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Borra Law > FDA

Obtaining a License to Operate and Registering a Product for COVID-19 products

Normally, obtaining a License to Operate (LTO) and a Certificate of Product Registration (CPR) from the Philippine Food and Drug Administration (FDA) takes quite some time. However, FDA released Circular No. 2020-024 which prioritizes COVID-19 related companies and products. In particular, priority shall be given to establishments with function intended for use in the diagnosis, cure, mitigation, treatment, prevention, and personal protective equipment (PPE) of COVID-19, and essential medicine. So, from the regular 2 to 3 months in obtaining a LTO, you may get it in 1 month. From the normal 12 months (minimum turn around time) in getting a...

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Selling Food, Drugs, Cosmetics, and Medical Devices in the Philippines

A lot of Filipinos and foreigners alike would like to sell food, drugs, cosmetics, and medical devices in the Philippines. However, one cannot just engage in this business without a license from the Philippine government. The government agency in charge of issuing licenses to businesses who would like to engage in the business of selling these regulated items is the Food and Drug Administration (FDA) of the Philippines. Here's a quick procedure in a nutshell: First, you need to get a License to Operate from FDA. Because of the volume of applications received by FDA, this process normally takes between three months, but...

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