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Medical devices – turnover declaration

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...

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Update instructions for distribution of DHPC in Luxembourg

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...

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Update Procedure for MA applications in Luxembourg

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...

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Labeling Medicinal products

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...

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Revision IML Code of Ethics

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...

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MEB starts authorizing temporarily different packaging

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...

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