[PRELIMS] PCOS LAB - Product Notification Flashcards
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.
Cosmetic
They allowed online application process to streamline the process by updating the submission of application requirements from the previously manual form to online submissions.
Food and Drug Administration (FDA)
The online application process modernization was kickstarted in March 2013 through what memorandum?
FDA Memorandum Circular No. 2013-
011
The complete name of the product should be given. T/F
True
In what sequence should the name of the product be in?
Brand Name
Line Name (If Applicable)
Product Name, If the Single Shade is Notified
The Shade Name / Number
If there are different shades, the shade name/number for each shade shall not be declared. T/F
False (Shall be declared)
The following information shall be declared in the Cosmetic Product Notification:
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
This refers to the function or use of the product and not the directions for use (e.g. to moisturize the face, hand, etc.).
Intended Use
The validity of the notification
may either be ____, ____, or ____ years at the option of the applicant
1, 2, 3 Years
Multiple Products exists in a single presentation form. T/F
False (A single product exists for a single presentation).
Combination Products in a Single Kit refer to similar and/ or different product types packed and sold in a single kit. T/F
True
Combination Products (e.g Make-up kits) can be sold separately. T/F
False (They cannot be sold separately)
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.
Local Company
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
True
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
True
Meaning of LTO?
License to Operate
It refers to the particulars of the manufacturer and/or supplier of the notified cosmetic product.
Establishment Information
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.
Person Representing the Local Company
All the ingredients in the product must be specified by using the nomenclature from the latest edition of standard references. T/F
True
What are the standard references for product ingredient list?
International Cosmetic
Ingredient Dictionary
British Pharmacopoeia
United States Pharmacopoeia
Chemical Abstract Services
Botanicals and extract of botanicals should be identified by its _______ and _______.
Genus
Species
The genus of botanicals and extracts in the ingredient list may be abbreviated. T/F
True
The application process has four (4) main parts, they are:
Submission
Payment
Download Result
Revalidation
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
Submission
It is the second step in the application process. It involves filing fee, depending on the number of years applied for.
Payment
It is the final step in the application process where you wait for the FDA’s evaluation.
Download Results/ Results
Failure to comply with the additional
documents or information required will lead to the rejection of the application for notification. T/F
True
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
True
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
False (There must not be no modification).
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.
Cosmetic
