This document from the Republic of the Department of Health Food and Drug Administration Center for Drug Regulation and Research outlines the requirements for initial sales promotion permit applications and amendments to existing permits. For initial applications, it requires an application form, letter of intent, list of participating products, valid product registration documentation, information sheet on promotion mechanics and materials, proof of payment, and self-assessment form. For amendments, it requires the same materials but substitutes a letter specifying the amendment type in place of the original letter of intent.
This document from the Republic of the Department of Health Food and Drug Administration Center for Drug Regulation and Research outlines the requirements for initial sales promotion permit applications and amendments to existing permits. For initial applications, it requires an application form, letter of intent, list of participating products, valid product registration documentation, information sheet on promotion mechanics and materials, proof of payment, and self-assessment form. For amendments, it requires the same materials but substitutes a letter specifying the amendment type in place of the original letter of intent.
This document from the Republic of the Department of Health Food and Drug Administration Center for Drug Regulation and Research outlines the requirements for initial sales promotion permit applications and amendments to existing permits. For initial applications, it requires an application form, letter of intent, list of participating products, valid product registration documentation, information sheet on promotion mechanics and materials, proof of payment, and self-assessment form. For amendments, it requires the same materials but substitutes a letter specifying the amendment type in place of the original letter of intent.
2. Letter of Intent for application of Sales Promo Permit 3. List of Participating Products in Excel format (Sheet 3 of Info Sheet) 4. Copy of the valid Certificate of Product Registration/ Notification/ Exemption 5. Information Sheet and Mechanics of the Sales Promotion 6. Layout of Promo materials (if applicable) 7. Proof of payment 8. Self-Assessment Form for Sales Promo Permit
AMENDMENT
1. Accomplished Integrated Application Form
2. Letter of Intent specifying the type of amendment 3. Copy of previously issued valid promo permit 4. Supporting documents for the requested amendment 5. Proof of payment 6. Self-Assessment Form for Sales Promo Permit
Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Office of Safety I, Pharmaceuticals and Medical Devices Agency