(ICS: 11.100)

Proyecto de Normativa técnica sanitaria sustitutiva de registro sanitario de productos naturales procesados de uso medicinal, y de buenas prácticas de manufactura para laboratorios farmacéuticos de productos naturales procesados de uso medicinal (Draft Substitute Sanitary Technical Regulation on the sanitary registration of natural processed products for medicinal use and good manufacturing practices for pharmaceutical laboratories working with natural processed products for medicinal use). (41 pages, in Spanish)

Purpose:

The purpose of the notified Sanitary Technical Regulation is to establish quality, safety and efficacy parameters for the sanitary registration of natural processed products for medicinal use and criteria for the promotion, control and monitoring of such products and the penalties relating to them.

It establishes the parameters for the operation, control and monitoring of, and penalties for, establishments that manufacture, store, distribute or market natural processed products for medicinal use.

It also seeks to establish requirements and guidelines for delivery of certificates of Good Manufacturing Practices to domestic pharmaceutical laboratories that manufacture, process, package, store, distribute and transport natural processed products for medicinal use.

Scope: The notified regulation is binding on all natural or legal persons, whether domestic or foreign, who need to register natural processed products for medicinal use for marketing in Ecuador, as well as natural or legal persons, whether domestic or foreign, who are responsible for manufacturing, importing, packaging or packing, transporting, storing, distributing and marketing natural processed products for medicinal use throughout the national territory.