Directorate General

Inspection

competent for all inspection and control activities

Industry Division

Inspections

120
good manufacturing practice inspections
46
good clinical practice inspections concerning medicines

Rapid alert systeem

418
rapid alerts on the quality of medicines

Analyses of products on the market

150
medicines
314
preparations
17
raw materials
90
products seized
8
medical devices

Distribution Division

Inspections

64
routine inspections concerning good distribution practices
129
inspections concerning good distribution practices for medicines for obtaining or amending a distribution authorisation
22
pharmacovigilance inspections
32
inspections of human body material establishments
3
inspections of establishments importing human body material
2
thematic inspections of depots for human body material
12
inspections of blood establishments and donation centres
2
thematic inspections blood (mobile collections)
5
inspections of advertising and other promotional activities

Investigations

48
investigations concerning the distribution of medicines
1
pharmacovigilance investigation
2
human body material investigations
2
human body material investigations

Checks on advertising and other promotional activities for medicines and health products

25
checks
49
investigations on medicines

Notifications

309
notifications from the local pharmacovigilance officer

Accreditation number of responsible qualified person

19
accreditation numbers awarded to people responsible for information
76
changes to the management of people responsible for information

Scientific and legal questions concerning good distribution practices

389
responses to scientific and legal questions concerning good distribution practices
71
responses to scientific and legal questions concerning human body material and blood
131
responses to questions on advertising and other promotional activities
131
responses to questions on advertising and other promotional activities

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

477
pharmacies open to the public
23
reinspections of pharmacies open to the public
60
hospital pharmacies for medicines
1
reinspection of hospital pharmacies for medicines
350
veterinary depots

Investigations

111
investigations on the dispensing of medicines (administrative files)
86
investigations on the dispensing of medicines (legal files)

Files veterinary depots

301
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

45
new authorisations
123
renewals
4
letters of no objection (import certificates)
107
extensions/amendments of authorisations

Narcotics and psychotropic substances

15
new annual activity authorisations
76
amendments to annual authorisations

4 817

authorisations for import and export

823
inspections of authorisations for import and export
6
additional inspections of activity authorisations

3 552

narcotics order forms (per 100 forms)

34
letters of no objection (import certificates)
458
validations of Schengen declarations
92
new or renewed end-user authorisations
8
amendments of end-user authorisations

Precursors

16
new authorisations
51
renewals or amendments
8
import authorisations

1 196

export authorisations

41
suspicious orders and transactions
8
inspections of authorisations
5
letters of no objection (import certificates)

Manufacturing and distribution authorisations

203
authorisations for the manufacturing/distribution of medicines
31
registrations for the import/manufacturing/distribution of pharmaceutical raw materials
30
certified copies
255
certificates for good manufacturing practices/good distribution practices

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

71
accreditations for human body material establishments
25
preliminary accreditations for human body material establishments
1
amendment to accreditations for human body material establishments
10
accreditations for establishments importing human body material
14
accreditations of biobanks

Pharmacies open to the public

288
new applications before the Commission for establishment of pharmacies open to the public
838
cadastral registration forms of pharmacies open to the public

authorisations of pharmacists-clinical biologists

27
authorisations of pharmacists-clinical biologists

Depositary veterinarians

329
notifications of a veterinary depot

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

14
inspections concerning good clinical practices involving medical devices
119
inspections of manufacturers of medical devices in Belgium
1
inspection of notified bodies abroad
3
inspections of notified bodies in Belgium
215
inspections of medical device distributors
28
inspections of hospitals concerning medical devices (including sterilisation divisions)
10
inspections of European authorised representatives
5
inspections of importers
1
inspection as an expert for Belac (Belgian Accreditation Body under the authority of the FPS Economy, to which Belgian companies and organisations can turn to obtain accreditations)
353
investigations into medical devices
333
questions about medical devices

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

679
closed investigations into illegal medicines in illegal circulation
48
investigations into illegal health products in illegal circulation
142
cases in which assistance was provided to police and public prosecutors
608
cases of advice given to other (domestic and foreign) authorities

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.

175
controls of consignments in transit (destined to another EU Member State)

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.