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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 & RENEWALS)

APPLICATIONS FOR VARIATIONS AND RENEWALS OF MARKETING AUTHORISATIONS

*RMSReference Member StateCMSConcerned Member StateNPNational procedure - national procedure for obtaining a marketing authorisation for medicines

APPLICATIONS FOR PARALLEL IMPORT

CALL CENTER

0
questions received
0
questions answered

VIGILANCE DIVISION (PHARMACO, MATERIO, HAEMO, BIO)

0

reports submitted

PHARMACOVIGILANCE OF MEDICINES FOR HUMAN USE

0
individual reports of adverse reactions
0
PSURsPeriodic Safety Update Report

TrendTrend

An increase in the number of reports of medicines for human use, mainly due to the increasing number of patient reports.

Reports of adverse reactions to the FAMHP

PHARMACOVIGILANCE OF MEDICINES FOR VETERINARY USE

individual reports of adverse reactions

PSURsPeriodic Safety Update Report

MATERIOVIGILANCE (MEDICAL DEVICES)

0

materiovigilance files

TrendTrend

The number of reports of incidents with medical devices continues to show an upward trend as in previous years.

HAEMOVIGILANCE
(BLOOD AND UNSTABLE BLOOD DERIVATIVES)

reports of serious adverse events and reactions

BIOVIGILANCE
(CELLS AND TISSUES)

reports of serious adverse events and reactions

HEALTH PRODUCTS DIVISION

MEDICAL DEVICES

0
notifications for distribution
0
export certificates
0
export certificates for in vitro diagnostic medical devices
0
notifications for marketing of class I medical devices
0
notifications for marketing of in vitro diagnostic medical devices

applications for CUCompassionate Use - the use of medical devices without certification of the conformity for a compassionate use

niew-icon-glitteNew

In August 2017 the Health Products Division of the FAMHPFederal Agency for Medicines and Health Products took over the responsibility from the WIV-ISPScientific Institute for the Public Health for in vitro diagnostic medical devices. Since December 2017 (FRNL), all actors active within the medical device sector must register and express their activities via the online registration system of the FAMHPFederal Agency for Medicines and Health Products.

PROPER USE DIVISION

ADDITIONAL RISK MINIMISATION ACTIVITIES

RMAAdditional Risk Minimisation Activities files
0
IN
0
OUT

ADVERTISING TO THE GENERAL PUBLIC

0
evaluated advertising notifications
0
visa applications for radio/TV advertising

OTHER FIGURES

0
treated exemptions in line with the sunset clause
0
notifications about the beginning/end of the commercialisation of a medicine
0
notifications about the beginning/end of the unavailability of medicines
0
data inserted in the E+R applicationExtra Plus Revised application is the authentic source of all medicines authorised in Belgium with the status of commercialisation per package and possible unavailibility for human and veterinary use

niew-icon-glitteNew

Expansion of the publication from commercialised medicines to all authorised medicines.

niew-icon-glitte

Launch of the SAMSource authentique de médicaments - authentic source medicines portal (FRNL). This reference database is an open source project that is used by companies that develop applications for doctors and pharmacists. SAMSource authentique de médicaments - authentic source medicines was initially developed as a reference database for the electronic procedure for applying for reimbursement for certain categories of medicines and grew into the reference database for the support of the entire medicines process (for example electronic prescription).

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