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.
22/12/2010: circular 575 + annexes
Application for clinical trials and submissions of substantial amendments.
28/10/2010: communication 572
To whom it may concern.
Transmission to the "Contact-point" at FAMHP of information regarding the application of the regulation relating to the struggle agaisnt excessive promotion of medicines and medical devices.
20/04/2010: circular 568
For marketing authorisation holders or registration holders.
Publication on the FAMPH website of the PIL and the SPC of the medicines approved and marketed in Belgium - Following the circular nr 561 of November 3rd 2009.
30/04/2010: circular 568
For marketing authorization holders or registration holders.
Publication on the FAMHP website of the PIL and the SPC of the medicines approved and marketed in Belgium. Following the circular nr 561 of November 3rd 2009.
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 - Hum - 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).
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