ANNEX B 
 
Guidelines on  Clearance  for Customs Release (CFCR)  
 Using eServices Portal System  
 
I. Guidelines  
 
1. All Clearance for Customs Release (CFCR)  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 “Declaration and Undertaking” conveys a binding agreement of the applicant 
company with the FDA to provide accurate information, affirm primary 
responsibility over the products, and comply with all the rules and regulations  set 
forth during and after the application process.   
3. In completing the fields in the eApplication form, the applicant will be assisted 
with written warnings/pop -ups/reminders before proceeding to the next step to 
ensure the accuracy of the information bei ng provided. The applicant applying for 
CFCR shall ensure that the declared information in the eApplication form is 
consistent with the uploaded supporting documents.  
4. The declared e -mail address under the Contact Information is unalterable once 
submitted. Hence, the applicant shall be responsible for making sure that the email 
address is within the scope and access of the Authorized Person/s, Qualified 
Personnel, and/or owner of the establishment. The FDA shall not be held liable in 
any way for loss of acce ss to the declared email address.  
The Company Authorized Officer or Qualified Personnel shall have the 
responsibility to comply with the regulatory and technical requirements of the 
FDA wherein:  
a. The Authorized Person  refers to the owner, President, Chief E xecutive 
Officers (CEO) or its equivalent, or any organic or full -time employee 
representing the establishment in an authorized or official capacity; and  
b. The Qualified Person refers to an organic or full -time employee of the 
establishment who possesses tec hnical competence related to the 
establishment’s activities and health products by virtue of his profession, 
training, or experience. A Qualified Person has the responsibility to 
comply with the technical requirements of FDA or clarify matters with the 
FDA  when submitting technical requirements or engage the FDA officials 
when conducting an inspection or post -market surveillance activities. The 
Qualified Person may also be the duly Authorized Person of the 
establishment.  
5. Documents required to be uploaded in the eApplication Form shall be in portable 
document file (PDF), with no more than 2 megabytes (MB) file size.  
6. Once the eApplication Form is completed, applicants can review the duly filled 
out form in the Self -Assessmen t Review. By agreeing to the terms and conditions, 
the applicant confirms the correctness of the information provided and data 
privacy terms.  
7. The Application Summary shall be automatically sent to the applicant’s registered 
email address to indicate the su ccessful submission of the application in the 
eServices portal.  
 
  
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 8. Applications filed after the prescribed working/office hours or during weekends 
and holidays shall be considered filed on the next working day.  
9. Status of the Application can be monitored at the eServices and validated through 
the email used for the application.  
 
The step -by-step procedure for CFCR applications through eServices Portal is attached 
as Annex (Annex C) in this issuance.  
 
II. Pre-assessment  
 
1. An evaluator/assessor  from the Center for Drug Regulation and Research (CDRR)  
shall conduct pre -assessment on the submitted application and documentary 
requirements with regard to their completeness. Applications with incomplete or 
incorrect data entry and document submissions shall not be accepted and the 
application will not proc eed to the next step of the process.  
2. The pre -assessment of applications shall be done within the working days and 
office hours of the FDA.  
3. The CDRR  shall inform the applicant through the registered email address of the 
result of the pre -assessment. If the application passed the pre -assessment step, the 
applicant shall receive the Order of Payment with Reference Number through 
email indicating the fees to be paid. However, if the application failed the pre -
assessment step, the FDA shall notify the reason/s f or non -acceptance (e.g., 
deficiencies found and prompt the applicant to apply again through the eServices 
Portal).   
 
III. Payment of Fees  
 
1. The payment of the total application fee as indicated in the Order of Payment (OP) 
shall be done through LandBank Link.Bi zPortal.  
2. Once the full payment is made, a record of the transaction shall automatically be 
posted on the eServices Portal.  
3. Applicants shall receive a system -generated mes sage on the successful payment 
through the registered e -mail address.   
 
IV. Evaluation  of Applic ation  
 
1. The veracity of the application and its compliance with all relevant FDA 
requirements and standards shall be checked.  
2. Evaluation shall be done within the prescribed working days and office hours. 
Applications filed after working  hours and during weekends/holidays shall be 
considered filed on the next working day.  
3. Applications with complete documentary requirements and payment shall receive 
an Acknowledgement Receipt from FDA. This shall contain the number/code of 
the employee who  received the application, reference number, the agency’s logo, 
the date and time of application, payment, and the statement of completeness of 
the documents submitted. An application is considered filed once the applicant 
receives the Acknowledgement Rece ipt. 
4. If the application is approved, the FDA shall send the CFCR to the registered email 
address of the applicant. If the application is disapproved, the FDA shall inform 
the applicant of the reason for such action on the application through their 
register ed email address.   
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V. Disapproval of Application  
1. For emphasis, the grounds for disapproval of CFCR application may be any of the 
following : 
a. The documentary requirements submitted does not meet the required 
technical requirements and/or appropriate standards,  
b. the applicant made misrepresentations, false entries, withhold relevant data 
contrary to the provisions of the law or appropriate standards,  
c. the applicant  has violated any of the terms and conditions of its license, 
and/or  
d. such other analogous grounds or causes as determined by the FDA.  
 
The disapproval of an application is without prejudice to reapplication. However, 
disapproval shall mean outright forfeiture of payment.  
 
VI. Release of CFCR  
1. The applicant shall receive the CFCR  in their registered email address and may 
also be accessed through the FDA eServices Portal.  
2. Upon receipt of the CFCR , applicant  shall print the CFCR  on a standard A4 size 
(21 cm by 29.7 cm) paper, on full -colored page and in portrait orientation.  
3. A QR C ode verifier shall be included in the CFCR  as the basis of legitimacy of the 
document.