15/02/2011:circular 577 + template
To the holders of MA or registration of medecines.
Legal obligations and practical measures as regards information on the marketing status of the authorized medecines.
16/11/2009: circular 545
To the holders of a belgian marketing authorisation (MA) or a belgian registration for medicinal products for human and veterinary use.
Reporting to the FAMHP by the MA or registration1 holders of the person responsible for human or veterinary pharmacovigilance
16/11/2009: circular 544 (update following to the Royal Decree of 16 March 2010 amending Articles 68 § 2 and 195 of the Royal Decree of December 14, 2006) + annex
To the applicants for a registration on the Belgian list of persons responsible for pharmacovigilance of medicinal products for human or veterinary use.
Application to be registered as the person responsible for pharmacovigilance of medicinal products for human or veterinary use.
03/11/2009: circular 561
To the marketing authorisation or registration holders for medicines.
Publication on the website of the FAMHP of the SPC's and the PIL's of the medicines authorised and marketed in Belgium.
29/07/2009: circular 547 - Human - Vet - Operating procedure
To the marketing authorisation holders.
Communication of data with reference to the actual presence on the Belgian market of medicines authorised by the European Commission (central procedure).
05/02/2009:circular 530
For the attention of the marketing Authorisation Holders for medicinal products for human use and veterinary use.
Royal Decree of 21 January 2009 setting the fees for the submission of a Periodic Safety Update Report
17/12/2008:circular 532
To marketing authorisation or registration holders of medicinal products for human use and veterinary use.
Risk management programs. Approval of "additional risk minimisation activities" by the national authorities.
12/12/2008:circular 520 + form + form
To the marketing authorisation holders for medicinal products for human and veterinary use.
To the Qualified Persons for Pharmacovigilance (QPPVs).
Pharmacovigilance inspections. Updating of the information relating to pharmacovigilance (human and veterinary).
27/02/2008:circular 513
To the manufacturers, importers, wholesalers and holders of a marketing authorisation or registration of medicines.
To the manufacturers, importers and wholesalers of medical devices.
Scientific event including at least one night. Reminder of the obligation of the MDeon visa.
19/03/2007:circular 489
To the manufacturers, importers, wholesalers and holders of marketing authorisations of medicines and medical devices.
Scientific event including at least one night. MDeon visa.
09/11/2006: circular 473 +Declaration of conformity-MRP/DCP-VET + Declaration of conformity-NP-VET
To the marketing authorisation holders for medicinal products for veterinary use
- Declaration of conformity for translations of the Summary of Product Characteristics (SPC), of the Leaflet and of the Labelling in view of the Mutual Recognition Procedure (MRP), the Decentralised Procedure (DCP) and the National Procedure (NP) for medicinal products for veterinary use.
- Template to be used for editing the leaflet and the labelling in Dutch, French and German.
For the other circulars, please see in French or Dutch.