Advice & reporting for the chemical and pharmaceutical industries

News & updates

Approval of medical information: guidelines Mdeon

posted on October 09th 2012 by Helena Van Overloop
The Federal Agency of Medicines and Health Products (FAMHP) has approved a short guidance document on promotional activities by the pharmaceutical industry. This document, prepared by Mdeon covers premiums and benefits for healthcare professionals as well as scientific activities that do not require an Mdeon visum.

Archemin accredited as advisor for "Strategic Entrepreneurship"

posted on August 21st 2012 by Ludwig Everaert
Archemin has been accredited as advisor for "Strategic Entrepreneurship" by the Enterprise Flanders (Agentschap Ondernemen), a government agency, charged with the economy and enterprise policy in Flanders, the Dutch speaking northern part of Belgium.

Dexdor reimbursed in Belgium (Class I reimbursement)

posted on July 25th 2012 by Inneke Van de Vijver
As from 1 August 2012 on Dexdor, a novel sedative with unique properties compared to current standard sedatives is reimbursed for hospitalised patients under Chapter I in Belgium.

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
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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.