Republic of The Philippines Department of Health: Food and Drug Administration

Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
FDA ADVISORY
No. ____________
TO : ALL STAKEHOLDERS AND THE GENERAL PUBLIC
SUBJECT : IMPLEMENTATION OF THE FOOD AND DRUG

ADMINISTRATION (FDA) ESERVICES PORTAL SYSTEM
FOR AUTOMATIC RENEWAL (AR) APPLICATIONS FOR
DRUG PRODUCTS
The FDA, in its commitment to provide stakeholders with streamlined and improved
government services, developed the FDA eServices Portal System for AR applications for
Drug Products.
The FDA advises and encourages all stakeholders to utilize the eServices Portal System for
AR applications. All applicant companies are hereby advised to apply through the FDA
eServices Portal starting 01 June 2021.
Please follow Annex A of this Advisory for the Guidelines on AR Applications Using
eServices Portal System and Annex B for Procedure on the Use of the FDA eServices Portal
System for AR Applications.
For comments and suggestions on the FDA eServices Portal, please send them to
[email protected].
ROLANDO ENRIQUE D. DOMINGO, MD.

Director General
20210511140203
2 0 2 1 0 5 1 1 1 4 0 2 0 3
Civic Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: [email protected]
ANNEX A
Guidelines on Automatic Renewal Applications Using eServices Portal System
I. Guidelines
1. All Automatic Renewal Applications shall be accomplished using the online

application form through the eServices Portal System
(https://eservices.fda.gov.ph). Creation of account and password is no longer a
requirement to obtain access to the online portal.
2. The declared e-mail address under the Contact Information is unalterable. The
applicant shall make sure that the e-mail address is within the scope and access
of the Authorized Person/s and/or Qualified Personnel handling the transaction.
Thus, FDA shall not be held liable in any way for loss of access to the declared
e-mail address.
3. All fields on the online application form have written warnings/pop-ups/

reminders before proceeding to the next step to ensure accuracy of information
provided.
4. The result of the application will be sent to the e-mail address of the applicant.
5. Documentary requirements shall be in pdf with 2 MB maximum file size.
6. All information filled-out by the applicant during the process shall be reflected
in the final output based on the consistency with uploaded documents. Thus, it
is imperative for the client to be diligent in filling out all the required
information.
II. Pre-assessment
1. An FDA evaluator/assessor shall conduct pre-assessment on the submitted

application and documentary requirements with regard to their completeness
and correctness. Applications with incomplete or incorrect data entry and
document submissions shall not be accepted and the application will not
proceed to the next step of the process.
2. The pre-assessment of applications shall be done within the prescribed working

days and office hours of the FDA.
3. The FDA shall inform the applicant of the result of the pre-assessment through
the registered e-mail address of the applicant. If the application passes the pre-
assessment step, the applicant shall receive the Order of Payment (OP) with
Reference Number through e-mail indicating the fees to be paid. If the
application did not pass the pre-assessment step, the FDA shall notify the
reason/s for non-acceptance (e.g., deficiency/ies found) and prompt the
applicant to apply again through the eServices Portal.
III. Payment of Fees
1. Payment of the total application fee as indicated in the OP may be done

through Over-the-Counter (OTC) payment at FDAC, On-Coll payment at Land
Bank of the Philippines (LBP) branches, or online payment through BancNet
(including LBP bills payment) based on existing FDA issuances. Always
indicate the Reference Number reflected in the OP. Clients will be informed of
other available channels of payment through an FDA issuance.
2. Once the payment is made, the payment channel (LBP or BancNet, except for
OTC payment at FDAC) will send a transaction report to the FDA which
usually takes a minimum of two (2) days. Upon receipt of the report, the
Cashier Section checks the details and posts the payment in the eServices
Portal if payment is made in full. Posting of payment may take a maximum of
two (2) days, depending on the volume of paid applications received.
3. Incomplete payment (amount paid is less than that of the OP amount) will not
be posted until the full amount as indicated in the OP is settled. This also
means that the application will not proceed to the next step of the process.
4. Applications will receive a system-generated message through the registered

e-mail address on the status of the payment made once posted or needs further
settlement. If full payment is made, e-mail will contain an Acknowledgement
Receipt, otherwise, a notification on payment deficiency.
IV. Evaluation
1. The veracity of the application and compliance with all the documentary
requirements and appropriate standards shall be further assessed.
2. The action on the application shall be Approval or Disapproval pursuant to

Republic Act (RA) No. 11032, otherwise known as the Ease of Doing Business
and Efficient Government Service Delivery Act.
3. Evaluation shall be done within the prescribed working days and office hours.
Applications filed after the working hours and during weekends/holidays shall
be considered filed on the next working day.
ANNEX B
Procedure on the Use of the FDA eServices Portal System for

Automatic Renewal Applications
1. Access the online portal through https://eservices.fda.gov.ph and click Applications

found at the upper right corner of the landing dashboard.
2. Click on the Certificate of Product Registration.

3. Click on the Drug.
4. Select the Application Type.

5. Read carefully the Declaration & Undertaking. Once done, check the box if you
agree with all the conditions stated. Click on the Start Application.
6. From the Applicant Information page, choose the Establishment Type. Fill out the
required fields such as LTO Number, Company Name, and Address. Please take note
that all fields marked with asterisk (*) are required to be filled out.
7. Click on Next.
8. Provide a valid and working e-mail address and mobile number in the Contact
Information page. Click on Next.
9. In the Contact Person page, supply the information of the company pharmacist or the
person in charge of the regulatory affairs. Click on Next.
10. Fill out all the required fields in the Product Information page.
11. In the Formulation, provide all the formulations reflected in your current Certificate
of Product Registration (CPR). Click on Next.
12. In the Packaging Description page, provide the details of all approved pack sizes.
Click on Next.
13. Provide the required details of all the establishments reflected in the CPR. Click on
Next.
14. Upload all the necessary documents for verification purposes. Click on Next.
15. The Applicant shall review if all the details are correct in the Self-Assessment
Review.
16. Once reviewed, the Applicant shall confirm the correctness of the data given and click
on Confirm to submit the application.

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Republic of the Philippines

TO : ALL STAKEHOLDERS AND THE GENERAL PUBLIC

SUBJECT : IMPLEMENTATION OF THE FOOD AND DRUG

ROLANDO ENRIQUE D. DOMINGO, MD.

Civic Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines

Guidelines on Automatic Renewal Applications Using eServices Portal System

1. All Automatic Renewal Applications shall be accomplished using the online

3. All fields on the online application form have written warnings/pop-ups/

5. Documentary requirements shall be in pdf with 2 MB maximum file size.

1. An FDA evaluator/assessor shall conduct pre-assessment on the submitted

2. The pre-assessment of applications shall be done within the prescribed working

1. Payment of the total application fee as indicated in the OP may be done

4. Applications will receive a system-generated message through the registered

2. The action on the application shall be Approval or Disapproval pursuant to

Procedure on the Use of the FDA eServices Portal System for

1. Access the online portal through https://eservices.fda.gov.ph and click Applications

2. Click on the Certificate of Product Registration.

4. Select the Application Type.

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