FDA CPR Certificate of Product Registration Requirements and Application Process in the Philippines

Certificate of Product Registration FDA Phils
Certificate of Product Registration FDA Phils.

Before you can start selling food items, cosmetics, or drugs in the Philippines, you need to secure first a Certificate of Product Registration (CPR) from the Food and Drug Administration (FDA).

Obtaining a CPR for your product involves knowing if it needs one, having the proper documents and requirements, and applying for it using the FDA’s system. Take note that each product being registered will have its own CPR. This means that each variant, flavor, and dosage will have its own certificate—basically, each item must be registered individually. There is no bulk processing option for FDA CPR application on their website.

Need to know more about how to apply for a Certificate of Product Registration from the FDA? Keep reading.

Click the links below to go directly to that part of this article:

  1. Products with Required Certificate of Product Registration (FDA CPR)
  2. Requirements for FDA CPR
  3. How to Get Certificate of Product Registration from FDA
  4. Automatic CPR Renewal
  5. Penalty for Products with no CPR

Products with Required Certificate of Product Registration (FDA CPR)

Which products need a CPR? The following items do:

1) Food Products (canned goods, bottled beverages, infant formulae, etc.)

2) Medicines, Pharmaceuticals, and Over-the-Counter Drugs

3) Medical Devices

4) Food Supplements (vitamins, minerals, energy boosters, etc.)

5) Toys

6) Veterinary Products (pet medications, vitamins, supplements, etc.)

7) Hazardous Household Products and Urban Pesticides (cleaning supplies, disinfectant sprays, etc.)

Do cosmetics need a Certificate of Product Registration?

Cosmetic products do not have a CPR, and instead are required to have a product notification. While the FDA needs to be informed regarding such cosmetics, the procedure outlined here is for obtaining a CPR only.

Requirements for FDA Certificate of Product Registration

If your product is listed above, you are required to process a CPR for your product. The following are the requirements for doing so:

1) A valid LTO or License to Operate which can be obtained from the FDA

2) A clear, scanned, and colored copy of loose labels of all packaging sizes for the products (or equivalent, as defined by FDA), as well as pictures of the product from all angles and in different packaging sizes. This allows easy recognition of a product as the same one being registered.

  • For food supplements, include blister packs, Alu-Alu packs, and secondary packaging (i.e. paper box or cardboard box).

3) Other requirements for traders, wholesalers, and distributors of locally manufactured food products / for importers and distributors

4) Documents to support product claims, such as:

  • Technical/nutrition health studies or reports
  • Market research studies
  • Certificate of analysis, quantitative analysis, and computations
  • Scientific reports or studies published in peer-reviewed scientific journals
  • Supporting certificates to allow the use of “Sangkap Pinoy”, Halal, Organic, Kosher, and other claims in compliance with current labeling requirements

5) Certificate of Analysis stating essential details to determine product compliance to food standards and regulations for the following:

  • Medium to high-risk products with standards of identity such as food for infants and young children, foods intended for special medical purposes, bottled water, etc) the certificate of analysis must be uploaded. The list of low, medium, and high risks can be found here on the FDA website.
  • Fortified food products covered by R.A. 8176 (iodized salt) and R.A. 8976 (cooking oil, flour, and refined sugar)

6) For food supplements, additional requirements include:

  • A stability study of the actual food supplement
  • Safety data, such as toxicity tests, must be attached to address safety concerns regarding the product.

7) Actual representative product sample of food supplement (for initial application only, and is not needed during CPR renewal).

Note: This is a list of general requirements; additional requirements and procedures may be required by the FDA depending on the product being registered. Confused? You can ask us about it.

Once you have these requirements, you can opt to register these products online using the FDA e-registration system, which can be found here.

How to Get Certificate of Product Registration from FDA

The following is the basic CPR e-registration procedure (as per FDA Circular 2016-014):

1) Secure your FDA E-registration log-in details.

2) Log in to the FDA website e-portal.

