Pharmaceutical products

Agua para uso farmacéutico: Guía para su registro sanitario y exigencias para antibióticos de uso oral (Water for pharmaceutical use: Guidance for sanitary registration and requirements for oral antibiotics) (20 pages, in Spanish)

The guidance issued by the Public Health Institute (ISP) establishes updated requirements for the sanitary registration of water for pharmaceutical use and sets out new requirements for orally administered antibiotics. The document aims to prevent risks of intoxication, contamination, and treatment inefficacy arising from improper reconstitution at home, requiring that all new registration requests for oral antibiotics in powder or granulated form include the necessary solvent as a combination product registration. It also classifies the various types of water and details their quality standards and intended uses in accordance with national and international regulations.