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Center for Drug Regulation and Research

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Center for Food Regulation and Research

Complete Guide on How to Apply for a Food CPR Version 2

LICENSING OF FOOD ESTABLISHMENTS

LTO is an authorization issued by the FDA to an establishment to grant permission to undertake a trade or carry out a business activity, such as manufacturing, importation, exportation, sale, offering for sale, distribution, or transfer of food products.

The following food establishments regulated by the FDA shall secure a License to Operate:

  • Manufacturers are establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formulating, filling, packaging, repacking, altering, ornamenting, finishing and labelling with the end in view of its storage, sale or distribution.
  • Repackers are establishment engaged in the process of packaging or changing of container, wrapper (that may include or not a changing of label) from a bulk material to retail packaging sizes in furtherance of distribution of food.
  • Toll manufacturers are manufacturer that conduct contract manufacturing where conditions of the contract are defined, agreed and controlled; and all aspects of contracted work are specified to obtain quality product/s conforming to the agreed standards.
  • Distributor/Importer/Exporter are establishments that that imports or exports raw materials, ingredients and/or finished products for its own use or for wholesale distribution to other establishments or outlets. If the distributor/importer/exporter sells to the general public, it shall be considered a retailer.
  •  Traders are establishment which is a registered owner of food and food products and/or procure the raw materials and packing components, quality control standards and procedures, but subcontracts the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage in the distribution and/or marketing of its products.
  • Wholesalers are establishments engaged in local distribution of pre-packaged food products in commercial quantity.

Application of License to Operate is through the FDA Electronic Portal. The use of the new application form and the corresponding procedures thru the e-portal facilitates application in terms of timeliness and ease of submission especially for the Applicants outside of the National Capital Region. Please refer to FDA Circular 2016-004. (FDA Circular No. 2016-004 )

The following documents shall be uploaded using the E-Portal. Scanned copy should be 100-150 dpi(dots per inch), maximum of 2MB.

  • Initial/Renewal
  1. For the declared authorized officer in the application form:
    1. Board resolution/Board Certificate for Corporation;
    2. Power of Attorney for single proprietorship;
    3. Partnership resolution for partners and
    4. Authority from the head of agency for government agency
  2. Business Name Registration:
  3. For single proprietorship Certificate of Business Registration issued by the Department of Trade and Industry (DTI);
  4. For corporation, partnership and other juridical person - Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation;
  5. For cooperative - Certificate of Registration issued by the Cooperative Development Authority and Articles of Cooperation; or
  6. For government-owned or controlled corporation - the law creating the establishment, if with original charter, or its Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation, if without original charter.
  7. Relevant credential/s of the declared qualified person in the application form (e.g. QPIRA certificate for Food/HACCP/Food Safety Seminar Certificate)
  • Variation

The list of variations, the conditions, and the documentary requirements is attached as Annex B of Administrative Order No. 2016-0003

Unless revoked, the LTO shall have the following validity period:

  1. An initial license issued shall be valid for two (2) years
  2. A renewed license shall be valid for five (5) years while a renewed license for bottled water processor is three (3) years.

Administrative order 153 s. 2004 (Revised Guidelines on Current Good Manufacturing Practice in Manufacturing, Packing, Repacking or Holding Food), AO 18-a s. 1993 and RA 8172 (ASIN Law)

Classification Initial

(2 years validity)

Renewal

(5 years validity)

1.  Food Distributors (Importer, Exporter, Wholesaler) 8,000.00 20,000.00
2.  Food Manufacturer    
     2.1 1M and below 2,000.00 5,000.00
     2.2 over 1M but below 5M 4,000.00 10,000.00
     2.3 5M but below 10M 6,000.00 15,000.00
     2.4 10M but below 20M 10,000.00 25,000.00
     2.5 20M but below 50M 20,000.00 50,000.00
     2.6 50M and above 30,000.00 75,000.00
3. For Bottled Water follow AO 18-A s. 1993 and RA8172 for iodized salt    

Note: Surcharges/penalties are imposed for late renewal as per FDA Circular 2011-004.

