Products subject to good manufacturing practices for medicinal gases

Proyecto de Normativa Técnica Sanitaria Sustitutiva para las Buenas Prácticas de Manufactura de Gases Medicinales (Draft Substitute Sanitary Technical Regulations for good manufacturing practices for medicinal gases) (99 pages, in Spanish)

The notified draft Regulations establish the requirements and guidelines for granting the certificate of good manufacturing practices to pharmaceutical laboratories producing medicinal gases, in order to ensure the quality of products intended for patient use. Once the Health Technical Regulations have been issued and have entered into force, they will be binding on all natural or legal persons, whether domestic or foreign, who are owners, legal representatives, technical officers or technical directors of pharmaceutical laboratories where medicinal gases intended for marketing within Ecuadorian territory are produced.