General

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.

SEC MC No. 28 – 2020

Securities and Exchange Commission (SEC/Commission) issues new requirement for corporations, partnerships, associations, and individuals to create and/or designate e-mail account address and cellphone number for transaction of business with the commission under SEC Memorandum Circular (MC) No. 28-2020.

Every corporation, association, partnership, and person under the jurisdiction and supervision of the Commission shall submit a valid official electronic mail (“e-mail”) address and a valid official cellular phone number within sixty (60) days from the effectivity of these rules ie., October 31, 2020. For future applications and those applications which are still pending primary registration with the Company Registration and Monitoring Department (CRMD), such information should be either indicated during the filling up of the registration forms or submitted within thirty (30) days from the issuance of the certificate of registration, license or authority.

Purpose of Email Addresses

The purpose of both the official and alternate e-mail addresses shall be where transactions, applications, letters, requests, papers and pleadings under the jurisdiction of, or for consideration by, the Commission may be processed, submitted and/or filed online. The Commission may likewise send notices, letter-replies, orders, decisions and/or other documents through the said e-mail addresses, and the corporations, associations, partnerships and individuals are deemed to have received those notices, letter-replies, orders, decisions and/or other documents on the date so sent by the Commission. Service of notice through this process shall be considered compliance with the notice requirement of administrative due process.

Purpose of Cellphone Numbers

The official cellphone number to be provided by all entities registered with the SEC in an additional security measure to ensure that the person accessing the e-mails sent by the Commission is the authorized person of the corporation or partnership to receive and retrieve the same. For every transmittal, Multi-Factor Authentication (MFA) utilizing mechanisms such as One-Time Personal Identification Number (OTP) scheme or Two-Step Verification by a Software-Based Authenticator will be performed by SEC to said cell phone number which the authorized person will have to input before the e-mail message can be retrieved.

Person in Control

The e-mail addresses and cellular phone numbers shall be under the control of the corporate secretary, the person charged with the administration and management of the corporation sole, the resident agent of foreign corporation, the managing partner, the individual, or the duly authorized representative. Provided, that the corporation, association, partnership or individual shall also submit proof of the authorized representative’s authority (i.e., special power of attorney or secretary’s certificate) to control the email addresses and cellular phone numbers, and to sign and file the Submission as (described in paragraph 6), Authorization and Certification of Authorization (described in paragraph 9), and/or Certification (described in paragraph 11) of the Memorandum Circular.

The Submission of the Email Addresses and Cellular Phone Numbers shall include the following:

a. Complete name of the corporation, association, partnership, or person;
b. The SEC registration number or identification number;
c. Official electronic mail address;
d. Official cellular phone number;
e. Alternate electronic mail address;
f. Alternate cellular phone number;
g. For corporations, the complete name and signature of the corporate secretary, the person charged with the administration and management of corporation sole, or the duly authorized representative;
h. For partnerships, the complete name and signature of the managing-partner or the duly authorized representative; and
i. For natural persons, his/her signature or his/her duly authorized representative’s signature.

Inclusion in General Information Sheet (GIS) or Notification Update Form (NUF)

Starting February 23, 2021 onwards the, the email addresses and cellular phone numbers shall be included in the General Information Sheet (GIS) or Notification Update Form (NUF) regularly filed with the Commission. If a corporation fails to include the email addresses and cellular phone numbers in the GIS or NUF regularly files with the Commission, such GIS or NUF shall be considered incomplete.

Electronic Commerce Act

The use of the Securities and Exchange Commission of email as a means of valid communication are based on the clauses below:

Whereas, Section 6 of Republic Act No. 8792, otherwise known as the Electronic Commerce Act (“ERA”), provides that information shall not be denied validity or enforceability solely on the ground that it is in the form of an electronic data message purporting to give rise to such legal effect, or that is it merely incorporated by reference in that electronic data message.

Whereas, Section 7 of ERA provides that electronic documents shall have the legal effect, validity or enforceability as any other document or legal writing.

Download the full memorandum circular: https://www.sec.gov.ph/mc-2020/mc-no-28-s-2020/

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)

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):

  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!

The Apostille: Simpler Authentication for Documents To Be Used Abroad

HCCH

Bringing documents from one state to another and having their validity recognized has always been difficult. A foreign corporation that wants to establish a Philippine subsidiary has to go through several steps just to authenticate its articles of incorporation from abroad. But with the Philippines recently joining the Apostille Convention, things are bound to get easier.

The Convention

The Apostille Convention (formally known as the Hague Convention Abolishing the Requirement of Legalisation for Foreign Public Documents) provides for the use of a security certificate called the “Apostille.” This simplifies the authentication process for public documents used across signatory countries. The Philippines officially became a member last September 12, 2018.

Drafted by the Hague Conference on Private International Law (HCCH), the international treaty will take effect between the Philippines and other states party to it on May 14, 2019. This is pending changes to be made by the Supreme Court to the Rules of Court with regards to foreign public documents. The Office of Consular Affairs under the Department of Foreign Affairs (DFA) will be responsible for implementing the treaty.