LRF – FDA Circular No. 2011-003 Collection of Legal Research Fee Imposed by RA 3870

Step 1: Go to the BancNet Online homepage. (https://www.bancnetonline.com). Select the Banc of your choice.

Step 2: A Security Message pop-up window will appear. Click “Continue” to proceed.

Step 3: Read the terms and conditions then click the “I Agree” button to proceed.

Step 4: Click “Payment” and set “FDA Philippines” as the Biller/Institution in the drop down.

Step 5: Take note of the “Account Number” found in the Order of Payment that will be generated right after filling up the FDA online registration form as this will serve as the “Reference Number”.  Enter the “Account Number” on the “Reference Number: text box and fill up the other information needed then click submit.

Step 6: Enter the Card Number found in the front of your debit card in the “ATM Card Number” text box. Select “Account type”. Enter the “Total Amount Due” in the “Amount to be paid” text box plus the Php 15.00 bank charge.

Step 7: Print the transaction receipt as your payment reference. Payments will be posted in the FDA system after 4-5 calendar days. FDA will issue an Official Receipt (OR) within 5-10 calendar days after posting. Present your printed transaction receipt upon claim of the FDA OR for verification purposes.

You may refer to FDA Advisory No. 2015-021

The LTO shall be renewed within 90 days before its expiration as per FDA Circular No 2016-006. Please refer to FDA Circular No. 2016-006.

Page 1 shall contain Type of application, Primary activities, Name of Establishment, Name of Owner, LTO Number and Validity and Payment Details.

Page 2 shall contain the additional activities (whenever applicable).

You may refer to FDA Circular No. 2016-006.

30 calendar days upon receipt of complete documents.

REGISTRATION OF PRE-PACKAGED, PROCESSED FOOD PRODUCTS (ISSUANCE OF CERTIFICATE OF PRODUCT REGISTRATION)

All processed food and food products including food additives, food supplements and bottled water manufactured and/or distributed (i.e. imported, exported and/or wholesale for local distribution), for trade and/or repacked are required to secure a Certificate of Product Registration before these are sold, offered for sale or use, distributed or supplied, among other marketing and promotional activities as per R.A. 9711 and A.O. 2014-0029.

Food establishments with License to Operate as Manufacturer and Trader who directly import and use raw materials, ingredients and food additives for their own use or for further processing to manufacture a processed food product, need not secure a CPR for the raw materials, ingredients and food additives. However, the sources of these raw materials should be notified to FDA to be reflected in the Licensing Database of Center for Food Regulation and Research.

You may refer to FDA Circular No. 2016-014 dated 12 August 2016, Procedure for the Use of Electronic (E-Registration) System for Pre-Packaged Processed Food Products prior to filing for registration. For further guidance on registration requirements and food regulations, please refer to Administrative Order No. 2014-0030 (Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products, for Other Purposes). You need to fill up Initial Application Form. You will also need to upload a scanned copy of the following documents in the system during application:

  1. Compliant labels in accordance with the prevailing labelling guidelines stipulated in Administrative Order No. 2014-0030
  2. Pictures of the product in all angles from at least two different perspectives allowing visual recognition of a product as the same with the one being registered pictures of the product in all angles

As applicable, documents to substantiate claims, such as technical, nutritional or health studies or reports, market-research studies, Certificate of Analysis, quantitative analysis and computations, scientific report or studies published in peer-reviewed scientific journals, certificates or certification to support use of logo/seal on SangkapPinoy, Halal, Organic, or Kosher food and in compliance with current labelling regulations.

Fees and charges will be computed by the system based on the number of years (2, 3, 4 or 5 years validity) applied for and type of product. You may refer to Administrative Order No. 50-2001 for the schedule of fees. Payment may be made through the FDA Cashier by presenting your printed Order of Payment form. Payments through Bancnet Online and LandbankOncoll are also accepted.

