On December 28th 2016, law number 13410 came into effect in Brazil adopting changes to the law number 11903 from 2009.
The law number 13410 requires the "ANVISA" authority to publish detailed regulations within the next four months. Well-informed sources close to GS1 currently speculate that the authority could fully support their standard.
In the current text the following characteristics are mentioned. They need to be printed on the packages:
I - registration number of the medicine in the competent federal health surveillance body;
II - the unique serial number of the medicinal product;
III - batch or starting number of the medicinal product;
IV - date of validity of the medicinal product;
Other requirements, that were mentioned in previous versions, haven been repealed.
It remains to be seen what ANVISA will publish over the coming months, the direction seems to be clear though.
The text is based on a translation of the Portuguese law. Only use the original published law as the basis for any actions. The text above is published for discussion purposes only.
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