Comment phased plan procedure

Final comment of Sanum-Kehlbeck GmbH & Co. KG on the BfArM’s notification “Prevention of dangers due to medicinal products, Step II” of 08.03.2012 and on the BfArM’s announcement of procedural conclusion of 12.10.2012.

In March of 2012, the BfArM announced in a phased plan procedure (Step II) revocation of the registrations of 30 homeopathic human remedies with preparations from moulds and yeasts (e.g. MUCOKEHL®, NOTAKEHL®, NIGERSAN®) up to a potency of 8X.

As the responsible pharmaceutical company and manufacturer, we were able to eliminate the BfArM’s concerns by presenting specific studies. Sanum-Kehlbeck was able to prove harmlessness of the products in question. Our products comply with the official requirements regarding toxicological safety and pharmaceutical quality.

The BfArM closed the phased plan procedure upon submission of all data on June, 11th 2013.

Thus, the remedies continue to be available without limitation in their current administration forms and potencies.

Thank you for your confidence.

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