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Update Royal Decree of 7 April 1995 on information and advertising for medicines for human use
Belgium An update of the Royal Decree of 7 April 1995 on information and advertising for medicines for human use was published to include the degree of “Master in pharmaceutical sciences” as an acceptable degree to obtain the RIP recognition: Source: Royal Decree of 7...
Code of conduct GMH and CGR tightens the rules
The Netherlands As previously announced, the Foundation for the Code for Pharmaceutical Advertising ("the CGR") and the Foundation for the Code of Conduct for Medical Devices (“the GMH”) have decided to further tighten their rules as of January 1st, 2024. We now have...
Reasonable maximum hourly rates for 2024
The Netherlands As of 1 January 2022, a new system came into force in the Netherlands providing for annual indexation of the reasonable maximum hourly rates for the remuneration of professionals for services rendered. We would like to inform you about the rates for...
EU Commision: Strategy Paper with Measures against Medicine Supply Shortages
Europe To prevent and mitigate shortages of critical medicines in the European Union, the EU commission has adopted a couple measures. These measures aim at ensuring adequate supply of medicines or managing medicine shortages. Examples of planned measures are:...
Data Tracking System (DTS)
Belgium On 16 October, the Belgian federal agency for medicines and health products (FAMHP) has introduced a new application for the effective management of marketing authorisation and vigilance dossiers. Data Tracking System (DTS) will replace 4 MeSeA applications:...
Webinar Full FMD implementation
Belgium The Belgian "National Medicines Verification System" (NMVS) is linked to the "European Alert Management System" (EAMS) via a "National Alert Management System" (NAMS) since 1 July 2023. Since there is now the possibility of real-time processing of EU-FMD...
Food Supplements
Europe The European Parliament has published their assessment report on the implementation and application of the Regulation on nutrition and health claims made on foods (EC) 1924/2006. Health claims and use of health claims on foods containing botanicals are at the...
Code of conduct GMH and CGR tightens the rules
The Netherlands The board of the codes of conduct issued by the Foundation for the Code for Pharmaceutical Advertising ("the CGR") and the Foundation for the Code of Conduct for Medical Devices (“the GMH”) have decided to further tighten their rules as of January 1st,...
Introduction to FAMHP portal – manufacturing inspections
Belgium The FAMHP will open a new web portal later this year for manufacturers based in Belgium who are subject to inspections in the context of a GMP certificate, manufacturing and import authorization (MIA), raw materials (AR 97), active ingredients (API) or...
RD export 19/01/2023 – mandatory application for export
Belgium The Belgian government has issued a royal decree (19 January 2023) allowing the export of medicines to be temporarily restricted. The decree allows an export in case of unavailability to be subject to prior authorisation, if it concerns essential medicines and...
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