v. 20 – Q4 2021

Market Executive Summary September 2021: The Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) published a revision to its traceability requirements for medical devices and medicines. The scope has been modified to medicines and medical devices in the RPIS (public health network) and allows for use of stickers to apply unique traceability code. It specifies data that needs to be captured along with the “Unique Traceability Code”. The amendment also includes changes to the traceability deadlines, as defined in Key Dates section.

February 2021: ARCSA published an updated list of medicines, biological products, and medical devices subject to the traceability controls established by the public health ministry.
Technical regulations for the issuance of operating permits for pharma were published on November 12, 2020. The purpose of these technical regulations is to establish the guidelines under which traceability mechanisms will be implemented to medicines and medical devices, as well as determining the criteria for traceability coding for tracking from production to dispensing.

The official Executive Directive was published on September 2, 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 Básicos). 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 Regulación, Control y Vigilancia Sanitaria (ARCSA) database. The directive assigns a technical lead to implement these guidelines once they are officially published in the regulations register.

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

Key Dates
  • September 2, 2020: Official Publication date of Decree
  • November 26, 2020: Supplemental guideline published in Official Gazette (supplement 338) setting out phased implementation
  • November 26, 2022: Phase 1
  • May 26, 2023: Phase 2
  • November 26, 2023: Phase 3
  • May 26, 2024: Phase 4

Phased compliance with reporting: four lists to be ready 24, 30, 36, and 42 months after the traceability system has been established (lists to be issued).

<-- Return to Countries