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German to English translations [PRO]
Medical - Medical: Dentistry | | German term or phrase: Präsentationsarzneimittel | Solche Produkte fallen nicht unter die Anwendung der Zweifelsfallregelung, weil sie weder Funktionsarzneimittel noch *Präsentationsarzneimittel* sind, deren nicht-pharmakologische, nicht-immunologische oder nicht-metabolische Wirkung nicht feststeht.
Aus einem Urteilsspruch eines Oberlandesgerichts. Es geht um natriumfluorid-haltige Zahnprodukte.
Bin mir nicht sicher ob villeicht Placebos damit gemeint sein könnten, habe 'Funktionsarzneimittel' mit ' do not function as drugs' umschrieben.
Wer weiß darüber Bescheid? Vielen Dank im Voraus |
|  Mech WhiteKudoZ activityQuestions: 5 (none open) Answers: 50
| | Local time: 01:02
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| | medicinal product by presentation | Explanation:
According to these EC documents.
The concept of a medicinal product
In its judgment, the Court recalled that the Community code relating to medicinal products for human use constitutes only the first stage of harmonisation, and that, in those circumstances, it is difficult to avoid the existence of differences in the classification of products between Member States. Nevertheless, a product must be regarded as a "medicinal product" if it satisfies the Community definition of that concept. A product may be a medicinal product either by presentation or by function.
http://curia.europa.eu/jcms/upload/docs/application/pdf/2009...
2. Kann ein Produkt, das kein Präsentationsarzneimittel ist, als Funktionsarzneimittel im Sinne des Art. 1 Nr. 2 der Richtlinie 2001/83 angesehen werden wegen eines Bestandteils, der in bestimmter Dosierung physiologische Veränderungen hervorrufen kann, dessen Dosierung in dem zu beurteilenden Produkt – bei bestimmungsgemäßem Gebrauch – aber dahinter zurückbleibt? Ist diese Frage dem Merkmal der „pharmakologischen Wirkung“ oder dem Merkmal der „Beeinflussung der menschlichen physiologischen Funktionen“ zuzuordnen?
2. Can a product which is not a medicinal product by presentation be regarded as a medicinal product by function within the meaning of Article 1(2) of Directive 2001/83 … because of a component which can produce physiological changes in a certain dosage but whose dosage in the product to be assessed – if used as intended – is too low for that? Is this question to be allocated to the criterion of “pharmacological action” or the criterion of “modifying physiological functions” in human beings?
http://eur-lex.europa.eu/Notice.do?mode=dbl&lang=de&ihmlang=...
DEFINITION OF MEDICINAL PRODUCT
Definition in Article 1(2) of Directive 2001/83/EC allows a substance or combination of substances to become a medicinal product in two ways:
(1) by presentation
when the substance/s is presented as having properties for treating or preventing disease in human beings;
or
(2) by function
when the substance/s may be used in or administered with a view to restoring, correcting or modifying physical functions by exerting a pharmacological immunological or metabolic action, or to making a medical diagnosis.
http://www.giuripol.unimi.it/Jmonnet/ammannati/locandina_jab... |
| Selected response from:
Alison MacG
United Kingdom
Local time: 00:02
| Grading comment Thank you for setting me on the right track, Alison ;-), after that it was easy!
4 KudoZ points were awarded for this answer |
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| Discussion entries: 0 |
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Automatic update in 00:
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47 mins confidence:   peer agreement (net): +3 medicinal product by presentation
Explanation:
According to these EC documents.
The concept of a medicinal product
In its judgment, the Court recalled that the Community code relating to medicinal products for human use constitutes only the first stage of harmonisation, and that, in those circumstances, it is difficult to avoid the existence of differences in the classification of products between Member States. Nevertheless, a product must be regarded as a "medicinal product" if it satisfies the Community definition of that concept. A product may be a medicinal product either by presentation or by function.
http://curia.europa.eu/jcms/upload/docs/application/pdf/2009...
2. Kann ein Produkt, das kein Präsentationsarzneimittel ist, als Funktionsarzneimittel im Sinne des Art. 1 Nr. 2 der Richtlinie 2001/83 angesehen werden wegen eines Bestandteils, der in bestimmter Dosierung physiologische Veränderungen hervorrufen kann, dessen Dosierung in dem zu beurteilenden Produkt – bei bestimmungsgemäßem Gebrauch – aber dahinter zurückbleibt? Ist diese Frage dem Merkmal der „pharmakologischen Wirkung“ oder dem Merkmal der „Beeinflussung der menschlichen physiologischen Funktionen“ zuzuordnen?
2. Can a product which is not a medicinal product by presentation be regarded as a medicinal product by function within the meaning of Article 1(2) of Directive 2001/83 … because of a component which can produce physiological changes in a certain dosage but whose dosage in the product to be assessed – if used as intended – is too low for that? Is this question to be allocated to the criterion of “pharmacological action” or the criterion of “modifying physiological functions” in human beings?
http://eur-lex.europa.eu/Notice.do?mode=dbl&lang=de&ihmlang=...
DEFINITION OF MEDICINAL PRODUCT
Definition in Article 1(2) of Directive 2001/83/EC allows a substance or combination of substances to become a medicinal product in two ways:
(1) by presentation
when the substance/s is presented as having properties for treating or preventing disease in human beings;
or
(2) by function
when the substance/s may be used in or administered with a view to restoring, correcting or modifying physical functions by exerting a pharmacological immunological or metabolic action, or to making a medical diagnosis.
http://www.giuripol.unimi.it/Jmonnet/ammannati/locandina_jab...
| Alison MacG
United Kingdom
Local time: 00:02
Native speaker of:  English
PRO pts in category: 4
|
| | Grading comment | Thank you for setting me on the right track, Alison ;-), after that it was easy! |
| Notes to answerer
Asker: Thank you Alison, this was extremely helpful
|
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