On November 30, 2022, the Institute of Public Health has issued resolution No. 5250 that complements resolution No. 2198/2022 that established the obligations addressed to holders of oral contraceptive products, consisting of active tablets and placebos.
Initially, Resolution No. 2198/2022 established that oral contraceptives consisting of active tablets and placebos must be made up of easily distinguishable units by visual and technological means, in terms of color and shape. In the same document, obligations and deadlines were established in relation to the updating of labels and patient information leaflet.
Resolution No. 5250 of November 30, 2022 aims to inform holders of the way in which they must request and process the obligations for oral contraceptives, as follows:
1. The obligation to update labels that detail the color and quantity of active tablets and placebos must be carried out through the respective modification of the sanitary registry (provision 4111010).
2. The update to the patient information leaflet, including the warning mandated by resolution No. 2198/2022, must be carried out through the respective modification of the health registry (provision 411011).
3. A term is granted until March 31, 2023 for the producto license holders subject to resolution No. 2198/2022 to make the modifications described above.
4. The institute will resolve the applications within a period not exceeding 3 months from the submission of the application.
5. Finally, modifications to oral contraceptives that are requested exclusively to comply with resolution No. 2198/2022 will have a zero-cost fee.
Source: www.ispch.cl
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