Advice & reporting for the chemical and pharmaceutical industries

News & updates

Selincro (nalmefene) reimbursed in Belgium

posted on March 25th 2014 by Ludwig Everaert
Class I reimbursement has been obtained for Selincro in Belgium. The product is expected to revolutionarize the treatment of alcoholism, a condition which affects millions of people. Selincro is original in the sense that the product can be taken as needed for the reduction of alcohol consumption in patients with alcohol dependence.

A 60% increase in sales tax on medical devices in Belgium

posted on January 01st 2014 by Ludwig Everaert
From 1 January 2014 on, the tax on the turnover of medical devices increases from 0.18417 to 0.29438%; this is an increase of nearly 60% (law of  15 December 2013, published in the Belgian State Gazette of 20 December 2013).

Pharmaceuticals in the environment… moving towards ecopharmacovigilance

posted on December 26th 2013 by Ingrid Nobels
The monitoring of chemicals in the aquatic environment is in Europe regulated by the water framework directive (WFD).  Agreement has been reached in Europe on an updated list of priority substances considered to present a risk to the aquatic environment.

Archemin updates its Pharmacovigilance Agreement Template

posted on December 09th 2013 by Tomas Bellemans
Updates of EU pharmacovigilance legislation called for an update of Archemin's template for Safety Data Exchange Agreements , contracts between a Marketing Authorisation Holder and the Qualified Person for PharmacoVigilance.

Archemin Delegation present at ISPOR 2013

posted on November 06th 2013 by Inneke Van de Vijver
Whereas the development of medicinal products used to be a purely sequential process, consisting of clinical development, registration process followed by a price and reimbursement application and then market launch, this is no longer realistic.

Interactive training session on Belgian Pricing and Reimbursement procedures for medicines

posted on October 18th 2013 by Inneke Van de Vijver
Archemin's Market Acces Specialists provide interactive trainings on Belgian Pricing and Reimbursement procedures for medicines. These 3-4 hour training sessions focus on

Course on developing and managing a compliant Pharmacovigilance system

posted on September 09th 2013 by Ludwig Everaert
The Archemin pharmacovigilance team, together with several customers' delegates, benefited from the frist of a very intensive interactive 2- day pharmacovigilance training course.

Belgium to implement the new EU PharmacoVigilance legislation on a local level

posted on July 26th 2013 by Tomas Bellemans
28 may 2013 a  Royal Decree was published in Belgium regulating the national implementation of the EU PharmacoVigilance legislation. More details on the interpretation of these legal texts by the Federal Agency for Medicines and Healthcare Products (FAMHP) can be found in 2 new circular letters. In summary:

Pharmacovigilance - Introducing a black symbol to identify Medicinal Products subject to additional monitoring.

posted on March 08th 2013 by Tomas Bellemans
To identify medicinal products that are subject to additional monitoring, the EU Commission adopted an implementing Regulation (198/2013) introducing a black symbol on the 7th of March.

Free samples - Medicines for Human Use

posted on December 19th 2012 by Helena Van Overloop
The Belgian Federal Agency for Medicines and Medicinal Products reminds pharmaceutical companies that samples can only be provided to prescribers upon presentation of a written request that strictly complies with the legal requirements. (circular letter number 594 dd 18 december 2012).