Publishing the Full Text of the Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) with the Subject "Clarification on the List of VAT-Exempt Drugs under Joint AO No. 2-2018"

November 3, 2020 REVENUE MEMORANDUM CIRCULAR NO. 122-20 SUBJECT : Publishing the Full Text of the Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) with the Subject "Clarification on the List of VAT-Exempt Drugs under Joint AO No. 2-2018" TO : All Internal Revenue Officers and Others Concerned For the information and guidance of all internal revenue officers, employees and others concerned, attached is the letter dated August 7, 2020 from Jesusa Joyce N. Cirunay, Director IV for the Center for Drug Regulation and Research of the FDA, clarifying certain drug products included in the lists initially provided for by the FDA that were circulated through RMC No. 62-2020 and RMC No. 101-2020, which is based on the International Non-Proprietary Name (INN) or generic name of the drug products which includes salt forms. SDHTEC All concerned are hereby enjoined to be guided accordingly and give this Circular as wide a publicity as possible. (SGD.) CAESAR R. DULAY Commissioner of Internal Revenue ATTACHMENT Department of Health Food and Drug Administration CENTER FOR DRUG REGULATION AND RESEARCH August 7, 2020 CAESAR R. DULAY Commissioner of Internal Revenue Bureau of Internal Revenue (BIR) Room 511, BIR National Office Bldg., BIR Road Diliman, Quezon City Subject : Clarification on the List of VAT-Exempt Drugs under Joint AO No. 2-2018 Dear Commissioner Dulay : In compliance with the Joint Administrative Order No. 2-2018, the Food and Drug Administration (FDA) regularly updates the "List of VAT-exempt Diabetes, High-Cholesterol and Hypertension Drugs." However, there might be some confusion about drug products included in the list. Please be informed that the list is based on the International Non-Proprietary Name (INN) or generic name of the drug products which include the salt forms. An example is Metformin, wherein its INN is Metformin while its generic name and its salt form is Metformin hydrochloride. Metformin hydrochloride is the active pharmaceutical ingredient used to make Metformin 500 mg Tablet. As such, Metformin and Metformin hydrochloride is one and the same drug product. You may encounter several Certificates of Product Registration (CPR) issued by the FDA indicating the salt form. The Center for Drug Regulation and Research is working on this to reflect the generic name in INN on the CPR. Also, we will provide the next list with corresponding salt forms, where applicable. Thank you. Very truly yours, By Authority of the Director General Per FDA Order No. 2016-005 (SGD.) JESUSA JOYCE N. CIRUNAY, RPh Director IV