Publishing Full Text of the February 21, 2023 Letter from the FDA of DOH Endorsing Updates to the List of VAT-exempt Products under TRAIN Law and CREATE Act

April 4, 2023 REVENUE MEMORANDUM CIRCULAR NO. 42-2023 SUBJECT : Publishing the Full Text of the February 21, 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. 11 534 (CRE ATE 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 21, 2023 letter (Annex "A") from Dr. Samuel A. Zacate, Director General of the FDA, for inclusion of certain medicines for cancer, diabetes, kidney disease, mental illness, and tuberculosis and correction for medicines for high cholesterol and hypertension to the published List of VAT-exempt Medicines under R.A. No. 11534 or the CREATE Act. HTcADC 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. ROMEO D. LUMAGUI, JR. Commissioner of Internal Revenue By: (SGD.) MARISSA O. CABREROS Deputy Commissioner Legal Group Officer-in-Charge ANNEX A Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION February 21, 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 20 February 2023, effective upon the issuance of an FDA Advisory. CAIHTE I. Inclusion A. Medicines Cancer Generic Name Dosage Strength Dosage Form Apalutamide 60 mg Film-Coated Tablet Brigatinib 30 mg Film-Coated Tablet Brigatinib 90 mg Film-Coated Tablet Brigatinib 180 mg Film-Coated Tablet Dabrafenib (As Mesilate) 50 mg Capsule Dabrafenib (As Mesilate) 75 mg Capsule Daratumumab 1,800 mg/15 mL (120 mg/mL) Solution for Injection (SC) Doxorubicin hydrochloride 2 mg/mL (50 mg/25 mL) Pegylated Liposomal Concentrate Solution for Injection for I.V. Infusion Fluorouracil 50 mg/mL (250 mg/5 mL) Solution for Injection (IV) Gemcitabine (as hydrochloride) 10 mg/mL Solution for Injection for I.V. Infusion (Ready-to-Infuse) Goserelin (as Acetate) 3.6 mg Depot in Pre-Filled Syringe (SC Injection) Goserelin (as Acetate) 3.6 mg Implant in Pre-filled Syringe for Subcutaneous (SC) Injection Goserelin (as Acetate) 10.8 mg Implant in Pre-filled Syringe for Subcutaneous (SC) Injection Goserelin Acetate (equivalent to Goserelin Base) 10.8 mg Depot Solution for Subcutaneous Injection Irinotecan (as hydrochloride) 20 mg/mL (500 mg/25 mL) Concentrate Solution for Intravenous (I.V.) Infusion Irinotecan Hydrochloride 20 mg/mL (500 mg/25 mL) Powder for Prolonged-Release Suspension for Injection (IM/SC) Irinotecan Hydrochloride 20 mg/mL (300 mg/15 mL) Powder for Prolonged-Release Suspension for Injection (IM/SC) Leuprorelin Acetate 1.88 mg/mL Powder for Prolonged-Release Suspension for Injection (IM/SC) Leuprorelin Acetate 3.75 mg/mL Powder for Prolonged-Release Suspension for Injection (IM/SC) Leuprorelin Acetate 11.25 mg/mL Powder for Prolonged-Release Suspension for Injection (IM/SC) Nilotinib (as hydrochloride dihydrate) 200 mg Capsules Nilotinib (as hydrochloride dihydrate) 150 mg Capsules Ondansetron (as hydrochloride dihydrate) 4 mg/5 mL Syrup Ondansetron (as hydrochloride) 2 mg/mL Solution for Injection (IM/IV) Pralsetinib 100 mg Capsule Trifluridine + Tiparicil (as Hydrochloride) 15 mg/6.14 mg Film-Coated Tablet Trifluridine + Tiparicil (as Hydrochloride) 20 mg/8.19 mg Film-Coated Tablet B. Medicines for Diabetes Generic Name Dosage Strength Dosage Form Gemigliptin (as tartrate