QuestionsQuestions (BFAD BUREAU CIRCULAR NO. 11-A, S. 1999)
To validate and update the records of registered drug products that are actually active in the market, by reviewing all validly registered products and those in active distribution.
All drug manufacturers, traders, and distributors.
A list of their products together with their CPR (Certificate of Product Registration) numbers, using the attached forms (A, B, C).
The circular directs submission using the attached form(s) identified as A, B, and C.
Not later than June 30, 1999.
To the Office of the Director, BFAD.
It signals BFAD to review the Certificates of Product Registration and delete inactive products from the list of registered drug products after due notice.
Those registered products that are not actually active in the market, based on the validation/update BFAD is undertaking.
Deletion will be done “after due notice,” indicating BFAD must notify the concerned parties before taking action.
It requires confirmation of products that are validly registered and actually active in the market; failure to submit suggests inactivity and triggers review and possible deletion.
William D. Torres, Ph.D. as Director of BFAD (adopted/SGD.) and Milagros L. Fernandez, M.D., MPH., CESO I as Undersecretary of Health for Standards and Regulations (approved/SGD.).
Adopted on June 9, 1999.
It signals that the directives are mandatory for regulated entities, enforceable through regulatory consequences for noncompliance.
BFAD will review the Certificates of Product Registration and delete inactive products from the list of registered drug products.
A complete list of products it handles with the corresponding CPR numbers, submitted using the prescribed forms (A, B, C) and addressed to the BFAD Director by the June 30, 1999 deadline.