Dr. Christoph Buss
Associate Director Regulatory Affairs & Pharmacovigilance
The affected active substances are:
According to the new regulation, Marketing Authorization Holders are obliged to place the following warning on their OTC products containing one of the above mentioned active substances,. It advises patients not to use the product for pain or fever longer than specified in the leaflet without seeking medical advice:
„Bei Schmerzen oder Fieber ohne ärztlichen Rat nicht länger anwenden als vom Apotheker oder von der Apothekerin empfohlen!“
The new labelling provision will become mandatory for all batches released after a 24 month transition period starting when the new regulation has become effective (presumably 01 July 2018). We therefore recommend starting the variation process soon.
Diapharm can support you in local regulatory affairs and in securing local compliance of your packaging materials – contact us!