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Registration of Cosmetic Products in the Philippines Made Easy

registration of cosmetic products in the philippines

The Philippines is a growing market for cosmetics, with analytics company GlobalData forecasting the industry to be worth PhP 228.8 billion (USD 4.2 billion) by 2023. Contributing to this potential for an upswing is the country’s increasing population as well as lower unemployment rates. The archipelagic nation’s citizens appreciate beauty and social interactions, driving the demand for cosmetic products in the Philippines.

Clearly, there is an opportunity to be had here for enterprising individuals and corporations. After all, cosmetics is an umbrella term. Products such as perfumes, hair dyes, lipsticks, soaps, lotions, and other skincare items are all in high demand and will continue to be so in the short and long term.

If you are interested in importing, selling, or distributing cosmetic products in the Philippines, you need to first secure necessary permits from the Food and Drug Administration (FDA). Going through the registration process will show potential customers that you care about their health and safety.  

In this article, we give you the lowdown on how to register cosmetic products in the country.

Regulation of Cosmetic Products in the Philippines

Main Cosmetic Regulations in the Philippines

The Philippine regulatory environment for cosmetics is primarily based on the ASEAN Cosmetic Directive (ACD), an initiative to promote trade among members of the Association of Southeast Asian Nations (ASEAN)  by harmonizing technical industry requirements while maintaining safety and quality standards. 

According to this directive, cosmetic products are “any substance or preparation intended to be placed in contact with the external parts of the human body… or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly for cleaning them, perfuming them, or changing their appearance, and/or correcting body odours and/or protecting or keeping them in good condition.” 

Several other regulations have also been released by the FDA which are related to ASEAN’s streamlining initiative. Among them is Administrative Order (AO) 2016-0003 (“Guidelines on Unified Licensing Requirements and Procedures of the Food and Drug Administration”), which aims to improve the approval processes for cosmetic products and to strengthen the institution’s post-market surveillance activities by unifying and harmonizing the licensing requirements of the FDA. 

Regulating Bodies in the Philippines

The Center for Cosmetics Regulation and Research (CCRR) is the main arm of the FDA that is responsible for cosmetic product regulation. This department further branches into two divisions — (1) the Licensing and Registration Division and (2) the Product Research and Standard Development Division.

Steps in Registering Cosmetic Products in the Philippines

License to Operate (LTO)

A company is required to obtain an LTO before it can legally import, distribute, sell wholesale, and/or manufacture cosmetics.

Here at Dayanan Consulting, we help our clients by facilitating their application process with the FDA from start to finish, from LTO to labeling. They just need to provide us the necessary information and we help prepare the documents needed.

But if you choose to try doing it by yourself, here are the requirements to secure one:

  • Notarized Petition form from the owner, incorporator, or authorized representative
  • Joint Affidavit of Undertaking signed by the owner and an authorized individual (an allied health science professional) stating that they understand the FDA’s regulation for LTO; note that the authorized individual must also present their professional license or board certification
  • Proof of your Business’ Registration
  • Site Master File (this is required from manufacturers of drugs, devices, and cosmetics)
  • Proof of occupancy or business address
  • Floor plan and vicinity map of the business location
  • Risk management plan
  • Application fee

After preparing these requirements, you may now proceed to file them with the FDA. Note that if you are just renewing your LTO, submission of the first, second, and last items would suffice. You will then have to wait for the FDA evaluation results.

For manufacturers, pre-opening inspection is required as part of FDA’s post-marketing surveillance activities. The FDA may inspect all covered establishments at any time so you need to be prepared and compliant with all standards.

Notification

Before the product can be released to the market, the FDA must be notified first using the procedures outlined in the  Cosmetic E-Notification v.2.0 User Manual for Applicants. 

