Section 12 of Republic Act (RA) No. 11534 known as the “Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act” provided Value-Added Tax (VAT) Exemption to certain health products including, Drugs for Hypertension, Cancer, Mental Illnesses, Tuberculosis, Kidney Diseases, Diabetes, High Cholesterol, and COVID-19 medicines and medical devices. Pursuant to the said law, the Food and Drug Administration (FDA) is directed to identify and transmit the VAT-Exempt Health products to other implementing agencies such as the Bureau of Internal Revenue (BIR), Bureau of Customs and Department of Trade and Industry.
Relative thereto, the FDA has issued FDA Advisory (FA) No. No.2023-0256 1 which provided the new implementation date of updates on the List of VAT-Exempt Health products, pursuant to BIR Revenue Memorandum Circular No. 99-20212.
In this regard, provided below are the latest updates on the List of VAT-Exempt Health Products pursuant to RA 11534, effective upon the issuance of this Advisory:
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 | 1.88mg/mL | Powder For Prolonged-Release Suspension for Injection (IM/SC) |
| Leuprorelin Acetate | 3.75mg/mL | Powder For Prolonged-Release Suspension for Injection (IM/SC) |
| Leuprorelin Acetate | 11.25mg/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) |
15mg/6.14mg | Film-Coated Tablet |
| Trifluridine + Tiparicil (as Hydrochloride) |
20mg/8.19mg | Film-Coated Tablet |
B. Medicines for Diabetes
| Generic Name | Dosage Strength | Dosage Form |
| Gemigliptin (as tartrate sesquihydrate) + Metformin hydrochloride | 50 mg/1g | Film-Coated tablet |
| Insulin Lispro | 100 Units/mL (3.5 mg/mL)
(50% Insulin Lispro and 50% Insulin Lispro Protamine) |
Suspension for Injection (SC) |
| 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/500mg | Sustained-Release Tablet |
| Pioglitazone (as Hydrochloride + Metformin Hydrochloride) | 30 mg/500mg | 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 Hydrochlorid | 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) | 100 mg/ 5mg | Tablet/Oral | Film-Coated Tablet |
Further, provided in the Annex is the signed letter dated 21 February 2023, endorsing the said updates to the BIR.
Should you have any question/clarifications, you may contact the FDA Policy and Planning Service via email at [email protected].
Dissemination of this Advisory to all concerned is kindly requested.