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 ANNEX B  
 
Guidelines on Notification of Importation/Exportation of Finished 
Pharmaceutical  Products and Raw Materials Using FDA eServices 
Portal System  
 
I. Guidelines  
 
1. All notifications of importation/exportation of finished pharmaceutical  
products and raw materials shall be accomplished using the online notification 
form through the FDA 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 
notifying company/Marketing Authorization Holder (MAH) 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 
notification process.   
3. In completing the fields in the eNotification  form, the notifying company will 
be assisted with written warnings/pop -ups/reminders before proceeding to the 
next step to ensure the accuracy of the information being provided. The MAH 
notifying the importation/exportation shall ensure that the declared 
information in the eNotification form is consistent with the uploaded 
supporting documents.  
4. The declared e -mail address under the Contact Information is unalterable once 
submitted. Hence, the MAH 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 access 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 
Executive 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 technical 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 eNotification Form shall be in 
portable document file (PDF), with no more than 2 megabytes (MB) file size.  
6. Once the eNotification Form is completed, applicants can review the duly  
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 filled out form in the Self -Assessment Review. By agreeing to the terms and 
conditions, the applicant confirms the correctness of the information provided 
and data privacy terms.  
7. The Notification Summary shall be automatically sent to the applicant’s 
registered email address to indicate the successful submission of the 
notification in the FDA eServices Portal System . 
8. Notifications may be filed anytime to ensure there are no delays in the 
shipment.  
9. Status of the Notification can be monitored at the FDA eServices Portal 
System and validated through the email used for the application.  
 
The step -by-step procedure for notification process through FDA eServices Portal 
System is attached as Annex C in this issuance.  
 
II. Release of Notification Acknowledgment  
1. Notification with complete documentary requirements shall receive a 
notification acknowledgment.  
2. The MAH shall receive the notification acknowledgment in their registered 
email address and may also be accessed through the FDA eServices Portal  
System . 
3. Upon receipt of the notification acknowledgment, MAH may print it on a 
standard A4 size (21 cm by 29.7 cm) paper, on full -colored page and in 
portrait orientation.  
4. A QR Code verifier shall be included in the notification acknowledgment as 
the basis of legitimacy of the document.