APPLICATIONS FOR VARIATIONS AND RENEWALS OF MARKETING AUTHORISATIONS
APPLICATIONS FOR PARALLEL IMPORT
CALL CENTER MARKETING AUTHORISATION
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 the obligation for marketing authorisation holders to report non-serious side effects.
Since 2017, the FAMHPFederal Agency for Medicines and Health Products has had a pharmaco-epidemiology team within the Pharmacovigilance (human use)/Evaluation Entity. The activities of this team make it possible to measure the effectiveness of actions taken by the FAMHPFederal Agency for Medicines and Health Products to optimise the safety of medicines. Three areas of interest have been defined: the use of medicines during pregnancy, dependence on and abuse of medicines, and the development of methods for the use of Belgian data.
In 2018, thanks to the activities of this team, the FAMHPFederal Agency for Medicines and Health Products conducted four surveys on:
- communication with health professionals (change of dosage of Perdolan syrup) (French – Dutch),
- the use of stimulant medicines by French-speaking students,
- the use of valproic acid (valproate) in women of childbearing age,
- physicians’ and pharmacists’ perception of the usefulness of small packages of benzodiazepines and related medicines in limiting the risk of abuse and dependence (French – Dutch).
Reports of adverse reactions to the FAMHPFederal Agency for Medicines and Health Products
PHARMACOVIGILANCE OF MEDICINES FOR VETERINARY USE
The number of reports of medicines for veterinary use still shows an increasing trend just as in previous years.
MATERIOVIGILANCE (MEDICAL DEVICES)
FSCAField Safety Corrective Actions‘s
The number of reports of incidents with medical devices continues to show an upward trend as in previous years.
(BLOOD AND UNSTABLE BLOOD DERIVATIVES)
The number of reports of incidents with blood and erratic blood derivatives shows a rising trend. In 2018, the FAMHPFederal Agency for Medicines and Health Products received the greatest number of reports since the start in 2006.
(CELLS AND TISSUES)
RASRapid Alert System of which
RASRapid Alert System via European platform
RASRapid Alert System sent via Belgium to member states
The number of reports of incidents with cells and tissues shows a rising trend.
HEALTH PRODUCTS DIVISION
actors (manufacturers, legal representatives, distributors, importers) registered via the online registration system
Marketing of class I medical devices
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
PROPER USE DIVISION
questions of patients answered
ADDITIONAL RISK MINIMISATION ACTIVITIES
RMAAdditional Risk Minimisation Activities files
ADVERTISING TO THE GENERAL PUBLIC
new central authorisations 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
new national authorisations inserted in the E+R application for human and veterinary use
Publication of a new online database containing all medicines licensed in Belgium for human and veterinary use, including a link to relevant documents such as the patient information leaflet, SPCsummary of product characteristics, RMARisk Minimisation activities en DHPCDirect Healthcare Professional Communication.
The database also contains information about availability and temporary inventory problems regarding medicines.