Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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S.L. 437.115 · Veterinary Medicinal Products (S.L. 437.115)

S.L. 437.115 Art. 19Advertising.

In KraftAmtlicher Text

(1) Any advertising of a veterinary medicinal product shall include:

(a) the trade name;

(b) a list of active ingredients;

(c) the pharmaceutical form;

(d) the major indications for use;

(e) the dosage and method of use;

(f) side effects, warnings, precautions and contraindications;

(g) the name and address of the marketing authorisation holder; and

(h) any research and, or publications on the use of the active substance.

(2) All the information contained in the documentation referred to in this regulation shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his own opinion of the therapeutic value of the veterinary medicinal product concerned.

(3) Quotations as well as tables and other illustrative matter taken from scientific works for use in the documentation provided for in this regulation shall be faithfully reproduced.

(4) The person who advertises veterinary medicinal products shall:

(a) keep for a period of not less than five (5) years a sample of all advertisements emanating from his undertaking together with a statement indicating to whom the advert is addressed, the method of dissemination and the date of first dissemination; and

(b) ensure that any decision taken and any conditions condition imposed by the Director are immediately and fully complied with.

(5) The Director may request any of the information provided for in this regulation at any time.