When reporting side effects in the product information, one can now refer to the FAMHP’s post box address.
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.
| Federal Agency for Medicines and Health Products - Vigilance Department | Agence fédérale des médicaments et des produits de santé – division Vigilance |
|
EUROSTATION II Square Victor Horta, 40/ 40 B-1060 BRUSSELS |
EUROSTATION II Place Victor Horta, 40/ 40 B-1060 BRUXELLES |
|
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).
Adjustments to SPC and PIL documents can be made via an editorial change together with a planned IB or type II variation under chapter C of the Commission Classification Guideline. This is only possible with a variation that also adjusts the product information. State this adjustment clearly in the application form in the scope of the variation and in the "present and proposed" section.
You can find information about an editorial change in the Q&A for the submission of variations of the CMDh/v, question 3.16.
This adjustment can also be submitted separately as a national Type IA C.I.Z variation.
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