regulations Flashcards
It is the primary regulatory body for cosmetics in the Philippines
The Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) is the primary regulatory body for cosmetics in the Philippines, mandated by the:
FDA Act of 2009 (Republic Act No. 9711).
The Philippines is part of the ASEAN Harmonized Regulatory
Scheme, and the country has adopted the ____ to ensure regional consistency in regulations.
ASEAN Cosmetic Directive (ACD)
Four centers under FDA
• 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
FDA Core Functions
• Licensing of Establishments
• Registration of Health Products
• Post-Marketing Surveillance of Regulated Entities
Licensing of Establishments
• Manufacturers
• Traders
• Distributors/Importers/Exporters/Wholesalers
• Retailers (Drugstores)
Registration of Health Products
• Drug
• Food and Food Supplements
• Medical Devices
• Household/Urban Pesticides
• Cosmetics (Notification)
• Toys and Childcare Articles (Notification)
Post-Marketing Surveillance of Regulated Entities
• Inspection (GMP/GDSP)/PIF Audit
• Health Product Vigilance
• Enforcement
• Advertisements and Promotions Regulation
All cosmetic companies
operating in the Philippines are
required to obtain a ___, issued by the FDA.
License to Operate (LTO)
The LTO is valid for ___ and can be renewed upon meeting the requirements. The FDA conducts regular inspections to ensure
compliance.
two years
To obtain an LTO, companies must demonstrate ____ compliance and have adequate facilities for
manufacturing, packaging, and storage.
Good Manufacturing Practices (GMP)
Processing of LTO Application
• Submission (0-1)
• Payment (3-10)
• Evaluation (11-15)
• Checking (16-19)
• QA (20-23)
• Approval (24-26)
Processing of LTO Application takes how many days
26 days
Requirements to secure an LTO
• 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
Product Notification Process
• Submission (0)
• Payment (1)
• Verification (2-7)
• Result (8-14)
• PMS
The FDA typically processes the
notification within 15 working days. Upon approval, a notification
number is assigned to the product and is valid for ____.
three years
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.
A wider choice of cosmetic products
The Consumers
One simplified regulatory system
The Govt/Regulatory Bodies
ASEAN as one single market
The Cosmetic Industry
Eliminate technical facilitate flow of
barriers to trade and products across ASEAN Member Countries to boost Economic Growth
The ASEAN Region
The Philippines has adopted the ___, a comprehensive list of ingredients allowed for use in cosmetics.
ASEAN Cosmetic Ingredient Listings
This section lists prohibited substances that cannot be used in
cosmetics, including carcinogenic and mutagenic ingredients.
Annex II of the ACD
This section lists restricted geqsubstances that can only be used under specific conditions or within specified limits.
Annex III of the ACD
The regulations specify allowed colorants, preservatives, UV filters, and other ingredients, ensuring the safety and quality of cosmetic products.
Principal Display Panel (PDP) Essentials
• Statement of Identity
• Net Quantity
• Prominence
Information Panel Requirements
• Ingredients List
• Warning Statements
• Name and Address
- An important reference when providing feedback to the
manufacturer/importer/distributor or regulatory authority regarding the product.
Batch number
- To allow you to identify and not buy products that are left on the shelf fol too long.
Manufacturing/expiry date of the product in clear terms (e.g month/year):
- To assist you in selecting the right product according to the intended use.
Brand and product name of the cosmetic product and its function:
- To assist you in selecting the right product size.
Product content (in weight/ volume):
- To inform you of the country where the product was made/ produced.
Country of Manufacture
To assist you in the proper use of the product in terms of application and frequency of use.
Instructions for use
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.
Special Precautions
- To keep you informed of what is contained in the product, just in case you are allergic to any particular ingredients used.
Full Ingredient List
- To enable you to contact them should there be any inquiries or clarifications required on the product.
Name and Address of the Company or Person responsible for placing the product in the market
Cosmetic manufacturers in the
Philippines are required to adhere
to __ to ensure the safety and
quality of their products.
Good Manufacturing Practices
(GMP)
The FDA requires cosmetic
manufacturers to conduct ____to ensure that their products are safe for human use.
safety assessments
___ guidelines are in place to ensure that cosmetic products maintain their quality and efficacy over time.
Stability testing
These are set to minimize the
risk of microbial contamination
and ensure the safety of
consumers.
Microbiological limits for cosmetic
products
The FDA’s ___ plays a vital role in ensuring the safety and quality of cosmetics available to consumers.
post-market surveillance program
It is an agreement among ASEAN countries to harmonize requirements of cosmetic products
ASEAN Cosmetic Directive (ACD)
