Detailed Mechanism Funding and Narrative

Years of mechanism: 2012 2013 2014 2015

Details for Mechanism ID: 12909
Country/Region: Vietnam
Year: 2013
Main Partner: U.S. Pharmacopeial Convention
Main Partner Program: NA
Organizational Type: Implementing Agency
Funding Agency: USAID
Total Funding: $150,000

Along with supporting treatment services, PEPFAR/Vietnam is working closely with the Government of Vietnam (GVN) in the transition process. Commodities transition appears to be the most challenging component, especially ARVs, not only because of its financial burden to GVN but also of the whole pharmaceutical, logistics and financing structures are not ready yet. Vietnam has very limited pharmaceutical market that failed can provide best international price and doesnt have a simple process to procure internationally neither. As a result, ARVs procured in country are between 3-17 times higher than PEPFAR procured ARVs and 2-3 times higher than Thailand, its neighbor country. This South to South exchange will support a study tour for relevant GVN managers to Thailand to learn about Thai experience in ensuring non-interrupted ARV supply chain for HIV program. The study tour will focus on ARV local production, procurement, logistics and financing systems.

Funding for Prevention: Injecting and Non-Injecting Drug Use (IDUP): $150,000

This is 2010 Partnership Framework money.

? Work closely with the Government of Vietnam to select potential manufacturers to produce methadone locally.

? Recommend two best companies for production based on Good Manufacturing Practices assessment of manufacturing plants of companies selected. Provide recommendations for addressing GMP deficiencies.

? Develop quality specifications for local production of methadone.

? Establish and validate process control and QA/QC. Develop other necessary technical documents as required for licensing authorization.

? Submit application to DAV for license to produce methadone in Vietnam, in accordance to the DAV requirements. Help the company to consolidate and respond queries from DAV as appropriate. Apply to DAV for registration number or marketing authorization.

? Develop post-marketing surveillance program within the supply chain to ensure the quality of locally produced methadone.

? Follow up and help the manufacturer to maintain GMP compliance and product quality throughout the supply and distribution chain.

Cross Cutting Budget Categories and Known Amounts Total: $30,000
Human Resources for Health $30,000