Did you know that without the approval of the Food and Drug Administration (FDA), you risk giving your product a bad reputation? The Agency is responsible for the safety of products circulating the market to uphold the right to health of Filipinos. As a result, establishments are notified of products that have not been scrutinized by the FDA. This affects production, distribution, and other aspects of the concerned products. 

For smooth sailing in the market, it is best to consider getting FDA approval. To know more, here’s a brief guide to the registration process: 

1. Apply for a License to Operate (LTO)

Having an LTO issued by the FDA authorizes your business to circulate products in the Philippines. With this, you need to provide the following:

• Notarized LTO application form
• Business registration
• Proof of business
• Location and floor plan

2. Accomplish the application form

You have to identify your product because the application form varies depending on the category your product belongs to:

• Certificate of Product Registration (CPR) 
• Certificate of Medical Device Registration (CMDR)
• Cosmetic Product Notification (CPN)

3. Provide product labels, documents, and samples

The product details will serve as proof. These will establish legitimacy and ensure adherence to FDA standards.

4. Pay the assessment fee of the FDA

One thing for you to remember, your certificate becomes invalid once changes are made to the product. 

Need any help?

There’s no shortcut to this stressful process of having to register your product. But with Pharmacopoeia Consultancy, we can make things easier for you because we understand the importance of getting your product compliant with standards. So book an appointment with us today and we will ensure your product becomes FDA-registered.