Philippines to Adopt A New Application System for LTO

On May 2 2016, Philippines Food and Drug Administration announced that it is to adopt a new application process and form for License to Operate (LTO) which is navigable and accessible on FDA Electronic Portal (e-portal). The new application system will be on a pilot run from June 1 to 31 August. Mandatory use of the web-based application form shall be strictly implemented starting September 1 2016 with no exemptions. The current Integrated Application Form will be replaced as of the same implementation date. To access the e-portal applicants are required to apply an authorized user account by submitting an Authorization Letter and sending a request to [email protected]. Applicants who want to try the new application form during the pilot run shall refer to the following schedules:

Key info:

Philippines Food and Drug Administration will adopt a new application process and form for License to Operate.
The new system will be mandatorily implemented starting September 1 2016 with no exemptions.

To access the e-portal applicants are required to apply an authorized user account by submitting an Authorization Letter and sending a request to [email protected]. Applicants who want to try the new application form during the pilot run shall refer to the following schedules:

Time	Applicant type
From 01 June 2016	Drugstores, Retail Outlet for Non-Prescription Drugs, Contract Research Organization/Sponsors
From 01 July 2016	All Distributors
From 01 August 2016	All Manufacturers

The new system will facilitate the application in terms of timeliness and ease of submission especially for applicants outside of National Capital Region (NCR) and improve transparency, accountability and greater operational efficiency.

LTO for Cosmetic Companies

In Philippines all cosmetic companies shall obtain a LTO prior to engaging in manufacturing, importation, distribution and sale of cosmetics. The LTO is issued to ensure that establishments that import and distribute cosmetics are duly registered with the FDA. The LTO is also an essential requirement to be able to register cosmetic products. It is valid for one year from the date of issuance by FDA and subject to a 2 year maximum renewal.