Republic of the Philippines Republic of the Philippines

Department of Health Department of Health

FOOD AND DRUG ADMINISTRATION FOOD AND DRUG ADMINISTRATION
Civic Drive, Filinvest Corporate City Civic Drive, Filinvest Corporate City
Alabang, City of Muntinlupa Alabang, City of Muntinlupa

ASSESSMENT SLIP ASSESSMENT SLIP

DTN : Lab No.: Date: 30 December 1899 DTN : Lab No.: Date: 30 December 1899

Company Name: 0 Company Name: 0

Product Information Product Information
Product Name: List of Generic Names (please use drop down menu) Expiry Date: 0 Product Name: List of Generic Names (please use drop down menu) Expiry Date: 0

Batch/Lot Number: / No. of Samples: Batch/Lot Number: / No. of Samples:

Type of Request: Type of Request:

Certificate/ Evaluation Amendment Certificate/ Evaluation Amendment
X Batch Notification Others X Batch Notification Others
Lot Release Certificate (Vaccine) Lot Release Certificate (Vaccine)
LGU Purchases LGU Purchases
Purchase Purchase
Analysis Requested: Analysis Requested:
Visual Examination Aerobic Plate Count Visual Examination Aerobic Plate Count
Dissolution Coliform/E.Coli (MPN) Dissolution Coliform/E.Coli (MPN)
pH Yeast and Molds pH Yeast and Molds
Identification Test Presumptive Test (Salmonella) Identification Test Presumptive Test (Salmonella)
Tablet Hardness Staphylococcus Aureus Count Tablet Hardness Staphylococcus Aureus Count
Sterility Test Heavy Metals Sterility Test Heavy Metals
Baterial Endotoxin Test (LAL) Vitamins Baterial Endotoxin Test (LAL) Vitamins
Assay/Potency (Single Component) Others: Assay/Potency (Single Component) Others:
Assay/Potency (Multi Component) Assay/Potency (Multi Component)

Assessed by: Assessed by:

Payment Details Payment Details
Amount: Amount:
OR Number: OR Number:
Date: Date:
Date Effective: 4-Nov-19 Assessment Slip Date Effective: 4-Nov-19 Assessment Slip
Form No.: QSP-CSL-PRO-01 Annex 3 Revision No.: 02 Page 1 of 1 Form No.: QSP-CSL-PRO-01 Annex 3 Revision No.: 02 Page 1 of 1
 ANTIBIOTIC DRUG PRODUCT BATCH NOTIFICATION
BATCH NOTIFICATION NUMBER
BN-OL-2021-88-88-8888

TO BE FILLED UP BY FDA OFFICIAL

Assessed and
Date: Received by
Date

PAYMENT INFORMATION
THE DIRECTOR GENERAL Amount Php
Food and Drug Administration
Civic Drive, Filinvest City, Alabang 1781
OR Number
Muntinlupa City, Philippines

Date
ATTENTION: COMMON SERVICES LABORATORY
Sir/Madam:

In accordance with Administrative Order No. 2008-0033, we wish to apply and notify the FDA of our intention to have our batch of antibiotic
product, more particularly described below, exempted from the required batch notification

PRODUCT PARTICULARS
List of Generic Names (please use drop down menu)
Generic Name/s :
(to be filled up if the generic name is not found in the drop down menu)
Brand Name :
Dosage Strength :
Dosage Form : Route of Administration :
Batch Number : Lot Number :
Manufacturing Date :
Expiration Date :
FDA Registration No. :
CPR Validity :
Batch Size :
Theoretical Yield in Number of Units :
Actual Yield/Volume of Importation in
Number of Units (as indicated in the
commercial invoice) :
Packaging Type :
Presentation or Pack Size :
COMPANY PARTICULAR
Manufacturer's Name LTO Number LTO Validity

Trader's Name LTO Number LTO Validity

Importer's Name LTO Number LTO Validity

Distributor's/Wholesaler's Name LTO Number LTO Validity

Repacker's Name LTO Number LTO Validity

Others (Packed by; Packed For; Marketed By; Marketed For; Repacked for) LTO Number LTO Validity

NOTE: Please fill-out the form completely in A4 size paper and write all entries legibly.
Date Effective: 20 January 2020 Batch Notification Application Form
Form No.: QWP-A/ANT/W-01 Annex 1 Revision No.: 11 Page 1 of 3

DECLARATION

In support of our exemption from batch certification, I, the undersigned, hereby declare under oath that:

1. I am duly authorized to bind the establishment I represent pursuant to the authority attached to this Notification form (Board
Resolution in case of corporation and Special Power of Attorney in all other cases both of which should be duly notarized);

