WHO TRS (Technical Report Series) 948, 2008 Annex 3

WHO TRS (Technical Report Series) 948, 2008 Annex 3

Procedure for assessing the acceptability, in principle, of TCu380A intrauterine devices for purchase by United Nations agencies

1. Introduction:

1.1 Background:

The United Nations, through its procurement agencies, supplies medicines and other health products to countries throughout the world, requiring access to a choice of products of acceptable quality, safety and efficacy.

The World Health Organization (WHO), the United Nations Population Fund (UNFPA) and other key partners developed an evidence-based list of Reproductive Health Essential Medicines (2005), which was subsequently approved by the WHO Expert Committee on Selection and Use of Essential Medicines. From this list and the recommendations of members of the Reproductive Health Supplies Coalition, it was agreed that WHO would include a core group of reproductive health essential medicines in the Prequalification Programme, implementation of which began in 2006. As part of this activity, it was agreed that UNFPA would take responsibility for the prequalification of copper-bearing intrauterine devices (IUDs) and male latex condoms and that the UNFPA scheme would be harmonized with that of the WHO Prequalification Programme.

WHO continues its normative work and together with key partners, WHO has recently supported the preparation of a Cochrane review13 on copper bearing IUDs in order to provide an evidence-base to support the revision of the International Standard for IUDs, ISO 7439: 2002. A Technical Review Committee convened by WHO in September 2006 reviewed the evidence on the safety, efficacy and performance of copper bearing IUDs and recommended the TCu380A IUD as the most appropriate device for bulk procurement by UNFPA. In addition, a detailed technical review process is currently being undertaken to update the bulk procurement specification for TCu380A IUDs. This will be published by July 2008. The current specification will be used until the revised specification has been published.

This document describes the implementation of the scheme for the TCu380A IUD. It is supported by a specific UNFPA management system with detailed standard operating procedures (SOPs).

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Table of contents

WHO TRS (Technical Report Series) 948, 2008 Annex 3:

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