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Notices of Suspension
As of
April 2009, the WHO Prequalification of Medicines Programme
will publish Notices of Suspension (NOS) after it has become
evident that there are serious concerns about the conduct of
a manufacturer, or data and/or information relating to a
prequalified product. Manufacturers of Finished Pharmaceutical Products (FPPs) What is a Notice of Suspension (NOS)? A Notice of Suspension is a letter issued by the WHO Prequalification of Medicines Programme, after it has become evident that there are serious concerns about the conduct of a manufacturer, or data and/or information relating to a prequalified product. An NOS will not disclose commercially confidential information. An NOS is issued to remind a manufacturer of its obligations and to inform suppliers and procurement agencies of potential risks associated with a given product. In situations of immediate public health concern the NOS may lead to the: · withdrawal of products from the "List of prequalified products"; · recall of batches of products on the "List of prequalified products" that had been supplied by a manufacturer; · rejection of applications submitted for assessment to the Prequalification Programme. Why is an NOS published? The World Health Assembly Resolution WHA57.14 "Scaling up treatment and care within a coordinated and comprehensive response to HIV/AIDS" of 22 May 2004, requests the WHO, among other actions: "3. (4) to ensure that the prequalification review process and the results of inspection and assessment reports of the listed products, aside from proprietary and confidential information, are made publicly available;"
This is
why the WHO Prequalification of Medicines Programme is
publishing on its web site the WHO Public Inspection Reports
(WHOPIR) and WHO Public Assessment Reports (WHOPAR).
To further respond to WHA57.14 Resolution, and the request of
The NOS
will inform procurement organizations and other users of the
specified medicinal products of concern related to the
product from a manufacturer.
The publication of an NOS should further motivate manufacturers to take appropriate corrective and/or preventive actions in a timely manner and to address observations and non-compliances for the benefit of patients. When will an NOS be published? How long is an NOS in effect?
An NOS will be issued to a manufacturer if there are
immediate concerns relating to a product and
WHO will proceed to publish the NOS on its web site. The
NOS
will remain active on the WHO Prequalification of
Medicines Programme web site until WHO has confirmed
that the corrective actions have been implemented
satisfactorily by the manufacturer.
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