Decreto 821 de 2017 "Por el cual se establece el reglamento técnico de emergencia para la obtención del registro sanitario de antivenenos y se adopta la Guía de Buenas Prácticas de Manufactura para su fabricación" (Decree No. 821 of 2017 establishing the emergency technical regulation on the sanitary registration of antivenins and adopting the guide to good manufacturing practices for antivenins) (25 pages, in Spanish)

The notified decree establishes the sanitary requirements to be met by any person in Colombia wishing to import or manufacture antivenins for treating injuries caused by venomous animals. It also adopts a guide to good manufacturing practices for antivenins. The text covers the following: Purpose; Scope; Definitions; Antivenin sanitary registration procedures; Pharmacological evaluation for antivenin sanitary registration purposes; Pharmaceutical evaluation of antivenins for sanitary registration purposes; Legal evaluation for antivenin sanitary registration purposes; Renewal of sanitary registration; Changes to sanitary registration; Depletion of stocks of products and packaging on the market; Certificate of good manufacturing practices and release of batches of antivenin; Pharmacovigilance, inspection, surveillance and control, and supply of antivenins; and Final provisions.