Lesson 2. Simulated Brand Name Clearance Application and Review

RA 6675

also known as The Generics Act of 1988

Generic Name

must always remain the central identity of a medicine and it must be indicated in their labels and packaging materials

proprietary brand name

However, if a pharmaceutical marketing authorization holder (MAH) wishes to introduce a _________________________, they must pass a dedicated assessment phase known as Brand Name Clearance (BNC).

Mandatory and Core Identity

According to RA 6675, the Generic Name is __________________________

active ingredient

According to RA 6675, the Generic Name is from the scientifically recognized ___________________.

governments, health agencies, prescribers, and drug outlets

According to RA 6675, the Generic Name is required by all _________________________________________________.

optional and heavily restricted

According to RA 6675, the Proprietary Brand Name is ________________________.

created by the manufacturer

According to RA 6675, the Proprietary Brand Name is a marketing name ____________________________________.

Brand Name Clearance (BNC)

According to RA 6675, the Proprietary Brand Name must pass ______________________________ assessment prior to FDA registration.

above

According to RA 6675, the Generic Name must appear ___________ the brand name which is optional.

RA 9502 is also known as:

Universally Accessible Cheaper and Quality Medicines Act of 2008

Mandatory Generic Production

According to Sec. 39 of RA 9502, every drug manufacturing company operating in the Philippines is required, subject to DOH rules and regulations, to produce, distribute, and make widely available to the general public an unbranded generic counterpart of the branded product.

Bureau Circular No. 21, series of 1999

covers the guidelines for the evaluation of brand names for products to be registered with the bureau of food and drugs

clarifying and updating the requirements and procedures

According to Bureau Circular No. 21 series of 1999, guidelines for the evaluation of brand names are there for _______________________________ 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.

Deceptive or Exaggerated Claims

AUTOMATIC REJECTION CRITERIA FOR BUREAU CIRCULAR NO. 21 SERIES OF 1999:

1. ___________________________ such as best, wonder drug, CureAll

2. ___________________________ such as Canadian Food Supplement made locally

3. _____________________________________ unless middle syllables create a distinct appearance

4. ______________________ such as a brand name used for one formulation cannot be reused for a new formulation with different active ingredients.

1 = ?

Geographically False Impressions

AUTOMATIC REJECTION CRITERIA FOR BUREAU CIRCULAR NO. 21 SERIES OF 1999:

1. ___________________________ such as best, wonder drug, CureAll

2. ___________________________ such as Canadian Food Supplement made locally

3. _____________________________________ unless middle syllables create a distinct appearance

4. ______________________ such as a brand name used for one formulation cannot be reused for a new formulation with different active ingredients.

2 = ?

Confusingly similar to First Syllables of Cleared Names

AUTOMATIC REJECTION CRITERIA FOR BUREAU CIRCULAR NO. 21 SERIES OF 1999:

1. ___________________________ such as best, wonder drug, CureAll

2. ___________________________ such as Canadian Food Supplement made locally

3. _____________________________________ unless middle syllables create a distinct appearance

4. ______________________ such as a brand name used for one formulation cannot be reused for a new formulation with different active ingredients.

3 = ?

Recycled Names

AUTOMATIC REJECTION CRITERIA FOR BUREAU CIRCULAR NO. 21 SERIES OF 1999:

1. ___________________________ such as best, wonder drug, CureAll

2. ___________________________ such as Canadian Food Supplement made locally

3. _____________________________________ unless middle syllables create a distinct appearance

4. ______________________ such as a brand name used for one formulation cannot be reused for a new formulation with different active ingredients.

4 = ?

Memorandum Circular 16-A, s. 1994 (July 15, 1994)

limiting the number of proposed brand names to 5 for a single drug product or pharmaceutical specialty

DOH AO NO. 2005-0016

General Guidelines Governing Brand Names of Products for Registration with the Bureau of Food and Drugs

Food, Cosmetics, Drugs, Devices and Diagnostic Reagents, and Household Hazardous Substances

Brand Name Clearance Classifications

Brand Name

DOH AO NO. 2005-0016

• proprietary name that distinguishes the drug from others

Certificate of Registration (CPR)

DOH AO NO. 2005-0016

• license needed before drugs and medical devices becomes available in the market

Certificate of Product Listing (CPL)

DOH AO NO. 2005-0016

• needed for cosmetics specialty because they don’t undergo registration, they undergo notification

Generic Name or Generic Terminology

DOH AO NO. 2005-0016

• refers to the API

Product Classification

DOH AO NO. 2005-0016

• differentiates between food, cosmetics, drug, veterinary, device, diagnostic agents, etc.

Identical in the Same Class

REJECTION CRITERIA ACCORDING TO DOH AO NO. 2005-0016

1. Names identical to those already registered within the exact same product classification.

2. Names that are offensive, obscene, scandalous, or contrary to public policy

1 = ?

Public Morals

REJECTION CRITERIA ACCORDING TO DOH AO NO. 2005-0016

1. Names identical to those already registered within the exact same product classification.

2. Names that are offensive, obscene, scandalous, or contrary to public policy

2 = ?

BNC and CPR/CPL are evaluated simultaneously within 30 days

In the former guideline, brand name clearance need to be approved before applying for a CPR, but DOH AO NO. 2005-0016 abolished this now, a.________________________________________. If there is no action, the name is deemed b.________________________________.

a = ?

automatically accepted

In the former guideline, brand name clearance need to be approved before applying for a CPR, but DOH AO NO. 2005-0016 abolished this now, a.________________________________________. If there is no action, the name is deemed b.________________________________.

b = ?