Introduction
Foreign companies are increasingly looking to set up shop in the Philippines, and with the improvement in the ease of doing business here, you might be one of them. However, if you’re selling consumable goods, remember that operating legally in the country entails stringent application processes to ensure public health safety.
Specifically, companies in the food and medicine industries must complete their registration with the Philippine Food and Drug Administration (FDA) before operating in the country. This process involves numerous requirements, so you don’t want to miss anything important when submitting your application. Read this guide by Yap, Kung, Ching & Associates Law Office to help prepare everything you need.
What Is an FDA Certificate of Product Registration, and Why Do You Need It?
Acquiring an FDA Certificate of Product Registration (CPR) is essential for foreign businesses selling goods and medicines in the Philippines as it signifies that you’re operating legally here. The certificate attests to the safety and efficacy of the products you’re introducing to the market—it’s a lot like your company’s badge of authenticity.
Without certification, your products will be recalled and banned. Worse, the public will receive a public health warning regarding your goods (which is always bad for business). As such, it’s important to go through the proper government processes and offer your products to consumers in good faith, starting with securing an FDA CPR.
Steps To Get an FDA Certificate in the Philippines
It’s now easier than ever to establish business operations in the Philippines, but only if you follow the steps religiously and accurately. Before you apply for an FDA certification, you must complete the following steps:
Register Your Business
The Philippine government must acknowledge your business before you apply for any certification. The concerned agency varies depending on your company structure—sole proprietors register with DTI, while corporations with SEC.
We recommend working with business registration experts, like our team at YKC Law, to clear up any uncertainties and challenges while navigating through local business legalities here.
Secure a License To Operate
A License to Operate (LTO) is a prerequisite for obtaining a CPR. This license is essential to legalize your business as a manufacturer and distributor on Philippine soil. The good thing is that the LTO is also issued by the FDA, making transactions more convenient.
The following are the requirements when applying for an LTO:
- Certificate of Business Registration
- Proof of Income
- Location Plan
- Name of Qualified Person Related to the Product Type
- Proof of Expertise (e.g., PRC ID)
Substantiate Product Claims
After securing your business registration and LTO, the next step is to ensure the FDA greenlights your product for manufacturing and distribution in the Philippines. You begin this one by ensuring you have documents supporting your claims about your goods.
For instance, if you market your product X as good for eye health, you should provide proof of that claim and evidence that the item is safe for consumption. Examples of documents substantiating your claims include nutrition health studies, market research studies, and peer-reviewed scientific reports.
Submit Certificates of Product Analyses
Closely linked to substantiating your claims is providing certificates of product analyses. Parameters for each analysis vary depending on the type of goods, which you can check from the FDA’s list of downloadable requirements.
You should also note risk levels—medium and high-risk products such as milk and food supplements have different, stricter requirements. Check with the FDA resources and your legal consultant to ensure you won’t miss anything.
Provide Label and Product Photos
Aside from studies and certificates, you must submit a scanned copy of all your product’s packaging labels and related artwork. Multiple package sizes and varieties should also have a corresponding scanned copy.
In addition, the FDA requires you to provide product photos from at least two different angles, each allowing clear recognition of your brand.
Follow FDA Registration Procedures
After preparing all your requirements, the next step is to register your product through the agency’s e-portal. Note that the platform requires sign-in credentials, which you can request using the FDA’s e-registration form.
Once you secure your credentials, log in to the e-portal and follow the instructions. Remember to keep all attachment sizes (in PNG or PDF format) at or below 2MB. Payments for online registration can be made on-site at the Philippine FDA’s main branch or through Bancnet.
Get Support From Local Consultants
While the application process is straightforward, obtaining the requirements for a Certificate of Product Registration with the FDA here in the Philippines can take some time. Fortunately, you can make navigating easier if you have a local to walk you through the legalities.
Many law firms can help you with business registration and LTO application—their expertise is something you’d like to leverage to ensure you’re doing everything right the first time.
Get Help From YKC Law To Secure Your FDA Licenses and Certificates
YKC Law’s business registration services can help you kickstart your manufacturing and distribution plans here in the Philippines. Our legal experts will walk you through local business laws, offer counsel regarding your plans, and help you obtain the necessary certifications so you can operate here with peace of mind.
We offer services for various business structures, from sole proprietorships to representative offices. We also support foreign companies’ market entry through our business analysis, tax and accounting, and labor law services.
Conclusion
A foreign company should complete its registration with the FDA before manufacturing and distributing goods and medicines in the Philippines. Before obtaining the much-needed Certificate of Product Registration, business owners should register their companies and secure a License to Operate, with each process requiring documents and fees.
While the government has poured efforts into streamlining business-related applications, foreign organizations may still want to enlist the help of local legal firms to ensure a smooth-sailing process. YKC Law specifically aims to support companies in their Philippine ventures through the help of our business registration and market entry experts.
Contact our firm today to learn how you can start operating here in the country!
