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The IRR of RA 9502 or the Universally Accessible Cheaper and Quality Medicines Act of 2008, restricts government offices from purchasing medicines through the PNDF.
COA advised the NDH management to seek authority from the city mayor, request approval from the National Center for Pharmaceutical Access Management (NCPAM) , and the Department of Health (DOH) to procure items not prescribed by the PNDF.
9502, otherwise known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, prohibits the government from purchasing drugs and medicines which are not included in the PNDF," he stated.
1993 requires PNDF listing before drug purchase by the government can be made," he added.
Under Republic Act 9502 or the Universally Accessible Cheaper and Quality Medicines Act of 2008, the government is prohibited from procuring drugs and medicines not under PNDF.
If not under PNDF, the approval of the Formulary Executive Committee (FEC) is required and to get its approval, the medicine's safety and efficacy must be established.
"It is significant to note, that the PNDF Exemption is necessary before Dengvaxia can be purchased by the government," they stated.
The COA said that while the IRR of EO 49 states that exemption from the PNDF manual may be allowed, it is subject to approval of the program director of National Center for Pharmaceutical Access and Management (NCPAM) upon recommendation of Formulary Executive Council (FEC) 'based on prescribed criteria.'
'Review of the documents submitted showed that the FEC recommendation for provisional exemption from PNDF was not submitted to the NCPAM Program Director as required under DOH AO No.
"The final approving authority on the inclusion or noninclusion in the PNDF, including the grant of exemption thereof, is expressly granted to the secretary of health," Ona said.
Biologics has not been approved in the list of the Philippine National Drug Formulary (PNDF).
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