UNITED STATES: FDA DRUG SUPPLY CHAIN SECURITY ACT (DSCSA)

The DSCSA compliance laws aim to facilitate the exchange of information at the individual package level about where a drug has been in the supply chain to:

• Enable verification of the legitimacy of the drug product identifier down to the package level
• Enhance detection and notification of counterfeit products in the drug supply chain
• Facilitate more efficient recalls of drug products

What manufacturers must do

• Lot-level management: Share “the 3Ts”: Transaction Information (TI), History (TH), and Statements (TS) at the Lot (or Batch) level of identification
• Item serialization (2017–2019): Serialize packages of drug products using a product identifier (GTIN or National Drug Code), serial number, lot number, and expiration date
• Serialized item-level traceability: By November 2023, make available information that will allow supply chain partners to trace ownership back to the initial manufacturer or repackager.

rfxcel products

rfxcel Traceability System (rTS) with Serialization Processing and Compliance Management 

What repackagers must do

• Lot-level management: Share the 3Ts
• Item serialization (2017–2019): Serialize packages of drug products using a product identifier (GTIN or National Drug Code), serial number, lot number, and expiration date

rfxcel products

rfxcel Traceability System (rTS) with Serialization Processing and Compliance Management

What wholesale distributors must do

• Lot-level management: Share the 3Ts
• Verify every product’s serial number
• Must receive verified serial numbers from manufacturers

rfxcel products

rfxcel Verification Router Services (rVRS)

What dispensers (e.g., hospitals, pharmacies, clinics) must do

• Lot-level management: share the 3Ts (to be prepared for audits)

rfxcel products

SNAP

EU FALSIFIED MEDICINES DIRECTIVE (FMD)

• Effective February 9, 2019
• Far-reaching, mandatory requirements for product coding, traceability, and tamper-evidence enforced in 30+ countries
• Virtually all unit-of-sale packs of prescription medicines must carry a “safety feature” comprising a DataMatrix barcode and human-readable data and must be tamper-evident.
• The code must contain at least four pieces of information: batch number, expiry date, GTIN, and a randomized serial number. Some countries require a fifth data string for national use.

rfxcel products

rfxcel Traceability System (rTS): Serialization Processing and Compliance Management

rfxcel Code Check (rCC)

RUSSIA (LAW 425-FZ)

• Effective January 2020
• Requires complete serialization and traceability of over-the-counter (OTC) and prescription medicines.
• All foreign pharmaceutical manufacturers and distributors must track and report up to 36 compliance events; the business use case dictates the type of compliance events to track and report, as well as different sequences of those events.
• Requires documenting and reporting aggregation. (FMD and DSCSA compliance regulations do not have aggregation requirements.)
• Non-compliant companies cannot import medicines into Russia or manufacture products in the country.

rfxcel products

rfxcel Traceability System (rTS): Serialization Processing and Compliance Management

BRAZILIAN HEALTH REGULATORY AGENCY (ANVISA) / NATIONAL MEDICINE CONTROL SYSTEM (SNCM)

• Effective May 2022
• Medicine traceability system to establish mechanisms and procedures for tracking and tracing drugs in Brazil
• Companies must have unit-level serialization, ability to track and trace products, monitor environmental conditions in the supply chain, and submit detailed transaction data to the government.
• Every supply chain actor must be able to capture, store, and exchange data electronically.
• All products must have a GS1 DataMatrix barcode that houses a GTIN, an ANVISA Medicine Registry Number, a unique serial number, an expiration date, and a lot/batch number.

rfxcel products

rfxcel Traceability System (rTS): Serialization Processing and Compliance Management

INDIA: DRUGS AUTHENTICATION AND VERIFICATION APPLICATION (DAVA)

• Effective 2015
• Established requirements for a track and trace system to prevent counterfeits in pharmaceutical consignments for export
• Exporters must mark consignments with GS1 barcodes at different packaging levels.
• Exporters must upload this information and the product hierarchy (i.e., parent-child relationship) to DAVA before the consignment is released for sale or distribution. 

rfxcel products

rfxcel Traceability System (rTS): Serialization Processing and Compliance Management

SAUDI ARABIA: SAUDI DRUG CODE (SDC)

• Effective November 2016: The Saudi Food and Drug Authority (SFDA) updated the country’s Drug Code to improve patient safety, reduce medication errors, detect counterfeit medicines, and aid product recalls and withdrawals.
• All product markings must have GS1 DataMatrix barcodes with, at minimum, a GTIN, expiration date, and batch or lot number.
• Regulations apply to all pharmaceutical products (human and veterinary drugs).

rfxcel products

rfxcel Traceability System (rTS): Serialization Processing and Compliance Management