Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

As announced, the National Capital Region will remain under the General Community
Quarantine starting 01 January 2021. Due to the current pandemic, the FDA-Common Services
Laboratory (CSL) is hereby extending the online submission of Batch Notification (BN)
Application for Antibiotic products until further notice. Please see the revised guideline below.

PROCEDURE

1. Pre-evaluation
1.1. Download BN Online Form (ECQ-COVID19) that was sent to you via
cslbn@fda.gov.ph
1.2. Accomplish batch notification application form completely and correctly filled out by
the current company pharmacist and print in A4 size paper
1.3. Notarize online BN application form and prepare other required documents
1.3.1. Clear scanned copy of CPR and/or COV application
1.3.2. Clear scanned copy of valid LTO of the:
● Manufacturer (if applicable)
● Wholesaler (if applicable)
● Trader
● Importer
1.3.3. Clear scanned copy of valid COA of the finished product reflecting similar
batch/lot number with sample submitted, batch size, theoretical and actual yield
1.3.4. For Imported products: clear scanned copy of the commercial invoice and /or
packing list reflecting the expiry date and batch/lot number of the product or any
document to prove actual volume of importation; Airway bill/Bill of lading of
the particular shipment
1.4. Prepare a letter of commitment to the FDA CSL indicating that you will be submitting
the notarized approved online BN application form, other documents, and the
representative samples within the required timeline. Address your letter to the
following,
TO:
Jocelyn E. Balderrama, RPh, MBA
Director II, Common Services Laboratory

THRU:
Camille Rosario C. Castañeda
Section Head, CSL- Antibiotic Section
 1.5. Take a clear picture of the representative sample, it’s primary and secondary packaging
wherein the company name and address, CPR registration number, Batch/Lot No.,
manufacturing date, and expiration date can be seen visibly
1.6. Scan the unnotarized BN application form together with the other required documents,
as well as the picture of the representative sample and its packaging
1.7. Compress/zip or save in one folder all the scanned documents, together with the soft
copy of the BN application form and rename with Generic Name_Batch/Lot No
1.8. Upload file in google drive and share the folder’s link or e-mail or attach file/s directly
to your message and email at cslbn@fda.gov.ph

2. Submission
2.1. Online submission through cslbn@fda.gov.ph will be accepted from 9 am to 2 pm, any
working day. Applications (including proof of payments) submitted beyond the given
schedule will be processed the next working day

3. Evaluation
3.1. Wait for the confirmation email and payment details
3.1.1. If found acceptable, reference number and payment details will be provided
3.1.2. If found unacceptable, you will be informed of the deficiency. Compliance will
not be accepted as re-application containing the corrections. You will be advised
to re-submit all documents the next working day.

4. Payment
4.1. Proceed to payment through Landbank Online Collection Scheme or Online
Banking/Fund Transfer.
4.2. Once payment has been made, email proof of payment with CSL Reference
Number/Batch Notification Number to cslbn@fda.gov.ph and Cc: (carbon copy) to
cashier@fda.gov.ph
4.2.1. Landbank Online Collection Scheme
Send a clear scanned copy or picture of the oncoll payment slip with signature
over printed name and date
4.2.2. Online Banking/Fund Transfer
Send a screenshot or confirmation email of your successful online transaction
with the date and reference number. Releasing of approved and signed BN form
will be on the next working day upon submission
NOTE: The approved BN shall be paid within 5 working days, any late payment will invalidate
your application. May we also remind you that any payment before the approval of your
application shall be voided.
4.3. Wait for the electronic copy of the signed/approved BN application form. A unique
password will be provided for you to access the said document

5. Post-submission
5.1. Submit only one (1) hard copy of the NOTARIZED APPROVED BATCH
NOTIFICATION APPLICATION ONLINE FORM, with the company pharmacist’s
signature (Page 3 of BN Form) together with the required documents and the
representative sample within 20 working days
NOTE: MAHs must also have their copy of the notarized approved online BN
application form.
5.2. Send a list of your submission via email. Include the following details:
● Date of submission
● Generic Name
● Batch/Lot Number
● Approved BN Number
5.3. Present all the required documents and representative samples at any working day at
the drop box provided at the main entrance of the Food-Drug Action Center, Starmall,
Alabang, Muntinlupa City
NOTE: The submitted documents and representative samples will still undergo checking. You
will be notified via email if there are any concerns regarding your post-submission. Any
revision after post submission will require a new BN application.

The onsite application of BN is still temporarily suspended until further notice.