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