Cosmetic e-Notification v.2.0 Booklet for Applicants
Contents
1. pal deg O ELECTRONIC COSMETIC PRODUCT NOTIFICATION COSMETIC E NOTIFICA TION USING THE FDA E PORTAL USER MANUAL OUTLINE BACKGROUND FDA E PORTAL o What is the FDA E Portal o Navigating the E Portal APPLICATION PROCEDURE o Submission o Payment o Result of Application o Revalidation BUSINESS PROCESS FLOW I 1 _ _M_ gt S S9 N oOz o O mm Fm I BACKGROUND COSMETIC PRODUCT NOTIFICATION With the adoption and implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme in 2005 by virtue of DOH Administrative Order No 2005 0015 and 2005 0025 the notification scheme for cosmetic products was implemented This was first fully implemented as a manual application process through FDA Bureau Circular No 2007 013 A The application process went electronic in March 2013 through FDA Memorandum Circular No 2013 011 This shift aimed to streamline the process by updating the submission of application requirements from the previously manual form to online submissions In August 2015 to further enhance the efficiency of the application process and transparency of information the cosmetic product notification scheme was updated and incorporated in the FDA E Portal II FDA E PORTAL A WHAT IS THE FDA E PORTAL This is accessible via https www fda gov ph and is the portal for several types of applications filed electronically with the FDA Users of the E Portal are provided with accounts to ac2. an application has been acknowledged it will also be routed to the Information Communication Technology Management Division ICTMD for posting on the FDA website http www tda gov ph Disclaimer This booklet is available for download at http Amww fda gov ph free of charge Produced for the purposes of information this should not be taken as an exhaustive guide on Cosmetic Product Notification It is highly recommended for the reader to refer to the FDA Issuances and the ASEAN Cosmetic Directive its Annexes and its Appendices for further information For updates on the implementation of the Cosmetic e Notification visit the FDA Philippines website References Administrative Order No 2005 0015 Administrative Order No 2005 0025 Bureau Circular No 2007 013 A FDA Memorandum Circular No 2013 011 FDA Memorandum Circular no 2013 015 FDA Advisory No 2015 021 FDA Memorandum Circular No FDA Memorandum Circular No Food and Drug Administration Center for Cosmetics Regulation and Research Civic Drive Filinvest Corporate City Alabang Muntinlupa http www fda gov ph For panes a contact the FD n va at 02 857 1984 N A info fda gov ph
3. Drug Administration Access the FDA e Portal at Pira pe en Scorre conto https www fda gov ph Login by entering the ae username and password of o the provided CCRR User Language Engien 7 account Logn In the HOME tab select New BI cases case in the navigation pane to ne proceed to the notification oratu ep Participated 20 fo rm G Unassigned 0 ii Paused 0 Accomplish the notification form as provided in parts by the application wizard Fill in the fields as completely as possible Fields marked with a red asterisk are required to be filled in Mark fields with Not applicable if not applicable An assessment slip will be generated at the end of the 4 Previous Step N i ste p Output document Order of Payment o Download the generated assessment en slip by clicking Open presented to the Cashier Create Date 2015 05 21 16 15 55 o To continue with your application ee click Next The application will then be placed in the Participated folder in the navigation pane o The status of the application may be checked in the Participated folder as indicated by the Task column va 1 SUBMISSION GUIDELINES IN FILLING THE NOTIFICATION FORM DECLARATION Proceed with the application by selecting your response using the drop down list and clicking Continue dh gt Next Step I hereby declare on behalf of my company that the product In the notification me
4. ESULT f INFORMATION f RESULT OF APPLICATION A cosmetic e notification application may either be acknowledged or disapproved and correspondingly issued with an acknowledged notification form or letter of disapproval respectively Download the result of 4 Previous Step Next Step Output document Notification of Cosmetic Product Description Notification of Cosmetic Product Please DOWNLOAD application by clicking Open via clicking OPEN Click Next Step to proceed with the next task Create Date 2015 05 22 16 06 21 Ale pdf Open ACKNOWLEDGED COSMETIC PRODUCT LETTER OF DISAPPROVAL NOTIFICATION Republic of the Philippines n Department of Health FDA Food And Drug Administration rr 447 A Civic Drive Filinvest Corporate City Alabang Muntinlupa City PHILIPPINES Notification of Cosmetic Product Pursuant to the existing rules and regulations of the Food and Drug Admir vation FDA for the notification of cosmetics the product notification is hereby acknowledged Cosmetic Notification Number NN 1000000177350 Validity 22 May 2016 Particulars of the Product Brand Name BRAND ABC Product Name BRAND ABC COLOR BA LIPSTICK Variant s PINK RED Particulars of the Manufacturer Name of the Manufacturer COSMETIC LAB alu SINC Address of the Manufacturer 123 ABC AVEN 2 ONTAR Country of Manufacture Canada Particulars of the Local Company Responsible for Pla ae Product in the Market Name of the Co