3) For first-time product applications, click on “New Case.”

4) Type the details of needed information of product, such as brand name, product name, food category, list of ingredients, product specifications, and other pertinent information.

5) Upload the required documents. The documents needed vary per product and if the product is for export or not. Please check the FDA website for more details.

Note: Maximum 2MB per attachment in PDF or PNG format, and 25 MB max for all attachments per application

6) Print Order of Payment and pay corresponding fees either in person at the FDA Main Office located in Alabang, through the Bancnet online payment gateway option as per FDA Advisory 2015-021, or whatever FDSA recommends on their site.

7) You can track the application progress through the process map indicated on the FDA website.

Automatic CPR Renewal

To make CPR renewal automatic, the following conditions must be met:

1) The renewal application must be filed before the expiration date of the CPR;

2) The automatic renewal fee must be paid prior to the filing of application; and

3) There should be no condition stated at the back of the issued Certificate of Product Registration.

In case of a condition, compliance with the condition must be met and proven by including a scanned copy of the acknowledgment letter from the FDA indicating that the condition has been met.

Penalty for Products with no CPR

What if you release the product to the market without the proper certification? Not only is this illegal, but once FDA is notified, they will issue a cease and desist order. They will take your products off the market AND require you to pay fines AND process CPRs for your products that were taken off the shelves.

Going against the law can destroy the name of your business as well. The FDA issues public health warnings against products without CPRs, and this means bad publicity for your brand.

All in all, the hassles and penalties brought about by not doing things properly is just not worth the risk.

Does the application for an FDA CPR sound too tedious?

If applying for a CPR sounds like a hassle to do it yourself, then let us help! Our team of experts can help you with the whole FDA process, not just for product registration. If you have any inquiries, you may contact us here.

The Complete FAQ Guide on How to Renew Your Business Permit in the Philippines for 2020

Having a business registered in the Philippines requires you to renew its business permits annually.

It doesn’t matter if the company is a Single Proprietorship, a One Person Corporation, a Partnership, a Corporation, a Branch Office, or a Regional Headquarter (ROHQ). All business establishments, per Philippine law, must renew their permits or face possible closure of their operations as well as a loss of face to their clients. 

To help you avoid long lines and heavy monetary penalties, we give you our complete FAQ guide on how to renew your business permit in the Philippines for 2020. 

Frequently Asked Questions (FAQs):

 

What permits do I need to renew? When is the deadline for each? 

Business permit renewal season involves coordinating with three different government entities: the barangay, the city or municipality, and the Bureau of Internal Revenue (BIR). 

1. Barangay Permit or Clearance (Deadline: January 20)

A barangay permit certifies that a business establishment is compliant with the requirements set by its local government unit (LGU) of operation. It is also a requirement when securing the Mayor’s Permit. 

2. Mayor’s Permit or Business License (Deadline: January 20)

Each city or municipality has its own rules to comply with. The Mayor’s Permit certifies that a company is compliant with the ordinances of the city or municipal it operates in. 

3. BIR Renewal of Registration (Deadline: January 31)

The BIR issues a Certificate of Registration (COR) to a company when it is first established. To ensure its validity from year to year, a business establishment must pay a renewal fee of PhP 500.00 every January 31.

 

What are the penalties for non-renewal or late renewal of business permits? 

City or Municipality

If filing is not accomplished by January 20 of each year, the LGU concerned will impose a 25 percent surcharge on top of the unpaid taxes, charges, and fees assessed. Also, a negligent company will incur a 2 percent monthly interest on all unsettled fees, including the surcharge, until everything is paid off.

Extremely delinquent businesses, on the other hand, run the risk of closure and/or seizure of its properties and assets.

All these penalties are imposed by the Local Government Code of 1991.

BIR

A company that did not comply to the January 31 deadline will be fined an amount ranging from PhP 5,000.00 to PhP 20,000.00. Its officers also face the risk of imprisonment, with the term ranging from six months to a maximum of two years. 