Only Initial applications for Food Supplement are required to submit a representative sample in commercial presentation consistent with the E-Registration application. It should be properly labelled with the respective case number, packaged accordingly to protect the contents and submitted to the Food and Drug Administration Main Office Building within ten (10) days upon payment of assessed fee through either of the following means:

  1. Personal delivery to the Food and Drug Action Center (FDAC) Unit Starmall Alabang; or
  2. Delivery via registered courier with the following information:

    -TO: FOOD AND DRUG ADMINISTRATION – Civic Drive, Filinvest City, Alabang, Muntinlupa City 1781
    -FROM: Company’s complete name and address
    -SUBJECT: Food Product E-Registration Application (Case No.)

A previously registered product initially for local distribution shall be allowed to be exported using the same CPR as long as the following conditions are met, and labelling and standards of the importing country are likewise met:

  1. The same brand name
  2. The same product name/variant
  3. The same product formulation/ ingredients in the same order of proportion

Amendment application of Packaging Design for export product shall be made and labels in the language of the importing country shall likewise be submitted.

Applications filed through the E-Registration system are processed within 114 calendar days. You may track the applications through the Process Map function of the system in the electronic portal.

Yes. Each importer should secure his/her own CPR for the products that he/she will import. The name and address of the importer is reflected on the CPR which is needed during importation and release of goods from the Bureau of Customs. The CPR also authorizes the importer/distributor/wholesaler to distribute the products locally.

The CFRR E-Registration User Account and Password is company-specific. An authorized representative handling multiple companies must secure a separate user account and password for each respective company. You must secure a notarized authorization letter from the company (with a valid License to Operate Number) being represented or the company account holder. Send the request for a User Account to [email protected] following the format specified below with the scanned notarized authorization letter:

SUBJECT: CFRR:E-Registration

BODY: Email Address:

          Last Name:

          First Name:

         Middle Name:

         Company Name:

The issued CFRR E-Registration User Account will be sent to the e-mail address you provided in the request. Be sure to check the Spam folder of your e-mail if you have not received a reply within 3 working days.

You may also use your E-LTO User Account and Password for E-Registration by having it validated through a request sent via email to [email protected] following this format:

SUBJECT: CFRR:E-Registration (Re-validate)

BODY: Email Address:

          Last Name:

          First Name:

         Middle Name:

         Company Name:

         User Account:

           Password:

The User Account and Password has a validity of 2 years. You will need to renew these by sending a request via email to [email protected] following this format:

SUBJECT: CFRR:E-Registration (Renewal of User Account & Password)

BODY: Email Address:

          Last Name:

          First Name:

         Middle Name:

         Company Name:

         User Account:

           Password:

You may refer to FDA Circular 2016-014 for other details and format of documents required in securing a User Account and Password for E-Registration.

The application was not forwarded to the cashier. To forward the application, go to the DRAFT section in your e-registration account and click the continue button after generating the Order of Payment Form. If the case number is already in the Participated, the forwarding of payment was successfully made.

No. This procedure is for Data Capture only wherein it is intended for the applications with existing CPR/Denied during manual procedure (Integrated Application Form). You may view previously approved and denied applications/case numbers in the Inbox of your E-Registration account.  Click the specific case number to be amended and choose “Amendment” as type of application.

In reapplication, click the case number of the denied application in the Inbox and a question “Would you like to reapply” will pop up. Click “yes” and upload the documents/compliance to your denial.

  • (From Manual Registration) this will fall under, Amendment Data Capture, Change in Importer. The new Importer must apply for CPR as amendment and must declare the current FR number and its validity. Attach all the Initial documents and requirements stipulated in AO 2014-0029 Annex D. Please note that the existing CPR named under the old Importer must be surrendered upon approval of the amendment.
  • (From Electronic Registration) this will fall under Amendment Change in Importer. The new Importer must apply for CPR as amendment using own E-registration account and must declare the current FR number and its validity. Attach all the Initial documents and requirements stipulated in AO 2014-0029 Annex D. Please ensure the completeness and correctness of the documents since the old Importer is required to cancel the CPR of the product in their account upon advice of the evaluator by clicking the case number in their inbox and choose “Cancellation” as type of application.

