Directorate General

Inspection

competent for all inspection and control activities

Industry Division

Inspections

120
good manufacturing practice inspections
49
good clinical practice inspections concerning medicines

Rapid alert system

375
rapid alerts on the quality of medicines
  • 84 class 1
  • 216 class 2
  • 52 class 3
  • 23 concerning fraud/counterfeiting

 

  • 325 concerning medicines for human use
  • 43 concerning medicines for veterinary use
  • 2 concerning raw materials
  • 7 concerning products for research

Analyses of products on the market

188
medicines
206
preparations
191
raw materials
111
products seized
9
medical devices

Trend

A new inspector was hired and coached in 2021. This led to an increase of about 30 % in the number of good clinical practices inspections compared to 2019. The additional inspections were mainly conducted in Belgium. The good clinical practices inspections focused primarily on clinical trials for medicinal products and vaccines against COVID-19. The outcome of these inspections was very good when it comes to quality. This proves that the Belgian researchers were very meticulous in their work.

Trend

The results for 2021 show that despite all the obstacles, the division’s routine work was carried out correctly and without any delays. The teams worked primarily on the access to new therapies, their safety and on maintaining the quality of traditional products. The teams also focused on larger projects such as the implementation of the new legislation on medicinal products for veterinary use and clinical trials. These activities took up a lot of time. This led, among other things, to a slowdown in the actual work done on, for example, the interpretation of specific cases and the standards to be applied to niche products. Nevertheless, all aspects were taken into account and the teams are now ready to work on these projects.

COVID-19

The COVID-19 crisis has brought many constraints. The production sites for the COVID-19 vaccines and the other medicinal products against COVID-19 needed urgent approval. However, inspectors had to take into account travel restrictions (many of the production sites are located outside the European Union). The inspectors also had to at least observe the restrictions imposed by the health and public safety measures. These situations also led to new inspection methods, both at the Belgian and European level: such as remote inspections of companies by means of tele- and videoconference, inspections based solely on delivered documents, and on-site inspections with colleagues from non-European competent authorities and with remote European inspectors. In other words, hybrid inspections, combining physical and remote inspections, were conducted on a large scale.

These new working methods put a lot of pressure on the teams because the procedures were not yet established at the onset. They were introduced as and when needed and without prior specific training. Remote inspections were time-consuming. The situation led to the development of new procedures, which will continue to be useful for specific cases and will facilitate cooperation between the competent authorities.

One of the benefits of this stressful time is that the expertise of our agency’s inspectors has been highlighted at the international level. This made it possible to develop relations based on mutual trust with authorities outside the European Union, including the competent authorities of the United States and Canada.

Distribution Division

Inspections

0
inspections concerning the advertising of medicines

In 2021, no inspections were carried out on the advertising of medicines due to the excessive workload of the inspectors in charge of reviewing good distribution practices in the fight against COVID-19. Priority was given to mandatory inspections of good distribution practices.

74
inspections concerning good distribution practices (routine)
156
inspections concerning good distribution practices for medicines for obtaining or amending a distribution authorisation
  • 49 investigations
  • 107 inspections on request
  • 6 re-inspections
9
pharmacovigilance inspections
  • 3 concerning medicines for human use requested by the European Medicines Agency
  • 3 concerning medicines for human use (thematic inspection)
  • 0 medicines for human use (re-inspection)
  • Re-inspections are only carried out when critical deficiencies have been identified in the last twelve months. That was not the case in 2021.
  • 1 concerning medicines for veterinary use requested by the European Medicines Agency
  • 2 concerning medicines for veterinary use (routine)
27
inspections of human body material establishments
9
thematic inspections of depots for human body material
9
inspections of blood establishments
25
thematic inspections blood (mobile collections)
63
responses to scientific and legal questions related to human body material and blood

Investigations

78
investigations concerning the distribution of medicines
2
pharmacovigilance investigations concerning medicines for human use
0
pharmacovigilance investigations concerning medicines for veterinary use

In 2021, the FAMHP did not receive any complaints or reports of problems related to this topic. No pharmacovigilance investigations were therefore needed.

Notifications

261
notifications from the local pharmacovigilance officer

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

25
investigations concerning medicinal products

Accreditation number of responsible qualified people

21
accreditation numbers awarded to people responsible for information
90
changes to the management of people responsible for information

Scientific and legal issues concerning good distribution practices

585
responses to scientific and legal questions

New

In 2021, thematic inspections were launched for good distribution practices for blood and human body material.

  • Good distribution practices

Unannounced thematic inspections of wholesaler-distributors of medicinal products for human use that focus on the obligations of the wholesaler-distributor regarding:

  • Blood

These inspections are carried out to ensure the quality and safety of blood collection and to check whether the legal requirements are met in the mobile collection operations organised by the blood establishments (collection of blood and blood components in mobile units).

