The Falsified Medicines Directive (FMD), sets forth a number of measures to prevent the introduction of falsified medicines on the market. Thus, all packages of medicines that fall under this regulation must have a unique code and an anti-tampering device (ATD). On packages that do not fall under this obligation, marketing authorization holders can voluntarily attach an ATD. This information is now available in the online medicines database.
The online medicines database contains information about all of the medicines licensed in Belgium.
This information within the framework of the Falsified Medicines Directive is now included in the database:
- FMD (Falsified Medicines Directive)
Indications of whether the medicine falls under the European Falsified Medicines Directive and whether the provisions of this directive are thus applicable.
- FMD Code (Falsified Medicines Directive Code)
Product code, consisting of 14 digits, that made up part of the two dimensional barcode on the package of the medicine.
- ATD (anti-tampering device)
Indication of whether the package of a medicine is equipped with an anti-tampering device.
Packages of medications that fall under this regulation are required to have an ATD. Packages of medications that do not fall under this obligation may also bear an ATD. The marketing authorization holder must submit an application for this to the FAMHP.