Draft Substitute Sanitary Technical Regulation on the sanitary certification of homeopathic products or medicines and good manufacturing practices for homeopathic pharmaceutical laboratories, the purpose of which is to establish the quality, safety and efficiency parameters for granting sanitary certification to homeopathic products or medicines. The notified text also lays down the criteria for the promotion, advertising, 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 homeopathic products or medicines.

In addition, it seeks to establish requirements and guidelines for delivery of the certificate of good manufacturing practices to domestic pharmaceutical laboratories that manufacture, pack, store, distribute and transport homeopathic products or medicines. The notified Sanitary Technical Regulation is binding on all natural or legal persons, whether domestic or foreign, that are required to register, re-register, modify or cancel homeopathic products or medicines for marketing in Ecuador. It is also binding on natural or legal persons, whether domestic or foreign, that are responsible for manufacturing, importing, packing or packaging, transporting, storing, distributing or marketing homeopathic products or medicines in national territory.

PROYECTO "NORMATIVA TÉCNICA SANITARIA SUSTITUTIVA DE NOTIFICACIÓN SANITARIA DE PRODUCTOS O MEDICAMENTOS HOMEOPÁTICOS, Y DE BUENAS PRÁCTICAS DE MANUFACTURA PARA LABORATORIOS FARMACÉUTICOS HOMEOPÁTICOS" (Draft Substitute Sanitary Technical Regulation on the sanitary certification of homeopathic products or medicines and good manufacturing practices for homeopathic pharmaceutical laboratories) (34 pages, in Spanish)

Draft Substitute Sanitary Technical Regulation on the sanitary certification of homeopathic products or medicines and good manufacturing practices for homeopathic pharmaceutical laboratories, the purpose of which is to establish the quality, safety and efficiency parameters for granting sanitary certification to homeopathic products or medicines. The notified text also lays down the criteria for the promotion, advertising, 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 homeopathic products or medicines.

In addition, it seeks to establish requirements and guidelines for the delivery of the certificate of good manufacturing practices to domestic pharmaceutical laboratories that manufacture, pack, store, distribute and transport homeopathic products or medicines. The notified Sanitary Technical Regulation is binding on all natural or legal persons, whether domestic or foreign, that are required to register, re-register, modify or cancel homeopathic products or medicines for marketing in Ecuador. It is also binding on natural or legal persons, whether domestic or foreign, that are responsible for manufacturing, importing, packing or packaging, transporting, storing, distributing or marketing homeopathic products or medicines in national territory.