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

Borra Law > FDA  > Obtaining a License to Operate and Registering a Product for COVID-19 products

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 CPR from drugs, you may get it in 6 months or less.

However, you still need to incorporate, get a Tax Identification Number (TIN), and a business permit in order to register with FDA, and this will take time. Right now, with the government-mandated restrictions, incorporating with SEC (which used to take less than a month) has taken 2 to 3 months. Getting a TIN from the Bureau of Internal Revenue is relatively easy and can be obtained within a week. The business permit takes time, depending on whether you are applying to be an importer, retailer, or distributor (normally one month).

So if you want to bring your product to market at the fastest possible time, you need to start incorporating now, even if you are still trying to get FDA authorization from the country of origin. And if you want the most affordable and most efficient option to bring your product to the market, get in touch with us now. Our team is a one-stop shop that can help you incorporate, get a TIN and business permit, and apply for a LTO and CPR in record time, without the hassle of you trying to engage a pharmacist to help apply for your FDA permits.

 

 

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