First Technical Note on RDC 54 Implementation

ANVISA has published the first of what is expected to be a series of technical notes and normative instructions on the implementation of RDC 54. Given their previously stated positions, there are no major surprises in ANVISA Technical Note No 01/2015, which confirmed the following key points:

Serialization

• Imported products that are serialized must also be aggregated, and aggregation may not be postponed until after importation.
• Verification of the IUM may be made by the marketing authorization holder locally but it must rely on serialization information which was already applied at the point of serialization overseas.

Traceability

• The registration holder must track drug products to the point of entry into the dispenser.
• The dispenser is responsible for tracking subsequent events including the dispensation/release event. These final events are not communicated to the registration holder or the previous links in the supply chain.
• Future evolution of the national SNCM will include the capture of the full dispensation data by ANVISA through remote interfaces (not noted if this interface is done by the registration holder or by the dispenser).
• For Phase 1, the marketing authorization holders must provide full traceability data for the 3 lots of product down to the dispenser through both XML files and remote access interfaces.
• All IUM movements across the pharmaceutical supply chain from marketing authorization holder to dispenser must be captured in the compliance system. This includes information about the CNPJs of the entities involved (sender, receiver, and shipment companies, where applicable).

Packaging

• The Human Readable form may contain the standard GS1 GTIN.
• The Datamatrix barcode must contain the ANVISA Registration Number, Serial Number, Expiration Date and Batch Number.
• Depending on the packaging changes required for RDC 54, ANVISA will require either a Notification or a new Authorization.
• Marketing authorization holders may optionally apply reactive (scratch off) ink.

Grandfathering

• Drug products that were manufactured prior to the effective date of RDC 43 (December 11, 2013) can be marketed in the supply chain through the end of their shelf life.