Publishing the Full Text of the November 29, 2023 Letter from FDA Endorsing Updates to the List of VAT-Exempt Products under R.A. No. 10963 and R.A. No. 11534

January 26, 2024 REVENUE MEMORANDUM CIRCULAR NO. 17-2024 SUBJECT : Publishing the Full Text of the November 29, 2023 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-Exempt Products under Republic Act (R.A.) No. 10963 (TRAIN Law) and R.A. No. 11534 (CREATE Act) 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 November 29, 2023 letter (Annex "A") from Dr. Samuel A. Zacate, Director General of the FDA, for an update to the published List of VAT-Exempt Medicines under R.A. No. 11534 or the CREATE Act, particularly the following: HTcADC 1. Inclusion of certain medicines for cancer, diabetes, hypertension, kidney disease, mental illness, and tuberculosis; and 2. Deletion of medicine for hypertension. As clarified under Q&A No. 1 of RMC No. 99-2021, the effectivity of the VAT exemption of the covered medicines and medical devices under the CREATE Act shall be on the date of publication by the FDA of the updates to the said list. All concerned are hereby enjoined to be guided accordingly and give this Circular as wide a publicity as possible. (SGD.) ROMEO D. LUMAGUI, JR. Commissioner of Internal Revenue ANNEX A Department of Health Food and Drug Administration November 29, 2023 ROMEO D. LUMAGUI, JR. Commissioner Bureau of Internal Revenue Quezon City SUBJECT : Endorsement of the Updates to the List of VAT-Exempt Products under Republic Act Nos. 10963 and 11534 Dear Commissioner Lumagui: With reference to the Implementing Guidelines on the Value-Added Tax (VAT) Exemption on Several Health Products provided under Joint Administrative Order (JAO) No. 2-2018 dated 21 December 2018 and JAO No. 2021-0001 dated 23 June 2021, may we provide you with the updates to the "List of VAT-Exempt Drugs for Hypertension, Cancer, Mental Illnesses, Tuberculosis, Kidney Diseases, Diabetes, and High Cholesterol." Further, DOH Department Memorandum No. 2021-0280 provided that all documents with reference to the VAT-Exempt list of all COVID-19 related medicines and medical devices shall be forwarded to the FDA. Listed hereunder are the updates as of 29 November 2023, effective upon the issuance of an FDA Advisory. CAIHTE I. Inclusion A. Medicines for Cancer Generic Name Dosage Strength Dosage Form Panitumumab 100 mg/5 mL (20 mg/mL) Concentrate for Solution for Infusion (IV) Fulvestrant 50 mg/mL (250 mg/5 mL) Solution for Injection (IM) B. Medicines for Diabetes Generic Name Dosage Strength Dosage Form Teneligliptin (as hydrobromide hydrate) 20 mg Film-Coated Tablet Sitagliptin (as phosphate monohydrate) + Metformin Hydrochloride 50 mg/500 mg Film-Coated Tablet Sitagliptin 50 mg Film-Coated Tablet Sitagliptin 100 mg Film-Coated Tablet Metformin Hydrochloride 500 mg Prolonged-Release Tablet C. Medicines for High Cholesterol Generic Name Dosage Strength Dosage Form Atorvastatin Calcium 20 mg Film-Coated Tablet Atorvastatin + Fenofibrate 40 mg/160 mg Film-Coated Tablet D. Medicines for Hypertension Generic Name Dosage Strength Dosage Form Clonidine hydrochloride 150 mcg/mL Solution for Injection (IM/IV) Clonidine hydrochloride 150 mcg Tablet Lisinopril (as dihydrate) 5 mg Tablet Lisinopril (as dehydrate) 10 mg Tablet Lisinopril (as dihydrate) 20 mg Tablet E. Medicines for Kidney Disease aScITE Generic Name Dosage Strength Dosage Form Mannitol 20 g/100 mL (20%) Solution for Injection (IV) Tolvaptan 15 mg Tablet Tolvaptan 30 mg Tablet Alpha Ketoanalogues + Essential Amino Acids Each film-coated tablet contains: Calcium-4-methyl-2-oxovalerate ( -ketoanalogue of leucine, calcium salt) 202 mg, Calcium-3-methyl-2-oxobutyrate ( - ketoanalogue of valine, calcium salt) 172 mg, Calcium-2-oxo-3-phenylproprionate ( -ketoanalogue of phenylalanine, calcium salt) 136 mg, Calcium-3-methyl-2-oxovalerate ( - ketoanalogue of isoleucine, calcium salt) 134 mg, Calcium-DL-2-hydroxy-4-(methylthio)-butyrate ( - hydroxyanalogue of methionine, calcium salt) 118 mg, L-Lysine acetate 210 mg, L-Threonine 106 mg, L-Histidine 76 mg, L-Tyrosine 60 mg, L-Tryptophan 46 mg, Total Nitrogen Content 72 mg Film-Coated Tablet F. Medicines for Mental Illness Generic Name Dosage Strength Dosage Form Desvenlafaxine (as succinate monohydrate) 50 mg Controlled-Release Tablet G. Medicines for Tuberculosis DETACa Generic Name Dosage Strength Dosage Form Bedaquiline (as Fumarate) 100 mg Tablet Isoniazid + Pyridoxine Hydrochloride 200 mg/10 mg per 5 mL Syrup II. Deletion A. Medicines for Hypertension Generic Name Dosage Strength Dosage Form Macitentan 10 mg Film-Coated Tablet Justification: The pharmacologic category of Macitentan is an endothelin receptor antagonist (ERA) with an approved indication for targeted pulmonary arterial hypertension (PAH) therapy which is not synonymous to systemic hypertension. Should you have any question/clarifications, you may contact the FDA Policy and Planning Service via email at [emailprotected]. (SGD.) DR. SAMUEL A. ZACATE Director General