APPLICATION FOR VACCINE and BIOLOGICAL LOT RELEASE CERTIFICATION

**
DOCTRACK NUMBER

LABORATORY NUMBER
ACCEPTED NOT ACCEPTED

Date: Received by
Signature
Date
THE DIRECTOR GENERAL P A Y M E N T D E T A I LS
Food and Drug Administration
Civic Drive, Filinvest City, Alabang 1781
Amount Php
Muntinlupa, Philippines
OR Number
ATTENTION: COMMON SERVICES LABORATORY Date
(FOR FDA USE ONLY)
Sir/Madam:

In accordance with Administrative Order No. 47-A series of 2001, we wish to apply for Lot Release certification of our product, We submit
herewith the following information and the requirements for lot release processing.

1. P R O D U C T I N F O R M A T I O N
1.1 FDA Registered Product Name:

1.2 FDA Registered Brand Name:

1.3 Dosage strength/label claim/amount of active substance: 1.4 Dosage form: 1.4a Route of administration:

1.5 Lot number (as appearing on the Summary Protocol/Fill Lot):

1.6 Lot/Batch No. of final container (as appearing on label of primary container): 1.6a Lot/Batch No. of final packaging (as appearing on secondary container or box):

1.7 Complete name of manufacturer: 1.8 Complete address of the manufacturer:

1.9 Date of manufacture (dd/mmmm/yyyy): 1.10 Date of expiration (dd/mmmm/yyyy):

1.11 FDA product registration number: 1.11a FDA CPR no.: 1.11b Validity of CPR (dd/mmmm/yyyy):

1.12 Type of final container in lot/batch: 1.13 Storage condition as per CPR:

1.14 Number of final container in lot/batch:

1.15 Is the product Lot imported from 1.15a If YES, when did it arrive? 1.15b If YES, where is it located?
another country?: (Y/N) (dd/mmmm/yyyy): (Please specify address):

1.15c Number of final containers imported?

2. DETAILS FROM THE BATCH/LOT RELEASE CERTIFICATE FROM THE NATIONAL REGULATORY AUTHORITY (NRA) OF THE COUNTRY OF ORIGIN
2.1 Name of NRA/NCL - Country:

2.2 Approved batch/lot no.: 2.3 Date of Issuance as per NRA/NCL approval: 2.4 Expiration Date of the Product as per NRA/NCL:
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3. C O M P A N Y I N F O R M A T I O N
3.1 Name of Marketing Authorization Holder (establishment Holding the CPR): 3.1a LTO Number: 3.1b LTO Validity (dd/mmmm/yyyy):

3.2 Complete Address: 3.2a Telephone Number: 3.2b Fax Number:

3.3 Name of Applicant/Representative 3.3a Position

3.4 Signature: 3.5 Date (dd/mmmm/yyyy): 3.3b E-mail address:

Date Effective: 27 June 2018 Form No: QWP-A/VBU/W-01 Annex 1 Revision No.: 03
Authorized by: Records Management Team Title of Form: Application for Vaccine and Biological Product Lot Release Certification Page No.: 1 of 2

DECLARATION

I, the undersigned, hereby declare under oath that:

1. The particulars given in this application are true and all data and information of relevance in relation to the release of this batch/lot have been supplied,
as well as, the documents attached herein are authentic or true copies.
2. I agree that the grant of certification shall be automatically revoked by the FDA in the event that there is subsequent findings or misrepresentation in
any of the data indicated in the required documents or any of the said documents is subsequently found to be falsified or fraudulently filed; and/or in
any case the samples belonging to the same batch/lot collected through post monitoring surveillance shall be found not to conform to the specification
of the registered product or its approved labelling.

3. The company that I represent shall automatically cease and desist from further distributing the batch/lot of vaccine and/or biological product subject for
revocation upon receipt of notice of cancellation of lot release and pending any administrative proceeding until further notice from the FDA.