2. In behalf of my company, the antibiotic drug product identified in the notification meets all the legal requirements, and
conforms to all existing standards and specification requirement applicable to the above product subject of exemption.
3. I declare that the particulars given in this notification are true and all data and information of relevance in relation to the
exemption have been supplied, as well as, the documents attached herein are authentic or true copies.
4. I agree that the acceptance and signing of this Notification shall not constitute as an agreement by FDA in anyway, that the
particular batch of the antibiotic drug product produced or imported meets all other pertinent regulatory requirements, such as
but not limited to, the product’s conformance to its registered specification or approved labelling.
5. I agree that the grant of exemption shall be automatically revoked by the FDA in the event that there is subsequent findings of
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 case the samples belonging to the same batch or batches of antibiotic drug product/s
collected through post monitoring surveillance shall be found not to conform to the product’s registered specification or
approved labeling.
6. The company I represent shall automatically cease and desist from further distributing the batch or batches of the antibiotic
product subject of revocation upon receipt of the notice of revocation and pending any administrative proceeding until further
notice of the FDA.
7. I or my company undertake to:
i. Ensure that the product’s technical and safety information is made readily available to the Food and
Administration (FDA) anytime when requested, and to keep records of the distribution of the products for
product recall purposes;
ii. Notify the FDA as soon as possible by telephone, facsimile transmission, email or in writing, and in any case,
no later than 7 calendar days after first knowledge of any fatal or life threatening serious adverse event if the
cause, whether proximate or otherwise, of such adverse events is the use of the antibiotic product subject of the
exemption;
iii. Report to the FDA of all other serious adverse events that are not fatal or life threatening as soon as possible,
and in any case, no later than 15 calendar days after first knowledge, using the Adverse Drug Event Report
Form if the cause, whether proximate or otherwise, of such adverse events is the use of the antibiotic product
subject of the exemption;
iv. Keep or hold FDA free and harmless against any and all third party claims arising from the above adverse
events or from the exemption of the subject antibiotic product; and
v. Respond to and cooperate fully with the Food-Drug Regulatory Officers with regard to any subsequent post-
marketing activity initiated by the FDA.
8. I understand that our company or establishment cannot place reliance on the acceptance of our antibiotic drug product
notification by the FDA in any legal proceeding concerning the above product, in the event that said product has failed to
conform to any of the standards or specifications previously declared to the FDA.
Date Effective: 20 January 2020 Batch Notification Application Form
Form No.: QWP-A/ANT/W-01 Annex 1 Revision No.: 11 Page 2 of 3

COMPANY PHARMACIST

Company Name :
Signature :
Printed Name :
Position/Designation :
Email Address :
Contact Number :
Date :

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 act and deed.

WITNESS MY HAND AND SEAL on the date and place first above written

Doc No.
Page No.
Book No.
Series of
Date Effective: 20 January 2020 Batch Notification Application Form
Form No.: QWP-A/ANT/W-01 Annex 1 Revision No.: 11 Page 3 of 3
 BATCH NOTIFICATION
DATE GENERIC NAME
NUMBER

30 December 1899 BN-OL-2021-88-88-8888 List of Generic Names (please use

drop down menu)
 OTHERS BRAND NAME DOSAGE STRENGTH DOSAGE FORM

(to be filled up if the generic name is 0 0 0

not found in the drop down menu)
 ROUTE OF MANUFACTURING
BATCH NUMBER LOT NUMBER
ADMINISTRATION DATE

0 0
 REGISTRATION
EXPIRATION DATE CPR VALIDITY BATCH SIZE
NUMBER

0 30 December 1899 0
 Actual Yield/Volumne of
Theoretical Yield in Importation in Number of Presentation or Pack
Units (as indicated in the Packaging Type
Number of Units Size
commercial invoice)

0 0
Manufacturer's Name LTO Number LTO Validity Trader's Name

0 30 December 1899 0
LTO Number LTO Validity Importer's Name LTO Number

30 December 1899 0
 Distributor's/
LTO Validity LTO Number LTO Validity
Wholesaler's Name

30 December 1899 0 30 December 1899

 Others (Packed by; Packed
Repacker's Name LTO Number LTO Validity For; Marketed By; Marketed For;
Repacked for)

0 30 December 1899 0
LTO Number LTO Validity Company Name Printed Name

30 December 1899 0 0
 Position/Designation Email Address Contact Number Date

0 0 0 30 December 1899
Assessed and
DATE OR NUMBER AMOUNT
Received by

30 December 1899 0 50.00

 DATE VERSION

30 December 1899 ECQ-COVID19

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