Why Do You Need to Acquire An LTO for Your Business?
Legal Requirement
Mandatory for businesses involved in manufacturing, importing, distributing, exporting, and selling FDA-regulated products.
Entry to Product Registration
A requirement for applying for FDA product authorization licenses, such as Certificate of Product Notification (CPN), Certificate of Product Registration (CPR), and Certificate of Medical Registration (CMDR).
Compliance with Public Health Standards
Demonstrates your company’s commitment to safety, transparency, and public welfare by meeting the standards set for public health protection.
Enables Legal Business Operations
Required for listing, distribution, and sale in established sales channels like retail stores, pharmacies, online marketplaces, etc.
Avoid Delays and Fines
Prevents cease and desist orders, delays in customs clearance, and administrative sanctions by the local authorities.
Mandatory Import Requirement
Mandatory customs requirements for importing regulated products. Customs may not release your shipment without an LTO.
Key Requirements for License to Operate Applications in the Philippines
- Completed e-Application Form: Must include the required declarations and undertakings.
- Barangay and Mayor’s Permit: Requirement for general business operations.
- Proof of Filing Fee Payment
- Proof of Business Registration: This includes the DTI for sole proprietors, the SEC for corporations, and the CDA for cooperatives.
- Site Master File: Required for manufacturers of drugs, devices, and cosmetics.
- Risk Management Plan: Especially for manufacturers and relevant distributors.
- Latest Audited Financial Statement: Includes Balance Sheet / Statement / Certification of Initial Capitalization.
- Contract of Agreements: Depending on business activity, like outsourcing, contract manufacturing, etc.
- Location Plan and/or GPS Coordinates: Requirement for distributors, exporters, and importers.
- Name and Professional Regulation Commission (PRC) ID of Qualified Person in Charge: For health product establishments.
- Proof of Occupancy/Ownership of Premises: Lease contract or title, especially for newly built or leased facilities.
License to Operate Application Process with Emerhub
1
Application Submission to the FDA
We’ll prepare and file your LTO application through the FDA’s online portal, ensuring all documentation is complete and aligned with current regulatory requirements.
2
FDA Pre-Assessment for the Application
Upon submission, the FDA will conduct a pre-assessment of the application. We will ensure that your application’s completeness, accuracy, and formatting meet FDA guidelines and approval to avoid any unnecessary delays.
3
Issuance of Order of Payment
The FDA will then issue an Order of Payment, which we will guide you through to ensure all fees are settled accurately and promptly.
4
Product Technical Evaluation
Our team will coordinate with the FDA for your product’s technical review, handling any queries and issues on your behalf to keep your application on track.
5
LTO Approval and Issuance
After approval, we will secure your License to Operate and ensure you are properly licensed to begin your operations without compliance issues.
Have questions or need more information?
Why Choose Emerhub As Your Registration Consultant in the Philippines?
Choosing the right FDA partner can make or break your market entry. With Emerhub, you have a reliable partner to guide you through the process.
Proven Regulatory Expertise
We specialize in FDA Philippines compliance, with 14 years of experience in handling LTO applications across various industries.
Transparent Communication
Our team will keep you informed at every stage of the application process, providing clear updates and timelines.
Dedicated Professional Team
We have a team of experienced professionals who continue to stay up to date with current FDA regulations and requirements, providing you with the latest information within the industry.
FAQs on License to Operate in the Philippines
No, the type of LTO required depends on your business activity and the product category. For example, a food manufacturer will apply under a different category compared to a cosmetic distributor.
Yes, all businesses, including online and home-based sellers, are required to obtain an LTO if they are selling FDA-regulated products such as food supplements, cosmetics, or medicines.
No, all LTO applications, including new applications, renewals, and variations, must be submitted via the FDA eServices/ePortal system.
Yes, if your business deals with drugs, medical devices, or products requiring technical supervision, the FDA requires a licensed pharmacist or qualified technical personnel, depending on the category.
Yes, the FDA will require a verifiable, physical address for the business, including storage facilities, if you are distributing or importing products. Absence of a physical office or facility will lead to disapproval. This applies even for online-only businesses.
An FDA LTO is typically valid for 1 to 3 years. The standard period is 3 years, but this can be shorter in specific sectors based on the FDA’s discretion. The exact validity will be stated on the license.
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Liz Servañez
Liz Servañez serves as Branch Manager in the Philippines.
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Christine Aguilar
Christine Aguilar serves as Head of Operations in the Philippines.
Set Up A Call With An Emerhub Specialist Today
Have questions about securing your LTO in the Philippines? Schedule a call with us and get expert, tailored guidance for your business.
Email Us
philippines@emerhub.com
Call Us
+63 945 726 2635
Visit Us
35th Floor Penthouse, Ecotower, 32nd Street, 9th Ave, Taguig, 1800 Metro Manila, Philippines