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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 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) 50mg

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/1g

Film-Coated Tablet

Dapagliflozin + Metformin Hydrochloride

10 mg/500 mg

Film-Coated Tablet

5 mg/1g

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/5mg

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 108mg

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 5.08 mg Chloride Hexahydrate

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

 

     F. 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)

 

Rationale: 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 plaque psoriasis in adults who are candidates for systematic therapy. Hence, the product is not classified as treatment for cancer.

Further, provided in the Annex is the signed letter dated 22 May 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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