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Verify Luxembourg MA Numbers in XEVMPD
Luxembourg All Marketing Authorization Holders (MAHs) should have received a communication from the Luxembourg authorities regarding discrepancies in Marketing Authorization (MA) numbers for MRP/DCP and national procedure products in XEVMPD. This is part of an ongoing...
Rates advice KOAGKAG
The Netherlands Keuringsraad KOAGKAG can be consulted for advice with regard to promotional material and claims taking into account the current codes and guidelines for medicinal products, medical devices and health products. As the complexity of the questions...
Announcement of changes in EU pharmacovigilance legislation
Europe In December 2024, a draft version of an amendment to the European legislation for pharmacovigilance activities (Implementing Regulation EU No. 520/2012) has been published by the European Commission. Public feedback was collected until the 15th of January 2025....
New European regulation for Health Technology Assessment
Europe The new European Health Technology Assessment (HTA) regulation came into force in January. The main goals of this EU HTA regulation (EU HTAR) are: to improve and speed up the availability of innovative medicines and medical devices to patients across the EU; to...
Pharma.be supports interactions with patients
Belgium Pharma.be organised a yearly round table event to discuss and improve interactions and collaborations with patients. They have published their main findings on their website, but we will list the most relevant ones for you here below: * A new Q&A guidance...
Update GMH code 2025
The Netherlands GMH has published an updated version of the GMH code. For example, the new maximum rates for service fees for this year, 2025, have been implemented. There were no alterations content-wise, but more explanation has been added on different points....
Adaptation variation payments Luxembourg
Luxembourg Since January 2025, the payment system for variation fees in Luxembourg has changed. In the past, variation fees were paid bi-annual and based on the number of products and variations included in the submission. As from January 2025, variations need to be...
Updated Belgian guidelines for the labelling and packaging of medicinal products
Belgium An update of the Belgian guidance regarding labelling and packaging of medicinal products for human use was published based on the most recent adaptations of the European directives. FAMHP has provided a shortlist of the most important updates: Updated...
Obligation for Manufacturers to Notify Interruptions or Discontinuations in the Supply of Medical Devices and IV Diagnostic Medical Devices
Europe From January 10, 2025, manufacturers of medical devices (MDs) and in vitro diagnostic medical devices (IVDs) placed on the European Union market must report any interruptions or discontinuations in supply when it is reasonably foreseeable that such absence...
New Royal Decree manufacturing and marketing of food supplements
Belgium On January 22, 2025, the Royal Decree of December 15, 2024, was published in the Belgian Official Gazette. This RD replaces the current RDs regarding nutrients, other substances and plants or plant preparations. Please find herewith the FR and NL...
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