Archemin

Advice & reporting for the chemical and pharmaceutical industries

News & updates

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
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. Read more	Price-Volume Contracts for Expensive Medicines posted on March 28th 2011 by Inneke Van de Vijver In Belgium pharmaceutical companies can in some instances agree with the authorities on price-volume contracts where "normal" reimbursement is unlikely. A price-volume contract aims at controlling the budget of expensive medicinal products, even at increasing volumes. Read more
Growing Team posted on November 03rd 2010 by Ludwig Everaert Pack Insert Readability Testing is picking up speed as predicted. We are in constant need of extra hands. In 2010 our team has already expanded by 30% and we are still hiring ... Read more	New Offices posted on June 28th 2010 by Ludwig Everaert From July 1st, 2010 onwards, our new business address is Lange Nieuwstraat 1 - 2800 Mechelen (Belgium). Read more
Class I Reimbursement posted on April 15th 2010 by Inneke Van de Vijver Hexvix has successfully passed its individual revision of Class I reimbursement. Read more	Medicines Price revision in Morocco posted on December 02nd 2009 by Inneke Van de Vijver The prices of medicines in Morocco are fixed by the health authorities. The existing system was in dire need of revision. A mathematical model was developed to help the health authorities to keep their national medicines budget under control. Read more

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