News & updates

Publication of confidential information by the NIHDI

posted on July 19th 2012 by Inneke Van de Vijver
A "gentleman's agreement" on the publication of price-volume contracts (article 81 of the Royal Decree of 21-12-2001) between the NIHDI and  the pharmaceutical industry was elaborated after mutual consultation.

Implementation of new EU Pharmacovigilance legislation in Belgium

posted on June 15th 2012 by Tomas Bellemans
The new EU legislation concerning pharmacovigilance comes into effect in July 2012. Together with tighter supervision by the Belgian Federal Agency for Medicines and Health Products (FAMHP) in this area, Marketing Authorisation Holders should take the following important matters into consideration during the coming months.

Adreview reimbursed in Belgium (Class I reimbursement)

posted on June 01st 2012 by Inneke Van de Vijver
As from 1 June 2012 on Adreview is reimbursed in Belgium when used in clinical cardiology for identifying patients most in need of additional medical treatment or the implantation of a cardiac defibrillator.

Public tenders in the Belgian hospital: good and/or cheap purchase of medicines?

posted on October 14th 2011 by Inneke Van de Vijver
What ?

10th Anniversary of the Commission for the Reimbursement of Medicines (Belgium)

posted on October 12th 2011 by Inneke Van de Vijver
The Belgian Commission for the Reimbursement of Medicines (CRM) celebrated its 10th anniversary. During their symposium, called “CRM 2.0”, representatives of the Authorities, Health Care sector and Pharmaceutical Industry discussed the past, the present and the future of reimbursement of pharmaceuticals in Belgium.

e-submissions Belgium

posted on August 30th 2011 by Ludwig Everaert
As from 1 September 2011 on, a validation report must be joined to all electronic registration applications submitted to the Belgian authority (FAMHP).

European Medicines Agency improves package leaflets

posted on July 25th 2011 by Helena Van Overloop
Readability testing conducted by our team has pointed out on several occasions that the rigid standard statements to be included in package leaflets often adversely affect user friendlieness.

Risk Management Plan

posted on July 19th 2011 by Tomas Bellemans
The Belgian Regulatory Authority (FAMHP) published background information on the structure and content of the Risk Management Plan that may be required for some medicinal products. Prior to their distribution, educational materials developed as part of the organisation of risk limiting activities, require FAMHP approval.

Good Distribution Practice of medicinal products for human use

posted on July 18th 2011 by Ludwig Everaert
The European Commission's Directorate General for Health and Consumer Policy (DG SANCO) has launched a public consultation on the revised ‘Guideline on Good Distribution Practice of Medicinal Products for Human Us

Pharmacovilance: EMA publishes format for data transmission

posted on July 02nd 2011 by Tomas Bellemans
The EMA just published detailed instructions for marketing authorisation holders on the electronic submission of safety information on medicinal products for human use.