APPLICATIONS FOR VARIATIONS AND RENEWALS OF MARKETING AUTHORISATIONS
APPLICATIONS FOR PARALLEL IMPORT
VIGILANCE DIVISION (PHARMACO, MATERIO, HAEMO, BIO)
PHARMACOVIGILANCE OF MEDICINES FOR HUMAN USE
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
MATERIOVIGILANCE (MEDICAL DEVICES)
The number of reports of incidents with medical devices continues to show an upward trend as in previous years.
(BLOOD AND UNSTABLE BLOOD DERIVATIVES)
(CELLS AND TISSUES)
HEALTH PRODUCTS DIVISION
applications for CUCompassionate Use - the use of medical devices without certification of the conformity for a compassionate use
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 (FR – NL), 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
ADVERTISING TO THE GENERAL PUBLIC
Expansion of the publication from commercialised medicines to all authorised medicines.
Launch of the SAMSource authentique de médicaments - authentic source medicines portal (FR – NL). 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).