Directorate General
Inspection
competent for all inspection and control activities
Industry Division
Inspections
Rapid alert systeem
Analyses of products on the market
Distribution Division
Inspections
Investigations
Checks on advertising and other promotional activities for medicines and health products
Notifications
Accreditation number of responsible qualified person
Scientific and legal questions concerning good distribution practices
New
In 2023, there was an increase in pharmacovigilance inspections, inspections of advertising and other promotional activities and of human body material establishments.
Pharmacovigilance: in addition to routine checks, the first pharmacovigilance inspections were also carried out this year in accordance with the provisions of the new European regulation on veterinary medicinal products (Regulation (EU) 2019/6) on holders of marketing authorisation for veterinary medicines.
Advertising and other promotional activities: these inspections were restarted again in 2023, following the COVID crisis.
Dispensing Division
Inspections
Investigations
Files veterinary depots
Questions
2 908
questions on the dispensing of medicines
New
Of the 477 inspections of pharmacies open to the public, 81 were carried out as part of an operating license application.
The new legislation on pharmacies open to the public, in particular the entry into force of the Royal Decree on autocontrol in pharmacies, and the new legislation on veterinarians (updated in the 2016 Royal Decree) have raised many more questions in the sectors concerned.
Trend
In 2023, 1.5 FTE inspectors were added to the Retail Pharmacies unit. This has enabled a greater number of inspections.
Authorisations Division
Hormones and antibiotics
Narcotics and psychotropic substances
5 786
authorisations for import and export
3 552
narcotics order forms (per 100 forms)
Precursors
1 196
export authorisations
Manufacturing and distribution authorisations
2 152
copies of certificates for good manufacturing practices/good distribution practices, authorisations for the manufacturing/distribution or registrations for the manufacturing/distribution of pharmaceutical raw materials
1 674
certificates for pharmaceutical products, including 201 urgent applications
1 717
e-legalisations of documents
Human body material and blood establishments
Pharmacies open to the public
authorisations of pharmacists-clinical biologists
Depositary veterinarians
New
The sharp decrease in the number of narcotics order forms is explained by the switch to a new electronic system from 1 September 2023.
Medical Devices Division
New
Reports on two thematic actions were published in 2023. The first concerned unregistered medical device distributors, and the second the distribution and rental of oxygen concentrators.
Trend
The number of inspections of medical device distributors has increased by over 49 %, from 144 to 215.
The number of questions and investigations into medical devices increased in 2023.
Special Investigation Unit
3 551
blocked postal packages sent from outside the European Economic Area to a Belgian addressee. The packages contained non-compliant medicines, medical devices and in vitro diagnostics.
New
In 2023, the SIU actively participated in writing two articles published by Sciensano.
In 2022 and 2023, the SIU provided Sciensano with samples of sildenafil and ivermectin in order to learn more about the risks posed by these substances.
Based on these samples, Sciensano was able to provide detailed reports to the SIU, and to draw up documents relating to the analyses carried out.
Overall, it was concluded that the majority of these samples present a health risk. Under- and overdosing are frequent. Some samples (both sildenafil and ivermectin) were bacteriologically contaminated. On the basis of these two findings, it would appear that hygiene conditions at the manufacturing sites of certain products in third countries are poor.
