Need To Know.docx

Requirements to submit to CEDRES: 1. Finished product sample – 6 vials (refer to price quotation email from CEDRES). *to be prepared at least 2-3 days before schedule of submission 2. Reference Standard/ Working standard sample– at least 200 mg *to be prepared one day before schedule (30 minutes before going home) 3. 1 copy COA of Finished product 4. 1 copy COA of RS/WS if available 5. Transmittal (2 copies) -* to be prepared at least 2-3 days before schedule of submission 6. Copy of the Price quotation from CEDRES - *prepare in advance 7. Check or Cash for payment

CONTACT NUMBERS and EMAILS: FDA Hotline: 857-1900 FDAC: 821-1176; 821-1177; 821-1159 FDA alternate email: [email protected] CEDRES: 785-6379; [email protected] DHL: 811-7000 SACCL: 310-9528; 310-9529; 310-5789

For GMP Clearance Scans: -Notice for Foreign GMO -DTN -Letter -Official Receipt (Php 3000) PCPR Docs: -Integrated Application Form -Annex B -CPR -LTO -PSDD -Foreign GMP -Product packshot

Batch Notification documents: -Batch Notification -Assessment Slip -CPR -LTO -COA - Packing List -Bill of Lading -Official Receipt -Sample