Department of Health(DOH)

Dear eFOI user,

Thank you for your requestOctober 03, 2025d yesterday, made under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.

We have received your request on Copy of package insert/leaflet,October 03, 2025d October 03, 2025. We will respond and process your request on or before Oct. 23, 2025, in compliance with the Executive Order’s implementing rules and regulations.

Please be informed that we endorsed your request to the Food and Drug Administration (FDA) for action. Kindly wait for their response, thank you.

Should you have any questions regarding this request, kindly contact me using the reply function on the eFOI portal for request with ticket number #DOH-922349043401.

Further, please be advised that this is a public site, and any information shared in this conversation thread will be visible to the public. Therefore, we kindly request that you refrain from disclosing any sensitive personal information or data in this thread.

Thank you.

Respectfully,

FOI Officer

Department of Health

Dear eFOI user,

Thank you for your request dated Oct. 2, 2025, made under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.

You have requested the Copy of package insert/leaflet

I am pleased to inform you that your FOI request has been approved. I have coordinated the request with the Center for Drug Regulation and Research. To date, the Marketing Authorization Holder (MAH) of the approved CPR has to submit the clean copy of the rectified product information sheet, i.e. package insert (PI) based on the corrections noted on the submitted proposed Package insert Version 10 Oct 2024 (per EUSPC 01 Sept 2024) by the evaluator. The MAH is required to comply within the CPR validity to make the information available for verification post authorization by the FDA. Non-compliance shall mean revocation/cancellation of the CPR with subsequent withdrawal of the subject product from the market. This was mentioned in the attached letter of CPR for Post Approval Commitment submission.

Since this is for research purposes (and not for public consumption), we are sharing the copy of the PI with annotation. Once the MAH submitted the corrected PI, it will then be uploaded in the FDA Verification Portal.

Your right to request a review

If you are dissatisfied with our response to your FOl request, you have the option to request an internal review. To initiate this process, kindly submit your written appeal for review addressed to the Central Appeals and Review Committee (CARC) at [email protected]. Please provide a detailed explanation of your dissatisfaction with our response within 15 calendar days from the date of receiving this response. We will conduct the review and communicate the outcome within 30 calendar days from the receipt of your review request. Should you remain unsatisfied with the review outcome, you retain the right to appeal to the Office of the President under Administrative Order No. 22 (s. 2011).

Please accomplish the FOI Request Feedback form at the link: https://bit.ly/DOHFOIFeedbackForm

Thank you.

Respectfully,

FOI Officer

Department of Health

DR-XY49503_PI - FOI Receiving Officer - [email protected]