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

6501
files submitted
6425
files closed

of which 3 869 were closed with impact on the marketing authorisation and the patient information leaflet

Closed marketing authorisations for parallel import

Trend

The number of closed applications for parallel imports has increased by 90 % compared to 2020.

Contact centre

1959
questions answered

Trend

In 2021, as in the previous year, there is a significant decrease in the compliance of meeting the statutory deadline for closing IA/IB variations of mutual recognition procedures with little or no impact on closing documents.
In total, the number of closed dossiers is also lower than the number of dossiers received. The reason is a decrease in the number of staff members. Some staff members also provided support to other departments of the FAMHP in managing the COVID-19 health crisis.

COVID-19

Business continuity and support to other services

Although the Marketing Authorisation Division (variations and renewals) was not directly involved in the management of the coronavirus crisis, our staff members supported other services within the FAMHP. For instance, we helped the Proper Use Division with the management of unavailabilities, the Medical Devices Division with the evaluation of antigen and antibody tests, and we contributed to the accounting of the strategic stock.

Our staff members have had to update their knowledge since these activities are not usually part of our range of tasks. This commitment, together with the departure of five staff members, has had a significant impact on the management of routine dossiers treated by the division, namely the variations and five-yearly renewals of marketing authorisations for medicinal products for human use and the applications, modifications and renewals of authorisations for parallel import.

To minimise the impact, we have taken several actions. For example, we have switched to a fully electronic working method for signing and sending authorisations. Because the documents no longer need to be printed, signed and sent on paper, we were able to free up time and resources for other tasks. Staff members were transferred to other teams and trained for other tasks, where the need was the greatest and within the capabilities of the existing team.

In this way, the entire team of the Marketing Authorisation Division (variations and renewals) was able to contribute to the management of the coronavirus crisis without forgetting the continuity of routine tasks. We also tried to meet the expectations of our stakeholders as best as we could considering the difficult circumstances.

Vigilance Division

44262
notifications received
5489
vigilance dossiers received

Medicinal products for human use

43354
notifications received
157
updated safety reports received

Notifications of adverse reactions for medicinal products
for human use

Trend

In 2021, there was a significant increase in the reporting of adverse reactions to medicinal products for human use. This was due to the large number of reports of adverse reactions to COVID-19 vaccines.

Medicinal products for veterinary use

908
notifications received
774
updated safety reports received

Notification of adverse reactions for medicinal products
for veterinary use

Trend

Increase of 6 % in the number of notifications of adverse reactions to medicinal products for veterinary use.

In 2021, the Vigilance Division provided important support to the preparation of new the Regulation (EU) 2019/6 on veterinary medicinal products.

Medical devices

4558
dossiers received

Notifications for medical devices

New

On 26 May 2021, the new Regulation (EU) 2017/745 on medical devices came into effect. There are new rules with regard to vigilance such as the change of the deadline to report serious incidents.

Trend

The FAMHP has noticed an increase in the number of reported incidents over the years. In 2021, we there was an increase of 36 % compared to 2020.

The number of reported safety-related corrective actions increased in 2021 to the highest level ever since the agency was founded.

Health Products Division

Medical Devices

2059
new actors

new actors (manufacturers, legal representatives, distributors, importers) were registered via the online registration system in 2021

1885
free sale certificates of medical devices
653
free sale certificates of in vitro diagnostic medical devices
1257
applications for marketing authorisations for class I medical devices received

784

new notifications

115

amendments

358

withdrawals

1576
applications for marketing authorisations for in vitro diagnostic medical devices received

1 045

new notifications

444

amendments

87

withdrawals

Implants and invasive medical devices notified to the FAMHP

Notification in our applications

New

actors registered and approved by the FAMHP in Eudamed

  • 125 importers
  • 407 manufacturers
    • 189 Belgian manufacturers
    • 218 from outside Europe
  • 54 legal representatives
  • 18 assemblers
    • 17 Belgian assemblers
    • 1 from outside Europe

COVID-19

  • 132 antigen tests for professional use notified
  • 48 serological tests for professional use notified
  • 17 recommended antigen self-tests notified

Proper Use Division

Questions from patients

789
questions from patients answered

Additional risk minimisation activities

89
files on risk minimisation activities approved

Advertising to the general public

680
new notifications of advertising issued
82
renewals of notifications of advertising issued
49
new visa applications for radio or television advertising issued
11
renewals of visa applications for radio or television advertising issued

Database

New files for medicinal products in the authentic source for all medicinal products authorised in Belgium with commercialisation status for each type of packaging and any non-availabilities (E+R-application)

1355
for medicinal products for human use
282
for medicinal products for veterinary use
2161
updates of centrally authorised medicinal products

Sunset Clause

9
variations processed in application of the Sunset Clause

Non-availability of medicinal products

2112
notifications of non-availability of medicinal products received

The most common reasons are delays in production (42.90 %) and increased demand (23.72 %)

The average duration of non-availability in 2021 is 57 days

695
notifications of a stop or interruption of marketing of medicinal products received and evaluated

New

  • A new version of PharmaStatus was launched with information on availability instead of unavailability, with a specific section for pharmacists and wholesaler-distributors and update of existing features.
  • Start of a monthly consultation on (the availability of) immunoglobulins with FAMHP, RIZIV-INAMI, FPS Economy, FPS Public Health and the strategic cell.
  • The increasing consumption of antibiotics in humans and animals has led to an increase of antimicrobial resistance. Infections with resistant bacteria are difficult to treat: about 530 deaths per year are attributed to antimicrobial resistance in Belgium. By 2050, that figure is estimated to rise to 22 500 unless additional measures are taken.

    Because humans, animals and the environment are inextricably linked, various governments and institutions are working together under the motto One World, One Health. In 2021, the FAMHP actively contributed to the development of the Belgian National Action Plan to tackle antimicrobial resistance, a plan that will further be developed over the next years with all relevant government bodies and scientific institutions.

    The FAMHP’s Proper Use Division also participated in actions aimed to improve the availability of essential antibiotics in Belgium and improve their rational use. For The Proper Use Division, for example, organised important discussions with the relevant pharmaceutical companies and candidate purchasers on antibiotics that were at risk of disappearing or for which unavailability was regularly reported. The discussions resulted in the return or retention of some essential antibiotics. Penicillin G was reintroduced to the market by Sandoz in 2021 and Amukin became available again in Belgium in early 2022.

Trend

The FAMHP brought together seventeen task forces to assess the critical unavailability of seven medicinal products (molecules) and develop recommendations.

COVID-19

In May 2021, the FAMHP launched the Stock Monitoring Tool to prevent as much as possible the unavailability of medicinal products used to treat COVID-19.

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FAGG

https://annualreport.fagg-afmps.be