- In the case of medicines, the advertising must contain the information on the data sheet filed to obtain the sanitary registry.
- In the case of medical devices, the advertising must contain its technical report filed to obtain the sanitary registry.
In both cases, such information must be given in a legible, visible, truthful, accurate, complete and updated manner according to the information filed to obtain the sanitary registry.
Also, advertising that disseminates scientific, clinical or pharmacological information must be supported and updated in the medicines and medical devices sanitary registry. In any type of printed material, in which medicines and medical are promoted and publicized, the technical and scientific information approved by the DIGEMID, as well as other relevant information as appropriate, must be disseminated in such a way that it is understandable, accessible, and consistent with what is authorized in its sanitary registry and/or mandatory health notification, thus promoting its easy reading and application.
If the announcements about the introduction of prescription-only medicines and medical devices are disseminated in mass written media, they must contain the following information:
- Name of the medicine or medical devices
- International Common Name of the Active Pharmaceutical Ingredient – IFA, even if it contains up to 3 Active Pharmaceutical Ingredient(s) – IFA(s), under the name clearly and legibly.
- In the case of a homeopathic product, the phrase “Homeopathic Product” must be entered, followed by the scientific name of the natural resource used in its formula;
- Pharmaceutical form;
- The amount of Active Pharmaceutical Ingredient – IFA (expressed in unit dose or concentration) of each. In the case of a homeopathic medicinal product, the degree of dilution must be recorded;
- Form of presentation;
- Sanitary Registry Number;
- Name, address and / or telephone number of the holder of the sanitary registry, specifically indicating that there is more information available about the product. If the product is imported, it also bears the name, address and / or telephone number of the importer.
The messages, symbols and images that are disseminated in the promotion and advertising of medicines and medical devices must not distort, or mislead or confuse the origin, results, benefits, characteristics, benefits or indications approved by the DIGEMID.
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