Product Registration Services in the Philippines for Local and Foreign Enterprises
Local and foreign enterprises seeking to manufacture, import, export, distribute, market, or advertise products in the Philippines are required to register with the Food and Drug Administration (FDA).
Our FDA consultants are closely involved in the product registration, classification, investigational device submissions, and procurement of forms for licensing. We also provide assistance on the renewal of permits/licenses and how to secure compliance with FDA’s specifications on production facilities.
We will assist you in securing and renewing the right licenses/certificates from the FDA, which could be any of the following:
- License to Operate (LTO)
- Certificate of Product Registration (CPR)
- Notification of Cosmetic Product (NCP)
What is the FDA?
The Food and Drug Administration (or FDA, formerly BFAD) is a government agency under the Department of Health responsible for licensing and regulating products for distribution in the Philippines.
FDA’s registration requirements and processing timeline will depend on the classification of the products you want to market, which could be any of the following:
- food
- food supplements
- drugs
- cosmetics
- household hazardous
- pesticides
- medical devices
- diagnostics
- veterinary products
Establishments involved in any of the following are required to register with FDA:
- manufacture
- packaging
- re-packaging
- trading
- importation
- exportation
- wholesale
- retail pharmacy (of FDA-regulated products)
Steps on How to Secure a LTO
To successfully register a food or drug product in the Philippines, local and foreign enterprises must secure a License to Operate (LTO) as (1) Importer, Distributor, or Wholesaler if they want to import their products from overseas; or as (2) Manufacturer if they intend to manufacture them locally.
After obtaining an LTO, they are required to apply for either of the following depending on the classification of their products:
- Certificate of Product Registration (CPR)
- Notification of Cosmetic Product (NCP)
CPRs are applicable for all product classifications except cosmetics, as these require an NCP to be officially registered with the FDA.
Requirements for Obtaining an LTO
- Accomplished Application Form
- Proof of Business Registration
- Site Master File (for manufacturers of drugs, devices, and cosmetics)
- Risk Management Plan
- Proof of payment of fees
Process for Securing an LTO
- Set up a Philippine business entity or partner with a local distributor
- Compile necessary documents:
- Proof of business registration
- Valid Mayor’s Permit
- Valid IDs of signatory and representative
- Request for a company-specific ePortal account
- Submit the documentary requirements for evaluation
- Pay filing fees
- Claim LTO from FDA
Steps on How to Secure a CPR
A CPR is only issued to enterprises and manufacturers that already have a valid LTO. If you have more than one product, you need to register EACH product, specifically their individual variant, flavor, dosage strength, etc. Each product must have its own registration number in the Philippines.
Requirements for Obtaining a CPR
- Accomplished Application Form
- Clear and complete loose labels or artworks of all packaging size
- Pictures of the product in all angles
- If applicable, justification of label claims (i.e., nutritional facts, Halal logo, nutritional and health claims)
- Product sample in actual commercial presentation (for food supplements)
- Proof of payment of fees
Process for Securing a CPR
- Have a valid LTO based on the company’s activities
- Revalidate the ePortal account to eRegistration
- Compile necessary documents:
- Product Labels (in compliance with FDA’s laws about labeling)
- Product Analysis (to substantiate claims of vitamins and nutrients based on Philippine RENI; or to prove absence of harmful microorganisms or chemicals)
- Product Sample
- Submit the documentary requirements for evaluation
- Pay filing fees
- Submit an actual commercial sample
- Claim CPR from FDA
Applying for an NCP
Similar to applying for a CPR, applying for an NCP requires a valid LTO. However, this is only a requisite for cosmetic products. All other products must be registered with the CPR.
Requirements for Obtaining an NCP
- Certificate of Manufacturer
- Certificate of Free Sale or Good Manufacturing Practice Certificate
- Names, functions, and percentage of each ingredient in the product formulation
- Clear and complete loose labels or artworks of all packaging size and commercial product packaging
- Proof of payment of fees
Renewal of Product Licenses/Permits
The validity of the licenses and permits that FDA issues will be in accordance with their product classification and registration.