You need to provide the following information in your Cosmetic Product Notification:

  • Brand Name / Product Name / Product Variants – The complete name of the product should be given in the following sequence: brand name, line name (if applicable), product name, and the shade name/number if a single shade is notified (e.g. BRAND ABC PRODUCT XYZ EYSHADOW SHADE 1). If there are different shades, the shade name/number for each shade shall be declared.
  • Product Types – the category of the cosmetic product for which you are applying for notification.
  • Particulars of the Product – The validity of the notification may either be 1, 2, or 3 years at the option of the applicant. 
  • Intended Use – This refers to the function or use of the product and not the directions for use e.g. to moisturize the face, hand, etc.
  • Product Presentations – select whether you are applying for (1) a single product, (2) a range of variants similar in composition for the same use but differs in colors, flavors, etc., (3) palette(s) in a range of one product type, or (4) combination products in a single kit. 
  • Local Company Responsible for Placing the Cosmetic Product in the Market – Indicate the local company responsible for placing the cosmetic products in the market. This company must also have a valid LTO number.  If the company responsible for placing the cosmetic product in the market is a distributor, then the applicant must also declare the details of the direct supplier or manufacturer of the cosmetic product, namely Country of Manufacture, Address, and others. 
  • Establishment Information – It refers to the particulars of the manufacturer and/or supplier of the notified cosmetic product.
  • Person Representing the Local Company – It refers to the company representative who may be contacted by the FDA in case there are questions on the cosmetic product or if additional documents are needed to substantiate the application. 
  • Product Ingredient List – All the ingredients in the product must be specified by using the nomenclature from the latest edition of standard references (International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstract Services). Botanicals and extract of botanicals should be identified by its genus and species. The genus may be abbreviated. The functions and percentages of ingredients must be declared if they are substances with restrictions for use as specified in the annexes of the ASEAN Cosmetic Directive.

To apply, follow the steps below:

  1. Obtain a CCRR User Account by requesting one from info@fda.gov.ph. You must provide the following information to proceed:
    1. Email address or company email address
    2. Name
    3. Position
    4. Contact No.
    5. Company Name
    6. Company Address
    7. Product Classification: Cosmetics
  2. Log in at the FDA e-portal (https://ww2.fda.gov.ph).
  3. Click on “New Case” and accomplish the ASEAN Notification Form.
  4. Download the “Order of Payment” and assign this task to the FDA Cashier.
  5. Pay the fee either through any Landbank branch or by online Bancnet payment methods.
  6. Wait for the Result of Application.
  7. Download and print the notice of acknowledgment once your application is approved.

Organizations that have submitted correct application documents will then be issued a Cosmetic Product Notification certificate which is valid for 1-3 years. Those with insufficient documentation will be given a Notice of Deficiencies wherein clarification or further explanation of details will be asked. Finally, anyone who declared misleading information or failed to meet FDA standards will merit a Letter of Disapproval.

Acknowledged cosmetic notifications may be revalidated for a new validity date, where the new validity date will be based on the date of submission of the revalidation application.

Note that the same process of application for cosmetic e-notification applies for revalidation. In the e-portal, the previously acknowledged case must be selected to continue with the task for Revalidation Application. There must be no modifications from the information provided during the previous application to avail of revalidation. Hence, any changes to the information will constitute a new notification application.

In the event that the notification is desired to be cancelled, the applicant may choose to cancel the application. This option is available in the Revalidation Application Task.

Manufacturing Requirements: GMP, Ingredients, and Labelling

For manufacturers, your manufacturing processes and practices — personnel, premises, equipment, sanitation and hygiene, etc. — must be compliant with the Good Manufacturing Practices (GMP) set by the ASEAN guidelines. 

Note that a Certificate of GMP Compliance will only be issued upon the demonstration of satisfactory compliance and will be effective up to the validity of your current LTO. Thereafter, it shall be issued every time your LTO is renewed.

