Publishing the Full Text of the May 22, 2023 Letter from the FDA of the DOH Endorsing Updates to the List of VAT-Exempt Products under R.A. No. 10963 (TRAIN Law) and R.A. No. 11534 (CREATE Act)

June 20, 2023 REVENUE MEMORANDUM CIRCULAR NO. 72-2023 SUBJECT : Publishing the Full Text of the May 22, 2023 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-Exempt Products under Republic Act (R.A.) No. 10963 (TRAIN Law) and R.A. No. 11534 (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 May 22, 2023 letter (Annex "A") from Dr. Samuel A. Zacate, Director General of the FDA, for an update to the published List of VAT-Exempt Medicines under R.A. No. 11534 or the CREATE Act, particularly the following: CAIHTE 1. Inclusion of certain medicines for cancer, diabetes, high cholesterol, hypertension, kidney disease, mental illness, and tuberculosis; 2. Correction of medicine for hypertension; and 3. Deletion of medicine for cancer. 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 May 22, 2023 ROMEO D. LUMAGUI, JR. Commissioner Bureau of Internal Revenue Quezon City SUBJECT : Endorsement of the Updates to the List of VAT-Exempt Products under Republic Act Nos. 10963 and 11534 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 22 May 2023, effective upon the issuance of an FDA Advisory. aScITE I. Inclusion A. Medicines for Cancer Generic Name Dosage Strength Dosage Form Amivantamab 350 mg/7 mL (50 mg/mL) Concentrate for Solution for Infusion (IV) Anagrelide (as hydrochloride) 500 mcg Tablet Atezolizumab 60 mg/mL (1.2 g/20 mL) Concentrate for Solution for Infusion 1200 mg/20 mL (60 mg/mL) Concentrate for Solution for Infusion (IV) Bendamustine Hydrochloride 45 mg/mL Concentrate for Solution for IV Infusion Bleomycin (as Sulfate) 15 Units Powder for Solution for Injection (IM/IV/SC) Bortezomib 2.5 mg Lyophilized Powder for Injection (IV/SC) Carfilzomib 60 mg Lyophilized Powder for Solution for Injection (IV) Dasatinib 140 mg Film-Coated Tablet 100 mg 80 mg Docetaxel 10 mg/mL (80 mg/8 mL) Solution for Injection for I.V. Infusion 20 mg/2 mL Solution for IV Injection Docetaxel (As Trihydrate) 20 mg/0.5 mL Concentrate Solution for Injection for IV Infusion 40 mg/mL (80 mg/2 mL) Concentrate Solution for IV Injection Doxorubicin Hydrochloride 2 mg/mL (50 mg/25 mL) Solution for Injection for I.V. Infusion Epirubicin (as hydrochloride) 50 mg Lyophilized Powder for Injection (IV) Epirubicin Hydrochloride 2 mg/mL (50 mg/25 mL) Concentrate solution for Injection (IV/Intravesical) 100 mg Lyophilized Powder for IV Infusion Etoposide 20 mg/mL) (100 mg/5 mL) Solution for I.V. Injection Everolimus 2.5 mg Tablet Ixazomib (as citrate) 4 mg Capsule 3 mg 2.3 mg Irinotecan Hydrochloride 20 mg/mL (300 mg/15 mL) Concentrate Solution for IV Infusion Lapatinib (as distosylate monohydrate) 250 mg Film Coated Tablet Oxaliplatin 2 mg/mL (50 mg/25 mL) Concentrate Solution for IV Infusion 2 mg/mL (100 mg/50 mL) Paclitaxel 6 mg/mL (300 mg/50 mL) Solution for Injection (IV Infusion) 6 mg/mL (260 mg/43.4 mL) Concentrate for Solution for I.V. Infusion Pemetrexed (as Disodium Hemipentahydrate) 500 mg Lyophilized Powder for Infusion (IV) Ruxolitinib (As Phosphate) 15 mg Tablet 20 mg Trastuzumab 420 mg Powder for Concentrate for Solution for Infusion (IV) Triptorelin (as Embonate) 22.5 mg Lyophilized Powder for Injection (IM) 11.25 mg Vinorelbine (as tartrate) 10 mg/mL Solution for I.V. Infusion B. Medicines for Diabetes Generic Name Dosage Strength Dosage Form Dapagliflozin + Metformin Hydrochloride 10 mg/1 g Film-Coated Tablet Dapagliflozin + Metformin Hydrochloride 10 mg/500 mg Film-Coated Tablet 5 mg/1 g 5 mg/500 mg Dapagliflozin + Metformin Hydrochloride (in extended-release form) 10 mg/1 g Film-Coated Tablet 10 mg/500 mg 5 mg/1 g 5 mg/500 mg Evogliptin (as tartrate) 5 mg Film-Coated Tablet Gliclazide + Metformin Hydrochloride 80 mg/500 mg Film-Coated Tablet Insulin Glargine 100 IU (equivalent to 3.64 mg)/mL Solution for Injection (SC) Metformin hydrochloride + Glibenclamide 500 mg/5 mg Tablet Sitagliptin (as phosphate monohydrate) + Metformin Hydrochloride 50 mg/1 g Film-Coated Tablet 100 mg/1 g Sitagliptin (as phosphate) + Metformin Hydrochloride 50 mg/500 mg Film-Coated Tablet Vildagliptin 