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ECUADOR

NEW CLASSIFICATION FOR FOOD SUPPLEMENTS

The National Agency of Regulation, Control and Surveillance (ARCSA in Spanish) issued Resolution No. 028-2016-YMIH establishing a new classification for dietary supplements and the requirements under which their sanitary notification will be granted. 

 

Food Supplements were defined as unconventional food products intended to provide supplemental dietary intake by including nutrients at concentrations that do not generate therapeutic indications or applied to disease states, and are administered in solid, semi-solid, liquid or other forms of gastrointestinal absorption.

The requirements to obtain their sanitary notification include:

  • That the food supplements are not manufactured in the same facilities where medicines are manufactured.
  • Having an operating license in force, evidencing the authorized activities.
  • Having a GMP (Good Manufacturing Practices) Certificate in force.