Vietnam: Compositions of dossiers for registration of demands for antiretroviral drugs

According to Article 3 of the Circular No. 22/2020/TT-BYT of the Ministry of Health of Vietnam, at the time of planning for use of antiretroviral drugs, if there are no drugs with valid registration numbers in the suggested technical criteria category, Vietnam Administration of HIV/AIDS Control shall adjust the quantity of drugs and technical criteria category of drugs as follows:

- Drugs in the next higher technical criteria category where registration numbers are available shall be selected. If none of drugs in higher technical criteria categories has valid registration numbers, drugs in the next lower category where registration numbers are available shall be selected.

E.g. Regarding A drug, the health facility suggests the technical criteria category 4 but, after completion of consolidation of provincial plans, there are no drugs with valid registration numbers in technical criteria category 4. Thus, drugs in technical criteria category 2, 1, or 5 will be taken into consideration accordingly.

- After adjustment, Vietnam Administration of HIV/AIDS Control shall give a written notification to the relevant provincial Department of Health whose suggested drug is adjusted. Upon receipt of the notification from the Vietnam Administration of HIV/AIDS Control, the provincial Department of Health shall notify the health facility whose suggested drug is adjusted in writing.

Note: Documents enclosed with a registration of demands for antiretroviral drugs submitted by a health facility to the provincial HIV/AIDS agency include:

- The plan for use of antiretroviral drugs formulated according to guidelines given by Vietnam Administration of HIV/AIDS Control, enclosed with the minutes of the meeting of the Drug and Treatment Council of the health facility;

- The report on receipt and use of antiretroviral drugs in the previous year, the quantity of drugs in stock and the quantity of planned drugs yet to be supplied of health facilities, the estimated number of patients sorted by treatment regimens, and demands for drugs in the planning year sorted by drug categories;

- If the quantity of drugs in the health facility’s plan increases or decreases by more than 30% compared to that in the previous year, it shall provide specific explanations thereof.

View more details at the Circular No. 22/2020/TT-BYT of the Ministry of Health of Vietnam, effective from January 20, 2021.

Le Vy

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