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FDA licensing for micro firms simplified

The Department of Trade and Industry (DTI) and Department of Health (DOH) have launched a six-month pilot program to fast-track the process for micro enterprises securing permits from the Food and Drug Administration (FDA).

Even as the program focuses on businesses producing low-risk food products with assets of not more than P3 million, FDA, an agency under the DOH, is set to launch an online portal to further simplify FDA applications, DTI said in a statement.

“This is a product of close and strong collaboration between the DTI and DOH. We employ a whole-of-government approach to achieve President Duterte’s goal of helping the little guys, the micro enterprises. These people chose to change the course of their lives through starting a business. Hence, we need to lessen their hurdles in growing their business and mainstreaming their products,” Trade Secretary Ramon Lopez said.

Lopez, Health Secretary Francisco Duque III, DOH undersecretary Rolando Enrique Domingo, and FDA director general Nela Charade Puno signed a memorandum of understanding last December 21 to launch the pilot program.

Starting January 2019, FDA will deploy representatives to all DTI Negosyo Centers in the National Capital Region to train micro enterprises and pre-assess their applications for Licenses to Operate (LTOs). Upon passing the pre-assessment, these applications will be forwarded to the FDA, which commits to release the LTOs in 15 days. Under the program, micro businesses will also be exempted from having to get Certificates of Product Registration.

Low-risk products, as listed in the FDA Circular 2016-014, include fats, oils, and fat emulsions; processed fruits, vegetable and edible fungi, seaweed, and nuts and seeds; confectionery; cereal-based products; processed meat and meat products, including poultry and game; bakery wares and bakery related products; sweeteners, including honey; salt, spices, soups, sauces, salads, and protein products; beverages; and ready-to-eat savories, like potato chips and chicharon.

With this program, Duque has committed to balance ease of doing business with consumer health and safety.

“Ensuring the safety of products by micro enterprises points to DOH’s mandate to protect the consumers most of all. They are the reason we’re doing this,” Duque said.

After the pilot run, the agencies will evaluate the program’s effectiveness and prepare for a possible rollout in more regions throughout the Philippines.

Puno said the program aims to first gauge the response of entrepreneurs to this change. This is also part of FDA’s move to be a more agile organization. Puno assured that FDA will not be a barrier to trade even as it continuously upholds public health.

FDA is also working on an online portal that allows users to fill out forms and pay online. The portal, named IDOL, or Initiative ni Digong Operation Livelihood, will have training modules to walk applicants through the process of getting FDA permits and licenses.


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