v. 15 – Q3 2020

Market Executive Summary An Executive Directive was published on May 26, 2020 for traceability control of strategic medicines and healthcare goods. The scope of this directive are medicines and medical devices purchased by the government (CNMB – Cuadro Nacional de Medicamentos Basicos). Guidelines are based on GS1 standards and apply to all packaging levels, including primary level.

The reporting should be done to the Agencia Nacional de Regulacion, Control y Vigilancia Sanitaria (ARCSA) database. The directive assigns a technical lead to implement these guidelines once they are officially published in the regulation register.

Note: The requirements currently give no details regarding the database and data reporting.

Key Dates
  • May 19 2021: Implementation date of requirements
  • August 14, 2020: Publication date of Decree

<-- Return to Countries