Aside from the procedures and processes, you also need to ensure that ingredients used in your cosmetic products adhere to ASEAN cosmetic regulations. The annexes of the ASEAN Cosmetic Directive provides prohibitions and regulations of cosmetic product ingredients as listed below:

Table 1. Annexes of ASEAN Cosmetics Directive that Provide the Regulations and Ingredient Prohibitions for Cosmetic Products in the Philippines

ASEAN Cosmetics DirectiveRegulations and Prohibitions
Annex IISubstances that are prohibited to form part of the composition of cosmetics products
Annex IIISubstances that are prohibited to be contained in cosmetic products except for the ones subject to restrictions and conditions laid down
Annex IVColoring agents that can be used in cosmetic products
Annex VIPreservatives that can be contained in cosmetic products

When it comes to labelling of cosmetic products in the Philippines, the following must be seen on your product’s packaging:

  • Weight or volume of the product content
  • Brand, product name, and its function
  • Batch number
  • Manufacturing or expiration date of the product in terms of (month/year)
  • Country where the cosmetic product is manufactured
  • Instructions on how the product is used
  • Special precautions (if any)
  • List of all the ingredients in the product
  • Name and address of the company or individual who placed the product in the market

For decorative cosmetic products that are marketed in multiple color shades, all coloring agents may be listed as long as the description includes the words, “may contain” or “+/”. 

Penalties Associated with Cosmetic Products in the Philippines

Misbranding of cosmetic products, whether deliberately or accidentally, will net violators jail time of at least one (1) year or a maximum of ten (10) years. Fines can also be imposed which range from Php 15,000 to Php 500,000. Some may even have to deal with both depending on a court’s decisions.

On the other hand, for violators who are manufacturers, importers, or distributors of any cosmetic product, the minimum jail time would be five years while the amount of the fine will range from Php 500,000 to Php 5 million.

FDA-Approved Food Supplements in the Philippines: A Quick Guide (Part 1)

As the threat of the COVID-19 pandemic continues to loom, the adage “health is wealth” has never been more true. People are starting to invest more seriously in the physical well-being of their families and loved ones. This is where FDA-approved food supplements in the Philippines come in.

With experts saying that a vaccine is at least a year away, maybe even more, prevention is taking center stage. Supplements help individuals increase their daily intake of recommended energy and nutrient requirements. This makes people less vulnerable to common illnesses as well as the dreaded COVID-19.

If you are thinking of selling, importing, and distributing food supplements in the Philippines, you must first obtain the approval of the Food and Drug Administration (FDA). This article provides you the basics of FDA Philippines food standards, including items such as the difference between drug-based and processed food categories for supplements, prohibited and allowed ingredients, making therapeutic claims, and what to include in a food label.

In the upcoming Part 2 article, we will discuss the detailed requirements for FDA approval and the corresponding fees and charges.

What are Food or Dietary Supplements?

As defined by Administrative Order No. 2014-0029, these are processed food products that help supplement the diet. A food supplement may contain dietary ingredients such as vitamins, minerals, herbs, amino acids, and other dietary substances made from plant, animal, natural, or artificial matter. It may take various forms, including those of liquids, capsules, pills, tablets, powders, and gels. It is not marketed as a conventional food or as replacement for drugs and medicines.

Does my dietary supplement fall under the Food or Drug category?

Based on FDA Philippines Officer Order No. 22 s. 1991, your vitamin or mineral product will be classified as drug-based if it meets the following conditions:

1) Has clinical therapeutic claim/s with regards to a specific vitamin deficiency or disease;

2) Has a concentration per dosage form of greater than 150 percent of the Philippine Dietary Reference Index (PDRI) for water-soluble vitamins and/or greater than 105 percent of the PDRI for fat-soluble vitamins;

3) Takes the form of a pharmaceutical dosage or injectable; and

4) Has additional pharmacologically-active ingredients present

On the other hand, your product will be categorized as a food supplement (more specifically a “processed food”) if:

1) Its indication is that of “Dietary or Health Supplement;

2) Its concentration per dosage form is less than 105% of the PDRI for fat- soluble vitamins and/or less than 150 percent for water-soluble vitamins;

3) It may be available in both non-pharmaceutical and pharmaceutical dosage form except parenterals;

4) It is available as either a purified or a natural product; and

5) It contains no additional pharmacologically-active ingredients.

Under FDA Philippines Administrative Order No. 2014-0029 (Annex A), food products are further classified according to microbiological risk: low, medium, and high. If your dietary supplement contains herbs and botanicals and/or products with other nutritional substances, it will be categorized as a high-risk food; if it has vitamins and minerals and/or amino acids, it will be considered as a medium-risk food. The authorization process and the inspection priorities of the FDA would depend on these subcategories.

