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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 pps@fda.gov.ph.

Dissemination of this Advisory to all concerned is kindly requested.

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