Introduction
Starting on July 3rd, 2023, the Resolution of the Collegiate Directorate (RDC) 768/2022 came into effect, implementing new rules for drug labeling in Brazil. This regulatory simplification reduces the number of codes from 26 to just four. The updated codes now focus solely on the type of request related to drug labeling, omitting the regulatory category of the drug.
New Codes for Labeling Requests
For requests regarding changes to labeling in accordance with the new RDC 768/2022 standard, organizations should use the following codes:
- Code 12268: "Notificação da alteração de labeling - Adequação à RDC 768/2022" (Notification of label alteration - Adaptation to RDC 768/2022) - This code is designated for cases needing alterations to align with the new standard.
- Code 12269: "Notification of label alteration" - This code covers instances where labeling modifications are necessary for reasons other than adherence to RDC 768/2022.
It is crucial for companies to begin utilizing these new subject codes for their drug labeling requests starting from the second Monday following July 3rd, 2023.
Summary of Subject Codes
| Code | Description of the Subject | Taxable Event |
|---|---|---|
| 12268 | Labeling change notification - Compliance with RDC No. 768/2022 | 4235 |
| 12269 | Labeling change notification | 4235 |
| 12270 | Labeling change | 4235 |
| 12271 | Inclusion of labeling - New destination | 4235 |
Further Information
For additional details, please refer to the official document: Resolution RDC No. 768/2022 - https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-768-de-12-de-dezembro-de-2022-450312757.