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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 04 December 2023:

 

I. Inclusion           

A. Medicines for Cancer

Generic Name Dosage Strength Dosage Form
Panitumumab 100 mg/5 mL (20 mg/mL) Concentrate for Solution for Infusion (IV)
Fulvestrant 50 mg/mL (250 mg/5 mL) Solution for Injection (IM)

 

B. Medicines for Diabetes

Generic Name Dosage Strength Dosage Form
Teneligliptin ( as hydrobromide hydrate) 20 mg Film-Coated Tablet
Sitagliptin (as phosphate monohydrate) +

Metformin Hydrochloride

50 mg/500 mg Film-Coated Tablet
Sitagliptin 50 mg Film-Coated Tablet
Sitagliptin 100 mg Film-Coated Tablet
Metformin Hydrochloride 500 mg Prolonged-Release Tablet

 

C. Medicines for High Cholesterol         

Generic Name Dosage Strength Dosage Form
Atorvastatin Calcium 20 mg Film-Coated Tablet
Atorvastatin + Fenofibrate 40 mg/160 mg Film-Coated Tablet

           

D. Medicines for Hypertension

 

Generic Name Dosage Strength Dosage Form
Clonidine hydrochloride 150 mcg/mL Solution For Injection (IM/IV)
Clonidine hydrochloride 150 mcg Tablet
Lisinopril (as dihydrate) 5 mg Tablet
Lisinopril (as dihydrate) 10 mg Tablet
Lisinopril (as dihydrate) 20 mg Tablet

 

E. Medicines for Kidney Disease

Generic Name Dosage Strength Dosage Form
Mannitol 20 g/100 mL (20%) Solution for Injection (IV)
Tolvaptan 15 mg Tablet
Tolvaptan 30 mg Tablet
Alpha Ketoanalogues + Essential Amino Acids Each film-coated tablet contains:

Calcium-4-methyl-2-oxovalerate (α-ketoanalogue of leucine, calcium salt)

202 mg,

Calcium-3-methyl-2-oxobutyrate (α-ketoanalogue of valine, calcium salt)

172 mg,

Calcium-2-oxo-3-phenylproprionate (α-ketoanalogue of

phenylalanine, calcium salt)

136 mg,

Calcium-3-methyl-2-oxovalerate (α-ketoanalogue of isoleucine, calcium salt)

134 mg,

Calcium-DL-2-hydroxy-4-(methylthio)-butyrate (α-

hydroxyanalogue of methionine, calcium salt)

118 mg,

L-Lysine acetate 210 mg,

L-Threonine 106 mg,

L-Histidine 76 mg,

L-Tyrosine 60 mg,

L-Tryptophan

46 mg,

Total Nitrogen Content 72 mg

Film-Coated Tablet

 

F. Medicines for Mental Illness           

Generic Name Dosage Strength Dosage Form
Desvenlafaxine (as succinate monohydrate) 50 mg Controlled-Release Tablet

 

G. Medicines for Tuberculosis 

Generic Name Dosage Strength Dosage Form
Bedaquiline (as Fumarate) 100 mg Tablet
Isoniazid + Pyridoxine Hydrochloride 200 mg/10 mg per 5 mL Syrup

 

II. Deletion

A. Medicines for Hypertension

 

Generic Name Dosage Strength Dosage Form
Macitentan 10 mg Film-Coated Tablet

 

Justification: The pharmacologic category of Macitentan is an endothelin receptor antagonist (ERA) with an approved indication for targeted pulmonary arterial hypertension (PAH) therapy which is not synonymous to systemic hypertension.

 

Dissemination of this Advisory to all concerned is kindly requested.

 

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