GUIDELINES FOR THE EVALUATION OF BRAND NAMES FOR PRODUCTS TO BE REGISTERED WITH THE BUREAU OF FOOD AND DRUGS

For purposes of clarifying and updating the requirements and
procedures in the evaluation of brand names for foods, drugs, medical
devices, diagnostic reagents, cosmetics, and household hazardous
products to be registered with the Bureau of Food and Drugs, the
following guidelines are hereby issued, for the information and guidance
of all concerned.

A.        General Requirements:

1.         Every brand name of a food, drug, medical device,
diagnostic reagent, cosmetics and household hazardous product to be
registered with the Bureau of Food and Drugs shall be subject to
evaluation and approval as part of the registration process. This is to
prevent similarity of the brand name with other previously registered
product.

2.         A brand name of imported product, though patented and/or
registered in other countries, will not be allowed if there exists an
identical or similar brand name already registered with BFAD.

3.         The following names shall not be allowed:

3.1  Deceptive brand name;

3.2  Deceptively descriptive brand names such as Best, Outstanding, Most Effective, Wonder Drug, and the like;

3.3  Geographically descriptive names which gives false impressions
to the country of origin of the product such as Canadian Food
Supplement, European Herbal Drug, etc.

3.4  A brand name which is identical or similar to another brand name that is registered or previously cleared with the BFAD;

3.5  A brand name which would confuse the public and unway
consumers and deceive them into believing that the product bearing one
label are similar or produced by the same manufacturer as those carrying
the other label;

B.        Specific Requirements for Pharmaceutical Products:

1.      For every manufacturer, trader, and
distributor/importer/exporter, only one brand name shall be allowed for a
given pharmaceutical formulation registered in their name. Differences
in a pharmaceutical formulation shall be based only in active
ingredient(s). However, products containing the same active
ingredient(s) but used for different therapeutic indication(s) shall be
allowed to carry another brand name.

2.      A brand name that has been used for a given formulation must
not be used for a new formulation with a different active ingredient or
additional active ingredient;

3.      The following guidelines shall be followed in the evaluation and approval of brand names for pharmaceutical products:

3.1     Brand name must not be confusing in speech, in rhyme or in
writing with other registered or previously cleared brand names;

3.2     Brand name must not be confusingly similar or identical
with the first syllables of a registered or previously cleared name,
unless the middle syllables created a distinctive appearance or sounds;

3.3.    Brand name must be different either in prefix, middle or
suffice syllables if applied to the different generic class of drug or
where the drugs have different indications to prevent confusion;

3.4     Brand name must not be identical nor similar to INN (International Non-Proprietary Names)

3.4.1       By changing or dropping a single letter or syllable from the INN

               Ex. Paracetam — Paracetamol is INN

3.4.2       By including INN stems (see list of INN Stem in Annex A)

               Ex. Laracillin — cillin is an INN stem 

3.4.3       By combining with INN elements for multi-component products

               Ex. “ Sulfaprim” for product containing Sulfadoxine and Trimethoprim

C.        Procedure for Approval of Brand Names

1.         Prior to the submission of application for registration of
branded products, the applicant company shall check the proposed brand
name against the list of BFAD registered and approved brand names, which
shall be posted in a convenient place within the BFAD, for any
similarities. It shall be incumbent upon the applicant company to ensure
that their proposed brand name is not identical or similar to any of
the listed brand names

2.         All applications for registration of branded product shall
be submitted and accepted in accordance with existing rules for product
registration

3.         The PSD evaluator shall consider the acceptability of the
proposed brand name in accordance with the requirements stated in
Sections A and B of this Circular, as part of the process of evaluation
of product for registration. Approval of the brand name shall be based
on its compliance with the above stated requirements.

4.         Unacceptable brand name shall be ground for the
non-approval/denial of the application for registration of the product.

D.        Special Condition to be Printed On the CPR of Branded Products

All Certificates of Product Registration (CPR) issued henceforth, shall carry the following Special Condition:

“Provided that nothing in the registration of the product herein
granted shall be interpreted or construed as an endorsement or
representation by BFAD, that Registrant has the right or privilege to
the use of the name or brand so registered; Registrant hereby agree and
affirm to indemnify and/or hold BFAD free and harmless against any and
all third-party claims on the infringement of patent, trademark or
industrial design rights arising from the registration of the product(s)
listed on the other side hereof.”

For the information and immediate compliance of all concerned.

Adopted: 27 Oct. 1999

(SGD.) WILLIAM D. TORRES, PH.D.
Director