S.L. 458.32 · Medicinal Products (Advertising) (S.L. 458.32)
S.L. 458.32 ст. 8Advertising material to persons qualified to prescribe.
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.