v. 15 – Q3 2020
|Market Executive Summary||
The Ministry of Health (MoH) 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 finalization of future serialization 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: Exception 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.