Appointment of a local pharmacist, list of prohibited ingredients and longer timelines. Find out 3 things that will definitely make a difference in the success of your application with the Food and Drug Administration:
1 – Your company must appoint a licensed pharmacist
When applying for a License to Operate as Cosmetic Importer/Distributor, your company will be required to appoint a pharmacist who will sign papers ensuring the safety of the said products and the compliance of the company with the Standard Operating Procedures (SOP). The SOP must describe the several steps followed by the company according to the FDA Requirements of Good Distribution Practice – World Health Organization.
The presence of the pharmacist is also required during the FDA inspection in the company’s premises as well as his/her signature in the application form for the LTO. The appointment of a pharmacist is mandatory for as long as the LTO is active.
2 – Check if the ingredients composing your cosmetic product are not included in the list of prohibited substances issued by the FDA
The FDA of the Philippines has issued a list of ingredients that cannot compose the formula of any cosmetic when applying for a Certificate of Product Registration (CPR). The list is named “List of substances which must not form part of the composition of cosmetic products” and contains 63 pages with substances completely prohibited – or allowed until a certain percentage.
Although these ingredients will not be evaluated during the LTO application, the list will be strictly taken into consideration by the time the applicant submit the package of application for the Certificate of Product Registration.
Despite of the bureaucratic process imposed by the FDA and the long timeline to approve documents submitted by the applicants, the governmental agency does not require the applicant to conduct laboratory tests and it’s not rare to find in the market cosmetic products containing hazardous substances. The last recall ordered by the FDA was released last May 13th requesting the removal of 28 cosmetic products from the market after the FDA found toxic elements in their composition, such as lead and mercury.
3- Endless Registration Process
If you are looking to register your cosmetics in the near future, it is better to start now. The process seems taking longer and longer. The timeline to register one single cosmetic product will not take less than 12 weeks, assuming your company was granted with the License to Operate as Cosmetic Importer/Distributor. However, due to recent changes in the FDA, including the reduction of internal staff, future applicants will need much more patience to finally see their products on the shelves of local stores.
When registering a new cosmetic product in the Philippines, it’s fundamental to receive accurate advice to avoid longer waits and additional costs. We have encountered several clients who didn’t receive proper guidance during the application and received a denial letter from the FDA. This happened almost a year without being communicated about missing documents.
If you are looking for a consulting firm with large experience in dealing with the FDA, don’t hesitate to Contact Triple i Consulting. Triple I has a track of over 350 applications with no denials so far. Our Pharma Division Triple i Consulting guarantees assistance from A-Z, advising on each step to succeed in this arduous path to apply with the FDA.
12F Sagittarius Building, 111, H.V. Dela Costa Street
Salcedo Village, Makati City 1227
T: +632 856 9631