Belgium
The address information of the FAMHP for reporting side effects in the document “Appendix V – ADR reporting details” of the QRD template has been revised. In addition to the known address, patients can now also use a post box address to report side effects in writing.
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Federal Agency for Medicines and Health Products – Vigilance Department |
Agence fédérale des médicaments et des produits de santé – division Vigilance |
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EUROSTATION II Square Victor Horta, 40/ 40 B-1060 BRUSSELS |
EUROSTATION II Place Victor Horta, 40/ 40 B-1060 BRUXELLES |
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PO Box 97 B-1000 BRUSSELS Madou |
Boîte Postale 97 B-1000 BRUXELLES Madou |
A simple mention of the FAMHP’s website will no longer be allowed. One of both addresses should be mentioned in the summary of product characteristics (SPC) and patient information leaflet (PIL). In this is currently not the case in the product information of your medicines, you need to amend your SPC/PIL by submitting (a) variation(s).