The FAMHP is updating the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials in Belgium, with the introduction of a new option for sponsors willing to participate : the VHP plus.
The FPS Public Health and the FAMHP invite you to participate in the public consultation on two clinical trials with the genetically modified medicinal product AAV5-hFVIII-SQ (BMN 270) against hemophilia A. The public consultation runs from 27 February 2019 to 29 March 2019 inclusive.
Notifications about anti-tampering device (ATD) or devices to prevent tampering on packaging of existing drugs that do not fall under the Falsified Medicines Directive
Within the framework of the Falsified Medicines Directive, FMD) which is effective as of February 9, 2019, all drug packaging falling under this legislation must be equipped with an anti-tampering device (ATD). Packaging of these drugs not subject to this obligation may also have an ATD. The marketing authorization holder must submit a request for this to the FAMHP.