  • Human body material

These inspections are carried out in order to check whether the legal requirements are met and whether the quality and safety standards are guaranteed in the depots of registered human body material banks.

A depot is a subdivision of a human body material bank located in a hospital, where a stock of released human body material is stored for human application inside that same hospital.

Trend

In 2021, there were 68 % more inspections of good distribution practices compared to 2020.

Trend

Due to the COVID-19 health crisis, there were fewer inspections of advertising and other promotional activities. Conferences were only organised virtually or they were postponed.

COVID-19

Due to the impact of the COVID-19 health crisis, the Distribution Division started remote (online) inspections in 2020. This practice was partially maintained in 2021 but on-site inspections resumed for pharmacovigilance, good distribution practices, advertising, blood and human body material.

The Distribution Division was given additional tasks in 2021 due to the COVID-19 health crisis. 

  • The inspectors and control officers of the Distribution Division prepared procedures for the transport and proper preparation of the different types of COVID-19 vaccines for the federate states and mobile teams.
  • The inspectors and control officers of the Distribution Division and Dispensing Division supported twenty-five vaccination centres to ensure that the COVID-19 vaccines were received, transported and prepared according to the procedures.
  • The inspectors and control officers participated on a weekly basis in the meetings of the Vaccination Strategy Task Force. In addition, several consultation meetings were held weekly with the Corona Commissariat, with the FPS Public Health and with the leading officials and staff of the federate states.

Dispensing Division

Inspections

489
of retail pharmacies
0
reinspections of retail pharmacies

Reinspections are only carried out on retail pharmacies who fail to follow the corrective and preventive measures (CAPAs) of a previous inspection. Pharmacists first receive a warning before a reinspection is carried out. There were no such cases in 2021.

56
inspections of hospital pharmacies for medicines
3
reinspections of hospital pharmacies for medicines
283
veterinary depots

Investigations

106
investigations on the dispensing of medicines (administrative dossiers)
108
investigations on the dispensing of medicines (legal dossiers)

Questions

519
questions about the dispensing of medicines

Dossiers veterinary depots

396
dossiers veterinary depots
175
registrations of new veterinary depots
112
modifications
109
discontinuations

New

  • In the summer of 2021, several retail pharmacies in Wallonia were affected by floods. The Dispensing Division actively searched for solutions. The inspectors identified the affected retail  pharmacies and ensured an accelerated procedure for temporary relocation of those pharmacies.
  • Amendment to the Royal Decree of 21 January 2009 on instructions for pharmacists: pharmacists who want to realise magistral preparations for other pharmacists through outsourcing have to notify the FAMHP.
  • Amendment to the Royal Decree of 30 September 2020 on the distribution of medicines in healthcare institutions: the registered pharmacists of a hospital pharmacy have to register with the FAMHP and veterinarians have to register the online sale of veterinary medicines for animals they are treating.

Trend

An increase in questions from citizens about the dispensing of medicines or about a retail pharmacy. The questions were received directly via the FAMHP generic e-mail boxes or via the call centres of other authorities such as the RIZIV-INAMI (national institute for health and disability insurance) and the FPS Public Health.

COVID-19

  • Inspectors and controllers from the Dispensing Division and Distribution Division supported twenty-five vaccination centres to ensure that the receipt, transport and preparation of COVID-19 vaccines were carried out in accordance with the procedures. The inspectors from the Dispensing Division also carried out evaluations of the vaccination centres.
  • There was weekly participation in the meetings of the Vaccination Strategy Task Force. Furthermore, there were several consultation meetings per week with the Corona Commission, with the FPS Public Health and with the leading officials and staff of the federated entities.
  • Due to the impact of the COVID-19 health crisis, many inspections were performed remotely. For inspections of pharmacies open to the public, the inspected pharmacy was never contacted in advance. This was also the case for on-site inspections.
  • The feasibility of the inspections was always discussed with the inspected hospital pharmacy, because of the pressure on the hospitals.