 

What requirements do you need for business permit renewal with each government office?

Barangay

1. 2019 Barangay Permit (original and photocopy)

2. Official Receipt from last year (original and photocopy)

3. Accomplished application form (2 copies)

4. Renewal fee (varies per barangay)

City / Municipality

1. 2020 Barangay Permit (to be availed first for the current year)

2. 2019 Mayor’s Permit (original copy)

3. 2019 Official Receipt (original copy)

4. 2019 Audited Financial Statement

5. Lease Contract (if changing address)

6. Community Tax Certificate (CTC) or Cedula (to be secured first from City or Municipal Hall)

7. Comprehensive General Liability Policy (CGLP) insurance for 2020

8. Official receipt of CGLP availed

9. Renewal fee (varies per city or municipality)

Depending on the LGU concerned, you may also be asked to provide the following documents:

1. Fire and Safety Inspection Certificate (original copy) 

2. Sanitary Permit (original copy)

BIR

1. BIR Payment Form 0605 (Click this link to download from the BIR website)

2. PhP 500.00 annual business registration fee

 

What are the steps for renewing business permits? How long will the process take? 

Barangay

Estimated Time Needed: 1 day

1. Visit the barangay hall in whose district your company operates in. Secure a renewal application form.

2. After filling out the form, submit it along with the original copies of your 2019 Barangay Permit and Official Receipt.

3. The barangay’s permit division will then assess your renewal application and documentary requirements. If everything is in order, you may then pay the necessary renewal fee.

4. You will be given the Official Receipt for your Barangay Permit. You may then claim your new Barangay Permit on the date indicated in the Official Receipt.

City / Municipality

Estimated Time Needed: 1 to 2 weeks

1. Secure a renewal application form from the Business Permits and Licensing Office (BPLO) of the LGU that your company operates in.

2. Fill out the form then submit along with the documentary requirements for evaluation.

3. Based on the submitted documents, the BPLO will issue an assessment notice containing the amount of local business tax, real property tax, and other fees that your company needs to pay for 2020. You can choose to pay the entire annual fee in full or in quarterly installments. You may also contest the amount and request a lower assessment. 

4. Bring the assessment notice and pay the required fees at the City Treasurer’s Office. They will provide you the Official Receipt to be presented when you claim the Mayor’s Permit certificate.

5. If your documents are in order, pay the Mayor’s Permit renewal fee at the City Treasurer’s Office. You will be given a receiving copy of your documents.

6. It will take some time for the certificate to be released. In the meantime, the Official Receipt will serve as proof that you renewed your Mayor’s Permit on time if asked. 

7. You may then claim your new Business License from the City Treasurer’s Office on the date indicated in the Official Receipt.

BIR

Estimated Time Needed: 1 day

1. Fill up BIR Payment Form 0605 with details of your business establishment.

2. Bring the BIR Payment Form 0605 to your RDO’s Authorized Agent Bank (AAB) and pay the PhP 500.00 annual business registration fee there.

 

What other tips should I know about business permit renewal?

1. Don’t procrastinate. Preparing the documents required by your LGU at the last minute will land you in long waiting lines and possible payment of penalties. Use the whole month of December if necessary. Remember: the deadline for the whole process of business permit renewal is January 20.

2. Be OC (obsessive-compulsive). Paying attention to small details can save you a lot of time. Organize your documents as soon as you receive or print them. Triple-check what is written in your application form and its attachments. Bring enough cash before you head to the battle lines. 

3. Patience is a virtue. No matter how early you start preparing, you will probably still face lines at your barangay hall, city hall, and BIR RDO. Make sure you’re ready to play the waiting game. Bring a fan, towel, bottled water, and even a good book if you’re so inclined.

4. Copies can save you. You never know how many copies of a particular document will be asked of you at the counter. Bring extra copies of your required documents so you don’t have to run out to the nearest photocopier (and lose your spot in the lines).