4. I or my company undertake to:

i. Ensure that the technical and safety information of the product is made readily available to the FDA anytime when requested, and to keep
records of the distribution of the products for product recall or withdrawals purposes.

ii. Notify FDA as soon as possible by telephone, facsimile transmission, email and in any case as soon as possible after first knowledge of any
Adverse Event Following Immunization (AEFI) or any serious adverse event if the cause, whether proximate or otherwise, of such adverse
events is the use of the above product.

iii. Respond to and cooperate fully with the FDA officers with regard to any subsequent post marketing activity or any investigation initiated by
the FDA.
5. I hereby acknowledge that failure to submit the complete requirements and give the correct information shall be grounds for outright denial of this
application and forfeiture of all payments.

Pharmacist (as per LTO) :

PRC License Number :
Signature :

ACKNOWLEDGEMENT

SUBSCRIBED AND SWORN TO BEFORE ME this __________________________________

personally appeared the following:

Name Residence Certificate Date Issued Place Issued

Known to me and to me known to be the same persons who executed the

foregoing instrument and they acknowledged to me that the same is their free and
voluntary
WITNESSact MY andHAND
deed. AND SEAL on the date and place first above written

Doc No.
Page No.
Book No.
Series of
Date Effective: 27 June 2018 Form No: QWP-A/VBU/W-01 Annex 1 Revision No.: 03
Authorized by: Records Management Team Title of Form: Application for Vaccine and Biological Product Lot Release Certification Page No.: 2 of 2
 REFERENCE NUMBER

LABORATORY
DATE OF FORM BARCODE DOCTRACK NUMBER
NUMBER

30 December 1899
*0* 0
 PRODUCT INFORMATION

1.3 Dosage
1.2 FDA Registered strength/label
1.1 FDA Registered Product Name:
Brand Name: claim/amount of active
substance:

0 0 0
ON

1.4a Route of 1.5 Lot number (as appearing on the

1.4 Dosage form: 1.4a ROA (Others:)
administration: Summary Protocol/Fill Lot):

0 0 0 0
 PRODUCT INFORMATION

1.6a Lot/Batch No. of

1.6 Lot/Batch No. of final
final packaging (as 1.7 Complete name of
container (as appearing on label
appearing on secondary manufacturer:
of primary container):
container or box):

0 0 0
ION

1.9 Date of
1.8 Complete address of the 1.10 Expiration date 1.11 FDA product
manufacture
manufacturer: (dd/mmmm/yyyy): registration number:
(dd/mmmm/yyyy):

0 30 December 1899 30 December 1899

 PRODUCT INFORMATION

1.12 Type of final 1.13 Storage

1.11b Validity of CPR
1.11a FDA CPR no.: container in condition as per
(dd/mmmm/yyyy):
batch/lot: CPR:

30 December 1899 0 0
FORMATION

1.15 Is the product 1.15b If YES, where

1.13 Storage 1.14 Number of final 1.15a If YES, when
Lot imported from is it located?
condition as per container in did it arrive?
another country?: (Please specify
CPR: batch/lot: (dd/mmmm/yyyy):
(Y/N) address):

0 0 0 0 0
 DETAILS FROM THE BATCH/LOT RELEASE CERTIFICATE FROM THE NATIONAL
REGULATORY AUTHORITY (NRA) OF THE COUNTRY OF ORIGIN

1.15c Number of 2.3 Date of Issuance

2.1 Name of NRA/NCL 2.2 Approved
final containers as per NRA/NCL
- Country: batch/lot no.:
imported? approval:

30 December 1899 0 30 December 1899 30 December 1899

ICATE FROM THE NATIONAL
COUNTRY OF ORIGIN

2.4 Expiration Date of 3.1 Name of Marketing Authorization

3.1b LTO Validity
the Product as per Holder (establishment Holding the 3.1a LTO
(dd/mmmm/yyyy):
NRA/NCL: CPR):

30 December 1899 0 0 0
 COMPANY INFORMATION

3.3 Name of
3.2a Telephone
3.2 Complete Address: 3.2b Fax Number: Applicant/Representa
Number:
tive

0 0 0 0
N

3.5 Date Pharmacist

3.3a Position 3.3b E-mail address:
(dd/mmmm/yyyy): (as per LTO)

0 30 December 1899 30 December 1899 0

 PAYMENT INFORMATION

Amount
PRC License Number OR Number OR Date
Php

0 0 0.00 ###