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Medical devices – turnover declaration
Belgium As from the start of 2023, a new system for funding market surveillance of medical devices by FAMHP applies. Unlike before, this will no longer be limited to the sale of medical devices to retailers and end users. All actors that carry out an activity...
Update instructions for distribution of DHPC in Luxembourg
Luxembourg Division de la Pharmacie et des Médicaments de la Direction de la Santé has published updated instructions for the distribution of DHPC in Luxembourg (version 2.0 - 02/2023). A significant change in the updated version is the addition of the paragraph...
Diploma for the Responsible Person for Information and Publicity (RIP)
Belgium The Royal Decree of April 7, 1995 on information and publicity of medicinal products for human use, describing which diplomas are eligible for recognition as RIP is being amended. The adaptation is made to follow the evolution in terminology of the relevant...
Update Procedure for MA applications in Luxembourg
Luxembourg On 20 January 2023, the Luxembourg authorities updated their document ‘Procedure for marketing authorisation applications in Luxembourg’, version 3.A new tab was created in the excel file with information regarding the Product information. The DPM of...
Labeling Medicinal products
Belgium The FAMHP would like to remind the pharmaceutical industry regarding the following topics: Pictograms related to the environment and recycling (e.g. green dot pictogram) do not comply with art.56§1 of the Royal Decree on medicines. The current guideline...
New clarification about Day 0 in local literature search published by EMA
Europe In January 2023 EMA published a new Q&A with a clarification of Day 0 in the context of local literature review when it concerns physical copies of journals. Marketing authorisation holders (MAH) must review and assess reports of suspected adverse...
Revision IML Code of Ethics
Luxembourg IML, the association of the innovative pharmaceutical industry in Luxembourg has revised and updated their Code of Ethics. The proposed amendments will be submitted for approval at the General Assembly to be held on 17 April 2023. Here below you can find a...
MEB starts authorizing temporarily different packaging
The Netherlands Marketing authorization holders who want to temporarily supply a medicine in a different packaging in the event of a medicine shortage will need permission from the MEB from 1 January 2023. The MEB will take over this task from the Healthcare and Youth...
Update Guidance document describing the food categories in the Regulation on Food Additives
Europe The European Commission had published an update of the Guidance document describing the food categories in Part E of Annex II to Regulation (EC) No 1333/2008 on Food Additives. In this new version the following changes are made: - update of Category 17, in line...
Mdeon, the Belgian ethical health platform, announces several novelties effective from January 1st, 2023.
Belgium Most important is the increase of hospitality that can be provided to healthcare professionals. The maximum amount for a lunch will be increased to 45€, for a dinner to 90€. A total maximum of 135€/day may be offered as hospitality to HCPs in the context of at...
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