regulations

Question 1

It is the primary regulatory body for cosmetics in the Philippines

Answer 1

The Food and Drug Administration (FDA)

Question 2

The Food and Drug Administration (FDA) is the primary regulatory body for cosmetics in the Philippines, mandated by the:

Answer 2

FDA Act of 2009 (Republic Act No. 9711).

Question 3

The Philippines is part of the ASEAN Harmonized Regulatory
Scheme, and the country has adopted the ____ to ensure regional consistency in regulations.

Answer 3

ASEAN Cosmetic Directive (ACD)

Question 4

Four centers under FDA

Answer 4

• Center for Drug Regulation and Research
• Center for Food Regulation and Research
• Center for Cosmetic Regulation and Research
• Center for Device Regulation Radiation Health and Research

Question 5

FDA Core Functions

Answer 5

• Licensing of Establishments
• Registration of Health Products
• Post-Marketing Surveillance of Regulated Entities

Question 6

Licensing of Establishments

Answer 6

• Manufacturers
• Traders
• Distributors/Importers/Exporters/Wholesalers
• Retailers (Drugstores)

Question 7

Registration of Health Products

Answer 7

• Drug
• Food and Food Supplements
• Medical Devices
• Household/Urban Pesticides
• Cosmetics (Notification)
• Toys and Childcare Articles (Notification)

Question 8

Post-Marketing Surveillance of Regulated Entities

Answer 8

• Inspection (GMP/GDSP)/PIF Audit
• Health Product Vigilance
• Enforcement
• Advertisements and Promotions Regulation

Question 9

All cosmetic companies
operating in the Philippines are
required to obtain a ___, issued by the FDA.

Answer 9

License to Operate (LTO)

Question 10

The LTO is valid for ___ and can be renewed upon meeting the requirements. The FDA conducts regular inspections to ensure
compliance.

Answer 10

two years

Question 11

To obtain an LTO, companies must demonstrate ____ compliance and have adequate facilities for
manufacturing, packaging, and storage.

Answer 11

Good Manufacturing Practices (GMP)

Question 12

Processing of LTO Application

Answer 12

• Submission (0-1)
• Payment (3-10)
• Evaluation (11-15)
• Checking (16-19)
• QA (20-23)
• Approval (24-26)

Question 13

Processing of LTO Application takes how many days

Answer 13

26 days

Question 14

Requirements to secure an LTO

Answer 14

• Notarized Petition form from the owner, incorporator, or authorized representative
• Joint Affidavit of Undertaking signed by the owner and an authorized individual (an allied health science professional)
• Proof of your Business’ Registration
• Site Master File
• Proof of occupancy or business address
• Floor plan and vicinity map of the business location
• Risk management plan
• Application fee

Question 15

Product Notification Process

Answer 15

• Submission (0)
• Payment (1)
• Verification (2-7)
• Result (8-14)
• PMS

Question 16

The FDA typically processes the
notification within 15 working days. Upon approval, a notification
number is assigned to the product and is valid for ____.

Answer 16

three years

Question 17

Before the product can be released to the market, the FDA must be notified first using the procedures outlined in the Cosmetic E-Notification v.2.0 User Manual for Applicants.

Question 18

A wider choice of cosmetic products

Answer 18

The Consumers

Question 19

One simplified regulatory system

Answer 19

The Govt/Regulatory Bodies

Question 20

ASEAN as one single market

Answer 20

The Cosmetic Industry

Question 21

Eliminate technical facilitate flow of
barriers to trade and products across ASEAN Member Countries to boost Economic Growth

Answer 21

The ASEAN Region

Question 22

The Philippines has adopted the ___, a comprehensive list of ingredients allowed for use in cosmetics.

Answer 22

ASEAN Cosmetic Ingredient Listings

Question 23

This section lists prohibited substances that cannot be used in
cosmetics, including carcinogenic and mutagenic ingredients.

Answer 23

Annex II of the ACD

Question 24

This section lists restricted geqsubstances that can only be used under specific conditions or within specified limits.

Answer 24

Annex III of the ACD

Question 25

The regulations specify allowed colorants, preservatives, UV filters, and other ingredients, ensuring the safety and quality of cosmetic products.

Question 26

Principal Display Panel (PDP) Essentials

Answer 26

• Statement of Identity • Net Quantity • Prominence

Question 27

Information Panel Requirements

Answer 27

• Ingredients List • Warning Statements • Name and Address

Question 28

- An important reference when providing feedback to the manufacturer/importer/distributor or regulatory authority regarding the product.

Answer 28

Batch number

Question 29

- To allow you to identify and not buy products that are left on the shelf fol too long.

Answer 29

Manufacturing/expiry date of the product in clear terms (e.g month/year):

Question 30

- To assist you in selecting the right product according to the intended use.

Answer 30

Brand and product name of the cosmetic product and its function:

Question 31

- To assist you in selecting the right product size.

Answer 31

Product content (in weight/ volume):

Question 32

- To inform you of the country where the product was made/ produced.

Answer 32

Country of Manufacture

Question 33

To assist you in the proper use of the product in terms of application and frequency of use.

Answer 33

Instructions for use

Question 34

To guide you on the proper use or storage and any other important information to take note of. This may include information on how to handle adverse reactions relating to the use of the product.

Answer 34

Special Precautions

Question 35

- To keep you informed of what is contained in the product, just in case you are allergic to any particular ingredients used.

Answer 35

Full Ingredient List

Question 36

- To enable you to contact them should there be any inquiries or clarifications required on the product.

Answer 36

Name and Address of the Company or Person responsible for placing the product in the market

Question 37

Cosmetic manufacturers in the Philippines are required to adhere to __ to ensure the safety and quality of their products.

Answer 37

Good Manufacturing Practices (GMP)

Question 38

The FDA requires cosmetic manufacturers to conduct ____to ensure that their products are safe for human use.

Answer 38

safety assessments

Question 39

___ guidelines are in place to ensure that cosmetic products maintain their quality and efficacy over time.

Answer 39

Stability testing

Question 40

These are set to minimize the risk of microbial contamination and ensure the safety of consumers.

Answer 40

Microbiological limits for cosmetic products

Question 41

The FDA's ___ plays a vital role in ensuring the safety and quality of cosmetics available to consumers.

Answer 41

post-market surveillance program

Question 42

It is an agreement among ASEAN countries to harmonize requirements of cosmetic products

Answer 42

ASEAN Cosmetic Directive (ACD)