CHL/479
WTO/TBT
CL Chile
  • 11 - Medizintechnik
2019-08-25
2019-07-04

Pharmaceutical products

Proyecto que sustituye la Norma Técnica "Guía para la realización y presentación de estudios de estabilidad de productos farmacéuticos" (D.S Ex. Nº29/2012 del MINSAL) (Draft replacing the Technical Standard "Guide to conducting and submitting stability studies for pharmaceutical products" (Ministry of Health Exempt Supreme Decree No. 29/2012)) (30 pages, in Spanish)

Updated regulations on the stability studies required for sanitary registration or authorization of use of a pharmaceutical product and if changes occur after authorization, which are intended to ensure that the quality and effectiveness of the product are maintained throughout its shelf life.