Circulars
03/11/2009: circular 561 (PDF, 435.57 Kb)
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 (PDF, 354.14 Kb) - Hum (ZIP, 343.83 Kb) - Vet (ZIP, 229.16 Kb) - Operating procedure (PDF, 29.23 Kb)
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 (PDF, 91.53 Kb)
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 (PDF, 446.26 Kb)
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 (PDF, 146.55 Kb) + form (DOC, 217.5 Kb) + form (PDF, 66.34 Kb)
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).
09/06/2008:circular 522 (PDF, 527.92 Kb) + AMM light (DOC, 231 Kb) + checklist for closing off of a dossier (DOC, 230 Kb)
To all applicants/ Marketing Authorisation Holders for medicinal products for human use.
Simplified Marketing Authorisation for medicinal products for human use. Unique registeration number for medicinal products for human use.
09/06/2008:circular 521 (PDF, 152.98 Kb)
To all applicants/ Marketing Authorisation Holders for medicinal products for human use.
Inactivation of files in the administrative finalisation phase.
27/02/2008:circular 513 (PDF, 235.66 Kb)
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 (PDF, 209.97 Kb)
To the manufacturers, importers, wholesalers and holders of marketing authorisations of medicines and medical devices.
Scientific event including at least one night. MDeon visa.
25/07/2006: Circular 469 (PDF, 143.68 Kb)/en/binaries/circular-469-EN_tcm292-27463.pdf+ Declaration of conformity - MRP/DCP (DOC, 221.5 Kb) + Declaration of conformity - NP (DOC, 221.5 Kb) + FAQ (PDF, 35.45 Kb)
To the marketing authorisation holders for medicinal products for human 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 human use.
- Template to be used for editing the leaflet and the labelling in Dutch, French and German.
- Readability test for leaflets.
- Braille format on labelling.
For the other circulars, please see in French or Dutch.