Other government information and services

DIRECTORATE GENERAL

POST AUTHORISATION

competent for all activities following approval of the first marketing authorisation for a medicine or health product

Divisions

Marketing Authorisation Division (variations and renewals)

Applications for variations and renewals of marketing authorisations

RMS, CMS, NP

Applications for parallel import

Contact centre

0
questions received
0
questions answered

New

In 2019, the FAMHP accepted 16 RMS switches from the United Kingdom. We noted a total of 28 RMS switches as a result of the Brexit. This was followed by:

  • 8 type II clinical variations
  • 4 type II analytical variations
  • 21 type IA variations
  • 21 type IB variations
  • 1 five-yearly renewal

This equates to 24% of the RMS files received in 2019.

Vigilance Division

0
individual reports received
0
vigilance files received

Pharmacovigilance of medicines for human use

0
individual reports of adverse reactions
0
PSUR's received

Trend

In 2019, we note an increase in the number of reports of adverse reactions for medicines for human use.

Reports of adverse reactions to the FAMHP

Trend

The number of reports of medicines for veterinary use once again shows an increase.

Pharmacovigilance of medicines for veterinary use

0
individual reports of adverse reactions
0
PSUR's received

Materiovigilance (medical devices)

0
reports received

2 035

incidents

459

FSCA’s

Trend

In 2019, we are once again seeing an increase in the number of reports of incidents with medical devices.

New

In March 2019, a user-friendly online report form for reporting adverse reactions to medicines by patients was published in order to encourage the reporting of adverse reactions by patients.

he proportion of reports of adverse reactions by patients continues to rise. In 2012, the FAMHP received 23 reports from patients; in 2019, the count was 498.

In March 2019, a user-friendly online report form for reporting adverse reactions to medicines by patients was published in order to encourage the reporting of adverse reactions by patients.

he proportion of reports of adverse reactions by patients continues to rise. In 2012, the FAMHP received 23 reports from patients; in 2019, the count was 498.

In 2019, a study on the use of stimulants with French-speaking students was concluded. More than 12,000 students took part in the research and around 5% of them were using a stimulant in the hope of improving their performance. All results of the study are available on the FAMHP’s website.

Human Body Material Unit

Haemovigilance (blood and unstable blood derivatives)

0
reports of incidents and serious adverse reactions received

23

RAS

12

updates

mainly on West Nile virus

Trend

The number of reports of incidents with blood and unstable blood derivatives remained stable compared to the number of reports received in 2018.

Trend

In 2019, we noted the highest number of reports of incidents with cells and tissues since reporting began.

Biovigilance (cells and tissues)

0
reports of incidents and serious adverse reactions received

50

RAS

12

updates

mainly on West Nile virus

Health Products Division

0
actors

(manufacturers, legal representatives, distributors, importers) registered via the online registration system

0
export certificates for medical devices received
0
export certificates for in vitro diagnostic medical devices received
0
new notifications
0
amendments
0
recalls

for the marketing of class I medical devices received

0
files for CU received

Proper Use Division

E-mailbox info.medicines

0
questions from patients answered

Additional risk minimisation activities

0
RMA files approved

Advertising to the general public

0
notifications on advertising evaluated
0
visa applications for radio or television advertising received

Database

0
new authorisations

for the marketing of a medicine in the E+R application for human and veterinary use introduced

0
reports

of the start/end of marketing for a medicine received

Sunset Clause

0
exemptions treated in line with the sunset clause

Unavailability of medicines

0
reports of the commencement or extension of the unavailability of medicines received
0
reports of the end of the unavailability of medicines received

Trend

Increase in the number of reports of unavailable medicines by 32%, which is partly explained by intensified monitoring and active awareness-raising among authorisation-holders.

New

Launch of PharmaStatus, a new online application with information on the availability of medicines in Belgium.

Up to date information can help patients, healthcare professionals and the pharmaceutical industry to limit the impact of unavailable medicines.

Anyone can sign up to stay up to date on the (un)availability of a specific medicine by e-mail.

Projects

The Proper Use Division was also responsible for monitoring a range of projects contributing to the proper use of medicines in 2019:

  • Drawing up a National Action Plan to combat AMR with the organisations concerned
  • SAMv2 (authentic source for medicines)
  • Development of the legal framework for PSP
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