Archemin

Advice & reporting for the chemical and pharmaceutical industries

News & updates

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. Read more	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. Read more
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. Read more	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. Read more
Public tenders in the Belgian hospital: good and/or cheap purchase of medicines? posted on October 14th 2011 by Inneke Van de Vijver What ? Read more	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. Read more
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). Read more	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. Read more
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. Read more	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 Read more

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