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S.L. 458.32 · Medicinal Products (Advertising) (S.L. 458.32)

S.L. 458.32 ст. 8Advertising material to persons qualified to prescribe.

ДействуетОфициальный текст

Any advertising of a medicinal product to persons qualified to prescribe or supply such products shall include:

(a) essential information compatible with the summary of product characteristics which shall include:

(i) the trade name;

(ii) a list of active ingredients;

(iii) the pharmaceutical form;

(iv) major indications for use;

(v) the dosage and method of use;

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

(vii) the name and address of the marketing authorization holder;

(b) the supply classification of the medicinal product. The advertising of a medicinal product to persons qualified to prescribe or supply such products may, notwithstanding paragraphs (a) and (b), include only the name of the medicinal product or its international non-proprietary name, where this exists, or the trademark if it is intended solely as a reminder and takes place by means of the use of promotional aids.