Requirements For Renewal Lto Application
Requirements For Renewal Lto Application
Department of Health
FOOD AND DRUG ADMINISTRATION
Alabang, Muntinlupa City
Tel. No. 857-1991
A. REGULAR RENEWAL
a. Accomplished and notarized Integrated Application Form
b. Proof of Payment of Fees
c. Copy of LTO including attachments
d. Requirements in support of amendments, if applicable, included in the renewal
of application, including scanned application letter stating the intended changes
(indicate changes/amendments to be made)
* Establishment will be subject to FDA inspection prior to renewal of LTO
B. AUTOMATIC RENEWAL
a. Accomplished and notarized Integrated Application Form
b. Proof of Payment of Fees
c. Copy of LTO including attachments
* There shall be automatic renewal of LTO without outright inspection when the
following conditions are met:
i. Submission of an affidavit of undertaking for automatic renewal with a
sworn statement indicating no change or variation or, as applicable, no
violation of FDA rules and regulations or non-compliance to the
requirements of GMP have been committed
ii. The application for renewal was filed before the expiration date of the
license
iii. The prescribed renewal fee was paid before the expiration date of the
license
** Companies with renewed LTO through automatic renewal are subject to
FDA inspection anytime within the validity of the issued LTO
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