Publishing the Full Text of the January 04, 2023 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-exempt Products under Republic Act (R.A.) No. 10963 (TRAIN Law) and R.A. No. 11534 (CREATE Act)

February 6, 2023 REVENUE MEMORANDUM CIRCULAR NO. 19-2023 SUBJECT : Publishing the Full Text of the January 04, 2023 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-exempt Products under Republic Act (R.A.) No. 10963 (TRAIN Law) and R.A. No. 11534 (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 January 4, 2023 letter (Annex "A") from Dr. Samuel A. Zacate, Director General of the FDA, for inclusion of certain medicines and devices for COVID-19 treatment to the published 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 be on the date of publication by the FDA of the 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.) ROMEO D. LUMAGUI, JR. Commissioner of Internal Revenue ANNEX A Republic of the Philippines Department of Health Food and Drug Administration January 4, 2023 ROMEO D. LUMAGUI, JR. Commissioner Bureau of Internal Revenue Quezon City SUBJECT : Endorsement of the Updates to the List of VAT-exempt Products under Republic Act Nos. 10963 and 11534 Dear Commissioner Lumagui : 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 provided that 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 as of 04 January 2023. I. For Inclusion A. Medicines for COVID-19 Treatment Generic Name Dosage Strength Dosage Form Budesonide + Formoterol Fumarate Dihydrate 200 mcg/6 mcg Metered Dose Pressurized Inhalation Suspension Budesonide + Formoterol Fumarate Dihydrate 80 mcg/4.5 mcg per Actuation Inhalation Aerosol (Pressurized Suspension for Inhalation) Budesonide + Formoterol Fumarate Dihydrate 160 mcg/4.5 mcg per Actuation Inhalation Aerosol (Pressurized Suspension for Inhalation) Budesonide + Formoterol Fumarate Dihydrate 400 mcg/12 mcg Dry Powder for Inhalation Budesonide + Formoterol Fumarate Dihydrate 400 mcg/12 mcg Dry Powder for Inhalation in Capsule B. Medical Devices for COVID-19 Treatment Category Product Respiratory Devices and its Accessories Inhalation Sedation and Equipment 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. SAMUEL A. ZACATE Director General