What ingredients can be included in my health supplement?

FDA-approved food supplements in the Philippines must meet the regulatory body’s key standards. Among these is the ASEAN Negative List, which details substances that should not be used in health supplements. The prohibited items include:

1) Deadly Nightshade

2) Marijuana

3) Hemlock

4) Chaparral

5) Opium / Poppy

For its part, FDA Philippines Circular 2006-016 enumerates all authorized food additives. These are some examples of what we call additives today:

1) Artificial sweeteners

2) Emulsifiers

3) Food Colors

4) Flavor Enhancers

5) Preservatives

Any food additive and functional classes that will be adopted by the Codex Alimentarius Commission (CAC) shall be automatically included as an addendum to the circular’s Appendix for Food Additives.

What kind of claims can my food supplement make?

Food product claims are regulated under FDA Philippines Circular 2007-002. This circular adopts the CAC Guidelines for Use of Nutrition and Health Claims as its standard for evaluating nutrition and health claims made in advertisements and food labels. It must be noted that products that make unproven claims could be banned from being sold in the Philippine market.

Other relevant regulations include:

1) Administrative order 2014-0029: prohibits the use of curative and therapeutic claims under Chapter VI, Part C of the Guidelines in the Registration of Processed Food Products.

2) Administrative Order 2014-0030: precludes the declaration of misleading and prohibited claims, specifically those in the labels of prepacked foods, under Section VII.

What should be on the label of my dietary supplement?

FDA Philippines Administrative Order No. 88-B s. 1984, as amended by Administrative Order 2014-0030, regulates the labeling of prepacked food, particularly food supplements. Its main provisions are:

1) The following details must be included on the label:

  • Product name
  • Brand name and/or trademark
  • Full ingredient list
  • Net content

Note: Either a per volume or per quantity indication is allowed. For multi-packs, the total quantity as well as the number of individual portions must be indicated.

  • Name and address of the manufacturer and/or repacker, packer, importer, trader, and distributor

Note: For imported products, the country of origin as well as the complete name and address of the importer should be indicated.

  • Lot identification
  • Storage conditions
  • Expiration date
  • Food allergen information (to be mentioned below the ingredient list)

Note: The following allergens and its derivative products must be clearly indicated on the label:

a) Cereals containing gluten
b) Crustaceans
c) Eggs
d) Fish
e) Milk, including lactose
f) Peanuts
g) Soybean
h) Sulfites
i) Tree nut and other nuts
  • Instructions for use
  • Nutrition information

Notes:

Full nutritional declaration is required, especially if a product claims to contain certain nutrients. Only foods for special purposes, medical or otherwise, are exempted. The quantities must be displayed in a tabular form and declared according to the portion size or a specific weight or volume. Vitamins and minerals are to be expressed in mg or µg. The exceptions are Vitamin A, D, and E, which are to be expressed in IU (International Units).

The indicated recommended daily allowance must conform to the Philippine Recommended Energy and Nutrient Intakes (RENI) for male adults aged 19 to 29. Foods for specific groups may use values applicable to such age groups, which will have to be indicated in the labeling. The actual nutrient content of vitamins and minerals should at no point be lower than 80 percent of what is declared on the label. There is no upper limit of overages for micro-nutrients and fiber though.

2) Additives must be properly labeled according to CAC standards.

3) All mandatory information on labels must be in English and/or Filipino. For imported products, the use of other languages is allowed but they should also carry a corresponding English translation.

4) For FDA-approved food supplements in the Philippines, the following statement in Filipino must be included in every advertisement or promotional effort as per Administrative Order No 2010-008:

“IMPORTANT REMINDER: THIS PRODUCT IS NOT A DRUG AND SHOULD NOT BE USED FOR ANY TYPE OF ILLNESS” (non-official translation)

This message should be printed in a size of at least one-third of the size of the largest letter or logo. It must be prominently printed using capital and bold letters using either Arial or Tahoma font.

