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New requirements for oral contraceptives

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. …

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Nuevo Formulario de notificación de eventos supuestamente atribuibles a la vacunación o inmunización (ESAVI)

New Form for Reporting Events Supposedly Attributable to Vaccination or Immunization (ESAVI)

Exempt Resolution N° 521 On March 18, 2022, the Public Health Institute has issued exempt resolution No. 521, approving the ESAVI notification form based on the need expressed by the Pharmacovigilance subdepartment to create a new version in order to incorporate information necessary to improve the monitoring of cases and the quality of the data …

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