Overview
Resolution No. 768 was published on December 12, 2022, establishing guidelines for medication labeling. The criteria outlined in this resolution aim to enhance the form and content of labeling for all medicines regulated in Brazil. This initiative seeks to ensure access to safe, clear, and adequate information to promote the rational use of medicines and enhance patient safety.
Mandatory Information for Drug Packaging
The following information is compulsory on the front face of the secondary drug packaging labels:
- The trade name of the drug.
- The Common Brazilian Denomination (DCB) of the active pharmaceutical ingredient(s) in lower case.
- The concentration of each active pharmaceutical ingredient.
- The route of administration.
- The specific pharmaceutical form.
- The restriction of use must include the phrase, in bold and capital letters, indicating the applicable age or weight restrictions:
- "ADULT USE"
- "ADULT AND PEDIATRIC USE OVER ___"
- "PEDIATRIC USE OVER ___"
- The logo, name, or both of the pharmaceutical company that owns the registration or notification and/or the companies responsible for packaging and marketing the medicine, provided this does not interfere with the mandatory information.
For further details, please feel free to reach out to us.
Effective Date
This Resolution will take effect on July 3, 2023.