The current postbox address of the FAMHP is no longer applicable. The contact details for reporting adverse reactions to the FAMHP should be changed by marketing authorisation holders in the product information of medicinal products for human use as soon as possible.
The new contact details are as follows:
| Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten www.fagg.be Afdeling Vigilantie Website: www.eenbijwerkingmelden.be E-mail: adr@fagg-afmps.be |
Agence fédérale des médicaments et des produits de santé www.afmps.be Division Vigilance Site internet : www.notifieruneffetindesirable.be E-mail : adr@fagg-afmps.be |
Föderalagentur für Arzneimittel und Gesundheitsprodukte www.afmps.be Abteilung Vigilanz Website: www.notifieruneffetindesirable.be E-Mail: adr@fagg-afmps.be |
The update of the summary of product characteristics (SPC) and product information leaflet (PIL) can be done through an ongoing variation, impacting the product information.
If there is no ongoing variation, the adaptation can be done through an ‘editorial change’ and can be included in the subject of a variation, with impact on the product information, along with a planned IB or Type II variation under Chapter C of the Commission Classification Guideline.
The proposed changes should be clearly indicated in the scope section of the electronic variation application form (eAF) as well as in the ‘present and proposed’ section.
More information on an ‘editorial change’ can be found in the European Commission's Q&A document on variations
The changes can also be submitted separately as a national Type IA C.I.Z variation.