The Apostille

Previously, a public document must be authenticated both by the foreign ministry of its originating country and the foreign ministry of the country where it is to be used. This process is usually handled by embassies and consulates of the concerned states. In the Philippines, the certification issued by the DFA is popularly called the “red ribbon.”

Once the Convention becomes effective, public documents would no longer need to be consularized. An apostillized public document will immediately have legal effect in a foreign country where it is presented. Of course, the affixing of a red ribbon is still needed for states which are not members of the Convention.

The apostille is a standard form that can be placed or attached to the original document. It testifies that a document bears the signature of an authorized person, the capacity of the signatory, and an official stamp or seal. It does not, however, certify the content or purpose for which the document was issued.

Covered Documents

Public documents that can be apostillized according to the Convention are the following:

a) documents emanating from an authority or an official connected with the courts or tribunals of the State, including those emanating from a public prosecutor, a clerk of a court, or a process-server (“huissier de justice“)

b) administrative documents

c) notarial acts
       Note: This may include seemingly “private” documents such as contracts and wills

d) official certificates which are placed on documents signed by persons in their private capacity, such as official certificates recording the registration of a document or the fact that it was in existence on a certain date and official and notarial authentications of signatures.

Those that are not valid for apostillization include:

a) documents executed by diplomatic or consular agents;

b) administrative documents dealing directly with commercial or customs operations.

 

The apostille, once it is fully implemented in the Philippines, can boost trade and investment while making personal transactions easier. It will be useful for the millions of Filipinos working abroad as well as the large number of expatriates who have made (or are planning to make) the Philippines their second home.

BI Issues New Rules on Work Permits

work permit swp pwp

The Bureau of Immigration (BI) is imposing stricter requirements and procedures in issuing special work permits (SWP) and provisional work permits (PWP) to foreigners intending to work in the country.

According to BI Commissioner Jaime Morente, the Bureau will now require foreign applicants to submit additional documents before they are issued work permits.

Morente also said that the BI will see to it that no work permit will be issued to aliens who will be employed as construction workers, cashiers, janitors, carpenters, and other blue-collar jobs. Professions classified as regulated by the Professional Regulation Commission (PRC) will also not be allowed without the approval of the PRC. 

“This is to ensure that these work permits are issued only to aliens whose jobs could not be performed by Filipinos,” the BI chief said.

Morente said that the new rules were issued to address the reported increase in the number of foreigners employed in the country to the alleged detriment of Filipino workers.

“These new rules are meant to protect the interest of local workers, as we have observed that in the past, foreigners may abuse their permits and take away jobs from our kababayans,” he stressed. 

Among the requirements that work permit applicants will submit are: validity of stay as tourists; address, existence, nature of business, and financial viability of petitioning company; and SEC and other government licenses to operate.

Only authorized BI officers at the main office and alien control officers in the bureau’s field offices may approve or disapprove applicants for SWP and PWP.

DOLE New Rules

For the issuance of Alien Employment Permits (AEP) DOLE now requires that a company have either 50 Filipino employees and PHP5,000,000 in paid-in capital, PHP10,000,000 in paid-in capital. This does not apply to IT Enterprises registered with PEZA.

Dayanan Business Consultancy’s accredited visa consultants are available to assist with all your visa applications.

Five Benefits of Document Imaging Systems

document_imaging_system

Businesses are constantly looking for ways to cut costs and increase productivity. One of the many ways this can be achieved is by investing in advanced technologies that will eradicate timely hand-operated tasks. These allow organizations to waste less time on routine but necessary office work and more time on Important Matters.

What is a Document Imaging System?

  • A Document Imaging System is a software that allows users to store, organize and retrieve digital records. (E.g. scanned images, photos and general office documents).

What can it do to help your Business?

  • Be able to instantly access documents anytime, anywhere.
  • Implement an electronic workflow.
  • Sophisticated search and retrieval capabilities.
  • Merge a Document Imaging System with other essential business applications to manage IT costs and propel efficiency.
  • Guarantee document recovery in the case of a disaster. It allows multiple backups to be stored at offsite locations providing a means to recover data.

Document Imaging Systems are vital to an organization’s capability to process and share information quickly, helping employees make decisions faster. However, This  is only one step forward. Organizations looking to get the most out of the technology often forget two other crucial technologies that make these systems possible, which are Optical Character Recognition and Data Capture.

It’s almost always the same story every time. Businesses purchased a Document Imaging System believing  it would improve the productivity and reduce inefficiencies in the workplace but in their evaluations, they neglected to think about all the documents they presently have sitting in their filing cabinets around the office.  Whilst they can effectively take care of new, electronic documents, they do not have way of digitizing or extracting important data from existing paper documents. Optical Character Recognition and Data Capture are what make this possible. They allow organizations to get rid of cabinets full of paper documents, and make all of the information held on them accessible online throughout the whole organization. Without this capability, employees are left with half of the information,therefore only half of the productivity gains. With these in place, employees can appreciate not having to run around back and forth to the file cabinet or be asked to track down a relevant document out of the Archive.