Applications under Notification of Amendment will not print a CPR unless it is Amendment Data Capture (The existing CPR is from manual). Once the case number is already in the inbox on your account, you can click the case number and view the Amendment Summary Table which reflects the result of your application. If the application is disapproved, you can see the remarks or reason for its disapproval on the right side of the table.

There is a new Food Categorization in the system under High Risk HRK2: Herbs and botanicals and/or Products with other nutritional substances and/or combination as Conventional Food Product. This new categorization is not yet specified in the Annex A of FDA Circular No.2016-014 and Administrative Order No.2014-0029 Annex A.

Same as the requirements for conventional food products as stipulated in the Administrative Order 2014-0029 with the addition of stability study, Certificate of Analysis (COA) of the finished product and as applicable, safety data (e.g. LD-50 Toxicity Test).  For food supplements containing herbs which are not listed in any official pharmacopeia and substances with no established safe levels.

Vitamins and Minerals levels are computed by % RENI, as per Office Order 22 s.1991.To be classified as food supplement, the maximum limit is 150% RENI for Water Soluble Vitamins and 105% RENI for Fat Soluble Vitamins. For minerals, PDRI 2015 & ASEAN can be used as reference for the maximum limit. Herbals and Botanicals that cannot be computed since it has no % RENI requires a justification for the safety and test for toxicity study (LD50 Toxicity Test) and/or inclusion in the GRAS list or Official Pharmacopeia Listing.

Either Dietary Supplement or Food Supplement is acceptable to use as per the definition of Dietary/Food Supplement on the RA 9711. Herbal Dietary Supplement maybe allowed for food supplement containing multiple herbs but not “Herbal Supplement”.

The Stability Data of the shelf life study should include: conclusion parameters used and methodology declaring the Product name, Batch number, Production date, dates of analysis, Tabulated data & results in terms of physical and chemical and Name and signature of the QA Analyst and QA Manager. We accept results for actual and accelerated shelf life study. If the shelf life study is on-going, results for at least 6 months is allowed.

No, but the levels of Vitamins & Minerals should conform with Office Order 22 s.1991 which sets the limit for vitamins and minerals to be classified as Food Supplement.

If a product is for institutional use where the “institution” is the sister company which has a separate licensed entity, the product should have a separate CPR.

If not company owned, either the manufacturer or distributor should register the product.

If the raw material is a specific additive, you may refer to FAO/WHO JECFA for specification on the limits for heavy metals. You may also refer to Food Chemical Codex for specifications of raw materials on limits for heavy metals.

In the absence of national standards, FDA Philippines only uses applicable Codex Alimentarius standards. As per Republic Act 10611 otherwise known as the Food Safety Act of 2013, Codex standards shall be adopted except when these are in conflict with what is necessary to protect consumers and scientific justification exists for action taken.

Open the case, go to information, and click process map.

Sending additional files to [email protected] does not guarantee approval of your application unless CFRR has notified you to submit compliance documents. Before sending additional files, be sure that you have received a notification from the concerned evaluator. Also, you must submit the said additional files within the timeline as mentioned in the notification received. Make sure that all attachments are complete before finishing the case/application.

LABELLING OF PREPACKAGED FOOD PRODUCTS

Yes, you can submit artwork or proposed label when you apply for product registration.

No, labels of products exclusive for export market only shall comply with the existing labeling regulations of the importing country or country of destination of the products.

Labels of products for local distribution should conform to the local labeling regulations (A.O 2014-0030) while the labels for export market should follow the existing labeling regulations of the importing country.  You need to print separate label for export market in order to comply with the labeling regulations of the country of destination of your products.