5. Avoid fixers. Do everything aboveboard. Don’t listen to individuals who promise shortcuts and discounts in the business permit renewal process. Their quick fixes may also quickly land you in hot water for tax evasion.

 

The best partner for renewing your business permit is someone who tells you the fees and steps needed exactly as it is. At DAYANAN Business Consultancy, we do exactly just that. Having helped over a hundred companies through the process, we know exactly how to save you time and effort. This allows you to focus on your core business functions better.

Let us take care of filling out forms and going to government offices for you. Contact us today!

FDA Consulting

The Food and Drug Administration (FDA) is the Philippine government agency charged with ensuring the quality and safety of the following products:

  • Processed food and drinks
  • Drugs and other pharmaceutical products
  • Dietary/herbal supplements
  • Medical devices
  • Cosmetics
  • Toys and child care articles
  • Household pesticides/cleaning agents
  • Veterinary products
  • Animal Feeds

In line with its mandate under the Department of Health (DOH), the FDA regulates the production, importation, and distribution of these products in the country.

A company that wishes to engage in such business activities must first obtain a License To Operate (LTO) from the FDA either as an importer or a manufacturer. Once done, the company must then apply for a Certificate of Product Registration (CPR) to ensure that its products comply with FDA technical standards.

DAYANAN can serve as primary liaison between your company and the FDA. Our familiarity with the regulatory framework and proactive approach will help ensure faster turnaround on your application. We will also link your company to laboratories recognized by the FDA to perform various required analytical tests on your products.

How to Register Your Business in Makati City, Philippines

Makati City business registration

Makati City has long been the country’s leading business and financial hub, serving as home to 40 percent of the country’s top 1000 multinational and local corporations. The city boasts of a highly-developed transport and communications infrastructure, quality shopping centers, state-of-the-art hospitals, and premiere residential areas. All these advantages have made Makati the location of choice for new businesses.

We have previously covered the steps on registering your Philippine-based corporation with national- and municipal-level agencies. In this article, we will highlight the specific, up-to-date requirements and steps for business registration in Makati City.

Makati City Business Registration / Mayors’ Permit

BASIC REQUIREMENTS:

1) Locational Clearance for Business

– to determine if the business activity you are applying for is allowed in the area

– will be issued by the Zoning Administration Division after five (5) working days if an inspection is needed

2) Proof of Business Address

a. Contract of Lease (if the place of business is rented)

b. Transfer Certificate of Title / Tax Declaration / Real Property Tax Receipt (if the place of business is owned)

3) Proof of Business Name and Activity / Line of Business

a. Business Name Certificate from the Department of Trade and Industry (DTI) (if sole proprietorship)

b. Articles of Incorporation or Partnership from the Securities and Exchange Commission (SEC) (if corporation
or partnership)

4) Barangay Clearance for Business

5) Comprehensive General Liability Insurance (CGLI)

– protects an enterprise from liability claims arising in the course of business

ADDITIONAL REQUIREMENTS BASED ON NATURE OF BUSINESS BEING APPLIED:

1) Residence Certificate A and B for Single Proprietorship, C and C1 for Corporation

2) Contractor’s License issued by the Philippine Contractors Accreditation Board (PCAB) for General/Specialty
Engineering Contractors

3) National Food Authority (NFA) License for Dealers of Rice/Corn and Wheat

4) Food and Drug Administration (FDA) Certification for Bakeries and Drugstores

5) Authority from Bangko Sentral ng Pilipinas (BSP) for Banking Institutions

6) Accreditation Certificate issued by DTI for Auto Repair Shop, Electronics, Radio, and other Electrical Equipment Businesses

7) Customs Broker’s Accreditation granted by the Bureau of Customs (BOC) for Customs Brokerage Businesses

8) Real Estate Broker’s License issued by the Professional Regulation Commission (PRC) for Real Estate Brokers

9) License issued by the Department of Labor and Employment (DOLE) for Local Manpower/Recruitment Agencies

