The purpose of the notified Sanitary Technical Regulation is to regulate and control medicines containing controlled substances (narcotics, psychotropics, chemical precursors and specific chemical substances). The provisions laid down in the notified Sanitary Technical Regulation are applicable to all national or foreign natural or legal persons based in Ecuador, that produce, import, export, store, market, distribute and dispense medicines containing controlled substances (narcotics, psychotropics, chemical precursors and specific chemical substances); with the exception of the dispensing, destruction, transfer, donation and notification of claims of such medicines in pharmacies operating in public and private health services. The notified Sanitary Technical Regulation does not apply to products for human use and consumption that contain in their formulation non-psychoactive cannabis or hemp, or the derivatives thereof, which shall be regulated in accordance with the regulations for products for human use and consumption containing non-psychoactive cannabis or hemp that the Agency may establish for such purpose.

PROYECTO DE NORMATIVA TÉCNICA SANITARIA PARA LA REGULACIÓN Y CONTROL DE MEDICAMENTOS QUE CONTENGAN SUSTANCIAS CATALOGADAS SUJETAS A FISCALIZACIÓN (Draft Sanitary Technical Regulation for the regulation and control of medicines containing controlled substances) (48 pages, in Spanish)

The purpose of the notified Sanitary Technical Regulation is to regulate and control medicines containing controlled substances (narcotics, psychotropics, chemical precursors and specific chemical substances).

The provisions laid down in the notified Sanitary Technical Regulation are applicable to all national or foreign natural or legal persons based in Ecuador, that produce, import, export, store, market, distribute and dispense medicines containing controlled substances (narcotics, psychotropics, chemical precursors and specific chemical substances); with the exception of the dispensing, destruction, transfer, donation and notification of claims of such medicines in pharmacies operating in public and private health services.

The notified Sanitary Technical Regulation does not apply to products for human use and consumption that contain in their formulation non-psychoactive cannabis or hemp, or the derivatives thereof, which shall be regulated in accordance with the regulations for products for human use and consumption containing non-psychoactive cannabis or hemp that the Agency may establish for such purpose.