Publishing the Full Text of the March 16, 2022 Letter from FDA of DOH Endorsing Updates to the List of VAT-Exempt Medicines under the CREATE Act

March 18, 2022 REVENUE MEMORANDUM CIRCULAR NO. 56-2022 SUBJECT : Publishing the Full Text of the March 16, 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 March 16, 2022 letter (Annex "A") from Dr. Oscar G. Gutierrez, Jr., OIC-Director General of the FDA, for the inclusion and correction of certain medicines for hypertension and inclusion of medicines for COVID-19 treatment 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 March 16, 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 Hypertension Generic Name Dosage Strength Dosage Form Bisoprolol Fumarate + Perindopril Arginine 5 mg + 5 mg Film-Coated Tablet Bisoprolol Fumarate + Perindopril Arginine 5 mg + 10 mg Film-Coated Tablet Bisoprolol Fumarate + Perindopril Arginine 10 mg + 5 mg Film-Coated Tablet Bisoprolol Fumarate + Perindopril Arginine 10 mg + 10 mg Film-Coated Tablet B. Medicines for COVID-19 Treatment Generic Name Dosage Strength Dosage Form Fentanyl 12 mcg/hr Transdermal patch Sodium Chloride 0.9%, 50 mL Solution for I.V. Infusion (Parenteral) Sodium Chloride 0.9%, 100 mL Solution for I.V. Infusion (Parenteral) Sodium Chloride 0.9%, 250 mL Solution for I.V. Infusion (Parenteral) II. For Correction A. Medicines for Hypertension Generic Name Dosage Strength Dosage Form Previously uploaded Correct 2.5 mg Film-Coated Tablet Bisoprolol Bisoprolol Fumarate Bisoprolol Bisoprolol Fumarate 5 mg Film-Coated Tablet Bisoprolol Bisoprolol Fumarate 5 mg Tablet Bisoprolol Bisoprolol Fumarate 10 mg Film-Coated Tablet Bisoprolol + Hydrochlorothiazide Bisoprolol Fumarate + Hydrochlorothiazide 2.5 mg + 6.25 mg Film-Coated Tablet Bisoprolol + Hydrochlorothiazide Bisoprolol Fumarate + Hydrochlorothiazide 5 mg + 6.25 mg Film-Coated Tablet Bisoprolol + Hydrochlorothiazide Bisoprolol Fumarate + Hydrochlorothiazide 10 mg + 6.25 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., MPA Officer-in-Charge-Director General