The legal classification of skin and hand disinfectants is still lively. The traditional”classification of such products as medicines is still defended by interested circles. Rightly, it is however assumed that skin and disinfectants now basically biocidal products may be marketed as, so any pharmaceutical regulatory approval require. Now the Verwaltungsgericht (VG) Cologne of judgment of 06.12.2011 has joined the. Although the Court could leave ultimately clarify the delimitation issue, as was in the case of a medicinal products approved through the subsequent approval, still considered medicinal products in accordance with 2 para 4 sentence 1 AMG. The VG revealed however, that it tends to classify skin and disinfectant usually not drug as biocides.
It was at a preparation with the indication of hygienic hand disinfection”, even with the addition in Bundesgesundheitsamtes, namely to a presentation of medicines, because the purpose not on the prevention of specific human diseases was not addressed. And the adoption of a medicinal product function is likely that the process of disinfection not on effects on physiological functions of the human body was and it also a pharmacological, immunological or metabolic action on the way to do this, might lack preclude the Court considers. As a subsumption within the definition of medicinal products is not always possible, the doubt regulation of 2 para 3 can’t get a AMG in these cases to the application. This conception of the VG Cologne is not only in the result to be welcomed, but also convincingly brings the essential arguments that speak against a flat classification of skin and hand disinfectants as medicines, to the point. The decision is the competent court for demarcation disputes with the Federal Institute for drugs and medical devices of great practical importance, since the VG Cologne (BfArM) is as approval authority for medicinal products for human. The decision however is by no means represents a carte blanche for to market skin and disinfectant in each case without drugs-legal authorisation. Because a clumsy”presentation of such preparations is quite in individual cases still classification as medicinal products into consideration. The careful wording of the claims in labelling and advertising, therefore special attention is to be.