Publishing the Full Text of the November 23, 2022 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-exempt Medicines under Republic Act (R.A.) No. 11534 Known as the Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act

December 7, 2022 REVENUE MEMORANDUM CIRCULAR NO. 156-2022 SUBJECT : Publishing the Full Text of the November 23, 2022 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-exempt Medicines under Republic Act (R.A.) No. 11534 Known as the Corporate Recovery and Tax Incentives for Enterprises (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 23, 2022 letter (Annex "A") from Dr. Samuel A. Zacate, Director General of the FDA, for inclusion of certain medicines prescribed for hypertension, diabetes, high cholesterol, tuberculosis, mental illness, and cancer to the published List of VAT-exempt Medicines under R.A. No. 11534 or the CREATE Act. 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 23, 2022 ROMEO D. LUMAGUI, JR. Commissioner Bureau of Internal Revenue Quezon City SUBJECT : Endorsement of Updated List of VAT-exempt Medicines under Republic Act (RA) 11534 Known as Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act 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 23 November 2022. DETACa I. For inclusion A. Hypertension Generic Name Dosage Strength Dosage Form Fimasartan potassium + Rosuvastatin (as calcium) 60 mg/5 mg Film-Coated Tablet Fimasartan potassium + Rosuvastatin (as calcium) 60 mg/10 mg Film-Coated Tablet Fimasartan potassium + Amlodipine (as besilate) 60 mg/10 mg Film-Coated Tablet Isosorbide Mononitrate 120 mg Extended-Release Tablet Olmesartan Medoxomil + Amlodipine + Hydrochlorothiazide 40 mg/10 mg/25 mg Tablet B. Diabetes Generic Name Dosage Strength Dosage Form Metformin hydrochloride + Gliclazide 500 mg/30 mg Sustained-Release Tablet Metformin hydrochloride + Gliclazide 500 mg/30 mg Sustained-Release Tablet Semaglutide 3 mg Tablet Semaglutide 7 mg Tablet Semaglutide 14 mg Tablet Semaglutide 1 mg Solution for Injection in Pre-filled Pen C. High Cholesterol Generic Name Dosage Strength Dosage Form Fenofibric Acid 105 mg Softgel Capsule Fenofibric Acid 35 mg Softgel Capsule Fimasartan potassium + Rosuvastatin (as calcium) 60 mg/5 mg Film-Coated Tablet Fimasartan potassium + Rosuvastatin (as calcium) 60 mg/10 mg Film-Coated Tablet D. Tuberculosis Generic Name Dosage Strength Dosage Form Rifampicin + Isoniazid 75 mg/50 mg Dispersible Tablet Pretomanid 200 mg Tablet E. Mental Illness Generic Name Dosage Strength Dosage Form Bupropion Hydrochloride 300 mg Extended-Release Tablet Clobazam 10 mg Tablet Clobazam 20 mg Tablet F. Cancer Generic Name Dosage Strength Dosage Form Busulfan 60 mg/10 mL Concentrate Solution for Intravenous Infusion Capmatinib (As Hydrochloride) 150 mg Film-Coated Tablet Capmatinib (As Hydrochloride) 200 mg Film-Coated Tablet Erdafitinib 4 mg Film-Coated Tablet Erdafitinib 3 mg Film-Coated Tablet Erdafitinib 5 mg Film-Coated Tablet Fludarabine (as phosphate) 25 mg/mL (50 mg/2 mL) Solution for Injection (IM/IV) Lorlatinib 25 mg Film-Coated Tablet Lorlatinib 100 mg Film-Coated Tablet Ofatumumab 20 mg/0.4 mL Solution for Injection (SC) Pegaspargase 750 U/mL Powder for Solution for Injection/Infusion (IV/IM) Pertuzumab + Trastuzumab 1200 mg/600 mg/15 mL Solution for Injection (SC) Pertuzumab + Trastuzumab 600 mg/600 mg/10 mL Solution for Injection (SC) Pomalidomide 4 mg Capsule Pomalidomide 3 mg Capsule Pomalidomide 1 mg Capsule Pomalidomide 2 mg Capsule Ribociclib (As Succinate) 200 mg Film-Coated Tablet Zanubrutinib 80 mg Capsule Should you have any questions/clarifications, kindly address them to the FDA Policy and Planning Service at [emailprotected]. Thank you very much. aDSIHc Very truly yours, (SGD.) DR. SAMUEL A. ZACATE Director General