Medicines - Ecuador

The National Sanitary Authority, through the National Agency for Sanitary Regulation, Control and Surveillance- ARCSA, grants the Sanitary Registration Certificate for medicines for human consumption and imported medicines.

In accordance with the Organic Health Law, medicines in general, nutraceutical products, biological, natural, and processed products for medicinal use, homeopathic medicines, and dental products are subject to sanitary registration; for import, export, marketing, dispensing and sale, including those received as a donation.

In Ecuador there is and it is viable to carry out approval processes, the National Agency for Regulation, Control and Sanitary Surveillance ARCSA, grants the Certificate of Sanitary Registration for medicines for human use and consumption, imported through Approval, when the quality requirements are met, safety, efficacy.

This process is aimed at the registration of sanitary registration for foreign-manufactured medicines by homologation, which enables the citizen to import and commercialize medicines.

For the purposes of the Sanitary Registration of medicines in general, Homologation shall be understood as the official recognition of the Sanitary Registrations granted by the Sanitary Authorities of the countries whose drug regulatory agencies are agencies of high sanitary surveillance.

The Ministry of Public Health of Ecuador carried out the socialization of the approval of the sanitary registry with the Republic of Korea, which allowed expanding the therapeutic supply of medicines in general and biologicals in the Ecuadorian market.

Aruna Asesores has a group of specialists in the area with experience in the field who will be available to solve any concern, guaranteeing proper handling of the different requirements necessary for your procedure in Ecuador.