Publishing Full Text of the February 18, 2022 Letter from FDA Endorsing Updates to the List of VAT-Exempt Medicines under the CREATE Act

March 3, 2022 REVENUE MEMORANDUM CIRCULAR NO. 30-2022 SUBJECT : Publishing the Full Text of the February 18, 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 February 18, 2022 letter (Annex "A") from Dr. Oscar G. Gutierrez, Jr., OIC-Director General of the FDA, for the inclusion, delisting and correction of certain medicines for cancer, diabetes, hypertension, high-cholesterol, mental illness, and COVID-19 to the List of VAT-Exempt Medicines under R.A. No. 11534 or the CREATE Act. 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 ANNEX A Department of Health Food and Drug Administration February 18, 2022 CAESAR R. DULAY 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 Dulay : 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 has been issued, wherein 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. aScITE I. For Inclusion A. Medicines for Cancer Generic name Dosage Strength Dosage Form Filgrastim 300 mcg/1.2mL Solution for Injection (IV/SC) Follitropin Alfa/Lutropin Alfa 300 IU/150 IU (0.48mL) Solution for Injection (SC) Siltuximab 400mg Powder for Concentrate for Solution for Infusion Durvalumab 120 mg/2.4 mL (50 mg/mL) Concentrate for Solution for IV Infusion Durvalumab 500 mg/10 mL (50 mg/mL) Concentrate for Solution for IV Infusion B. Medicines for Diabetes Generic name Dosage Strength Dosage Form Desmopressin (as Acetate) 60 mcg Oral Lyophilisate C. Medicines for Hypertension Generic name Dosage Strength Dosage Form Indapamide 1.5 mg Prolonged-Release Tablet D. Medicines for High-Cholesterol Generic name Dosage Strength Dosage Form Ezetimibe + Rosuvastatin (as Calcium) 10mg/5mg Film-Coated Tablet/Oral Ezetimibe + Rosuvastatin (as Calcium) 10mg/20 mg Film-Coated Tablet/Oral Ezetimibe + Rosuvastatin (as Calcium) 10mg/10 mg Film-Coated Tablet/Oral E. Medicines for Mental Illness Generic name Dosage Strength Dosage Form Lamotrigine 50 mg Tablet F. Medicines for COVID-19 Generic name Dosage Strength Dosage Form Arbidol Hydrochloride 100 mg Tablet Beclomethasone + Formoterol 100 mcg + 6 mcg/actuation, 120 actuations Powder for Inhalation Bivalirudin 250 mg Lyophilized Powder for Injection (IV) Casirivimab + Imdevimab 120 mg/mL + 120 mg/mL Concentrate for Solution for Infusion Clopidogrel (As Bisulfate) 75 mg Film-Coated Tablet Dexamethasone (as sodium phosphate) 4 mg/mL Solution for Injection (IM/IV) Dexamethasone (as sodium phosphate) 50 mg/mL Solution for Injection (IM/IV) Dexamethasone (as sodium phosphate) 4 mg/mL (8 mg/2 mL) Solution for Injection (IM/IV) Dexamethasone (as sodium phosphate) 5 mg/mL Solution for Injection (IM/IV) Dexamethasone (as sodium phosphate) 5 mg/mL (10 mg/2 mL) Solution for Injection (IM/IV) Dexamethasone (as sodium phosphate) 2 mg/mL Solution for Injection (IM/IV) Dexamethasone (as sodium phosphate) 2 mg/mL (4 mg/2 mL) Solution for Injection (IM/IV) Enoxaparin Sodium 4000 IU Anti-Factor Xa (Equivalent to 40 mg) 0.4 mL Solution for Injection (SC) Enoxaparin Sodium 60 mg/0.6mL Solution for Injection (IV/SC) Enoxaparin Sodium 4,000 IU/0.4mL (40 mg/0.4 mL) Solution for Injection (SC) Enoxaparin Sodium 8,000 IU/0.8mL (80 mg/0.8 mL) Solution for Injection (SC) Enoxaparin Sodium 6,000 IU/0.6mL (60 mg/0.6 mL) Solution for Injection (SC) Enoxaparin Sodium 2,000 IU/0.2mL (20 mg/0.2 mL) Solution for Injection (SC) Heparin Sodium 1,000 IU/mL (5,000 IU/5mL) Solution for Injection (IV/SC) Heparin Sodium 5,000 IU/mL (25,000 IU/5mL) Solution for Injection (IV/SC) Heparin Sodium 25,000 IU/5mL (5,000 IU/mL) Solution for Injection (IV/SC) Heparin Sodium 10,000 IU/10 mL (1,000 IU/mL) Solution for Injection (IV/SC) Heparin Sodium 5,000 IU/mL Solution for Injection (IV/SC) Heparin Sodium 5,000 IU/5mL (1,000 IU/mL) Solution for Injection (IV) Itolizumab N/A Lyophilized Powder for IV Injection Medical Grade Oxygen N/A N/A Propofol 10 mg/mL (1% w/v) Emulsion for Injection (I.V./Infusion) Remdesivir 100 mg/20 mL Concentrate for Solution for IV Infusion Tinzaparin Sodium 1,000 Anti-Xa IU/mL Solution for Injection (SC) Tocilizumab 400 mg/20 mL Concentrate for Solution for Infusion (IV) Tocilizumab 80 mg/4 mL (20 mg/mL) Concentrate for Solution for Infusion (IV) Tocilizumab 400 mg/20 mL (20 mg/mL) Concentrate for Solution for Injection (IV Infusion) Tocilizumab 200 mg/10mL Concentrate for Solution for Injection (IV) Vancomycin HCI 125 mg Capsule II. Delisting A. Medicines for Cancer Generic name Dosage Strength Dosage Form Ursodeoxycholic Acid 200 mg Tablet III. Correction A. Medicine for COVID-19 Generic name Dosage Strength Dosage Form Previously submitted Correct Beclomethasone + Formoterol + Glycopyrronium 100 mcg + 6 mcg + 10 mcg /actuation, 120 actuations 100 mcg + 6 mcg + 12.5 mcg /actuation, 120 actuations Metered Dose Inhaler Should you have any questions/clarifications, kindly address them to the FDA Policy and Planning Service at [emailprotected]. Thank you very much. Very truly yours, (SGD.) DR. OSCAR G. GUTIERREZ, JR., MPA Officer-in-Charge-Director General