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Initial Registration of Veterinary Biological Product

Frontline Service  Initial Registration of Veterinary Biological Product   
 Clients:   Veterinary Biological Products Manufacturer and Importers   
 Requirements:   1.       Application Letter   
                                2.       Vaccine Dossier   
 Name, Description, Composition (Product data sheet)   
 *Certificate of Establishment (manufacturer and importer) Registration   
 Product Registration   
 *GMP Certificate   
 *Certificate of Free Sale   
 Outline of Production   
 Quality Control Test (Certificate of Analysis)   
 a.       Safety  c.  Sterility  e. Efficacy 
 b.      Purity  d.  Potency  f. Stability 
 Original Product Label and Insert   
 Field Trial Studies/Other Scientific Studies conducted   
 3.       VBSS Form No. 1   
 4.       Technical Declaration Form   
 Note: * must be authenticated by the Philippines Consular Office at the Country of Manufacture if foreign produced   
 Schedule of Availability of Service:   Monday to Friday, 8:00 am to 5:00 pm   
 Fees:   (Refer to Service Pledge)   
 Total/Maximum Duration of Process:   180- 365 Days   
 How to Avail of the Service:      
 Step No.  CLIENT STEP  AGENCY ACTION  OFFICE/PERSON RESPONSIBLE  LOCATION OF OFFICE DURATION OF ACTIVITY 
 1  Get requirements for application for product registration at VBSS  Issue list of requirements  Licensing and Registration Unit (LRU), Veterinary Biologics Standardization Section (VBSS)  VBSS Bldg., BAI compd.  15 mins.
 2    Submit application for Veterinary Biological Product Registration to Office of the Director (OD)    Receive and record documents   Office of the Director Staff    VBSS Bldg., BAI compd.    (Day 1)
 Issue instruction from the Director  1 day 
 Forward the documents to Laboratory Services Division (LSD)
 3      Receive the documents  Office of the Chief staff, LSD    Office of the Chief, Viral Vaccine Production Lab., BAI compd.    (Day 2)
 Issue instruction from the LSD Chief 2 hours
 Forward the documents to VBSS
 4        Receive and record the documents Receiving Staff, VBSS   VBSS Bldg., BAI compd.   1 hour 
 Issue instruction from the VBSS Head
 Forward to LRU
 5  Get the bill of statement  Receive and record documents  LRU Staff, VBSS   VBSS Bldg., BAI compd.   
Issue bill of statement  10 mins
 6  Get the Order of Payment  Issue Order of Payment  Accounting Section  GF Research Bldg.  5 mins
 7  Pay the corresponding fee and receive the Official Receipt (OR) of payment  Receive the payment and issue OR  Cashier Section  -do-  10 mins
 8    Present the OR to LRU, VBSS    Record the OR#  LRU Staff, VBSS    VBSS Bldg., BAI compd.    30 mins  
 Number the documents in chronological order (First Come, First Serve Basis)
 Forward to Technical Evaluator
 9        Preliminary evaluate the documents  Technical Evaluator, VBSS    VBSS Bldg., BAI compd.    (Day 2-31)
 Enumerate lacking requirements  1 month 
 Indorse to VBSS Head
 10      Final review of the documents  Section Head, VBSS   VBSS Bldg., BAI compd.   (Day 32-63)
 Prepare notice of lacking requirements/ compliance  1 month
 11  Receive the Notice of Lacking Requirements Issue Notice of Lacking Requirements  Section Head, VBSS  -do-  (Day 64) 10 mins
 12  Submit compliance to VBSS within a month time  Receive and record compliance documents  VBSS Receiving Staff  -do-  (Day 64-95)
Issue instruction from the VBSS Head 1 hour
Forward the documents to concerned Technical Evaluator
 13   Review the submitted compliance documents Technical Evaluator, VBSS VBSS Bldg., BAI compd. (Day 96-98)
Indorse to VBSS Head for approval 3 days
Recommend issuance of provisional import permit for limited number of product samples for quality control bai
