Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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S.L. 458.32 · Medicinal Products (Advertising) (S.L. 458.32)

S.L. 458.32 Art. 11Free samples. Cap. 101. Cap. 31.

In KraftAmtlicher Text

(1) Free samples shall be provided on an exceptional basis only to persons qualified to prescribe them and on the following conditions:

(a) the number of samples for each medicinal product each year on prescription shall be limited;

(b) any supply of samples shall be in response to a written request, to be signed and dated, from the prescribing agent;

(c) persons supplying samples shall maintain an adequate system of control and accountability;

(d) each sample shall be no larger than the smallest presentation on the market;

(e) each sample shall be marked "free medical sample -not for sale" or shall show some other wording having the same meaning;

(f) each sample shall be accompanied by a copy of the summary of product characteristics;

(g) no samples of medicinal products containing psychotropic or narcotic substances as defined under the First Schedule to the Dangerous Drugs Ordinance and the Third Schedule to the Medical and Kindred Professions Ordinance, may be supplied.

(2) Without prejudice to subregulation (1), samples of medicinal products classified in terms of article 29(2) of the Act as being medicinal products that can only be prescribed by a specific class of prescriber shall only be distributed to such class of prescribers.

(3) Starter packs shall not be regarded as samples and shall not be labelled as such.