Circulars publised from 2002 to 2008

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).

09/06/2008:circular 522  + AMM light + checklist for closing off of a dossier
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
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
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.

25/07/2006: Circular 469/en/binaries/circular-469-EN_tcm292-27463.pdf+ Declaration of conformity - MRP/DCP  + Declaration of conformity - NP  + FAQ
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.

Last updated on 08/03/2010