Veterans Memorial Medical Center, Dnd Tender

Description Bicalutamide 50mg Tab Film Coated 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 Distributionship (ced) 5. Submit Any One Of The Ff. Requirement: A. Certificate Of Analysis * Must Not Be Expired * Must Be Specific Brand, Exact Dosage, And Information 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 Any Of The Ff. -director Of The 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 For The Alternative Mode Of Procurement To Be Submitted Together With The Bid Proposal/offer. Small Value Procurement: 1. Philgeps Registration No. 2. Mayor’s Permit/ Business Permit 3. Income Tax Return 4. Omnibus Sworn Statement (for Abcs Above 50k) W/ Sec. Certificate Or Spa (as Applicable) 5. Pcab License (for Infra) *procuring Entities Already Maintaining An Updated File Of Any Of The Bidder’s Mentioned Requirements, Whether Through The Philgeps Certificate Of Registration And Membership Or Its Own Records, May No Longer Require Its Re-submission.