Prequalification for LENACAPAVIR — UNDP Quality Assurance Policy

The UNDP Quality Assurance Policy for health products procured by the organisation is developed in line with WHO norms and standards for health products. The objective of UNDP QA Policy is to ensure sourcing of high-quality medicines and medical products from a reliable source, efficient utilization of public funds at the best interest of the patients, to obtain the best health care outcomes. The ITP summarizes UNDP’ technical and regulatory requirements for the Finished Pharmaceutical Product (FPP) used to prevent HIV infection. The products are procured according to the UNDP QA Policy for Health Products, which is aligned with QA policies from other UN organizations and The Global Fund.

UNDP is taking a careful approach on selecting manufacturers through the ITP listed evaluation stages. This approach is expected to address the general requirements for completeness of application submission forms; the products prequalification status (WHO, SRA or ERP); experience in supplying pharmaceuticals at international level; as well as the documented policies, standards and procedures required to ensure consistency.

General Information on Invitation To Prequalification

Clarification, request for additional information and exchange of information

Applicants requiring any clarification of prequalification documents and procedure may send written request for clarification to the following e-mail address: [email protected] and cc to  [email protected]

In response to a clarification request UNDP publishes all the received questions and answers (without indicating the source of query) on Quantum Supplier Portal.

UNDP may make the amendments to the document, at any time but not later than 5 calendar days prior the deadline for submission, that will be published and accessible by the Applicants.

Applications must be submitted directly in the system following this link:   http://supplier.quantum.partneragencies.org using the profile you may have in the portal. In case