BFAD ADMINISTRATIVE ORDER NO. 41-A, S. 1999, November 29, 1999
FEE FOR RE-SUBMISSION OF APPLICATION FOR INITIAL OR RENEWAL REGISTRATION OF PHARMACEUTICAL PRODUCTS PREVIOUSLY DISAPPROVED PURSUANT TO BUREAU OF FOOD AND DRUGS (BFAD) BUREAU CIR…
otherwise known as “The Consumer Act of the Philippines” and in
consonance with DOH Administrative Order No. 67 s. 1989, an application
fee of One Thousand Pesos (P1,000.00) shall be collected by Bureau of
Food and Drugs (BFAD) from drug establishment for re-submission of
application for initial or renewal registration of pharmaceutical
products.
This shall cover applications received starting January 4, 1999
which were disapproved for non-compliance with the requirements for
product registration pursuant to BFAD Bureau Circular No. 6, s. 1999
(Subject: Revised Bureau Circular No. 4, s. 1999 “New Protocol for
Registration of Drugs, Foods, Cosmetics and Medical Devices”).
The resubmission fee shall only be for applications resubmitted
within six (6) months fro the date of notice of disapproval of the same
application. Applications submitted after six (6) months from the date
of notice of disapproval shall be considered as initial registration.
Adopted: 29 Nov. 1999
(SGD.) ALBERTO G. ROMUALDEZ, JR., MD
Secretary of Health