The European Falsified Medications Directive came into effect on February 9, 2019. From that time most of the prescription and reimbursable medicines on the market must bear safety features. At each link in the distribution chain, the safety features must be checked so that the authenticity of the medicine upon delivery can be guaranteed.

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.

As of 1 January 2019, the holders of a marketing authorisation (MA) must use the OTC version of the QRD template for drugs delivered on medical prescription or written request according to article 3 of the regent decree dated 6 February 1946.

Last updated on 29/06/2017