New National Regulation for Analgetics in Germany

15.06.2018 | Dr. Christoph Buss
Buss

Dr. Christoph Buss
Associate Director Pharmacovigilance

On June 09, 2018 the German Bundesrat [Federal Council of Germany] has approved a new national regulation concerning special warnings on the outer packaging of pharmaceutical products containing analgetics, the "Analgetika-Warnhinweis-Verordnung". Marketing Authorization Holders are obliged to place warnings on their OTC products if they contain certain active substances.

The affected active substances are:

  • Acetylsalicylic acid
  • Diclofenac
  • Ibuprofen
  • Naproxen
  • Paracetamol (Acetaminophen)
  • Phenazone
  • Propyphenazone

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!

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