Pharmaceutical products: oral contraceptives

Resolución exenta que establece requisitos para los registros sanitarios de medicamentos anticonceptivos orales (Exempt Resolution establishing requirements for the sanitary registration of oral contraceptives) (5 pages, in Spanish)

The notified Exempt Resolution establishes requirements for oral contraceptives consisting of active and placebo tablets.

It establishes a time limit for holders of sanitary registration to implement an evaluation and technical transformation procedure aimed at differentiating the placebo tablet from the active tablet by its shape. It also establishes a warning to be included in the patient information leaflet.