The duration of product validity per classification are as follows:
For LTOs
- Foods – 5 years
- Cosmetic Products – 2 years
- Medical Devices – 2 years
- Drug Products – 2 years
For CPRs
- Foods – 5 years
- Medical Devices – 1 year
- Drug Products – 1-2 years
For NCPs
- Cosmetic Products – 1-3 years
BGC and Co. CPAs is a mid-sized progressive auditing firm providing comprehensive set of cost effective solutions to organizations like yours.
Our services include auditing, accounting, bookkeeping, business management, and HR consulting. Further, we provide other business services like VISA processing in Bureau of Immigration (BI), Philippine Retirement Authority (PRA).
We are equipped with state of art tools and techniques along with dedicated professional to evaluate potential opportunities and risks effective auditing and assurance services. We understand a value adding auditing and assurance service focus on scope of business improvement rather than merely preparing financial statements and reporting on figures.
The firm was formed to assist clients on the preparation of compliances relating to tax, financial management, forecasting and accounting software and system installation. Assist clients in tax investigations, internal auditing procedures and provide on financial, taxation, accounting and auditing matters when needed. Processing of business registration, cancellation / termination.
Our Mission
Deliver reliable cost effective professional services in time meeting specific customer requirements.
Our Vision
To become one of the best auditing and accounting firm in the Philippines providing the utmost satisfaction to all the clients. We would like to be known as one of the finest company to partnered with in all the aspects.
Our Team
Our teams of dedicated professionals led by senior qualified accountants are obliged to give you quality services which will enable you to serve your clients better and there by improve your business. We together with our associates enable to give you the best in the industry.
ABOUT OUR SERVICES
Auditing and Assurance
We are equipped with state of art tools and techniques along with dedicated professional to evaluate potential opportunities and risks delivering effective auditing & assurance services. We understand value adding auditing and assurance service focus on scope of business improvement rather than merely preparing financial statements and reporting on figures.
Our expertise in analyzing accounting systems, designing better systems with proper internal controls and management information reporting help our clients to adequately plan their business building strategy and give them the confidence to pace up with the rapidly growing economy.Accounting and Bookkeeping
Accounting and bookkeeping is a necessity of every organization irrespective of its size. Our professionally qualified and experienced accountants understand and analyze business transactions and ensure compliance with the accounting standards. BGC has well trained staff familiar with many of the accounting system and most especially to the rapid changes in the BIR rules and regulations. Qualitative and timely accounting reports are crucial for the success of any business organization. BGC ensures relevant and reliable financial reports are delivered on regular intervals to assess performance and to facilitate decision making. Outsourcing of accounts department helps you to get professional expertise at lower cost and BGC provides the most efficient and effective bookkeeping solutions.
We assist you with below services:
• Accounts preparation and supervision
• Preparation and presentation of financial reports
• Bookkeeping services
• Payroll processing
• Training of accounting staffBusiness Set-up and Termination
We do assist in setting up different types of business organizations through registrations to different government agencies such as:
• Securities and Exchange Commission (SEC);
• Bureau of Internal Revenue (BIR);
• Local Government Unit (LGU);
• Department of Trade and Industry (DTI);
• Social Security System (SSS);
• Philippine Health Insurance (Philhealth);
• Pag ibig;
• Food and Drug Administration (FDA)
We also assist our foreigner clients for the following:
• VISA extension;
• Bureau of Internal Revenue (BIR);
• 9g VISA;
• Special Resident Retiree’s VISA (SRRV)
• Social Security System (SSS);
• Passport RenewalSERVICES
CONTACT US
ADDRESS
- 7TH FLOOR, PCCI CORPORATE CENTER, L.P. LEVISTE ST., SALCEDO VILLAGE, BRGY. BEL-AIR MAKATI, PHILIPPINES 1209
- Info@bgcco.ph
- lconvento@bgcco.ph
- Working Hours : 8:00 a.m - 5:00 p.m
PROFILE
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想了解更多欢迎联系和咨询我们，中文 微信BGC998 电报@BGC998
想了解更多欢迎联系和咨询我们，微信BGC998 电报@BGC998
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