Authorisations Division

Hormones and antibiotics

61
new authorisations
128
renewals
21
letters of no objection (import certificates)
105
extensions/amendments of authorisations

Narcotics and psychotropic substances

Activity authorisations

24
new annual activity licences
12
without inspection
12
with inspection
83
amendments to annual authorisations
791
inspections of authorisations for import and export
6785
authorisations for import and export
3
additional inspections of activity licences
7228
narcotics order forms (per 100 forms)
56
letters of no objection (import certificates)
175
validations of Schengen declarations

Precursors

12
new licences
109
renewals or amendments
14
import authorisations
1029
export authorisations
39
suspicious orders and transactions
11
inspections of authorisations
31
letters of no objection (import certificates)

Manufacturing and distribution authorisations

302
authorisations for manufacturing/distribution of medicines
35
authorisations for the manufacturing/distribution of pharmaceutical raw materials
26
copies of authorisations for the manufacturing/distribution of pharmaceutical raw materials
332
certificates for good manufacturing practices/good distribution practices
458
copies of authorisations for the manufacturing/distribution of medicines
2264
copies of certificates for good manufacturing practices/good distribution practices
1925
certificates for pharmaceutical products
1606
e-legalisations of documents

Human tissue material and blood establishments

47
accreditations for human tissue material establishments
17
preliminary accreditations for human tissue material establishments
6
amendments to accreditations for human tissue material establishments
4
accreditations for establishments importing human tissue material
25
accreditations of biobanks

Retail pharmacies

New applications before the Commission for the establishment of retail pharmacies

34
long-distance transfer
48
transfer within the immediate vicinity
12
temporary transfer
13
mergers between retail pharmacies
15
temporary closure

Registration forms for the registry of retail pharmacies

102
opening, a transfer or a merger
820
other changes
684
grouped changes
482
change of named pharmacist in charge of a pharmacy
21
duplicate of licence/registration

Pharmacists-clinical biologists

17
recognitions of pharmacists-clinical biologists

Depositary veterinarians

287
notifications of a veterinary depository

Medical Devices Division

4
inspections concerning good clinical practice involving medical devices
49
inspections of manufacturers of medical devices in Belgium
1
inspection of notified bodies abroad
2
inspections of notified bodies in Belgium
104
inspections of medical device distributors
1
inspection of healthcare professionals (depot/business premises)
0
inspections of hospitals concerning medical devices

In 2021, only questions and surveys were subject to a follow-up. No routine inspections were carried out.

1
inspection of European authorised representatives
1
inspection as an expert for Belac (Belgian Accreditation Body under the authority of the FPS Economy, to which companies and organisations can turn to obtain accreditations)
562
investigations into medical devices
422
questions about medical devices

New

Adjustment of the inspection method due to the stricter requirements set out in Regulation (EU) 2017/245 on medical devices. For example, the requirements for importers and distributors are now set at European level and the requirements for manufacturers (including quality system requirements and technical files) are described in much more detail.

Trend

The number of investigations has increased significantly: from an average of 120 investigations per year to 562 in 2021.

Trend

The number of inspections into good clinical practices and the number of hospital inspections has decreased due to the COVID-19 health crisis, so as not to place an even greater burden on hospitals.

Special Investigation Unit

332
closed investigations into illegal medicines or illegal circulation
23
investigations into illegal health products or illegal circulation
186
cases in which assistance was provided to police and public prosecutors
159
ases of advice given to other (domestic and foreign) authorities
3613
blocked postal packages sent from outside the European Economic Area to a Belgian addressee. These parcels contained non-compliant medicines, medical devices and in-vitro diagnostics.

These parcels contained non-compliant medicines, medical devices and in-vitro diagnostics.

403
controls of consignments in transit (being sent to an address in another European Member State)

New

Customs, the Federal Police, the FAMHP and the Federal Agency for the Safety of the Food Chain participated in operation SHIELD II, against doping, counterfeit medicines and abuse of medicines. This operation ran from 1 April to 15 October 2021 and was coordinated by Europol. The Pharma and Food Crime Platform, a partnership involving all stakeholders in charge of fighting food and pharmaceutical crime, also took part in this operation. During this operation, the Belgian authorities seized 87 241 tablets and 99 549 ampoules.

Trend

In 2021, the Special Investigation Unit gave more advice as a centre of expertise to external partners. This will lead to a broader and more intensive cooperation with other domestic and foreign inspection services and authorities such as customs, the police and the Department of Justice.

No counterfeit or non-compliant vaccines against COVID-19 were ever found in postal consignments.

At the beginning of the COVID-19 crisis in particular, the service was heavily impacted by the importation of illegal and/or non-compliant surgical masks. These cases were handled in close cooperation with the Medical Devices Division of the DG Inspection.

Trend

In 2021, there was a decrease in the number of postal items that were seized as a result of a more specific risk-based selection system applied by customs. The system was initiated in close cooperation between custom and the Special Investigation Unit and is continuously optimised to ensure a more efficient long-term follow-up of parcels sent by post.

COVID-19

Many of the products seized were presented as COVID-19-related medicines: antibiotics, (Chinese) over-the-counter medicines and especially counterfeit ivermectin, a medicine that is authorised within the European Union as a treatment for certain parasitic infections. Also, the import, distribution and sale of non-compliant COVID-19 self-tests became a common phenomenon in the investigations conducted in 2021.

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FAGG

https://annualreport.fagg-afmps.be