Notices of Suspension
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
Manufacturers of Finished Pharmaceutical Products (FPPs)
What is a
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.
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
Why is an NOS published?
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
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;"
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 Member
and international procurement organizations to enhance
transparency, the WHO Prequalification of Medicines
Programme will publish negative outcomes.
will inform procurement organizations and other users of the
specified medicinal products of concern related to the
product from a manufacturer.
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
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
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.