Resources

Patient Level Verification Position Statement

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.


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Packaging Level Position Statement

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.


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Principles for Using Serialization Position Statement

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.


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Model Serialization Regulation – Editable Download

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.


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Serialization Implementation Roadmap & Model Regulation

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.


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Clarifying Statement on India White Paper

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.


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Implementing India’s Drug Serialization and Traceability Requirements to Advance Patient Safety and Support Global Trade

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.


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Position Statement: Benefits and Complexity of Common Serialization Models

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.


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Position Statement on Unit Identifier

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.


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Position Statement on Implementation

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


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