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 [email protected].
Dissemination of this Advisory to all concerned is kindly requested.