Chile: Sanitary registration process for pharmaceutical products

 

Chile has published Ministry of Health Supreme Decrees No. 54/2019 and No. 65/2019: Sanitary registration process for pharmaceutical products (Decreto Supremo Ministerio de Salud N° 54/2019 y N° 65/2019: Proceso de Registro Sanitario de Productos Farmacéuticos)

The purposes of the notified Ministry of Health Supreme Decrees No. 54/2019 and No. 65/2019 are to simplify the processes associated with administrative procedures for the sanitary registration of pharmaceutical products for human use in Chile and deal with the demonstration of therapeutic equivalence. Both Supreme Decrees amend Ministry of Health Supreme Decree No. 3 of 2010 and, for reasons of urgency, were published in the Official Journal of Chile on 21 August 2020.