v. 28 – Q4 2023

Market Executive Summary September 2020: The Ministry of Health released a draft resolution on implementation of data standardization of medicinal products. The MoH is not aligning with the international standards for the submission of master data describing a medicinal product (i.e., IDMP). The resolution foresees the attribution of a National code for medicinal product (Identificador Unico de Medicamento – IUM) by INVIMA.

Various medicines traceability pilots have been carried out since 2013, awaiting finalisation of future Serialisation requirements.

Major change announced in 2017 by INVIMA – Instituto Nacional de Vigilencia de Medicamentos y Alimentos) in the shape of a National Plan on Medicines Traceability: Expectation is that all participants in the medicines supply chain will need to participate in the traceability system.
However, following pushback from industry, no further details or compliance dates have been announced.

Key Dates None

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