No, labels of imported products shall declare the corresponding English translation of mandatory label information. A provisionary sticker can be used for a maximum of six months only.  Labels of products in the market should be compliant with the labeling regulations.

One label for each product should be submitted showing the principal display panel and side panels.  A picture of the product showing all angles should be submitted. If your product has different packaging sizes, labels of all different packaging sizes should also be submitted.

You need to file for amendment of the CPR under label change(s) in the e-portal.  You need to upload the ff. requirements: letter requesting for label change, revised label incorporating the changes to be made and amendment fee of PhP 210.00.

No, you cannot use the brand name of products previously registered with FDA unless you have authorization from the brand name owner.

If labels of imported products are not compliant with the local labeling regulations, you may opt to print your own labels to be compliant with the FDA regulations.

No, the label of your product must declare expiry/expiration date or use by date or consume before date in day/month/year format with the name of the month spelled out to be compliant with the labeling regulations.

If the product has multiple SKUs with different design s but with the same formulation, manufacturer, brand name and product name including description you only need to upload all labels of different packaging sizes on your application.

No. Color is food additive, therefore common name and nature must be declared on the label.

YES. Stickering is allowed. However, the label information should be printed on, or on a remedial sticker on the label itself and it is only allowed for six months from the date of approval.

Yes it is allowed if the main ingredients have no safety issues (Ex. Malunggay, Mangosteen) and it does not contain vitamins exceeding the prescribed limits.

YES. However, the License-to-Operate of the local company must have LTO as Food Importer and that the product is exclusively imported or manufactured for that company.

This is the current RENI adopted by the FDA as per Bureau Circular No. 16 s. 2005

Yes. However, the corresponding RENI percentage is not mandatory for imported products but all 9 nutrients must be reflected even if it has no value but need to include “0” or “-“.

SALES PROMOTION PERMIT APPLICATION

Yes, you can submit artwork or proposed label when you apply for product registration.

No, labels of products exclusive for export market only shall comply with the existing labeling regulations of the importing country or country of destination of the products.

Labels of products for local distribution should conform to the local labeling regulations (A.O 2014-0030) while the labels for export market should follow the existing labeling regulations of the importing country.  You need to print separate label for export market in order to comply with the labeling regulations of the country of destination of your products.

No, labels of imported products shall declare the corresponding English translation of mandatory label information. A provisionary sticker can be used for a maximum of six months only.  Labels of products in the market should be compliant with the labeling regulations.

One label for each product should be submitted showing the principal display panel and side panels.  A picture of the product showing all angles should be submitted. If your product has different packaging sizes, labels of all different packaging sizes should also be submitted.

You need to file for amendment of the CPR under label change(s) in the e-portal.  You need to upload the ff. requirements: letter requesting for label change, revised label incorporating the changes to be made and amendment fee of PhP 210.00.

No, you cannot use the brand name of products previously registered with FDA unless you have authorization from the brand name owner.

If labels of imported products are not compliant with the local labeling regulations, you may opt to print your own labels to be compliant with the FDA regulations.

No, the label of your product must declare expiry/expiration date or use by date or consume before date in day/month/year format with the name of the month spelled out to be compliant with the labeling regulations.

If the product has multiple SKUs with different design s but with the same formulation, manufacturer, brand name and product name including description you only need to upload all labels of different packaging sizes on your application.

No. Color is food additive, therefore common name and nature must be declared on the label.

YES. Stickering is allowed. However, the label information should be printed on, or on a remedial sticker on the label itself and it is only allowed for six months from the date of approval.

Yes it is allowed if the main ingredients have no safety issues (Ex. Malunggay, Mangosteen) and it does not contain vitamins exceeding the prescribed limits.

YES. However, the License-to-Operate of the local company must have LTO as Food Importer and that the product is exclusively imported or manufactured for that company.

