Europe
Appendix V of the QRD template has been updated. This appendix lists the details of the national reporting systems for communicating adverse reactions, which must be stated in the SmPC and the package leaflet.
In the most recently updated versions of Appendix V (Version 21 and 22), the website, e-mail and contact address has been updated for Belgium:
| Galileelaan 5/03 1210 BRUSSEL | Postbus 97 1000 BRUSSEL Madou |
Website: www.eenbijwerkingmelden.be / www.notifieruneffetindesirable.be
E-mail: adr@fagg-afmps.be
Source: EMA Europe