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A Quick Guide to Securing a License to Operate (LTO) from the FDA

May 07, 2018

There’s more to putting up a business than simply securing sufficient capital and creating a striking brand. You also need to obtain different kinds of certification and permit. One of the documents that you need to secure is a license to operate (LTO) from the Food and Drug Administration (FDA), especially if your business involves the production and sale of goods and medicines.

 

 

The FDA is the government agency that is responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. They also regulate the production and distribution of nation’s food supply, cosmetics, and products that emit radiation. Their job is to protect the public health so you should anticipate a stringent certification process. Here’s a glimpse of the FDA certification process.

 

Submit the Necessary Documents

 

If you are applying for an LTO for the first time, chances are you know little about the different documents you need to submit. You don’t have to worry because a list of the requirements will be given to you upon inquiry at the Public Assistance Information & Compliance Section. In fact, they will even give you a routing slip for the different stages of the FDA registration after paying the initial fees.

The general requirements include the following:

 

  1. Notarized accomplished Application for Authorization Form
  2. Proof of registration
  3. Proof of occupancy – office
  4. Proof of occupancy – warehouse
  5. Proof of occupancy – manufacturer
  6. Photocopy of Notarized Fixed Asset & Operating Capital or Financial Statement (new requirement)
  7. Location Plan
  8. Floor Plan
  9. Tentative list of food products to be manufactured or distributed identified on its classification and category
  10. Facsimile of Proposed Label (for local manufacturer) / sample label of product to be imported or a digital image of the document in an FDA-approved file type.

 

These documents, however, are only the introductory part of your application with the FDA. The other part details the nature and quality of your business, which will be FDA’s ultimate basis for their decision on whether or not to award you an LTO. Of course, the requirements will depend on the type of business you are or will be putting up. It is important to also keep in mind that before you can apply for an LTO, you must have a registered business. Remember to finish your business registration before applying an LTO

 

If you are a retailer, for instance, you only need to submit a photocopy of your notarized contract with the manufacturer along with the manufacturer’s LTO. On the other hand, if you are a food importer for raw materials, you have to provide a list of sources and materials to be imported. Other types of business, whether directly or indirectly producing or distributing goods, have their own specific requirements to accomplish.

 

For a guaranteed successful LTO application, consider seeking the help of a lawyer specializing in business registration law. It pays to have a professional guiding you through the process and smoothing out obstacles that might cost you a huge deal of time and money. A law office such as Yap Law Office is your best bet for legal support.

 

Source:

https://www.fda.gov.ph/