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.
As of 1 January 2019, the holders of a MA of a medicine delivered on medical prescription or written request must use the OTC header in the leaflet for the patient. Section 15 in the packaging text must be completed according to the QRD template and the mode of delivery must be listed on the packaging consistent with the mode of delivery on the MA.
This makes the use of the QRD template for these drugs consistent with the scope of the directive 2011/62/EU or Falsified Medicines Directive (FMD).
The revision can occur in the first subsequent file with impact on these documents or if there is no file in the near future, via notification.