This is the current RENI adopted by the FDA as per Bureau Circular No. 16 s. 2005

Yes. However, the corresponding RENI percentage is not mandatory for imported products but all 9 nutrients must be reflected even if it has no value but need to include “0” or “-“.

ISSUANCE OF BOC CLEARANCE

The requesting party needs to submit the hard copy of the following documents to FDAC:

  1. Application Letter – addressed to Director Pilar Marilyn M. Pagayunan, this should state the company’s reason for importation
  2. Affidavit of Undertaking (Original and Notarized) – a statement/clause stating that “the imported products will not be offered for sale or for commercial distribution” or similar statement that the imported products will not reach trade
  3. Certificate of Analysis OR Certificate of Free Sale – either of the document is acceptable
  4. Commercial or Proforma Invoice
  5. Packing List
  6. Bill of Lading or Airway Bill – submit if available, however, the request for clearance will still be facilitated even though this is not submitted.
  7. Valid LTO – a company without Importer activity may still secure/request BOC clearance
  8. Payment (Php 510 per Invoice)

The requesting party should submit the hard copy of the following documents to FDAC:

  1. Bureau of International Health Cooperation (BIHC) Endorsement Letter
  2. Application Letter or Letter of Intent– addressed to Director Pilar Marilyn M. Pagayunan, this should state the company’s reason for importation
  3. Certificate of Origin or Certificate of Quality – this should have a statement on the expiration date of the donated products. The expiration date should at least be 12 months uponarrival in the Philippine port.
  4. Commercial or Proforma Invoice
  5. Packing List
  6. Bill of Lading or Airway Bill – submit if available, however, the request for clearance will still be facilitated even though this is not submitted.
  7. Payment (Php 510 per Invoice)
  8. Letter or Certificate of Donation
  9. Deed of Acceptance

After the clearance is issued to the requesting party, they should contact the Customs Liaison Unit (CLU) for the schedule of inspection. The shipment will not be released without inspection from CLU. Reference: DOH Administrative Order 2016-0004

The Customs Liason Unit of the Regional Field Office – NCR is now handling this type of request.

The limit is as follows:

  1. Wine – 2 bottles not exceeding 1.5 liters each
  2. Processed foods – 10 kilograms
  3. Food supplement – 500 grams

Reference: BOC and DOH-FDA Joint Circular No. 1 dated 22 June 2015

No, you just have to notify the Center for Food Regulation and Research (CFRR) on the product’s change in alcohol content and/or vintage.

The following documents should be submitted:

  1. Application Letter/ Letter of Intent – state the changes in the wine
  2. Affidavit of Undertaking (Original and Notarized) – this should state that the only change in the subject wines are alcohol content and/or vintage
  3. Label – the submitted label should be the same with the previous label with the exception of alcohol content and/or vintage

An FDA-CFRR issued letter will be presented to BOC together with the valid CPR to facilitate the release of wines. Reference: FDA Circular 2014-022

This type of clearance is processed by the FDA Central Laboratory and signed by CSL-Director.

You need to submit complete requirements as follows:

  1. Application Letter – addressed to Director Pilar Marilyn M. Pagayunan, this should state the company’s reason for importation and the event/exhibit it will partake in
  2. Affidavit of Undertaking (Original and Notarized) – a statement/clause stating that “the imported products will not be offered for sale or for commercial distribution” or similar statement that the imported products will not reach trade
  3. Certificate of Analysis OR Certificate of Free Sale – either of the document is acceptable
  4. Commercial or Proforma Invoice
  5. Packing List
  6. Bill of Lading or Airway Bill – submit if available, however, the request for clearance will still be facilitated even though this is not submitted.
  7. Payment (Php 510 per Invoice)

The requesting party should have a valid License to Operate to be able to join the exhibit abroad and Payment of Php510.

SALES PROMOTION PERMIT APPLICATION

All promotional campaigns/announcements for consumer products, services, credit facilities which include sponsorships of games shows and similar activities.

