Publishing the Full Text of the May 30, 2022 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-exempt Medicines under Republic Act (R.A.) No. 11534 Known as the Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act
Revenue Memorandum Circular No. 110-2022 • Bureau of Internal Revenue (BIR) Issuances • Revenue Memorandum Circulars • Jul 1, 2022
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July 1, 2022 REVENUE MEMORANDUM CIRCULAR NO. 110-2022 SUBJECT : Publishing the Full Text of the May 30, 2022 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-exempt Medicines under Republic Act (R.A.) No. 11534 Known as the Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act TO : All Internal Revenue Officers and Others Concerned For the information and guidance of all internal revenue officers, employees and others concerned, attached is the May 30, 2022 letter (Annex "A") from Dr. Oscar G. Gutierrez, Jr., OIC-Director General of the FDA, for the inclusion of certain medicines prescribed for cancer and COVID-19 treatment to the List of VAT-exempt Medicines under R.A. No. 11534 or the CREATE Act. As clarified under Q&A No. 1 of RMC No. 99-2021, the effectivity of the VAT exemption of the covered medicines and medical devices under the CREATE Act shall take effect on the date of publication by the FDA of the said updates to the said list. All concerned are hereby enjoined to be guided accordingly and give this Circular as wide a publicity as possible. (SGD.) LILIA CATRIS GUILLERMO Commissioner of Internal Revenue ANNEX A Department of Health FOOD AND DRUG ADMINISTRATION May 30, 2022 CAESAR R. DULAY Commissioner Bureau of Internal Revenue Quezon City SUBJECT : Endorsement of Updated List of VAT-exempt Medicines under Republic Act (RA) 11534 known as Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act Dear Commissioner Dulay: With reference to the Implementing Guidelines on the Value-Added Tax (VAT) Exemption on Several Health Products provided under Joint Administrative Order (JAO) No. 2-2018 dated 21 December 2018 and JAO No. 2021-0001 dated 23 June 2021, may we provide you with the updates to the "List of VAT-exempt Drugs for Hypertension, Cancer, Mental Illnesses, Tuberculosis, Kidney Diseases, Diabetes, and High Cholesterol." Further, DOH Department Memorandum No. 2021-0280 has been issued, wherein all documents with reference to the VAT-exempt list of all COVID-19 related medicines and medical devices shall be forwarded to the FDA. Listed hereunder are the updates. I. Inclusion A. Medicines for Cancer Generic Name Dosage Strength Dosage Form Recombinant Human Erythropoietin Alfa 4000 IU/0.8 mL Solution for IV Injection B. Medicines for COVID-19 treatment Generate Name Dosage Strength Dosage Form Fluticasone Propionate 500 mcg/mL (0.05% w/v) 50 mcg per actuation Suspension for Nasal Spray Azelastine Hydrochloride + Fluticasone Propionate 137 mcg/50 mcg per actuation Nasal Suspension (Spray) Fluticasone + Salmeterol 125 mcg/25 mcg Metered-Dose Inhaler Fluticasone + Salmeterol 250 mcg/25 mcg Metered-Dose Inhaler Fluticasone Furoate 27.5 mg/actuation Suspension for Nasal Spray Fluticasone Furoate + Umeclinidium (As Bromide) + Vilanterol (As Trifenatate) 100 mcg/62.5 mcg/25 mcg Dry Powder for Inhalation Fluticasone Furoate + Vilanterol (As Trifenatate) 100 mcg/25 mcg ( ILLEGIBLE PORTION 92 mcg/22 mcg delivered dose) Dry Powder for Inhalation Fluticasone Propionate 500 mcg/mL (50 mcg/0.1 mL spray) Suspension for Nasal Spray Fluticasone Propionate 500 mcg/mL Suspension for Nasal Spray Fluticasone Propionate 50 mcg Aqueous Nasal Spray Fluticasone Propionate 125 mcg/actuation Metered-Dose Inhaler (Non-CFC) Fluticasone Propionate 250 mcg/mL Suspension for Inhalation (Nebules) Fluticasone Propionate 50 mcg/Actuation Suspension for Nasal Spray Fluticasone Propionate 125 