50 mg Film Coated Tablet C. Medicines for High Cholesterol Generic Name Dosage Strength Dosage Form Fenofibrate 160 mg Micronized Capsule Inclisiran (as sodium) 284 mg/1.5 mL Solution for Injection (SC) D. Medicines for Hypertension Generic Name Dosage Strength Dosage Form Amlodipine (as besilate) + Bisoprolol fumarate 5 mg/5 mg Film-Coated Tablet Irbesartan + Amlodipine (as besilate) 150 mg/5 mg Film-Coated Tablet Losartan (as Potassium) 50 mg Film-Coated Tablet 100 mg Losartan Potassium + Hydrochlorothiazide + Amlodipine (as besilate) 100 mg/12.5 mg/5 mg Film-Coated Tablet 100 mg/12.5 mg/10 mg 50 mg/12.5 mg/5 mg Macitentan 10 mg Film-Coated Tablet Nebivolol (as Hydrochloride) 2.5 mg Tablet E. Medicines for Kidney Disease Generic Name Dosage Strength Dosage Form Alpha Ketoanalogues + Essential Amino Acids Each tablet contains: a-Ketoisoleucine, Calcium Salt 67 mg a-Ketoleucine, Calcium Salt 101 mg a-Ketophenylalanine, Calcium Salt 68 mg a-Ketovaline, Calcium Salt 86 mg a-Hydroxymethionine, Calcium Salt 59 mg L-Lysine Acetate 105 mg L-Threonine 53 mg L-Tryptophan 23 mg L-Histidine 38 mg L-Tyrosine 30 mg Total calcium 50 mg Film-Coated Tablet Alpha Ketoanalogues + Essential Amino Acids Each sachet contains: Calcium-3-methyl-2-oxovalerate (a-Ketoanalogue of isoleucine, Calcium salt) 201 mg Calcium-4-methyl-2-oxovalerate (a-Ketoanalogue of leucine, Calcium salt) 303 mg Calcium-2-oxo-3-phenylpropionate (a-Ketoanalogue of phenylalanine, Calcium salt) 204 mg Calcium-3-methyl.2-oxobutyrate (a-Ketoanalogue of valine, Calcium salt) 258 mg Calcium-DL-2-hydroxy-4-(methylthio)-butyrate (a-Hydroxy analogue of methionine, Calcium-salt) 177 mg L-Lysine Acetate 315 mg L-Threonine 159 mg L-Tryptophan 69 mg L-Histidine 114 mg L-Tyrosine 90 mg Total Nitrogen content I sachet 108 mg Calcium/sachet 3.75 mmol = 150 mg Granules for Oral Solution Epoetin Alfa (Recombinant Human Erythropoietin) 2,000 I.U./0.5 mL Solution for Injection (S.C./I.V.) Everolimus 2.5 mg Tablet Mycophenolate Mofetil 250 mg Capsule Peritoneal Dialysis Solution Low Calcium With 1.5% Dextrose Each 100 mL contains: Dextrose hydrous 1.5 g, USP Sodium Chloride 538 mg, USP Sodium Lactate 448 mg, USP Calcium Chloride Dihydrate 18.3 mg, USP Magnesium Chloride Hexahydrate, USP 5.08 mg Dialysis Solution (Intraperitoneal) Peritoneal Dialysis Solution Low Calcium With 4.25% Dextrose Each 100 mL contains: Dextrose hydrous 4.25 g, USP Sodium Chloride 538 mg, USP Sodium Lactate 448 mg, USP Calcium Chloride Dihydrate 18.3 mg, USP Magnesium Chloride Hexahydrate 5.08 mg Dialysis Solution (Intraperitoneal) Peritoneal Dialysis Solution with 2.3% Dextrose Each L of Solution contains: Glucose (Dextrose) 22.73 g equivalent to 25 g glucose monohydrate Sodium Chloride 5.786 g Sodium Lactate 3.925 g Calcium chloride dihydrate 0.1838 g Magnesium chloride hexahydrate 0.1017 g Peritoneal Dialysis Solution Potassium Citrate 1.08 g (10 mEq) Extended-Release Tab Sevelamer (as Carbonate) 800 mg Film Coated Tablet Spherical Carbon Adsorbent 500 mg Tablet F. Medicines for Mental Illness Generic Name Dosage Strength Dosage Form Agomelatine 25 mg Film-Coated Tablet Aripiprazole 5 mg Film Coated Tablet Midazolam (as Hydrochloride) 5 mg/mL (5 mg/1 mL) Solution for Injection (IM/IV) Venlafaxine (as hydrochloride) 150 mg Sustained Release Tablet G. Medicines for Tuberculosis Generic Name Dosage Strength Dosage Form Bedaquiline (as Fumarate) 20 mg Tablet II. Correction A. Medicines for Hypertension Generic Name Dosage Strength Dosage Form Previously uploaded Correct Metoprolol Metoprolol Succinate 23.75 mg Controlled-Release Tablet Metoprolol Metoprolol Succinate 95 mg Controlled-Release Tablet III. Deletion A. Medicines for Cancer Generic Name Dosage Strength Dosage Form Ixekizumab 80 mg/mL Solution for Injection (SC) Justification: Upon evaluation of the Certificate of Product Registration (CPR) and package insert of the abovementioned drug product, it was noted that it is approved as Interleukin Inhibitor indicated for the treatment of moderate to severe plague psoriasis in adults who are candidates for systematic therapy. Hence, the product is not classified as treatment for cancer. 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