The notified regulations are the draft "Substitute Sanitary Technical Regulations for the Substitute Regulations on Sanitary Registration for Medicines in General", which will replace the "Substitute Regulations on Sanitary Registration for Medicines in General", issued by Ministerial Decision No. 586.

Proyecto Normativa Técnica Sanitaria Sustitutiva del Reglamento Sustitutivo de Registro Sanitario para Medicamentos en General (Draft Substitute Sanitary Technical Regulations for the Substitute Regulations on Sanitary Registration for Medicines in General) (39 pages, in Spanish)

Draft Substitute Sanitary Technical Regulations for the Substitute Regulations on Sanitary Registration for Medicines in General The notified regulations are the draft "Substitute Sanitary Technical Regulations for the Substitute Regulations on Sanitary Registration for Medicines in General", which will replace the "Substitute Regulations on Sanitary Registration for Medicines in General", issued by Ministerial Decision No. 586. The purpose of these Technical Regulations is to establish the legal and technical requirements that ensure quality, safety and efficacy, under which the Sanitary Registration Certificate will be granted to medicines in general for human use and consumption, as well as the criteria for the control and surveillance of such medicines.