Publishing the Full Text of the February 5, 2024 Letter from FDA Endorsing Updates to the List of VAT-exempt Products under R.A. No. 10963 (TRAIN Law) and R.A. No. 11534 (CREATE Act)

March 5, 2024 REVENUE MEMORANDUM CIRCULAR NO. 34-2024 SUBJECT : Publishing the Full Text of the February 5, 2024 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 February 5, 2024 letter (Annex "A") from Dr. Samuel A. Zacate, Director General of the FDA, for the inclusion of certain medicines for cancer, hypertension, and mental illness to the published List of VAT-exempt Medicines under the TRAIN Law and the CREATE Act. HSAcaE 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 February 5, 2024 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 medicines 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." Listed hereunder are the said updates as of 5 February 2024, effective upon the issuance of an FDA Advisory. AScHCD I. Inclusion A. Medicines for Cancer Generic Name Dosage Strength Dosage Form Sonidegib (as phospate) 200 mg Capsule Pemetrexed (as disodium heptahydrate) 100 mg Lyophilized Powder for IV Infusion Asciminib (as hydrochloride) 20 mg Film-Coated Tablet Asciminib (as hydrochloride) 40 mg Film-Coated Tablet Palbociclib 75 mg Film-Coated Tablet Palbociclib 100 mg Film-Coated Tablet Palbociclib 125 mg Film-Coated Tablet Pemetrexed (as disodium hemipentahydrate) 100 mg Powder for Concentrate for Solution for Infusion (I.V.) Pemetrexed (as disodium hemipentahydrate) 10 mg/mL (500mg/50 mL) Solution for Injection (IV Infusion) Cabazitaxel 60 mg/1.5 mL Concentrate for Solution for Injection (I.V.) Entrectinib 100 mg Capsule Entrectinib 200 mg Capsule B. Medicines for Hypertension Generic Name Dosage Strength Dosage Form Losartan Potassium + Amlodipine (as besilate) 100 mg/10 mg Film-Coated Tablet Losartan Potassium + Amlodipine (as besilate) 100 mg/5 mg Film-Coated Tablet Irbesartan + Amlodipine (as Besilate) 300 mg/5 mg Film-Coated Tablet Irbesartan + Amlodipine (as Besilate) 300 mg/10 mg Film-Coated Tablet C. Medicines for Mental Illness Generic Name Dosage Strength Dosage Form Cariprazine (as hydrochloride) 1.5 mg Capsule Cariprazine (as hydrochloride) 3 mg Capsule Cariprazine (as hydrochloride) 4.5 mg Capsule Cariprazine (as hydrochloride) 6 mg Capsule Should you have any questions/clarifications, you may contact the FDA Policy and Planning Service via email at [emailprotected] . HESIcT (SGD.) DR. SAMUEL A. ZACATE Director General