BFAD MEMORANDUM CIRCULAR 16-A

: The maximum number of proposed brandnames allowed per application is five (5) for a single drug or pharmaceutical specialty.
: The list of proposed brandnames must be submitted according to the company's order of preference.
: If one brandname has already been cleared and approved, the remaining proposed brandnames will no longer be evaluated or cleared.
: The purpose is to facilitate the evaluation process of brandname clearance applications.
: The Bureau of Food and Drugs (BFAD), under the Department of Health (DOH), is responsible for the evaluation and clearance.
: It was adopted on July 15, 1994.
: The memorandum was signed by Quintin I. Kintanar, M.D., Ph.D., Director - CESO 1.
: It is applicable to a single drug product or pharmaceutical specialty per brandname clearance application.
: Brandname clearance refers to the official approval given by BFAD to allow the use of a particular brandname for a drug or pharmaceutical specialty.
: The memorandum does not specify penalties for non-compliance within the text provided.