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5/15/17 – Anvisa adopts drug tracking mechanism

Anvisa has published a resolution establishing new mechanisms and procedures for the tracking of drugs.

Tracking will be accomplished through the capture, storage and electronic transmission of data via a two-dimensional bar code on pharmaceutical products in Brazil.

The code standard is DataMatrix, specified in ISO / IEC 16022: 2006. The holder of the drug registration is responsible for the management of the data that make up the Unique Drug Identifier (IUM).

Some drugs will be excluded from the new tracking method during the experimental phase: sera and vaccines that are part of the National Immunization Program, radiopharmaceuticals, over-the-counter drugs, and free samples, among others.

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