5. PRODUCT IN THE MARKET o Place the appropriate and valid LTO number of the company responsible for placing the cosmetic product in the market o Select the activity of the company as per the provided LTO and fill in the additional fields provided o Distributor Country of Manufacture Supplier Details if applicable Manufacturer details o Trader Manufacturer details o Ensure that the provided information is consistent with the current valid LTO of the company o To continue to the next step click Next 4 DETAILS OF THE PERSON REPRESENTING THE COMPANY o The name and designation of the person representing the company will automatically reflect the current user o To continue to the next step click Next 5 PRODUCT INGREDIENT LIST o Indicate the full ingredient list of the cosmetic product indicated in the application The function and percentage of restricted ingredients in the formulation are required to be provided o To continue to the next step click Next SUBMISSION Previous Step Next Step Local Company Responsible for Placing the Product In the Market Company Name As listed In E ni COMPANY ABC CORPORATION 0 Address As listed In LTO GF ABC BUILDING 123 ABC AVENUE MAKATI CITY Region NCR v LTO No CCRR NCR CD 000 Contact Information gt New Type Detall 1 Telephone Y 02 123 4567 Delete Establishment Information Please select the activity of t
6. TER OF DISAPPROVAL 29 April 2015 Gabrielle Gabriel Gab Cosmetic Products Civic Drive Filinvest Corporate City Alabang Muntinlupa Mane Phi iele Gabrie iCal Wei atest Gaar This is to inform you that the application for notification 100000014191 th thi Jffice of your product LANC ME LANCOME MY FRENCH PAI TE with the following variant s 1A 2A 3A 4A SA 6A TA was not able to comply with existing standara gt sulations for the Towing reason s eason s for Disapproval ontains O AMINOPHENOL an ingredient found Annex l ist of substances hich must not form part of the composition of cosm gt products oe Thus is o DISAPPROVED 1 are ordereu w ic from distributing such products after receipt of this letter For your information and compliance Very truly yours MM Aa Mabel Str kes aot TIA Ph MSc Officer Ina rge Cente Cosme cgulatiyy and Research Wi Hi REVALIDATION 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 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 reva
7. bi BRAND ABC PA ABC COLOR BALM LIPSTICK PINK RED 2 COMMERCIAL CORPORATION Years Appl d l Applic un Fee LRF Amount Clients may pay for their applications through the bank facilities made available by FDA The current payment options available are through BancNet online payment FDA Advisory No 2015 021 and the LandBank OnColl Payment Facility FDA Memorandum Circular No 2013 015 f Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION xo 2018 021 FDA 20 April 2015 SUBJECT THE FOOD AND DRUG ADMINISTRATION FDA IS NOW ONLINE THROUGH THE BaneNet FOR CLIENTS ONLINE PAYMENT GATEWAY SYSTEM The FDA registration fee can now be paid thru the BancNet online payment gateway 24 7 anytime The system allows FDA clients to to FDA in Alabang or queuing at the FDA Cashier make payments without going Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION DA aad d brug Ndnwnntratior PHILIPPINE 30 April 2013 FDA MEMORANDUM CIRCULAR No 20 3 015 SUBJECT GUIDELINES FOR BANK PAYM COSME T NOTIFI TENT OF ELECTRONIC OSMETIC PRODUCT C N E N ICAT ATION E NOTIFICATION In the interest of service Online Collection OnColl Facility provided by Landbank of the Philippines LBP for Electronic Cosmetic Product Notification E Notification shall be implemented effective 16 May 2013 DOWNLOAD ADDITIONAL PRODUCT R
