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).

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.

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.

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

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.

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.

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 ...

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).

Class I Reimbursement

posted on April 15th 2010 by Inneke Van de Vijver
Hexvix has successfully passed its individual revision of Class I reimbursement.

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.

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