Publishing Full Text of the April 11, 2022 Letter from FDA of DOH Endorsing Updates to the List of VAT-Exempt Medicines under the CREATE Act

April 18, 2022 REVENUE MEMORANDUM CIRCULAR NO. 51-2022 SUBJECT : Publishing the Full Text of the April 11, 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 April 11, 2022 letter (Annex "A") from Mr. Oscar G. Gutierrez, Jr., OIC-Director General of the FDA, for the inclusion of certain medicines for COVID-19 treatment and hypertension and correction of medicines for cancer 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. CAESAR R. DULAY Commissioner of Internal Revenue By: (SGD.) MARISSA O. CABREROS Deputy Commissioner Legal Group Officer-in-Charge ANNEX A DEPARTMENT OF HEALTH FOOD AND DRUG ADMINISTRATION April 11, 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. I. For Inclusion A. Medicines for COVID-19 Treatment Generic Name Dosage Strength Dosage Form Enoxaparin Sodium 4000 IU/0.4 mL Solution for Injection (IV/SC) Enoxaparin Sodium 6000 IU/0.6 mL Solution for Injection (IV/SC) Enoxaparin Sodium 40 mg/0.4 mL Solution for Injection (IV/SC) B. Medicines for Hypertension Generic Name Dosage Strength Dosage Form Isosorbide Dinitrate 1 mg/mL (10 mg/10 mL) Concentrate Solution for Intravenous Infusion Isosorbide Dinitrate 1 mg/mL (10 mg/10 mL) Solution for I.V. Intrusion Isosorbide Dinitrate 10 mg Tablet Isosorbide Dinitrate 20 mg Tablet Isosorbide Dinitrate 20 mg Sustained-Release Tablet Isosorbide Dinitrate 40 mg Retard Tablet Isosorbide-5-Mononitrate 30 mg Film-Coated Tablet Isosorbide-5-Mononitrate 30 mg Sustained-Release Capsule Isosorbide-5-Mononitrate 30 mg Sustained-Release Tablet Isosorbide-5-Mononitrate 60 mg Film-Coated Tablet Isosorbide-5-Mononitrate 60 mg Sustained-Release Capsule Isosorbide Mononitrate 20 mg Tablet Isosorbide Mononitrate 30 mg Tablet Isosorbide Mononitrate 30 mg Prolonged-Release Tablet Isosorbide Mononitrate 30 mg Sustained-Release Tablet Isosorbide Mononitrate 30 mg Film-Coated Tablet Isosorbide Mononitrate 40 mg Tablet Isosorbide Mononitrate 60 mg Prolonged-Release Tablet II. For Correction A. Medicines for Cancer Generic Name Dosage Strength Dosage Form Previously Uploaded Correct Anastrazole Anastrozole 1 mg Film-Coated Tablet 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. Officer-in-Charge-Director General