The most notable differences can be summarized as follows:
Elimination of Obtaining the Serial Number from the National System
The Draft Regulatory Guide previously required obtaining the Unique Identifier (UID) directly from the National Electronic System.
However, Law No. 804 makes no reference to this requirement, which represents a fundamental shift and an effective cancellation of the obligation to obtain serial numbers from the national platform.
Change in Identification Terminology and Standards
Law No. 804 introduced alternative terminology, including:
- Replacing GLN with the Location Code
- Replacing GTIN with the Trade item number
- Using the term Serial Number instead of UID (Unique Identifier)
Definition of the Role of Third-Party Logistics Providers (3PL)
Law No. 804 explicitly defines the role of Third-Party Logistics (3PL) providers within the pharmaceutical track & trace ecosystem.
This role was not previously defined in the Draft Regulatory Guide.
Introduction of the Toll Manufacturer Role
For the first time, Law No. 804 formally defines the role of the Toll Manufacturer within the pharmaceutical track & trace process.
This role was absent from the earlier draft decision and regulatory guide.