All processed food and food products (complete list is in AO 2014-0029) including:

FOOD Category (Imported & Locally Manufactured)

  • Bakery & Bakery Products
    • Non-alcoholic beverages & beverages mixes
  • Candies & confectionary products
  • Cocoa & Tea and non-dairy creamer
  • Condiments, sauces and seasoning
  • Culinary products
  • Gelatin, Desert preparation & Mixes
  • Dairy Products
  • Dressing & spreads
  • Flour/Flour mixes & Starch
  • Fish and other marine products
  • Fruits, vegetable & edible fungi
  • Meat and poultry products
  • Noodles, pastas and pastry wrapper
  • Nut and Nut products
  • Native delicacies
  • Oils, fats and shortenings
  • Snack foods and breakfast cereal
  • Sugar and other related products
  • Alcoholic Beverages
  • Food Supplements
  • Tea (Herbal)
  • Bottled Drinking Water
  • Food for Infant & Children (Growing-up Milk)*
  • Foods for Special Dietary Use
  • Transgenic food products (use of genetic engineering/biotechnology)
  • Ethnic food products with indigenous ingredient(s) not common in the Phil.
  • Dispensed Non-Alcoholic Beverages (for discussion)

* To be referred to I.A.C–DOH

>>Marketing and practices covered by the Milk Code shall be forwarded to IAC Secretariat to be deliberated by the IAC on EO 51.

However, only food products duly registered with FDA are allowed to conduct sales promotional activities.

  1. Government – sponsored Sales promotion campaigns sponsored, when the same is conducted in the exercise of their governmental functions;
  2. Social, civic, political, religious, educational, professional and other similar organizations) which extend promotional activity among their members. Provided that the promotional activity is not considered sales promotion campaign as defined under these Rules (per Rules & Regulations Implementing RA 7394).

The following requirements in soft copy must be submitted to FDAC:

For Initial Application

  1. Integrated Application Form
  2. Letter of Intent from the Company of Advertising Agency
  3. Accomplished Information Sheet and Mechanics of the Promotion
  4. Detailed Mechanics of the Promotion
  5. Copy of valid CPR and LTO
  6. Advertising/ Collateral Materials to be used in the Promotion
  7. Proof of Payment

For Amendment

  1. Integrated Application Form
  2. Letter of Intent from the Company of Advertising Agency
  3. Copy of approved permit
  4. Additional Advertising/ Collateral Materials to be used in the Promotion if any
  5. Proof of Payment

The fee depends on the coverage of the promotional activity and amount of prizes to be won (per DTI-DOH Joint AO No. 1 s. 2000)

Coverage Fee
NCR only or in several regions in NCR and Nationwide Php 1, 010
More than one (1) region but excluding NCR Php 760
Several provinces/ cities/ municipalities within a single region Php 560
Single province/ city/ municipality Php 260
Amount of Prizes Fee
150,000.00  & below  -       300,000.00 Php 1,010.00
300,001.00 - 500,000.00 Php 2,020.00
500,001.00 - 1,000,000.00 Php 3,030.00
Above 1, 000,000.00 Php 5,050.00

For amendment including extension, the fee is Php 310.00, but depends if the amount of prizes will be increased.

Products Involved Concerned Center
Drugs, Food, Cosmetics, Device, HHS (or Drug with any categories) Center for Drug Regulation and Research (CDRR)
Food, Cosmetics, Device, HHS (or Device with any product categories excluding Drug) Center for Device Regulation, Radiation Health and Research (CDRRHR)
Food, Cosmetics, HHS Center for Food Regulation and Research (CFRR)
Cosmetics and HHS Center for Cosmetic Regulation and Research

(Per FDA Memorandum Circular 2013-028)

Processing period is within fourteen (14) calendar days upon receipt from FDAC.

At least thirty (30) days before the actual commencement of the sales promotion (per Article 116 of R.A. 7394).

