FDA Order No. 2014-003-A - Prescribing the Procedure for the Receiving and Further Action by all center and Offices of the Food and Drug Administration
Amendment FDA Order No. 2014-003, the subject of which is "Prescribing the Procedure for the Receiving and Further Action by all center and Offices of the Food and Drug Administration (FDA) of all applicants for License to Operate Filed by Establishment within the National Capital Region" To Apply To All Regions Nationwide.
FDA Satellite Office - Ali Mall Cubao, Quezon City
The Food and Drug Administration (FDA) Satellite Office in Ali Mall Cubao, Quezon City will start receiving applications for License to Operate (LTO), Certificate of Product Registration (CPR) and other authorizations following the Public Assistance, Information and Receiving (PAIR) procedure beginning 15 September 2014, Monday from 10am - 6pm. However, only those applications scheduled for the day with payment of appropriate fees and charges will be accepted. Applicant companies are further advised to submit product registrations for vaccines and biological at FDA Alabang.
Submission of letter request and other communication such as ADRs/AEs, Clinical Trial Protocols and other related documents will be also received following the existence procedure.
For your Information and Guidance.