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Germany’s Ministry of Health has enforced BGBl. I S. 864 Analgesics Warning Statement on July 1, 2018.

This regulation provides the requirements for the authorization of medicinal products (analgesics) in accordance with the European Directive (EU) 20151535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of information society service.

Medicinal products may only be placed on the market if the following warning label is affixed on the outer packaging or if there is only one container: “In case of pain or fever, do not use medical advice longer than specified in the leaflet!”

The warning shall be permanently affixed to the front of the outer envelope or, if only one container is present, on the container in a clearly legible font.

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