5) Qualification for other standards such as for halal (Muslim) and kosher (Jewish) may be included in the label but would require proper substantiation. The assigned registration number may also be included on the label.

Need help with registering your food or dietary supplement?

If we handle it, you are guaranteed to have your FDA-approved food supplements in the Philippines. Let us help you. Contact us here and stay tuned for our next article on the registration process, requirements, and fees.

Fees and Requirements for FDA-Approved Food Supplements in the Philippines (Part 2)

Here’s Why You Should Retire in the Philippines

Did you know that you can migrate to and retire in the Philippines as early as 35 years old? Yes, you can! This is just one of the reasons why retiring in the Philippines could—and should—be on your bucket list. But before you pack your suitcases, it would be wise to research and weigh the pros and cons of such an important decision. Here is a list that will hopefully help you decide whether to get a retirement visa in the Philippines or not:

Pros:

Cons:

Pros of retiring in the Philippines
In a nutshell: If you want to live comfortably even on a budget, enjoy paradise-like surroundings, and interact with friendly English-speaking people, then this archipelago is the retirement destination for you.
Low Cost of Living
According to Investopedia, the Philippines is the fifth cheapest country to retire to for 2018. Most expats can live comfortably on about USD800 to USD1,200 a month—including dining out and in-country travel, at least according to International Living, a website that covers living costs in different countries.
Household help is also abundant and cheap, so you can easily find someone to cook, clean, and do other chores around the house—even with a small budget.
Friendly Filipinos





Filipinos are world-renowned for being happy people who serve with a smile. What’s more, they speak English well given its inclusion in the school curriculum and the prevalence of American tastes in pop culture.
If you’re an English speaker, you will find communicating with locals to be relatively easy. The English Proficiency Index 2019 ranked the Philippines as #1 in Southeast Asia (#2 in Asia, second only to Singapore) and #20 Worldwide (out of 100 countries surveyed), proving the country’s high proficiency in the language.
Picturesque Scenery
The Philippines is a beautiful country. Home to six UNESCO World Heritage Sites, the tropical country has something to offer for everyone. From the mountains, beaches, and even sand dunes, the country is a sight to see — and you don’t need to break the bank to do so. The following is just a tiny sample of what you can expect:
All these among many, many others.
Government Incentives for Expats
A dedicated government office, the Philippine Retirement Agency (PRA), ensures the provision of benefits to expats such as senior citizen discounts, duty-free imports (up to USD7,000 worth of household goods, and exemption from airport travel taxes. Expats in the Philippines are also allowed to start and own businesses.
Lastly, holders of the retiree visa (called the SRRV or Special Resident Retiree Visa) are considered permanent Philippine residents and would no longer need to have periodic visa renewals. That means you can leave and return to the country whenever you please without having to re-apply for residency.
Low Minimum Retirement Age
As mentioned earlier, you don’t have to wait until you’re 60 to enjoy the fruits of your labor. As long as you submit the requirements, you can retire in the Philippines even as a 35-year-old—something that sets the country apart from its peers in Southeast Asia. Application and process requirements for Philippine immigration are also relatively simple compared to neighboring countries.
Cons of retiring in the Philippines
In a nutshell: If you are used to First-World infrastructure and healthcare even in rural areas, or are easily spooked by the smallest possibility of risk, the archipelago could slide a little down your list of retirement destinations.
Less-developed Infrastructure
The local infrastructure may not be the same or at par with those of more developed countries. This is more of an issue with the rural provinces, but if you decide to live in the urban metropolises (e.g. Manila, Cebu, or Davao), you can expect good-enough transportation and utility services.
Public Safety
As of April 2019, the US has placed the Philippines in Alert List Level 2 and reminds its citizens to “Exercise Increased Caution” when traveling in the country. It must be noted though that five (5) out of the top 10 safest South East Asian Cities in 2018 came from the Philippines. If you avoid the southern island of Mindanao, you are generally safe from terrorist threats.
Inaccessible Rural Healthcare
If you need regular check-ups and treatment, living in rural areas might not be the best option. The country’s capital, Manila, may be famous for its traffic jams, but it more than makes up for it with healthcare that’s both accessible and affordable for expats.
Where do you get a retirement visa in the Philippines?
The Philippine Retirement Authority (PRA) issues the Special Resident Retiree’s Visa (SRRV), a special non-immigrant retirement visa in the Philippines. The PRA is actually under the Department of Tourism and NOT the Bureau of Immigration. Having the SRRV actually exempts you from some Philippine immigration requirements.
Is retiring in the Philippines for you?
Every country has its pros and cons. All possible factors should be carefully evaluated before making any decisions. though It may be prudent to visit the country a few times and to look at it from the perspective of a potential resident, not a tourist.
Need help in visa processing?
Have you decided to retire in the Philippines? DAYANAN Business Consulting can assist in processing visas for you. Reach out to our Visa Specialist here.
How to Apply for FDA LTO (License to Operate) in the Philippines
 
