v. 28 – Q4 2023

Market Executive Summary Resolution DINAVISA 52/2022 (Dirección Nacional de Vigiilancia Sanitaria) has come into force, requiring medicinal products (as well as other sanitary products) to be assigned a product registry number and to have a QR code printed on the product carton.

This QR code / product registry number will be used to access the information held on the integrated management information system for sanitary registries and healthcare establishments regulated through the National Agency for Sanitary Surveillance (DNVS – Dirección Nacional deVigilancia Sanitaria).

The scope of the DINAVISA system includes the Official List of Registered and Marketed Medicinal Products (LOMECO –
Listado Oficial de Medicamentos Registrados y Comercializados
) extended to include the alphanumeric QR code for product identification and information.

NOTE: The QR does not include any variable information and does not fulfil any traceability purposes, it is just a link to access digital information.

All products will use the same QR code for 5 years until the official registry is renewed.
Information to be entered in the national product register as well as on the carton include:

  • Product commercial name
  • Product registry number
  • Product generic name (API)
  • API concentration
  • Qualitative-Quantitative formula
  • Pharmaceutical form
  • Presentation
  • Batch Shelf life
  • Sale conditions
  • Owner of the registry
  • Manufacturer
  • Leaflet
Key Dates March 24, 2022: Resolution is made effective on date of signature

<– Return to Countries