questions from the public and health professionals answered
Availability of medicinal products for veterinary use
Notifications on unavailability for medicinal products for veterinary use
Additional risk minimisation activities
Advertising of medicinal products for human use directed at the general public
New
On 18 December 2023, the FAMHP launched PharmaInfo, a web portal for citizens and patients containing easily understandable and reliable information on medicines and health products.
- 97 new medicine information sheets published
- 5 new information sheets on medical devices published
- 28 new themes published
- 7 news items published
More information on this subject can be found in the “In the Spotlight” section of our annual report.