10) License issued by the Philippine Overseas and Employment Agency (POEA) for Manning and Crewing Services

11) Pest Control License issued by Fertilizers and Pesticide Authority for Pest Control Services

12) License issued by the Optimal Media Board (OMB) for Video Rental Services

13) Occupancy Permit for Real Estate Lessors

14) License to Operate from the Philippine National Police (PNP) for Private Security Agencies

15) Clearance issued by the Department of Environmental and Natural Resources (DENR) for Mining Companies

16) Franchise granted by the Land Transportation Franchising and Regulatory Board (LTFRB) for Rent-A-Car and Transportation Services

17) License to Own and Possess Firearms issued by PNP

18) Accreditation issued by the Department of Information and Communications Technology (DICT) for Messengerial or Courier Services

19) License issued by the Department of Energy (DOE) for Dealers of Liquefied Petroleum Gas (LPG)

20) License issued by the National Telecommunication Commission (NTC) for Telecommunications Companies

21) Certificate of Accreditation issued by Philippine Shippers’ Bureau for Seafreight Forwarders

22) Accreditation issued by the Technical Education and Skills Development Authority (TESDA) for Training Centers

23) Accreditation Certificate issued by the Department of Education (DepEd) for Educational Institutions

24) Certificate of Authority to Operate issued by SEC for Financial Lending Institutions

3EASY STEPS FOR GETTING YOUR MAYOR’S / BUSINESS PERMIT

   STEP 1:

   Location: Business Permits Office (BPO), Ground Floor, New Makati City Hall Building II

   Estimated Time Frame: 30 minutes

a. Secure application form from receiving or processing clerks. Be informed of the requirements and processes.

         Note: If your business is considered “Subject for Inspection,” you will have to proceed to the Inspection Division.

b. Have the BPO check your requirements and accept your application. Officials will evaluate and assess taxes, fees, and charges. The BPO Chief will then sign the billing statement and application form to indicate approval.

   STEP 2:

   Location: Business Tax Division / Treasury Department, Ground Floor, New Makati City Hall Building II

   Estimated Time Frame: 5 minutes

a. With your approved application form and billing statement at hand, pay the corresponding fees and tax at designated windows.

   STEP 3:

   Location: BPO

   Estimated Time Frame: 15 minutes

a. Claim your Business Permit, Sanitary Permit, and Fire Safety Inspection Notice.

Note: Inspections will be conducted after release of Business Permit by the Bureau of Fire Protection (BFP), Health Department, and Engineering Office.

TOTAL TIME: 50 minutes

 

Want to save even more time? Let the experts at DAYANAN Business Consultancy do the work for you! We’ll be happy to guide you through the ins and outs of the Philippine business registration process!

 

Source: Makati City BPO

Makati City skyline image taken from www.makati.gov.ph

BUSINESS PERMIT RENEWAL 2017

Business Permit Renewal

 January is time for Business Permit renewal in the Philippines, and should be done between January 1st – 20th, 2017.  The law requires, every business establishment to annually renew its registration with the local government unit (LGU) that has jurisdiction over its place of business.

 

REQUIREMENTS FOR RENEWAL

  • Renewal of Barangay Clearance – present the Original copy of 2016 Barangay and Official Receipt of the previous year
  • 2016 Mayor’s Permit / License issued / Billing Assessment
  • Official Receipts of payments – 1st to 4th quarters or annual payment of the year 2016
  • Declaration of Gross Sales / Receipts for the preceding year, number of employees, floor area (in sq. meters) of the office /factory or premises/compound occupied
  • Residence Certificate A and B for single proprietorship, C and C1 in case of Corporation or partnership for the current year (cedula)
  • Income Tax Returns and Financial Statements (FS) for the preceding  calendar year which were filed with the BIR during the current year
  • SSS Clearance
  • Public Liability Insurance
  • Affidavit of No Income / No Operation, if no operations/ no income
  • Authorization Letter authorizing the representative to process all the above.

