Evaluation and Approval Process
- The BFAD will evaluate the proposed brandnames submitted in the application.
- If one brandname among the five proposed has already been cleared and approved by the BFAD, the evaluation of any remaining brandnames in the same application will be discontinued.
- Only the approved brandname will be cleared for use, ensuring efficiency in processing applications.
Purpose and Implementation
- The regulation aims to streamline and facilitate the evaluation process for brandname clearance applications.
- It seeks to prevent unnecessary administrative workload and duplication of effort in the evaluation of multiple brandnames for the same drug.
- This policy applies to all companies seeking brandname clearance for drugs or pharmaceutical specialties.
Effective Date and Authority
- The memorandum circular was adopted on July 15, 1994.
- It was issued under the authority of the Director of the Bureau of Food and Drugs, reflecting official guidance to all concerned stakeholders.