Law Summary
Purpose of the Memorandum
This Memorandum Circular is issued to streamline the evaluation process for brandname clearance applications of drug products or pharmaceutical specialties.
- Objective: To facilitate the assessment of applications for brandname clearance.
Proposed Brandnames Limitations
The Memorandum imposes a limit on the number of proposed brandnames a company can submit for clearance.
- Limit: Each application may contain a maximum of five (5) proposed brandnames.
- Order of Preference: The submitted list must reflect the company's order of preference for the proposed brandnames.
Evaluation Criteria
The evaluation of the submitted brandnames is contingent on the approval status of the proposed names.
- Cleared Brandname: If one of the submitted brandnames has already received clearance and approval, the remaining proposed brandnames will not be evaluated or cleared by the Bureau of Food and Drugs (BFAD).
Adoption and Accountability
The regulations outlined in this Memorandum Circular were formally adopted by the BFAD.
- Date of Adoption: July 15, 1994.
- Authority: Signed by Quintin I. Kintanar, M.D., Ph.D., Director - CESO 1.
Key Definitions
- Brandname Clearance: The official approval by the BFAD allowing a drug or pharmaceutical specialty to be marketed under a specific name.
- Drug Product/Pharmaceutical Specialty: Refers to any medication or pharmaceutical formulation intended for patient use.
Important Requirements
- Application Submission: Companies must ensure that only five brandnames are included in their submission.
- Preference Order: The brandnames should be arranged according to the company's preference.
Consequences of Non-compliance
While the Memorandum does not specify penalties, it implies that failure to adhere to these guidelines may result in the disallowance of brandname evaluations and approvals.
Key Takeaways
- Each drug or pharmaceutical specialty application is limited to five proposed brandnames.
- If one brandname is approved, the others will not be evaluated.
- The regulations aim to streamline the clearance process for pharmaceutical companies.
- The Memorandum was adopted on July 15, 1994, under the authority of the BFAD Director.
This summary captures the essential elements of BFAD (DOH) Memorandum Circular 16-A, s. 1994, providing clarity on its provisions and implications for pharmaceutical companies seeking brandname clearance.