8. cess the processes Using this portal tasks i e steps in the procedure are accomplished in a simple workflow and cases i e applications are filed using specialized forms NAVIGATING THE E PORTAL The interface may be likened to common e mail programs It has two key parts 1 Navigation pane oFound at the left side of the interface olt contains the following folders a New Case selected when an applicant wishes to apply for a new application When New Case is selected in the navigation pane the window displays the list of processes which may be availed by the applicant To proceed with submitting an application the user may select from the list their preferred process to be undertaken New Case View od and Dr Account Name EBA yi fio Account Name Process Information B Notification pica Process selector for New Case Part cipated 19 Navigation Pane G Unassigned 0 i Paused 0 New case Inbox Draft Working days Sun Participated Debug Mode Unassigned Paused Category Calendar NAVIGATING THE E PORTAL b Inbox displays all current tasks delegated to the user When Inbox is selected in the navigation pane the window displays the list of applications that are currently for further action i e pending tasks by the user It is a tabular representation with columns provided for 1 case number 2 Summary summary of application 3 Case Notes notes on t
9. date 1000000186420 BRAND ABC BRAND ASEAN Cosmetic Notification Web Post briel Gabrielle Sosa teres 2015 06 02 13 48 40 NORMAL ABC COLOR BALM LIPSTICK 1000000186420 BRAND ABC BRAND ASEAN Cosmetic Notification Revalidation Application ABC COLOR BALM LIPSTICK 1000000186220 BRAND ABC BRAND ABC COLOR BALM LIPSTICK 1000000185267 BRAND ABC BRAND ASEAN Cosmetic Notification ABC COLOR BALM LIPSTICK 1000000184714 BRAND ABC BRAND ASEAN Cosmetic Notification ABC COLOR BALM LIPSTICK 100000018441 1 BRAND ABC BRAND ASEAN Cosmetic Notification ABC COLOR BALM LIPSTICK 1000000184352 BRAND ABC BRAND ASEAN Cosme ABC COLOR BALM LIPSTICK ZA co ses S 9 S SG Ss Ss se so s oso so BRE vA 1000000184310 BRAND ABC BRAND ASEAN Cosmetic Notification ABC COLOR BALM LIPSTICK E NAVIGATING THE E PORTAL C d e f 2 Window Draft displays all cases started but not fully accomplished Participated displays all applications with completed tasks Unassigned displays all applications with no current user delegated Paused displays all paused applications This displays dynamic content depending on the selected folder in the navigation pane lil APPLICATION PROCEDURE The process consists of 4 four main parts Submission Payment Download Result and Revalidation Submission Payment Download Result Revalidation SUBMISSION OVERVIEW OF SUBMISSION FDA 2 Food and
10. ets all the requirements of the ASEAN Cosmetic Directive Its Annexes and Appendices which have been transposed Into local legislation I undertake to Ensure that the products technical and safety Information Is made readily avallable to the regulatory authority concerned the Authority and to keep records of the distribution of the products for product recall purposes e Notify the Authority of fatal or life threatening serious adverse event as soon as possible by telephone facsimile transmission email or In writing and In any case no later than 7 calendar days after first knowledge e Complete the Adverse Cosmetic Event Report Form within 8 calendar days from the date of my notification to the Authority In para 211 above and to provide any other Information as may be requested by the Authority e Report to the Authority of all other serious adverse events that are not fatal or life threatening as soon as possible and In any case no later than 15 calendar days after first knowledge using the Adverse Cosmetic Event Report Form e Notify the Authority of any change In the particulars submitted In this notification e Ensure that If and when directed by the authority will recall the product from the market and discontinue selling or supplying the product I declare that the particulars given In this notification are true all data and Information of relevance In relation to the notification have been supplied and that the d
11. he local company responsible for Distributor v placing the product In the market Is the product directly sourced yes Y Country of Manufacture pnilippines x Complete Name of E COMPANY ABC CORPORATION Manufacturer Complete Address of 123 ABC NATIONAL ROAD STA ROSA LAGUNA Manufacturer Next Required Field Previous Step Next Step Name Household Urban and Hazardous Substances Designation Contact Detalls New Detal 02 123 4567 1 Telephone Previous Step gt Next Step Product Ingredient List variant Full Ingredient Name Function Percentage of ingredient RICINUS COMMUNIS SEED OIL Delete OLEIC LINOLEIC LINOLENIC POLYC CAPRYLIC CAPRIC TRIGLYCERIDE HYDROGENATED POLYCYCLOPENTI EUPHORBIA CERIFERA WAX MENTHA PIPERITA OIL Delete HYDROGENATED PALM GLYCERIDE Delete PHENOXYETHANOL PRESERVATIVE MENTHOXYPROPANEDIOL CI 77288 CHROMIUM OXIDE GREE Delete SUBMISSION INFORMATION TO BE DECLARED IN THE PRODUCT NOTIFICATION BRAND NAME PRODUCT NAME PRODUCT VARIANTS PRODUCT TYPES INTENDED USE PRODUCT PRESENTATIONS LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC PRODUCT IN THE MARKET ESTABLISHMENT INFORMATION PERSON REPRESENTING THE LOCAL COMPANY PRODUCT INGREDIENT LIST The complete name of the product should be given in the following sequence brand name line name if applicable product name if a single shade is notified t
