Circulars published in 2012 (English version)
18/12/2012: circular 593
To the attention of sponsors of clinical trials.
Development safety update report - DSUR
30/10/2012: circular 592
For the attention of holders of marketing authorisation and/or registration for medicines.
Publication of the famhp website of the SmPCs and patient information leaflets of the authorised medicines marketed in Belgium (following on from circulars 561 and 568).
19/06/2012: circular 586
To sponsors and applicants for clinical trials.
National implementation of the new version of the "Detailed guidance on the collection, verification and presentation of adverse event/ reaction reports arising from clinical trials on medicinal products for human use ('CT3')".
08/06/2012: circular 589
For the attention of those persons entitled to deliver and/or supply medicines, to those authorised to sell medicines by wholesale and to wholesale – distributors
Collection of fees per pack as laid down in the new framework law of 29th March 2012
08/06/2012: circular 588
For the attention of holders of marketing authorisations and/or authorisation for parallel imports
Collection of the annual fees as laid down in the new framework law of 29th March 2012