Philippines to Summarily Reject Cosmetic Notification Applications Due to Incomplete Documentation

Takehome:

The Philippines FDA decided that from Oct 1st 2017, several industries including the cosmetic industry would receive immediate disapproval when applying for notification or license if incomplete documentation is supplied or if the application fails to meet technical requirements.

Regardless of whether or not the application was submitted through the FDA e-portal or through FDA Action Center, if the documentation and/or technical requirements are incomplete, the following applications will be immediately rejected:

1. Issuance of License to Operate (LTO), Certificate of Product Registration (CPR) and Production Notification (initial and renewal/revalidation);
2. Re-issuance due to variations of License to Operate (LTO) and Certificate of Product Registration (CPR);
3. Issuance of other authorization, certificates, clearances and/or permit.

Product notification is the most relevant application type for the cosmetic industry. The new system has been implemented since October 1st. Applications received by FDA prior to Oct 1st will be processed based on previous requirements.

The documentation required for cosmetic notification application includes:

1. Declaration of the enterprise that the notified product meet the requirements of the ASEAN Cosmetic Directive and its annexes and appendices;
2. Information of fatal or serious accidents;
3. Information about the product:

• product name
• manufacturers
• local companies placing cosmetic products on the market
• representatives of local companies
• importers
• product ingredient list

4. Product Information File:

• the qualitative and quantitative composition of the product (in case of perfume compositions, the name and code number of the composition and the identity of the supplier);
• specifications of the raw materials and finished product;
• the method of manufacture complying with the GMP as laid down in the ASEAN
• assessment of the safety for human health of the finished product (its ingredients, chemical structure and level of exposure);
• existing data on undesirable effects on human health result;
• supporting data for claimed benefits of the product (should justify the nature of its effect);
• available methods used to check if the ingredients are compliant;
• criteria used for microbiological control of cosmetic products and chemical purity;
• and/or methods for checking compliance with those criteria