Interested in FDA LTO application (License to Operate from the Philippine Food and Drug Administration) but don’t know where to start? 

This new guide gives you a complete step-by-step process on how to apply for an FDA LTO in 2020.
While there are quite a few articles online on FDA LTO application, they are mostly outdated. 

One major change to the process is that it is now done online via https://eportal.fda.gov.ph (the integrated application form may be found here). 

Once processed and approved, the LTO will be mailed to you; no need to pick it up from regional FDA centers.
Click the links below to go directly to that part of this article:
  1. What is an LTO? Why would you need one?
  2. How to Apply for FDA eLTO User Account
  3. License to Operate Requirements
  4. Steps for FDA LTO Application
  5. Tips to make application easier and faster
What is an LTO or License to Operate? Why would you need one?
An LTO allows you to legally import, distribute, sell wholesale, and/or manufacture food, drugs, cosmetics, and medical devices. It is also a requirement before you can obtain a Certificate of Product Registration (CPR), a seal of approval which indicates that your product complies with health, safety, and technical standards set by the FDA in the Philippines.
Operating without a license can spell disaster for your business. If caught, your LTO may be suspended, revoked, canceled, or disapproved upon renewal. Likewise, existing licenses that were not renewed after one-hundred twenty (120) days from the date of expiration will be automatically canceled by the FDA. Not only that, but the company will automatically be delisted from the FDA’s list of licensed establishments, so be sure to renew on time.
Important Reminder: 
Only companies incorporated in the Philippines may apply for LTO.
All guidelines and penalties may be found on the FDA website: http://www.fda.gov.ph
 
How to Apply for FDA eLTO User Account
Per FDA Circular 2016-004 (Procedures on the Use of the New Application Form for License to Operate through the FDA Electronic Portal), the application process has been moved online. With the goal of increasing transparency, accessibility, and efficiency of the process, this decision has been especially beneficial for businesses based outside Metro Manila.
Before you can access the E-portal, you must first create a User Account, the application for which is not as straightforward as what you may be used to. Instead of a simple sign-up button, it instead involves sending a few emails. Here’s how to create a new User Account for the FDA E-Portal System:
Creating eLTO User Account
  • First, accomplish an authorization letter for the eLTO User Account Application. This will designate a specific individual as eLTO account holder.
  • Next, send an email to request for a User Account to the FDA’s Public Assistance, Information and Receiving (PAIR) unit via pair@fda.gov.ph with the following format:
SUBJECT: Request for eLTO User Account

BODY: 

