Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2005-0016)
The purpose is to establish general policies and guidelines governing brand names of products for registration with the Bureau of Food and Drugs and promote generic/unbranded pharmaceutical products while recognizing the jurisdiction of BFAD, IPO, and courts over intellectual property rights.
It covers all food, cosmetics, drugs, devices, and household hazardous substances applying for initial registration, change in brand name, or inclusion of brand name for registered generic/unbranded pharmaceutical products with BFAD.
Brand Name is defined as the name appropriated by the manufacturer, trader, or importer to distinguish its product in the market.
Brand names that are identical to those already registered under the same product classification with BFAD, or names that are offensive, obscene, scandalous, or contrary to public morals and policy shall not be allowed.
No, BFAD's acceptance of a brand name does not approve, endorse or represent that the applicant has the right or privilege to use the brand name. Intellectual property rights are under the jurisdiction of the IPO or courts.
The applicant must execute an affidavit of undertaking to change the brand name if the right to use it is denied by proper authorities, and to indemnify and hold BFAD harmless against third party claims.
BFAD will respond that intellectual property matters are outside its mandate and that the proper recourse is with the Intellectual Property Office or courts with competent jurisdiction.
No, the filing shall not suspend, delay, or affect the processing or issuance of CPR/CPL unless restrained or enjoined by proper authorities like the IPO or courts.
The remaining provisions shall remain valid and enforceable as if the invalid or unenforceable part were not included (Separability Clause).
Administrative Order No. 76, series of 1984, Bureau Circular No. 21, series of 1999, Bureau Circular No. 08, series of 2003, and all other inconsistent administrative issuances, circulars, and memoranda are repealed or revoked accordingly.