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Reporting changes
Dec 3, 2019
Dr.K.Sivakumar
Reporting changes
• Requirement
• Changes to be reported
• When and how to report changes
• Outcomes and follow up
Reporting changes - requirements
• UNFPA Prequalification is based on the
information provided in the documents
submitted and their verification by site
inspection and testing of PQ samples
“ 2.8 Maintenance of prequalification status
Once the product is included in the list
prequalified male latex condoms and
corresponding manufacturing sites, the
applicant/manufacturer is required to advise
UNFPA, within four weeks, of any matter that
affects the information on which the approval
was based.”
not limited to:
• change of premises; layout, storage
spaces;
• change in production and testing
equipment; process; capacity;
• change in senior management;
corporate structure;
• product recalls; notifiable complaints;
• change in certifications or licences
held by the manufacturer; scope
• reports of adverse events;
Reporting changes - Changes to be reported
not limited to:
change in condom design; colour,
texture, thickness, flavour;
• change in suppliers of latex not
previously listed in the Site Master
File summary;
• change in specification of raw
materials;
• change in packaging; ( including
packaging materials);
• new information about shelf-life;
Reporting changes - Changes to be reported
not limited to:
• transition to comply with revised/ new
regulatory requirements, purchase
specifications; applicable
International Standards;
• Sourcing of condoms, if applicable;
• Suspension of production,
discontinuance of operations in the
site;
• Discontinuance of product types;
Reporting changes - Changes to be reported
Reporting changes - Changes to be reported
It is the applicant’s responsibility to provide
UNFPA with the appropriate documentation
(referring to relevant parts of the Dossier)
to prove that the implementation of any
intended variation will not have an adverse
impact on the quality of the product
that has been prequalified.
Reporting changes - When and how to report changes
• Within four weeks of planning/ implementation
of the changes.
• By mail to PQ team – Ms. Ashley Moyo
with cc to Ms. Seloi Mogatle
• Reference to the relevant sections of the
document already submitted
• UNFPA will assess the impact of
reported changes, accept or
• Request for additional information, if
necessary to decide on the impact
• Make changes to PQ information,
published,
• Plan follow up inspection
Reporting changes - Outcomes and follow up
10
Thank you
UNFPA
11
The United Nations
reproductive health
and rights agency
Ensuring rights
and choices
for all