a. E-mail address (preferably company email address) 
b. Name of the authorized company representative (preferably permanently employed and not merely a consultant) 
c. Position in the company 
d. Contact Number 
e. Company Name
  • Don’t forget to attach a scanned Authorization Letter in PDF format. Be sure that it is completed (signed and notarized) and virus-free.
Below is a sample email provided by the FDA:
From: https://ww2.fda.gov.ph/attachments/article/330042/FDA%20Circular%20No.%202016-004.pdf
About the eLTO User Account
Please take note that the User Account details will be sent to the company email address provided in the body of the email, not to the original sender’s email address. User Accounts are usually issued within two (2) days upon receipt of the completed request by the FDA in the Philippines. Requests received after 5:00 pm on regular working days, holidays, Saturdays, and Sundays shall be processed on the next working day.
Each User Account is unique to one company and is valid for one (1) year. Requests for replacing the authorized company representative as well as account reactivation must be sent to pair@fda.gov.ph at least three (3) months before the expiration of the User Account.
Once you have a valid User Account in hand, the E-Portal can now be accessed. Filling up the forms and uploading the documents can now be done via the portal. The E-Portal accepts new, renewal, and variation applications.
The accomplishment of the eLTO may be done via http://www.fda.gov.ph.
License to Operate Requirements
The following are the License to Operate requirements for initial and renewal applications. Ensure that all documents are secured before applying to avoid processing delays.
Requirements for FDA LTO - Initial and Renewal Application
FDA LTO Initial Requirements:
  • Completed Application Form with Declaration and Undertaking
  • Proof of Business Name Registration
  • Risk Management Plan
  • Site Master File (for manufacturers of drugs, devices and cosmetics)
  • Fees payment
FDA LTO Renewal Requirements:
  • Completed Application Form with Declaration and Undertaking
  • Payment of fees
Now that you have all the requirements, the application for the actual license can now follow.
Steps for FDA LTO Application
Applying for an initial FDA LTO consists of the following steps: filing, evaluation, and inspection. An application is considered filed only if all necessary requirements are met, including payment of fees. After filing, the FDA will evaluate all LTO applications to determine whether to grant the license or not. Lastly, a pre-opening inspection shall be conducted for manufacturers. In addition, all establishments covered under the FDA may be inspected anytime by the agency to ensure proper compliance with its set rules and regulations.
  • Log-in to the e-Portal using the User Account provided by FDA at http://www.fda.gov.ph.
  • Click “New Case” on the upper left-hand side and select “License to Operate v2.0” which can be found under Electronic Licensing.
  • Make sure you’ve read and fully understood the “Declaration and Undertaking” and click the “I Agree” button before proceeding.
  • Under the General Information tab, select the appropriate Product Type, Primary Activity, and Type of Application from their respective drop-down menus.
  • (Each primary activity has its applicable sub-options. Accomplish the General Information appropriately).
  • Under Establishment Information, provide the complete establishment name, TIN, address, and contact details. Use the Show Map Tool and move the arrow to the exact address of the establishment and click the “Submit” button.
  • Provide needed information under “Details of the Authorized Officer” and “Details of the Applicant.”Upload the required documents (depending on LTO type). Make sure documents are in PDF format.
  • Double-check the total amount to be paid by looking at the Order of Payment section, which can be downloaded if needed.
  • Payment can be made using existing FDA mechanisms.
  • Please note: Under the “Assign Task” section, please click the “Continue” button in order for the application to be processed by the FDA.
Here are some tips to make application easier and faster:
Tips for Faster and Easier FDA LTO Application
Tip 1: Follow documentary requirements listed in Administrative Order (AO) 2016-0003 (“Guidelines on Unified Licensing Requirements and Procedures of the Food and Drug Administration”):
  • Submit files in PDF format and ensure that there are no bugs, viruses, or anything that can jeopardize the system of the FDA.
  • All documents must be scanned and compiled with 100-150 dots-per-inch (dpi).
  • All document file names must be less than 40 characters, should not contain the following characters: \ ? / : * ” > <
Tip 2: Make sure to submit all forms completely. Do not forget to attach files to emails before sending them.
Tip 3: Get assistance from DAYANAN Business Consultancy! With our FDA Consulting services, you would no longer have to stress and fret over the LTO application process.
After you’re done applying, expect your FDA License to Operate (LTO) in the mail! We hope these tips answer your queries on how to apply for an FDA LTO. If you would like to avail of our FDA consulting services, you may contact us here.
FDA Consulting Philippines
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):
  1. What permits do I need to renew? When is the deadline for each?
  1.  What are the penalties for non-renewal or late renewal of business permits? 
  1. What are the needed requirements and fees for business permit renewal with each government office?
  1. What are the steps for renewing business permits? How long will the process take? 
  1. What other tips should I know about business permit renewal?
 
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!
 
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