COMPUTATION OF BUSINESS PERMIT FEES

Business tax is imposed upon the company’s gross sales or receipts.  Rates vary depending on the nature of the business under Section 143 of the Local Government Code of the Philippines.

Gross Sales or Receipts include the total amount of money or its equivalent representing the contract price, compensation or service fee, including the amount charged or materials supplied with the services and deposits or advance payments actually or constructively received  during the taxable quarter for the services performed or to be performed  for another person excluding  discounts if determinable at the time of sales, sales returns, excise tax, and value added taxes (Book II, Section 130 (n) Local Government Code).

PENALTIES FOR LATE FILING AND UNDER DECLARATION OF GROSS SALES/RECEIPTS

Local Government Units typically impose a 25% surcharge on the unpaid amount plus 2% interest per month, on top of the unpaid amount, if filing is not accomplished by January 20th.
Failure to renew your business permit on time, may result in City Hall ordering the closure of your business.

If Gross Sales /Receipts declared in the Company’s 2016 Business Permits are lower than the Actual Gross Sales /Receipts per 2016 Audited Financial Statements the company will be subjected to a penalty of 25% surcharge and 2% interest per month for any computed Tax Deficiency/Delinquency noted during assessment.

BUSINESS PERMIT COMPLIANCE

Avoid the hassle of long lines and red tape, outsource your business permit renewal to Dayanan Business Consultancy.

What You Need to Know about Business Permits in the Philippines

Philippines Business RegistrationEvery business whether a corporation or partnership registered with the SEC or a sole proprietorship registered with the DTI is under the obligation to immediately obtain business permits in the municipalities where they operate.
Corporations whether PEZA registered or not operating without the necessary business permits will incur fines, penalties or closure from the BIR or City Hall.

Registration is required for every separate or distinct establishment or place of business including facility types where sales transactions occur and warehouse where inventory of goods for sale are kept, and must be obtained before commencement of business and payment of any tax due.

BIR FINES

Failure to Register

– Fine of not less than P5,000 but not more than P20,000 and imprisonment of not less than 6 months but not more than 2 years.

Compromise Fees

a. Cities 20,000
b. 1st class municipalities 10,000
c. 2nd class municipalities 5,000
d. 3rd class municipalities 2,000

Official Receipts

Failure to issue receipts/invoices 1st violation 10,000 – 2nd violation 20,000
Refusal to issue receipts/invoices 1st violation 25,000 – 2nd violation 50,000

The above are just a few of the penalties that the BIR may impose.

Mayor’s Permit

None registration with City Hall has its own penalties;

Makati City Penalty example:
SEC. 3A.11. Penalty – Any violation of the provisions of this Article shall be punished by a fine of not less than One Thousands Pesos (P 1,000.00) nor more than Five Thousands Pesos (P 5,000.00), or imprisonment of not less than one (1) month not more than five (5) months, or both, at the discretion of the Court.

The above does not includes a surcharge of 25% for late payments and a 2% monthly interest on the unpaid taxes, fees or charges including surcharges.

The documentation required varies according to the municipality, below are listed :

– Barangay Clearance/Permit for the new year
– Previous Year’s Business Permit
– Financial Statement/ Income Tax Return for the preceding year
– Latest Community Tax Certificate
– Contract of Lease/ Lessor’s Permit
– Comprehensive General Liability Insurance
– List of Company Employees with Medical Certificates

Documentary requirements may vary from year to year, we recommend that you check for changes before filing your business permit renewal with City Hall.

Annual Mayor’s Permit Fees (business tax) vary according to the nature of the company’s business, the company’s preceding years gross sales are used to calculate the amount of tax due which can be less than 1% to 3% or more, regardless of when the business started to operate .

In the case of a newly-started business the initial tax for the year shall be calculated on the capital investment or paid up capital, contract of lease and size of office.

All business permits should be prominently displayed in every location where business is transacted.