Guide on LTO from BFAD

August 31, 2013
Drugs and FDA

Your business might require you additional permits and licenses to operate. Businesses that involves manufacture, packaging, re-packaging, local distribution, import, export, and retail of processed foods, drugs, cosmetics, medical devices, hazardous substances and chemicals, are required to secure a License to Operate(LTO) from the Philippine Food and Drug Administration, which was previously known as Bureau of Food and Drugs (BFAD). Depending on the number of your activities and the types of goods involved, you might be required to have more than 1 License to Operate.

The classification of the License to Operate you need will depend on the classification of products that you will be marketing or manufacture. And the requirements to acquire these Licenses to Operate varies depending on the products and activity involved, while some of these requirements do not change.

Your business’ activities are limited by the License/s to Operate you have. Like, a License to Operate as Distributor of Food cannot be used for distributorship of drugs. And License to Operate as Exporter does not cover the activity to import. In a case where you import raw materials, manufacture it into goods, and export it, you will be required to have 3 licenses to operate because your business is involve in 3 different activities.

Acquiring an LTO may take a period of 1 to 2 months, depending on availability of documents and results of your establishment inspection by the BFAD-FDA officer. This processing period is more realistic than the suggested processing period posted in government websites. Having someone knowledgeable about the preparation of technical requirements and processes for the application of LTO will hasten the application process.

Only after acquiring a valid License to Operate you can start registering your products to the Philippine Food and Drug Administration.


Rovie Ray Roldan RPh.

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