Publishing the Full Text of the August 15, 2022 Letter from FDA of DOH Endorsing Updates to List of VAT-exempt Medicines under the (CREATE) Act

August 22, 2022 REVENUE MEMORANDUM CIRCULAR NO. 124-2022 SUBJECT : Publishing the Full Text of the August 15, 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 August 15, 2022 letter (Annex "A") from Dr. Samuel A. Zacate, Director General of the FDA, for the updates to the List of VAT-exempt Medicines under R.A. No. 11534 (CREATE Act), to wit: 1. Inclusion of medicines prescribed for cancer, tuberculosis, and mental illness; and 2. Correction to medicines prescribed for diabetes and hypertension. 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 take effect 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.) LILIA CATRIS GUILLERMO Commissioner of Internal Revenue ANNEX A Department of Health Food and Drug Administration August 15, 2022 LILIA CATRIS-GUILLERMO 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 Guillermo : 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 15 August 2022. I. For Inclusion A. Medicines for Cancer Generic Name Dosage Strength Dosage Form Ibandronic Acid 50 mg Film-Coated Tablet Ibandronic Acid 150 mg Film-Coated Tablet Ibandronic Acid (as sodium monohydrate) 50 mg Film-Coated Tablet Ibandronic Acid (as sodium monohydrate) 150 mg Film-Coated Tablet Human Papillomavirus 9-Valent Vaccine Recombinant 0.5 mL dose Suspension for Intramuscular Injection-Single Dose Syringe Human Papillomavirus Vaccine (Types 6, 11, 16 and 18) (Recombinant Adsorbed) Each 0.5 mL contains: Type 6 L1 protein 20 ug Type 11 L1 protein 40 ug Type 16 L1 protein 40 ug Type 18 L1 protein 20 ug Suspension for Injection (I.M.) Human Papillomavirus Vaccine (Types 6, 11, 16 and 18) (Recombinant Adsorbed) 0.5 mL Suspension for Injection (I.M.) Human Papillomavirus Vaccine [Types 16, 18] (Recombinant, Adjuvanted, Absorbed) 0.5 mL Suspension for Injection (I.M.) Human Papillomavirus Vaccine [Types 16 and 18] (Recombinant, Adjuvanted, Absorbed) Formulation: 1 dose (0.5 mL) contains: Human Papillomavirus type 16 L1 protein* 20 mcg Human Papillomavirus type 18 L1 protein* 20 mcg *adjuvanted by AS04 containing 3-O-desacy1-4-monophosphoryl lipid A (MPL) and Aluminum hydroxide, hydrated [A1(OH)3] Suspension for Injection (I.M.) Human Papillomavirus Vaccine 9-Valent Vaccine (Recombinant, Adsorbed) Formulation: Each dose (0.5 mL) contains: Human Papillomavirus Type 6 L1 protein 30mcg Human Papillomavirus Type 11 L1 protein 40mcg Human Papillomavirus Type 16 L1 protein 60mcg Human Papillomavirus Type 18 Li protein 40mcg Human Papillomavirus Type 31 L1 protein 20 mcg Human Papillomavirus Type 33 L1 protein 20mcg Human Papillomavirus Type 45 L1 protein 20mcg Human Papillomavirus Type 52 L1 protein 20mcg Human Papillomavirus Type 58 L1 protein 20mcg Adsorbed on amorphous aluminum hydroxide sulphate adjuvant 500 mcg A1 Suspension for Injection (I.M.) B. Medicines for Tuberculosis Generic Name Dosage Strength Dosage Form Bacillus Calmette-Guerin (BCG) Vaccine 0.5 mg/1.0 mL Lyophilized Powder for Injection (ID) Bacillus Calmette-Guerin, Live Vaccine 40 mg/mL Lyophilized Powder for Intravesical Instillation Bacillus Calmette-Guerin (BCG) Vaccine 500 mcg/mL (250 mcg/0.5 mL) Freeze-Dried Powder for Intradermal Injection BCG Vaccine 500 mcg Freeze-Dried Powder for Injection (I.D.) Tuberculin Purified Protein Derivative 2 TU/0.1 mL Solution for Injection (ID) Tuberculin Purified Protein Derivative 5 TU/0.1 mL Solution for Injection (ID) Tuberculin Purified Protein Derivative 50 TU Freeze-Dried Powder for Injection C. Medicines for Mental Illnesses Generic Name Dosage Strength Dosage Form Esketamine (as hydrochloride) 28 mg Nasal Solution (spray) II. Correction A. Medicines for Diabetes Generic Name Dosage Strength Dosage Form Previously uploaded Correct Previously uploaded Correct Dapagliflozin + Metformin Hydrochloride Dapagliflozin (as propanediol monohydrate) + Metformin Hydrochloride 5 mg/1000 mg Tablet Film-Coated Tablet Dapagliflozin + Metformin Hydrochloride Dapagliflozin (as propanediol monohydrate) + Metformin Hydrochloride 10 mg/1000 mg Tablet Film-Coated Tablet B. Medicines for Hypertension Generic Name Dosage Form Dosage Strength Previously uploaded Correct Previously uploaded Correct Metoprolol + Felodipine Felodipine + Metoprolol Succinate Extended Release Tablet 50 mg + 5 mg 5 mg/47.5 mg (equivalent to 50 mg Metoprolol Tartrate) 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. SAMUEL A. ZACATE Director General