[PRELIMS] PCOS LAB - Product Notification

Question 1

Defined by ASEAN as any substance or preparation intended to be place in contact with the external parts of the body, or with the teeth and the mucous membrane of the oral cavity with a view exclusively or mainly for cleaning them, perfuming them, changing their appearance and/ or correcting body odors and /or protecting or keeping them in good condition.

Answer 1

Cosmetic

Question 2

They allowed online application process to streamline the process by updating the submission of application requirements from the previously manual form to online submissions.

Answer 2

Food and Drug Administration (FDA)

Question 3

The online application process modernization was kickstarted in March 2013 through what memorandum?

Answer 3

FDA Memorandum Circular No. 2013-
011

Question 4

The complete name of the product should be given. T/F

Answer 4

True

Question 5

In what sequence should the name of the product be in?

Answer 5

Brand Name
Line Name (If Applicable)
Product Name, If the Single Shade is Notified
The Shade Name / Number

Question 6

If there are different shades, the shade name/number for each shade shall not be declared. T/F

Answer 6

False (Shall be declared)

Question 7

The following information shall be declared in the Cosmetic Product Notification:

Answer 7

Product Types
Product Presentations
Product Ingredient List
Particulars of the Product
Person Representing the Local Company
Establishment Information
Intended Use
Local Company Responsible for Placing the cosmetic product in the market

Question 8

This refers to the function or use of the product and not the directions for use (e.g. to moisturize the face, hand, etc.).

Answer 8

Intended Use

Question 9

The validity of the notification
may either be ____, ____, or ____ years at the option of the applicant

Answer 9

1, 2, 3 Years

Question 10

Multiple Products exists in a single presentation form. T/F

Answer 10

False (A single product exists for a single presentation).

Question 11

Combination Products in a Single Kit refer to similar and/ or different product types packed and sold in a single kit. T/F

Answer 11

True

Question 12

Combination Products (e.g Make-up kits) can be sold separately. T/F

Answer 12

False (They cannot be sold separately)

Question 13

It refers to the company responsible for placing the cosmetic products in the market, which may be a local manufacturer or an agent appointed by a manufacturer to market the product or the company that is responsible for bringing in the product for sale in the country.

Answer 13

Local Company

Question 14

If the company responsible for placing the cosmetic product in the market is a distributor, then the applicant must also declare the details of the direct supplier or manufacturer of the cosmetic product, namely Country of Manufacture, Address, and others. T/F

Answer 14

True

Question 15

The applicant for notification must have a valid LTO and must state in the notification application the LTO number of the company responsible for placing the cosmetic product in the market. T/F

Answer 15

True

Question 16

Meaning of LTO?

Answer 16

License to Operate

Question 17

It refers to the particulars of the manufacturer and/or supplier of the notified cosmetic product.

Answer 17

Establishment Information

Question 18

This person may be contacted by the FDA in case there are questions on the cosmetic product, or if additional documents are needed to substantiate the application.

Answer 18

Person Representing the Local Company

Question 19

All the ingredients in the product must be specified by using the nomenclature from the latest edition of standard references. T/F

Answer 19

True

Question 20

What are the standard references for product ingredient list?

Answer 20

International Cosmetic
Ingredient Dictionary
British Pharmacopoeia
United States Pharmacopoeia
Chemical Abstract Services

Question 21

Botanicals and extract of botanicals should be identified by its _______ and _______.

Answer 21

Genus
Species

Question 22

The genus of botanicals and extracts in the ingredient list may be abbreviated. T/F

Answer 22

True

Question 23

The application process has four (4) main parts, they are:

Answer 23

Submission
Payment
Download Result
Revalidation

Question 24

It is the first step in the application process where it is now done through the FDA’s portal. It is done once you have filled up the necessary details of the cosmetic product to be notified

Answer 24

Submission

Question 25

It is the second step in the application process. It involves filing fee, depending on the number of years applied for.

Answer 25

Payment

Question 26

It is the final step in the application process where you wait for the FDA’s evaluation.

Answer 26

Download Results/ Results

Question 27

Failure to comply with the additional
documents or information required will lead to the rejection of the application for notification. T/F

Answer 27

True

Question 28

Acknowledged cosmetic notifications may be revalidated for a new validity date, where the new validity date will be based on the date of submission of the revalidation application. T/F

Answer 28

True

Question 29

There must be some modification from the information provided during the previous application to avail of revalidation. Hence, any changes to the information will constitute a new notification application. T/F

Answer 29

False (There must not be no modification).

Question 30

Defined by ASEAN as any substance or preparation intended to be place in contact with the external parts of the body, or with the teeth and the mucous membrane of the oral cavity with a view exclusively or mainly for cleaning them, perfuming them, changing their appearance and/ or correcting body odors and /or protecting or keeping them in good condition.

Answer 30

Cosmetic