News & updates

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).

Financing LOKs / GLEMs (Local Quality Circles)

posted on December 10th 2012 by Helena Van Overloop
Physicians are required to continuously update their professional knowledge and regular meetings of multidisciplinary Local Quality Circles (LOKs / GLEMs) have become an essential tool to promote the quality of Belgian Health Care.

Development of your Pharmacovigilance Quality System

posted on October 30th 2012 by Tomas Bellemans
Even though the rules on pharmacovigilance have been improved in 2010, potential weaknesses were brought to light in 2011. Therefore, the Commission proposed extensive additional amendments to the legislation. Parts of the new EU legislation already entered into force in July 2012 and are now being transposed in national legislation.

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.