12. he application by authorized users 4 Case name of the application 5 Process process where the application is lodged 6 Tasks current task to be undertaken for the application 7 Sent By User name of the last user who delegated the case 8 Due Date due date by which the task ends 9 Last Modify date by which the application was last modified 10 Priority level of priority of a case all applications are by default of Normal priority Other folders in the navigation pane will display a similar tabular presentation of information as shown in the figure below Inbox View FDA Food and Drug Administration Case Application Information HOME DESIGNER nread All Case as en Priority 0000190191 Brand ABC Brand ABC ASEAR Cosmetic Notification Gad Gabrielle 20155 03 14 00 4 2015786 02 16 40 22 NORMAL Lists the Indicates the Userwho Due date of Date the names processes of currentstep delegate the current application COC of the i dthe step was last applications application case to Red due modified you date has 1000000189591 BRAND ABC BRAND ASEAN Cosmetic Notification Download Result passed 2015 06 02 08 10 27 NORMAL ABC COLOR BALM LIPSTICK Esgabrie Green 1000000189618 BRAND ABC BRAND STi K ABC COLOR BALM LIPSTIC 1000000189591 BRAND ABC BRAND ASEAN Cosmetic Notification Web Post briel Gabrielle before due 2015 0 NORMAL ABC COLOR BALM LIPSTICK gsgabrie
13. he shade name number e g BRAND ABC PRODUCT XYZ EYSHADOW SHADE 1 If there are different shades the shade name number for each shade shall be declared The illustrative list ACD Annex I is not exhaustive and you can include other types of cosmetic products not in the list by selecting others and specifying what it is This refers to the function or use of the product and not the directions for use e g to moisturize the face hand etc A SINGLE PRODUCT exists in a single presentation form A RANGE OF VARIANTS SIMILAR IN COMPOSITION FOR THE SAME USE BUT DIFFERS IN COLOURS FLAVOURS ETC is a range of cosmetic products which are similar in composition and produced by the same manufacturer and are intended for the same use but are available in different shades of colour e g lipsticks eye shadows or nail polish but not composite packs of different types PALETTE S INA RANGE OF ONE PRODUCT TYPE refers to a range of colours as defined above which may be presented in a series of palettes COMBINATION PRODUCTS IN A SINGLE KIT refer to similar and or different product types packed and sold in a single kit They cannot be sold separately e g a make up kit of eye and lip colours a set of skin care products sold in a single kit Please note that components of such kits must be notified separately It refers to the local company responsible for placing the cosmetic products in the market which may be a local manufacturer or an agent ap
14. lidation 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 11 Mk E T NS o5 o m IV BUSINESS PROCESS FLOW COSMETIC PRODUCT NOTIFICATION A cosmetic notification application undergoes the following business process flow APPLICANT CASHIER ICTMD E Revalidation ppicaion p plication Verification Acknowledgement Download Result PIF Audit Schedule Web Posting I PAYMENT Applications after being routed by the applicant to the Cashier for payment shall undergo payment validation 2 VERIFICATION Once the payment has been appropriately validated CCRR will start processing the application through verification of the information declared in the application A recommendation for either acknowledgement or disapproval will then be provided 3 ACKNOWLEDGEMENT Applications appropriately verified and possessing adequate recommendations will then be routed to the CCRR Director for acknowledgement or disapproval An acknowledged product notification or letter of disapproval will be made available in the Download Result task of the applicant 4 PIF AUDIT SCHEDULE AND PIF AUDIT When a notification has been recommended for audit it will be routed within CCRR for appropriate action 5 WEB POSTING When
