Resources

Pharmaceuticals are identified through a number of standardized identifiers at varying levels to enable addressing different needs in global markets. Each type of identifier can serve distinct purposes. Further, any of those identifiers can be encoded into different types of barcodes or data carriers to support logistical efficiency. As noted in our RxGPS document, “Principles for Using Serialization,” it is necessary to understand each country’s goal in order to identify the best way to achieve that goal, as different identifiers can support different goals. This document provides an overview of the hierarchy of common identifiers to help regulators understand their role in meeting various policy objectives.

This document outlines how to leverage serialization data, through standardized communication and data reporting protocols and infrastructure, to advance supply chain security and other market-specific goals. Detailed are 7 key considerations for the utilization of serialized data and how they vary across the chosen model for data sharing (i.e., verification or traceability) or across a chosen data architecture (i.e., centralized database/repository or distributed, company-owned databases).

Truly achieving pharmaceutical supply chain security requires efforts across a spectrum of organizations, projects, and sectors. This stakeholder map was designed to paint a picture of the spectrum of global stakeholders and the great work that these organizations are doing individually, and collectively, to promote global pharmaceutical supply chain security.

Patients should have confidence in the products that they are receiving. Some markets have begun to discuss patient level verification as an approach to increase patient autonomy and peace of mind. However, RxGPS supports a verification approach that reserves core traceability for the pharmaceutical supply chain. In this position statement RxGPS outlines the significant challenges associated with patient level verification that must be balanced against any potential benefits.

Global regulators utilize the terms “primary,” “secondary,” and “tertiary” to distinguish between common packaging levels and to dictate which packaging level must bear a unique identifier for purposes of verification and/or tracing. However, this terminology is not aligned with the standard units of trade across the pharmaceutical industry. A lack of consistent terminology within and across markets has led to significant confusion. It is important that industry has clarity on packaging levels terminology and how best to utilize the various terminology. This document provides clarity on packaging level terminology and recommendations around how best to identify on which packaging levels/units a serial number should be applied.

As pharmaceutical serialization gains momentum globally, regulators and other stakeholders around the world are assessing potential uses for pharmaceutical serialization and serialized data that go beyond supply chain security. This document outlines RxGPS’ recommendations for assessing the challenges and benefits associated with serialization uses beyond supply chain security.

The Model Regulation is intended for use by global regulators in development and implementation of pharmaceutical serialization requirements, and is designed to be amended to account for individual market dynamics. This editable document has been made available to allow global regulators to utilize the text and also tailor the requirements to their individual market as indicated throughout.

The Implementation Roadmap and Model Regulation are two resources for global regulators and supply chain stakeholders looking to develop and implement pharmaceutical serialization requirements to advance supply chain security. The Implementation Roadmap builds on the prior Position Statement on Implementation to add detail to the implementation process, particularly the regulatory process, for markets that have not yet begun that process. The Model Regulation is intended for use by global regulators in development and implementation of pharmaceutical serialization requirements, and is designed to be amended to account for individual market dynamics.

RxGPS has issued a clarifying statement regarding the Implementing India’s Drug Serialization and Traceability Requirements to Advance Patient Safety and Support Global Trade white paper.

The Stakeholder Consultation on Drug Serialization and Traceability in India, hosted by the Indian Council for Research on International Economic Relations (ICRIER) and RxGPS, was held on 3 March, 2017 in New Delhi to discuss India’s serialization and traceability requirements. The Stakeholder Consultation was attended by more than 60 representatives of the Indian and global pharmaceutical markets, patient and public health advocates, global regulatory authorities, and Indian regulators. This white paper captures the dialogue and conclusions of the Stakeholder Consultation and sets forth a roadmap for strengthening the Indian pharmaceutical serialization and traceability system.

This document provides rationale for why RxGPS recommends implementing a serialization system beginning with point-of-dispense verification prior to consideration of a full traceability model.

This document outlines the serialization and unit identifier specifications that RxGPS recommends be adopted by any country implementing serialization, including the format, data elements, and location (i.e., packaging level) of the identifier.

[Revised August 22, 2016]
RxGPS provides guiding principles for implementation of effective serialization requirements and a sample timeline of an appropriate, phased implementation process.

The purpose of this primer is to explain the components of serialization, the use of serialization data, and the processes and systems necessary to leverage serialization data to achieve greater security and safety in the supply chain.

RxGPS offers the rationale behind the ten general principles that we believe, if followed, promote the effective and efficient implementation of traceability, help to secure the supply chain, and protect patients from the harmful effects of falsified and counterfeit pharmaceuticals.

RxGPS offers ten general principles that we believe, if followed, promote the effective and efficient implementation of traceability, help to secure the supply chain, and protect patients from the harmful effects of falsified and counterfeit pharmaceuticals.