PFDA’s simplified License to Operate (LTO)-related transactions
Interested manufacturers and establishments can now utilize a simplified procedure as all LTO transactions, initial application, renewal, or variation, can now be made through FDA’s new E-service Portal System without the need for a QPIRA certificate based on DOH Administrative Order No. 2020-0017 published last May 21, 2020.
The major changes include the following:
- - The said issuance redefined the coverage of activities and establishments regulated by the different FDA centers and rendered previous AO 2016-0003 obsolete.
- - Removal of QPIRA certificate requirement for all FDA transactions. While the Professional Regulatory Commission (PRC) ID of allied health profession or diploma for those without board or licensure exam is still required for a qualified person, the seminars, training, and learning development activities can now come from other organizations besides FDA.
- - Risk Management Plan and Site Master File are no longer listed as requirements for LTO application. Instead, these must be present when required by the FDA Inspector for review or inspection.
- - A pre-assessment step on the submitted application and documents was added prior to the payment of fees.
- - Transfer of location of drug retailers and transfer/addition of warehouse are now considered minor variation which no longer needs pre-approval inspection.
In addition to AO 2020-0017, the Anti-Red Tape Authority (ARTA) conducted a webinar discussing the new guidelines of doing business with FDA. In relation to AO 2020-0017, here are additional information from the said webinar:
- - An e-portal account is no longer needed to apply for LTO removing the need to request creation of an account prior to application.
- Notarized declaration of undertaking will be replaced by a legally binding online Terms and Condition and Self-declaration.
- - After payment of fees, PFDA expects to release LTO or disapproval notice after 20 working days but this is still subject to finalization and system optimization.
- - Hard copy of the LTO will no longer be released but applicant can print the electronic LTO in the convenience of their office or home.
PFDA expects to be fully implement this system before the end of this year. The agency is planning to conduct the adaptation to its different divisions (Drugs, Cosmetics, Food and Medical Device) in different phases.