15. mpany COMPA TY ABC COMME TIAL CORPORATION Alina dla Ca y aoe O SUILDING 123 AVENUE MAKATI LTO Number CCRR NCi D 0v The product is allowed to be sold in the local mai t subject w compliance with the requirements of the ASEAN Cosmetic Directive and the FDA laws nd its implementing rules and regulations This notification should not be ti rantee a or endorsement of the safety quality and claimed benefit of the produc ny subseguir zes to the information submitted in this notification will render this notifica invalid and a new notification will have to be submitted The company hereby ensures that they sha mond and cooperate fully with the FDA with regard to any subsequent nost marketing activity imu d by the FDA Further the company shall be responsible for er hat each consignment of the product continues to meet all the legal requirements and c forms ic andards and specifications of the product declared to the FDA This authorization is subje te spension cancellation or recall should aye violation of FDA laws and its iw nlementing rules egulations involving the product be committed BY AUTHOR Y OF THE ACTING DIRECTOR GENERAL Fa Ai sth a 4 M ES ITIERREZ RPh MSc Offic ae ae Conte s osmetics Regulati 7 and Research Republic of the Philippines Department of Health _ _ Food And Drug Administration FDA wy Civic Drive Filinvest Corporate City Alabang Muntinlupa City LET
16. ocuments enclosed are authentic or true copies I understand that shall be responsible for ensuring that each consignment of my product continues to meet all the legal requirements and conforms to all the standards and specifications of the product that have declared to the Authority I understand that cannot place rellance on the acceptance of my product notification by the authority In any legal proceedings concerning my product In the event that my product has falled to conform to any of the standards or specifications that had previously declared to the Authority I have examined the latest revisions of the Annexes Il to VII of the ASEAN Cosmetic Ingredient Listing as published In the latest amendment of the ASEAN Cosmetic Directive and confirmed that the product In this notification does not contain any prohibited substances and Is In compliance with the restrictions and conditions stipulated In the Annexes I undertake to respond to and cooperate fully with the regulatory authority with regard to any subsequent post marketing activity Initiated by the authority 2 As defined In the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products 3 Set out In Appendix I to the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products ves lagree VY Continue 2 PARTICULARS OF THE PRODUCT o Validity of the notification may either be 1 2 or 3 years at the option of
17. pointed by a manufacturer to market the product or the company that is responsible for bringing in the product for sale in the country etc It refers to the particulars of the manufacturer and or supplier of the notified cosmetic product It refers to the person representing the local company responsible The e notification program automatically reflects the account details of the applicant in this portion 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 Download the generated assessment form and print copies as needed Note the Reference Number for the payment option s to be availed Date Case No Reference No Company Nam Bran Name Pr duct Name V ciants No ot Varia s Civic Drive Filinvest Corporate City Alabang Muntinlh va Citv PAYMENT Republic of the Philippines Department of Health Food And Drug Administration Cosmetic Ne Featio Assessn nt Fo m 2015 05 21 17735 100000 7 59 COMPA Y A
18. the applicant o To add variants packaging sizes packaging types GTIN into the list click New to add another line Click Delete if you wish to delete the entry o Utilize the drop down lists when selecting the Product Type and Presentation When Others is selected please specify using the provided space o To continue to the next step click Next Ed 4 p reni ne u 4 Previous Step Next Step Particulars of the Product Brand Name BRAND ABC Product Name BRAND ABC COLOR BALM SHAMPOO a Number of Years applied for 2vears Y Product Variants or Shade Names gt New Varlanty Shade Name BLUE Delete 2 YELLOW Delete Product Type Bath or shower preparations salts foams olls gels etc v0 Intended Use CLEANSES HAIR a I Product Presentation A range of product variants similar In composition for the same use but _Y W Additional Product Information Product Information Including existing packaging sizes and their corresponding Global Trade Identification Number GTIN may be updated here Please note that once Information has been submitted it will no longer be modifiable Hence any change to the provided Information would merit a new notification application New Packaging size Packaging type GTIN 1 Moml Samet 98274524563485 Delete 2 100 mt Bottle 92483598734735 Delete Next Required Field 3 LOCAL COMPANY RESPONSIBLE FOR PLACING THE
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