sesquihydrate) + Metformin hydrochloride 50 mg/1 g Film-Coated tablet Insulin Lispro Protamine Insulin Lispro (rDNA) 100 Units/mL (3.5 mg/mL) (25% Insulin Lispro Solution + 75% Insulin Lispro Protamine) Suspension for Injection (SC) Metformin Hydrochloride 1 g Prolonged-Release Tablet Pioglitazone (as Hydrochloride + Metformin Hydrochloride) 15 mg/500 mg Sustained-Release Tablet Pioglitazone (as Hydrochloride + Metformin Hydrochloride) 30 mg/500 mg Sustained-Release Tablet C. Medicines for Kidney Disease Generic Name Dosage Strength Dosage Form Ketoanalogues + Essential Amino Acids 630 mg Film-Coated Tablet Peritoneal Dialysis Solution with 1.5% Dextrose Each L of solution contains: Glucose anhydrous (equivalent to 16.5 g glucose monohydrate) 15 g Calcium Chloride Dihydrate 257.3 mg Magnesium Chloride Hexahydrate 101.7 mg Sodium Lactate 3.925 g Sodium Chloride 5.786 g Dialysis Solution (Intraperitoneal) Peritoneal Dialysis Solution with 1.5% Dextrose Each L of solution contains: Glucose (equivalent to 15 g glucose anhydrous) 16.5 g Calcium Chloride Dihydrate 183.8 mg Magnesium Chloride Hexahydrate 101.7 mg Sodium Lactate 3.925 g Sodium Chloride 5.786 g Solution for Peritoneal Dialysis (Intraperitoneal) Peritoneal Dialysis Solution with 4.25% Dextrose Each 1000 mL contains: Sodium Lactate 3.925 g Sodium Chloride 5.786 g Magnesium Chloride Hexahydrate 0.1017 g Calcium Chloride Dihydrate 0.2573 g Glucose Monohydrate (Glucose anhydrous) 42.5g Peritoneal Dialysis Solution Peritoneal Dialysis Solution with 4.25% Dextrose Each L of solution contains: Glucose (Dextrose) (equivalent to 46.75 g glucose monohydrate) 42.5 g Sodium Chloride 5.786 g Sodium Lactate 3.925 g Calcium Chloride equivalent to 0.1838 g calcium chloride dihydrate 0.1387 g Magnesium Chloride equivalent to 0.1017 g magnesium chloride hexahydrate 0.0577 g Solution for Peritoneal Dialysis (Intraperitoneal) D. Medicines for Mental Illness Generic Name Dosage Strength Dosage Form Lurasidone Hydrochloride 40 mg Film-Coated Tablet Lurasidone Hydrochloride 80 mg Film-Coated Tablet Lurasidone (as Hydrochloride) 80 mg Film-Coated Tablet Risperidone 1 mg Orodispersible Tablet Risperidone 2 mg Orodispersible Tablet E. Medicines for Tuberculosis Generic Name Dosage Strength Dosage Form Rifampicin + Isoniazid + Ethambutol Hydrochloride 150 mg/75 mg/300 mg Film-Coated Tablet II. Correction A. Medicines for High Cholesterol Generic Name Dosage Strength Dosage Form Previously uploaded Correct Ezetimibe + Simvastatin 10mg/10mg Tablet/Oral Tablet Ezetimibe + Simvastatin 10mg/20mg Tablet/Oral Tablet Ezetimibe + Simvastatin 10mg/40mg Tablet/Oral Tablet B. Medicines for Hypertension Generic Name Dosage Strength Dosage Form Previously uploaded Correct Previously uploaded Correct Losartan potassium + Amlodipine camsylate Losartan potassium + Amlodipine camsylate (as camsilate) 50mg/5mg Tablet/Oral Film-Coated Tablet Losartan potassium + Amlodipine camsylate Losartan potassium + Amlodipine camsylate (as camsilate) 100mg/5mg Tablet/Oral Film-Coated Tablet Should you have any questions/clarifications, kindly address them to the FDA Policy and Planning Service at [emailprotected]. DETACa Thank you very much. Very truly yours, (SGD.) DR. SAMUEL A. ZACATE Director General