QuestionsQuestions (FDA CIRCULAR NO. 2011-004)
It is based on Section 3, Paragraphs (A)(2) and (B)(2) of Article I of Book II of the IRR on Licensing of Establishments and Registration of Health Products under RA 9711.
Only when the renewal application is received after the original date of expiration of the LTO or CPR.
Surcharge/Penalty = 2 × (renewal licensing/registration fee) + 10% per month (or fraction of a month) of the same renewal fee, up to a maximum of 120 days (four months).
Every fraction of a month (including the first day and thereafter) is treated as one whole month for purposes of applying the 10% increment.
The 10% increment applies up to a maximum of four months, i.e., a maximum additional 40% corresponding to 120 days.
The LTO or CPR is considered valid and existing until a decision or resolution by the FDA is rendered on the renewal application.
It is considered expired and treated as an initial application; it must pay an initial filing fee plus the total surcharge/penalty, and it will undergo the initial filing and evaluation procedure.
Total Surcharge/Penalty = 2 × (renewal licensing/registration fee) + 40% (renewal licensing/registration fee). The total fee then equals Initial Filing Fee + Total Surcharge/Penalty.
No new transaction/activity is allowed until the application is approved; for LTO, all existing CPRs covered by that license are deemed not valid until the license is approved.
No. The circular states there shall be no automatic renewal of an LTO or CPR when the application is filed after the expiration date; it is treated as an ordinary renewal application and the applicable rules apply.
LRF = 1% of the applicable renewal fee alone, but it cannot be less than Php10.00.
Based on the renewal fee alone: LRF = 1% (renewal fee), subject to a minimum of Php10.00.
The circular states strict implementation on November 15, 2011.
Each month (or fraction) adds 10% to the renewal fee amount used in the surcharge formula, increasing from 10% (first month) up to 40% (fourth month/120 days).
Surcharge/Penalty = 2×Php2,000 + 20%×Php2,000 = Php4,000 + Php400 = Php4,400.