Veterans Memorial Medical Center, Dnd Tender

Description Epoetin Alfa (recombinant Human Erythropoetin) 4000iu/ml, 1ml Vial (iv,sc) . . Drugs And Medicines Requirements For Shopping And Svp 1. Certificate Of Product Registration (cpr) • Issuing Office Is Fda • Cpr That Is About To Expire 3 Months Prior Should Present The Official Receipt Of Renewal Of Application With The Document Tracking Log For The Cpr From Fda. 2. Current Good Manufacturing Practice (cgmp) A. For Philippine Made Drug Product, An Authenticated And Valid Cgmp Issued By Fda. B. Manufacturer/address Must Correspond As What Stated In The Cpr. C. Any Changes Pertaining To The Address Or Manufacturer Itself Should Have A Notation From The Fda. D. Fda-issued Cgmps (pics) Do Not Require Any Authentication From The Philippine Embassy. E. Foreign-issued Cgmp Require An Authentication From The Philippine Embassy Or An Apostille. 3. Valid License To Operate (lto) 4. Certification Of Exclusive Distributorship (ced) 5. Submit Any One Of The Following Requirement: A. Certificate Of Analysis • Must Not Be Expired • Must Be A Specific Brand, Exact Dosage, And Formulation Of The Drug Being Offered. B. Certificate Of Innovatorship C. Usfda's Orange Book Or In The Latest Philippine Fda List Of Equivalent Products, If Applicable. D. Valid Bioavailability/bioequivalence (ba/be) Studies • Must Be In The Exact Dosage And Formulation Of The Drug Being Offered E. Published International Or Local Clinical Trial Or Study On The Drug Showing That It Is Effective And Safe For Its Intended Use. • The Drug Used Is The Brand Of The Drug Of The Bidder. 6. Certificate Of No Adverse Drug Reaction (no Adr) Except For Innovator Drug With Certificate Of Innovatorship • Certification From One (1) Tertiary Medical Hospital Signed By: Anyone Of The Following. -director Of Hospital -chairperson, Therapeutic Committee -end-user (e.g. Head Of Anesthesia) -chief, Adr Committee -chief, Pharmacist 7. For Drugs And Medicines That Have Not Been Used In The Vmmc In The Last Two (2) Years Except For Innovator And Those With Vmmc-issued Certification Of No Adr. A. Drugs/medicines Must Be At Least (2) Years In The Market. Proof Of This Shall Consist Of The Ff. 1. Purchase Order (po) For The Brand Of The Drug Product In The Certificate Of Product Registration 2. Official Receipt Of The Same Po/sales Invoice 3. The Official Receipt Must Be Issued By A Tertiary Government Institution Or Private Hospital. Requirements Of Small Value Procurement: 1. Mayor’s/business Permit 2. Income Tax Return (for Abcs Above 500k) 3. Philgeps Reg. No./certificate 4. Omnibus Sworn Statement (for Abcs Above 50k) And Secretary Certificate Or Special Power Of Attorney Or Board Resolution **to Be Submitted Together With The Bid Proposal/offer. ** Registry Requirements: 1. Philgeps Certificate 2. Sec/dti Certificate 3. Mayor’s/business Certificate 4. Tax Clearance 5. Audited Financial Statement