WHO publishes draft about health product traceability policies

The World Health Organization (WHO) has published a draft about health product traceability policies, open for comment. WHO recognizes that tracking systems and technologies can be leveraged to ensure the integrity and efficiency of supply chains.

To ensure a harmonized and effective supply chain, the WHO, since 2019, has been working to develop normative guidance on the establishment of traceability systems and necessary policies at the national and regional levels of Member States. The first phase was to convened a drafting group of regulators from the regions that are part of WHO to manage this document.

The draft of this document has now been published and is open to public comments until February 28, 2020. The final version of this document will be submitted to the 9th meeting of the Member State mechanism on substandard and falsified medical products which will take place the week of 26-30 October 2020.

The draft covers the supply chain and its legitimate, registered or licensed stakeholders, from manufacturers of the final product (batch release) to the point of dispensing the health product (for example, a pharmacy) or its point of use ( for example, a hospital). APIs used to manufacture final products are outside the scope of this document.

It is also noted that the examples given by the drafting group were based on the implementation of a set of standards known as GS1, and which is used in most Member States. GS1 is a global organization active in the field of standardization of the coding methods used in the supply chain and based in Belgium.

It is important to mention that traceability systems help to minimize the risk of substandard and counterfeit drugs, in addition to shortages and expired products.

Access the complete draft through the website: http://bit.ly/2OPIfnj

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