Question & AnswerQ&A (FDA CIRCULAR No. 2014-027)
The primary purpose is to update and streamline regulatory approaches in licensing drug establishments, provide faster public access to drug products, and promote transparency through universal electronic transactions.
Applicants must submit a notarized application form, proof of business registration (DTI, SEC, or other applicable agencies), credentials of the pharmacist-in-charge, Risk Management Plan, location plan with GPS coordinates, Site Master File, proof of payment, and a Self-Assessment Toolkit.
The application form must be signed by the pharmacist and the owner or authorized representative of the establishment.
The pharmacist-in-charge must provide valid PRC ID, Certificate of Attendance to FDA Licensing Seminar, and resignation letter from previous employer if applicable. The pharmacist is also responsible for supervising activities as reflected in the licenses.
The RMP must detail how the establishment identifies, characterizes, prevents, or minimizes risks related to their products, including pharmacovigilance activities and interventions.
The pre-opening inspection verifies compliance with PIC/S-Good Manufacturing Practices and other documentary requirements before approving the LTO.
Major variations including change of ownership, additional production line, transfer of location, and change of activity require prior approval.
Yes, they may continue operations provided that an application for the minor variation has already been filed with the FDA.
Exemption may be granted if the activities belong to one establishment with the same business name and ownership, and the activities are confined within the same premises with proper documentation of duties and supervision hours.
LGUs monitor licensed drug manufacturers in their localities for compliance with laws and FDA regulations and must report violations to the FDA for regulatory action.