Senate publishes report for second debate of bill proposing criteria for drug packaging
2 junio 2021


On May 20, the Congress published the positive report for the second debate of the bill that proposes to establish criteria to prevent confusion in the dispensing and use of medicines. The regulatory proposal states that drugs marketed under International Nonproprietary Names (INN) must be labeled in accordance with the international standards and agreements signed and ratified, as well as with technical trade agreements, in order to avoid confusion between such packaging and/or containers. The published report is now ready to be voted on by the full Senate, which is expected to happen in the short term.

At the same time, the bill states that drugs for institutional use must have a different packaging from that of the commercial channel and an engraved legend stating “institutional use prohibited for sale”, which must be easily identifiable. Likewise, the manufacturing laboratories must implement a labeling in Braille system that allows the identification of the medicines according to their name and/or International Common Denomination, grammage, expiration date and the name of the laboratory. In this way, visually impaired people will be able to recognize the medicines they consume. 

The initiative also proposes that medicines in their different primary and secondary packaging must have an international standard identification system that allows the visibility and identification of the product throughout the supply chain. For its part, the Ministry of Health will define the regulation of the standard and will publish it within 12 months after its issuance. Meanwhile, the pharmaceutical industry will have 24 months from its entry into force to comply with the provisions of the law.

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