 14      Process provisional import permit  LRU Staff  -do-   (Day 99)
 Sign permit  LRU Head  15 mins
 15    Affix signature on the permit  VBSS Head  -do-  10 mins
 16    Recommend approval of the permit  LSD Chief  VVPL Cmpd. BAI Compd.  2 hours
 17    Receive and record document  OD Staff  Office of the Director, BAI Cmpd  (Day 100)
Approve the issuance of permit Director 1 day
 18   Record and dry seal the permit Records Section Staff 3rd floor, Research Bldg. (Day 101)
Forward documents to VBSS, LRU 1 hour
 19 Get Bill of Statement Issue Bill of Statement VBSS, LRU VBSS Bldg., BAI compd. 10 mins
 20 Get Order of Payment Issue Order of Payment Accounting Section Staff GF Research  Bldg., BAI cmpd. 5 mins.
 21 Pay corresponding fee and get the OR Receive payment and issue OR Cashier Unit Staff GF Research  Bldg, BAI cmpd. 5 mins.
 22 Present OR to LRU, VBSS and get the approved permit Record OR# and issue the approved permit LRU, VBSS VBSS Bldg., BAI compd. 30 mins.
 23 Submit vaccine samples for bai in a month time Receive and record vaccine samples VBSS Receiving Staff VBSS Bldg., BAI compd. (Day 102-133)
Forward the samples to concerned bai Unit 20 mins.
 24 Submit several copies of proposed field trial protocol to the Office of Veterinary Technical Advisory Committee (VTAC) Chair Receive the proposed protocol Office of VTAC Chair BAI Cmpd (Day 65)
Distribute the protocol to VTAC members 2 hours
 25   Review the protocol VTAC Chair, Members and VBSS concerned Technical Staff BAI Cmpd (Day 65-126)
Meet, discuss, recommend 2 months
Request the company to present the proposed protocol
Approve the protocol
 26 Conduct the field trial in 3 farm sites Investigate, monitor and evaluate the conduct of field trial VBSS Field Trial Investigator VBSS Bldg., BAI compd. (Day 127-309) 6 months
 27 Present the final report of the field trial protocol Discuss the results VTAC and concerned VBSS Technical Staff BAI Cmpd (Day 310)
Approve the result of the field trial 4 hours
 28      Conduct vaccine quality control tests (safety, purity, sterility)   VBSS concerned bai Unit   VBSS Bldg., BAI cmpd.   (Day 311-360)
 469 days (actual conduct and observation time)
 29        Prepare report of test results  VBSS concerned bai Unit    VBSS Bldg., BAI cmpd.    (Day 361)
 Affix signature  1 hour 
 Forward to VBSS Head
 30   Approve and sign test report VBSS Head VBSS Bldg., BAI cmpd.  1 hour
 31   Approve and sign test report for the Director LSD Chief VVPL Cmpd  2 hours
 32   Prepare Certificate of Product Registration (CPR) LRU Staff VBSS Bldg., BAI cmpd. (Day 361)
Affix initial signature LRU Head 1 hour
 33   Affix initial signature VBSS Head VBSS Bldg., BAI cmpd. 20 mins
 34   Recommend approval of CPR LSD Chief VVPL Cmpd 2 hours
 35   Approve the CPR BAI Director BAI Cmpd (Day 362) 1 day
 36   Receive, record and dry seal CPR Records Section Research Division Bldg. 3rd Flr., BAI compd. (Day 363)
Forward to LRU-VBSS 1 hour
 37 Get the bill of statement Issue bill of statement LRU, VBSS VBSS Bldg, BAI compd. 10 mins.
 38 Get Order of Payment Issue Order of Payment Accounting Section Staff Research Division Bldg. 3rd Flr., BAI compd. 5 mins
 39 Pay corresponding fee and receive OR Receive payment and issue OR Cashier Unit Research Division Bldg. G/F, BAI compd. 10 mins.
 40 Present OR to LRU, VBSS and receive the approved CPR Record OR# LRU, VBSS VBSS Bldg, BAI compd. (Day 363)
Issue CPR 30 mins
File the duplicate copy of CPR and other attached documents
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