WHO TRS (Technical Report Series) 1025, 2020 Annex 8

WHO TRS (Technical Report Series) 1025, 2020 Annex 8

Points to consider for setting the remaining shelf-life of medical products upon delivery

1. Introduction:

Following discussions relating to establishing a document for the remaining shelf life of medical products upon delivery, and considering the discussion between the Interagency Pharmaceutical Coordination group (IPC) representatives, it was decided to initiate a project to establish a document on remaining shelf-life for procurement and supply of medical products.

The concept and project to establish such a document was also discussed during the meeting of the Fifty-third Expert Committee on Specifications for Pharmaceutical Products (ECSPP) in October 2018. It was noted that some guidance documents were available from different procurement agencies. It was agreed that the World Health Organization (WHO) would initiate the discussion and preparation of a document, while following the WHO process for the establishment of such a paper.

Information and policy on remaining shelf-life was collected from different agencies and interested parties and a first draft document was prepared after an informal discussion meeting in Geneva, Switzerland, in January 2019.

It was then agreed that the document should not cover only finished pharmaceutical products but should be extended to also cover other products, including, but not limited to, medical devices, vaccines and in vitro diagnostics (IVD) products. (These products are collectively referred to as “medical products” hereafter.)

A draft document was prepared and circulated to IPC members, as well as other interested parties, inviting comments. The comments received were reviewed during an informal discussion meeting in June 2019 and the draft document was updated.

The aims of this document are:

■ to facilitate the national authorization of importation of medical products where applicable;

■ to promote and support the efficient processing of medical products in the supply chain at all levels and thus prevent wastage because of delays;

■ to assist in ensuring that there is sufficient stock of medical products, with acceptable remaining shelf life, in-country;

■ to prevent dumping of medical products;

■ to ensure that barriers to access and supply of medical products are addressed;

■ to prevent out-of-stock situations;

■ to prevent receipt of donations of medical products that are not in accordance with this guideline; and

■ to prevent having expired stock of medical products.

The document is intended to provide guidance on setting the remaining shelf-life of medical products upon delivery and should be considered by all stakeholders in the supply chain of medical products. It is also recommended that the recommendations herein should be considered for inclusion in the national policy of countries.

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WHO TRS (Technical Report Series) 1025, 2020 Annex 8:

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