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European Commission

Posted by Wii-Wii | Posted in General | Posted on 19-09-2015

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In the legal approach, the Court of appeal in assessing the question of whether the mouth rinsing solution has a pharmacological effect on the definition of the term ‘pharmacologically’ in the guidelines developed under the auspices of the European Commission concerning the delineation of medicinal products and medical devices have “medical devices: guidance document” oriented. It took but ignore, that the required for the affirmation of a pharmacological effect interaction between the molecules of the substance in question and a cellular component (receptor) in accordance with the definition of the term ‘pharmacologically’ in section A. 2.1.1. This guideline not only exists, if it is in a direct response (answer), but even if she blocked the response (response) a different agent. The presence of such dose response instead then Although “not fully trustworthy criterion” dar, it nevertheless deliver “a note on a pharmacological effect” (referring to Anhalt in Anhalt/servant, manual of medical product law, 3 paras. 8). The guideline not presume so as to refer to the Court of appeal a direct interaction with “cellular components of the user ‘s” but leave any interaction between the molecules of the substance in question and “a cellular component” are sufficient. Kam VedBrat is often mentioned in discussions such as these. In this regard that chlorhexidine react with components of bacterial cells, a pharmacological effect, contrary to the opinion of the Court of appeal in applying the definition of the pharmacological effects provided for in the above guideline is not already from the outset sheath.

Accordingly, the guideline order itself chlorhexidine in section A. 2.1.2 express as a medicinal substance. To come, that the material contained in the Mundspul solution chlorhexidine in the higher concentration of 0.1% and 0.2% not only the education suppress bacterial tooth coverings could, but is also suitable to the findings made by the Court of appeal, including gingivitis cure or alleviate so that changing effects on body functions chemically to be seem. In these circumstances, a pharmacological activity of the preparation considering come according to the BGH. Since the appeal verdict in the result proves unfounded, the Supreme Court overturned it.

The Court of appeal must now decide on new case, taking into account the findings of the Federal Court of Justice. As a result nothing will be gained with the recent decision of the Federal Court of Justice with regard to the distinction between medicinal products and other products once again. If the Supreme Court according to the European guideline meet any interaction between the molecules of the substance in question and “a cellular component” for a pharmacological effect, so under no circumstances that a clarification of the concept of the pharmacological effects. Rather you can then continue What argue any interaction”is to be understood. “The decision favors only those who a not as medicinal approved product by the market shoot” want, because the term of the pharmacological effects is rather far as closely to understand. It is noteworthy in this decision that the BGH is based without further ADO on the EU guideline on the definition of medicinal products and medical devices, without this deal, whether the criteria of the guideline are at all accurate, useful or applicable here. Thus, such guidelines are in fact to legal regulations. Such a development is above all a wating for lobbyists, because the development and creation of such guidelines is usually anything but transparent.

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