Considering the alerts issued by the health authority regarding contraceptives, on June 6th, 2022, resolution No. 2198 (May 19, 2022) was published in the official gazette, which instructs marketing authorization holders of oral contraceptives submit to the Institute of Public Health (ISP) a proposal that complies with differentiating by color between active and placebos tablets. Considering preferably that the placebo tablet is white.
The holders have a period of 30 business days from the publication in the official gazette to submit the proposal to the ISP.
ISP will rule on the proposal submitted by the marketing authorization holder, establishing the requirement to submit the modification in the sanitary registration, if it deems it necessary.
Additionally, it is established that the patient information leaflet must contain the following warning: “This product is a contraceptive, and its effectiveness depends on its correct use. Before you start using it, check that the product corresponds to the one prescribed by your doctor or midwife and that the contents of the blister coincide with what is detailed on the package label. In case of doubt, ask to the pharmacist.”
Source: www.diariooficial.cl
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