The sales promotion campaign shall have a duration of not more than a year, extendible to a maximum of six (6) months upon approval by the department (per Article 116 of R.A. 7394).

As per Book II, Article V of IRR of RA 9711

  1. No health product that has not been registered or authorized shall be advertised, promoted or subjected to any marketing activities;
  2. No claim in the advertisement, promotion and sponsorship, and other marketing activities shall be made other than those contained in the approved label or packaging of the health product, or as duly approved by the FDA;
  3. No claims, therapeutic or scientific otherwise, shall be made that has not been duly approved by the FDA;
  4. All health products that are permitted to be promoted must specifically state the authority or reference number that approved the same promotional, sponsorship, or marketing activities.

No. Where such qualification is made in a sales promotion campaign with a period, the sponsor shall be liable therefore throughout the duration of the promotion, whether or not the supply of the products under promotion has been depleted (per Article 116 of R.A. 7394).

Any price reduction promotion on any consumer product or service shall not exceed three (3) months.  However, in case of closing – out sales, the period shall be six (6) months (per Article 116 of R.A. 7394).

The status of your application may be checked through the DOCTRACK STATUS function of the FDA website. You may also call us at 857-1900 loc. 8112 or 8115.Follow-ups may be done after ten (10) working days upon receipt. Per FDA Memorandum Circular 2013-028, follow-ups shall be entertained after the processing time.

No. Only products with valid CPR may be applied for sales promotion (per RA 9711 Article V Section 2). The company may apply for promotions once the renewed CPR has been released.

Seven (7) working days before the actual activity (per Rules & Regulations Implementing RA 7394).

FOOD SAFETY UNIT

Joint Administrative Circular No. 02 s. 2016 or the “Transfer of Functions in the Regulation of Processed Meat” and FDA Circular No. 2016-013 or the “Guidelines on the Implementation of Joint FDA-NMIS Administrative Circular No. 02 on the Transfer of Functions in the Regulation of Processed Meat”.

There is no difference in the application of LTO and CPR for processed meat with other processed food products. The company will comply with existing guidelines, requirements, and procedures of FDA on filing and submission of applications such as DOH Administrative Circular 2016-0003, FDA Circular No. 2016-004, FDA Circular 2016-014, DOH Administrative Order No. 2014-0030, etc.

You may directly report your complaint to the manufacturer/ distributor of the product, if there are available consumer hotline services (telephone or mobile numbers) or email of the company. If not, you may download and fill out the FDA Product Complaint Form at http://www.fda.gov.ph/advisories-2/others-advisories-pertaining-to-general-category/227368-fda-citizen-s-charter-handling-of-customer-complaints, attach the product picture in all angles, copy of receipts and all related supporting evidences / documents and send to the Food Safety Unit of CFRR at email address [email protected]

You may report it by downloading and filling-out the FDA Product Complaint Form at http://www.fda.gov.ph/advisories-2/others-advisories-pertaining-to-general-category/227368-fda-citizen-s-charter-handling-of-customer-complaints, attach the product picture in all angles, copy of receipts, and medical abstract from the hospital or clinic, medical certificate/ report from physician, and send to the Food Safety Unit of CFRR at email address [email protected]. If you are residing near FDA Alabang, you may bring and submit the sample to FDA. Otherwise, submit it to the nearest FDA accredited laboratory.

You may file your complaint at any nearest Acting Consumer Arbitration Office (ACAO) of the Department of Health (e.g. For Metro Manila residence, the ACAO is at DOH-Mandaluyong City).

You may send all the details of your report to [email protected].

Note: Your information will be treated with utmost confidentiality.

You may visit the nearest Local Government Unit in your area, specifically to the City Health Development Office or Sanitation Office and file your report to them.

Center for Cosmetics and Household Urban and Hazardous Substances Regulation and Research

Coming soon…

Center for Device Regulation, Radiation, Health and Research

Coming soon…