mcg per actuation Metered-Dose Inhaler Fluticasone Propionate 50 mcg per Actuation Nasal Spray Fluticasone Propionate 50 mcg Nasal Spray Fluticasone Propionate + Formoterol Fumarate dihyrate 250 mcg/10 mcg per actuation Metered Dose Inhaler (Suspension) Fluticasone Propionate + Formoterol Fumarate dihydate 50 mcg/5 mcg per actuation Metered Dose Inhaler (Suspension) Salmeterol (as Xinafoate) + Fluticasone Propionate 25 mcg/250 mcg Metered Dose Inhaler Salmeterol (as Xinafoate) + Fluticasone Propionate 25 mcg/250 mcg Metered Dose Inhaler (Suspension) Salmeterol (as Xinafoate) + Fluticasone Propionate 25 mcg/125 mcg Metered Dose Inhaler Salmeterol (as Xinafoate) + Fluticasone Propionate 25 mcg/125 mcg Metered Dose Inhaler (Suspension) Salmeterol (as Xinafoate) + Fluticasone Propionate 50 mcg/100 mcg Dry Powder for Inhalation Capsule Salmeterol (as Xinafoate) + Fluticasone Propionate 50 mcg/250 mcg Dry Powder for Inhalation in Capsule Salmeterol (as Xinafoate) + Fluticasone Propionate 50 mcg/500 mcg Dry Powder for Inhalation in Capsule Salmeterol (as Xinafoate) + Fluticasone Propionate 25 mcg/125 mcg per Actuation Metered Dose Inhaler (CFC) (120 doses) Salmeterol (As Xinafoate) + Fluticasone Propionate 25 mcg/250 mcg per Actuation Metered Dose Inhaler (CFC Free) (120 doses) Salmeterol (As Xinafoate) + Fluticasone Propionate 25 mcg/125 mcg per actuation Metered Dose Inhaler Salmeterol (As Xinafoate) + Fluticasone Propionate 25 mcg/125 mcg Pressurized Metered Dose Inhaler (CFC Free) Salmeterol (As Xinafoate) + Fluticasone Propionate 25 mcg/250 mcg Pressurized Metered Dose Inhaler (CFC Free) Salmeterol (As Xinafoate) + Fluticasone Propionate 25 mcg/250 mcg per Actuation Metered Dose Pressurized Liquid for Inhalation Salmeterol (As Xinafoate) + Fluticasone Propionate 25 mcg/125 mcg per Actuation Metered Dose Pressurized Liquid for Inhalation Salmeterol (As Xinafoate)/Fluticasone Propionate 25/250 mcg Metered Dose Inhaler Salmeterol (As Xinafoate) + Fluticasone Propionate 50 mcg/500 mcg Dry Powder for Inhalation Salmeterol (As Xinafoate) + Fluticasone Propionate 50 mcg/250 mcg Dry Powder Inhalation Capsule Salmeterol (As Xinafoate) + Fluticasone Propionate 25 mcg/50 mcg per Actuation Metered Dose Inhaler Salmeterol (As Xinafoate) + Fluticasone Propionate 50 mcg/100 mcg per dose Dry Powder for Inhalation Salmeterol (As Xinafoate) + Fluticasone Propionate 50 mcg/250 mcg per dose Dry Powder for Inhalation Salmeterol (As Xinafoate) + Fluticasone Propionate 25/250 mcg per Actuation Metered Dose Inhaler (Suspension) Salmeterol (As Xinafoate) + Fluticasone Propionate 25 mcg/250 mcg per actuation Metered Dose Inhaler Salmeterol (As Xinafoate)/ Fluticasone Propionate 100 mcg/50 mcg Dry Powder for Inhalation (DPI) Salmeterol Xinafoate + Fluticasone Propionate 25 mcg/125 mcg per Actuation Metered Dose Inhaler Salmeterol Xinafoate + Fluticasone Propionate 50 mcg/100 mcg Dry Powder for Inhalation (In Capsule) Salmeterol Xinafoate + Fluticasone Propionate 50 mcg/250 mcg Dry Powder for Inhalation (In Capsule) Salmeterol Xinafoate + Fluticasone Propionate 50 mcg/500 mcg Dry Powder for Inhalation (In Capsule) Salmeterol Xinafoate + Fluticasone Propionate 25 mcg/50 mcg Metered Dose Inhaler Salmeterol Xinafoate + Fluticasone Propionate 25 mcg/250 mcg Metered Dose Inhaler Salmeterol Xinafoate + Fluticasone Propionate 50 mcg/500 mcg Powder for Inhalation Salmeterol Xinafoate + Fluticasone Propionate 50 mcg/250 mcg Powder for Inhalation Salmeterol Xinafoate + Fluticasone Propionate 50 mcg/500 mcg Powder for Inhalation Should you have any questions/clarifications, kindly address them to the FDA Policy and Planning Service at [emailprotected]. Thank you very much. Very truly yours, (SGD.) DR. OSCAR G. GUTIERREZ, JR. Officer-in-Charge-Director General
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