Proyecto "Normativa Técnica Sanitaria sustitutiva para la vigilancia y control de la publicidad y G/TBT/N/ECU/546 - 2 - promoción de medicamentos en general, productos naturales procesados de uso medicinal, productos o medicamentos homeopáticos y dispositivos médicos" (Draft Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices) (21 page(s), in Spanish)

Consumer information, labelling (TBT); Prevention of deceptive practices and consumer protection (TBT); Protection of human health or safety (TBT)

The aim of the draft Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices is to regulate, control and monitor the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices, in accordance with the provisions of the Organic Law on Health, with a view to promoting and providing information on the rational use and proper handling of the above-mentioned products. Only products with a sanitary registration certificate classifying them as over-the-counter products may be advertised.

Link to ePing

11.040 - Medical equipment; 11.120 - Pharmaceutics

Labelling

The aim of the draft Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices is to regulate, control and monitor the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices, in accordance with the provisions of the Organic Law on Health, with a view to promoting and providing information on the rational use and proper handling of the above-mentioned products. Only products with a sanitary registration certificate classifying them as over-the-counter products may be advertised. The provisions set out in the notified draft Regulation are applicable and mandatory throughout the national territory for natural and legal persons, whether national or foreign, that are engaged in or disseminate advertising and/or promotion activities in establishments and through mass media; it concerns the products that are mentioned above and that have undergone the sanitary registration or notification in effect in the country.

1:File here 2:File here

EN:File here

FR:File here

ES:File here

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