Title
BFAD Circular on Registered Drug Products
Law
Bfad Bureau Circular No. 11-a, S. 1999
Decision Date
Jun 9, 1999
The Bureau of Food and Drugs mandates all drug manufacturers, traders, and distributors to submit a list of validly registered and market-active drug products by June 30, 1999, to ensure accurate records and compliance, with potential removal of inactive products from registration.

Purpose and policy objective

  • BFAD Bureau Circular No. 11-A, s. 1999 requires submission to validate and update records of registered drug products active in the market.
  • The circular mandates that BFAD must look at all validly registered products and those actually active in the market to pursue the activity.

Who must comply

  • BFAD Bureau Circular No. 11-A, s. 1999 directs all drug manufacturers, traders, and distributors to submit the required list of products.
  • The required list must be submitted by the persons/entities that have registered drug products and are involved in distribution and trading in the market.

What must be submitted

  • BFAD Bureau Circular No. 11-A, s. 1999 requires submission of a list of products together with their CPR numbers.
  • Submission must be made using the attached form (A, B, C).

Deadline and where to file

  • BFAD Bureau Circular No. 11-A, s. 1999 requires submission not later than June 30, 1999.
  • All submissions must be addressed to the Office of the Director, BFAD.

Consequences for non-submission

  • BFAD Bureau Circular No. 11-A, s. 1999 provides that failure to submit the required list will prompt BFAD to review the Certificates of Product Registration.
  • BFAD Bureau Circular No. 11-A, s. 1999 provides that BFAD may delete inactive products from the list of registered drug products after due notice.

Administrative compliance requirement

  • BFAD Bureau Circular No. 11-A, s. 1999 states that the directive is issued for compliance.
  • Compliance is measured by timely submission of the required product list with CPR numbers using the attached forms (A, B, C) by June 30, 1999.

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