The Best System we’ve come across, so far, has been Enadoc. Where you are able to Search efficiently, Organize, Capture and Secure your document, and  most importantly save time and money.

Has your organization invested in a Document Imaging System? If so, did they simultaneously acquire Optical Character Recognition and Data Capture solutions?

 

Contact us NOW for a presentation on how Enadoc can help your business succeed.

Starting a Business in the Philippines

Starting Business PhilippinesWhy would anyone want to start and do business in the Philippines?

The bureaucratic and legal hurdles a company or entrepreneur must overcome to incorporate and register a new firm here can be frustrating. However, with the help of a business consultant, that has extensive experience in Philippines business registration and setting up foreign owned businesses here, such as Dayanan Business Consultancy, that is not an issue.

The fact that so many foreign companies have regional headquarters, representative offices, foreign branch offices and other business setups in the Philippines, speaks volumes that it is well worth wading through the red tape to have operations here.

English Speaking and Talented Human Resources

One of the biggest advantages of doing business in the Philippines is that it has a higher level of English proficiency than any other Asian country. There is also an immense pool of talented Filipino graduates and experienced workers providing cost effective human resource solutions.

In addition, the Philippine Government offers incentives through a dozen Investment Promotion Agencies (IPAs) promoting “Economic Zones” in selected areas of the country. Incentives include various tax exemptions, tax holidays, special investor’s visas, and others to promote investment in businesses.

These include:

•    The Philippine Board of Investments (BOI)
•    The Philippine Economic Zone Authority (PEZA)
•    The Tourism Infrastructure and Enterprise Zone Authority (TIEZA)
•    Aurora Special Economic Zone Authority
•    Authority of the Freeport Area of Bataan (AFAB)
•    Bases Conversation Development Authority (BCDA)
•    Clark Development Corporation
•    Cagayan Economic Zone Authority (CEZA)
•    PHIVIDEC Industrial Authority
•    Philippine Retirement Authority
•    Regional Board of Investments (ARMM)
•    Subic Bay Metropolitan Authority (SBMA)
•    Zamboanga Economic Zone Authority

These secure ready-to-occupy world-class, environment-friendly, and competitively priced Special Economic Zones are waiting for various types of businesses, both commercial and industrial, to take advantage of them.

Depending on which Investment Promotion Agency is being utilized; these can include manufacturing, BPO, tourism, agri-business, IT services and more.

For example, the Philippine Board of Investments is focused on BPOs, the electronics industry, shipbuilding, and renewable energy. PEZA’s priorities are focused more on manufacturing and industrial agricultural manufacturing for export and BPO’s, as well as overall economic zone development and operation. There is some overlap in the kinds of businesses to which the IPAs will grant incentives.

It’s More Fun in The Philippines!

The Tourism Infrastructure and Enterprise Zone Authority of course – “encourage local and foreign investments in our tourism industry through the establishment of Tourism Enterprise Zones (TEZs) in strategic areas of the country.”

The tourism industry opens up a tremendous amount of opportunities for businesses, especially in the small to medium range.
TIEZA is giving incentives for the development of tourism related businesses such as:

•    Travel and tour services
•    Transport services – land, sea, and air
•    Adventure sports such as mountaineering, spelunking, and scuba diving
•    Convention organizers
•    Accommodation establishments – hotels, resorts, condotels, Inns, motels and homestay operators that cater to tourist
•    Tourism estate management services
•    Restaurants, shops, and department stores
•    SPAs
•    Health and Wellness facilities
•    Museums and Galleries (Especially in cultural heritage zones)
•    Theme Parks
•    Convention Centers
•    Zoos

To learn more about the procedures, time, and cost involved in starting a business in the Philippines, business contact the DBC Team now for a free consultation.

Opening Personal & Corporate Bank Accounts in the Philippines

Corporate Bank Accounts Philippines

Corporate Bank Account Philippines

All corporations doing business in the Philippines need a local bank account. There are many local banks, foreign owned banks and branches of foreign banks to choose from. The main advantage of opening an account with a local bank is their numerous branches all over the country, mall outlets open on weekends and payroll ATM accounts for employees.

 

Requirements for Company, Corporate or Commercial Bank Accounts in the majority of Philippine Banks:

1.    Certificate of Incorporation or License to Transact Business
2.    Articles of Incorporation
3.    By-laws
4.    Board Resolution to open bank account naming the authorized signatories
5.    Board Resolution election of company officers
6.    Secretary’s Certificate certifying the Board Resolution to open bank account naming the authorized signatories
7.    General Information Sheet
8.    Two valid IDS for each signatory

Requirements for Foreign Individuals Bank Accounts in the majority Philippine Banks:

Foreign Individuals: most banks require that foreigners present an Alien Certificate of Residence (ACR) issued by the Bureau of Immigration. Tourists who stay in the Philippines for more than 59 days will be issued an ACR. All others who are issued work visas or any other kind of long stay visa will also be issued an ACR.

Two  Valid IDs:
Passport
Driver’s license
ACR
Retirement ID issued by an official authority
DOLE ID

Some banks may require proof of address.