The following are the License to Operate requirements for initial and renewal applications. With the goal of increasing transparency, accessibility, and efficiency of the process, this decision has been especially beneficial for businesses based outside Metro Manila. Per FDA Circular 2016-004 (Procedures on the Use of the New Application Form for License to Operate through the FDA Electronic Portal), the application process has been moved online. You also need to obtain different kinds of certification and permit. Photocopy of duly notarized valid contract or agreement with the manufacturer, and, as appropriate, the License to Operate (LTO) of the manufacturer where the product will be sourced for repacking 5. The Philippine National Trade Repository is here to serve both local and foreign importers, exporters, and anyone in need of Philippine trade information. Seek medical attention immediately if you experience any side effects and report it to FDA at [email protected] or via online reporting through our website: www.fda.gov.ph. Blindness can also happen in severe cases. 46, AIRPORT ROAD, LAOAG CITY, ILOCOS NORTE. Davao City, Philippines, _____ , 20 _____. This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph. The Order provides that certain HUHS establishments which were previously exempt from obtaining a license to operate (LTO) from the Food and Drug Administration (FDA) will now need to obtain an LTO before engaging in the manufacture, importation, distribution, repacking, and other activities involving certain HUHS products. Please be informed that the conduct of ULS-ARMM in Cotabato City (Course Code:ULS-ARMM) scheduled on 2 July 2019 is cancelled due to very low number of course participants that registered in the seminar. FDA Circular 2016-004. AUTHORIZED PERSON TO PICK-UP / CLAIM THE AUTHORIZATIONS: 2. Requests received after 5:00 pm on regular working days, holidays, Saturdays, and Sundays shall be processed on the next working day. Not only that, but the company will automatically be delisted from the FDA’s list of licensed establishments, so be sure to renew on time. Do not forget to attach files to emails before sending them. Accomplish the General Information appropriately). To report continuous sale or distribution of the above unregistered food product, e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105. The FDA will also ensure that adequate coordination with the Law Enforcement Agencies shall be done to facilitate their own investigation. For more information and update regarding FDA seminars, please visit the FDA website, www.fda.gov.ph. Attachment: CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019. If you would like to avail of our FDA consulting services, you may contact us here. Now that you have all the requirements, the application for the actual license can now follow. – Surrender original / old License to Operate and COC / CTR This post is about the Certificate of Product Registration (CPR). In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC). Please note the following changes in schedule: Only the first one-hundred (100) pre-registered participants (per session) who received a confirmation email shall be accommodated in the venue. Unlike other consumer products purchased over the internet, medicines have the potential to cause serious side effects and health problems if not used and stored properly. Attachment-> : ULS DAVAO VENUE on 22 August 2019. 2011-003, a Legal Research Fee (LRF) amounting to “one percent (1%) of the filing fee imposed, but in no case lower than ten pesos” shall be collected. The Food and Drug Administration (FDA) warns the public on the dangers associated with the use of injectable lightening agents such as glutathione. The FDA hereby reiterates its previous Advisories following the casualties due to the consumption of unregistered food products including alcoholic beverages that have not gone through this agency’s registration and testing. CHECKLIST OF REQUIREMENTS FOR THE ISSUANCE OF LICENSE TO OPERATE FOR COSMETIC ESTABLISHMENTS I. INITIAL/OPENING APPLICATIONS A. 2. All confirmed participants of this seminar shall be automatically moved to the rescheduled date. Incomplete requirements shall not be processed. Please be informed that the conduct of Center for Food Regulation and Research (CFRR) QPIRA Seminar (Course Code: QCFRR-Min) on 17-18 July 2019 within Davao City shall be rescheduled to 3-4 December 2019 and GMP-FMT Seminar (Course Code: GMP-FMT-MEC) on 19 July 2019 shall be rescheduled to 5 December 2019. This is due to very low number of course participants that registered in the course. Republic of the Philippines Department ofHealth FOOD AND DRUG ADMINISTRATION ANNOUNCEMENT : ALL CONCERNED STAKEHOLDERS FDA Food and Drug Administration PHILIPPINES : APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS/ENNDS PRODUCTS This is to inform all concerned stakeholders that the following are now available online A medicine bought online may contain no active ingredient; too much or too little of active ingredients which may result to your condition not being treated correctly. License to Operate For a company to be able to import, distribute, market, advertise or manufacture their products here in the Philippines, they must first secure a License to Operate (LTO) as Importer/Distributor/Wholesaler, for products imported from different countries, or as Manufacturer, for locally manufactured products. All guidelines and penalties may be found on the FDA website: http://www.fda.gov.ph. Currently, FDA only allows online ordering services provided that the seller has an existing FDA-licensed Pharmacy or Botika with physical address. Further, the FDA has requested the assistance of the Epidemiology Bureau of the Department of Health to ensure that proper information from the patients relative to this incident is collected and verified. The FDA hereby warns the public on the consumption of the implicated product as this is currently unregistered and has been confirmed to contain a high level of methanol. Each User Account is unique to one company and is valid for one (1) year. All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents: We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly. Make sure you’ve read and fully understood the “Declaration and Undertaking” and click the “I Agree” button before proceeding. COE will NO LONGER be issued for non-registrable products but in case of point of entry and/or as part of bidding requirements, the License to Operate (LTO) of the establishment should be provided. Regular transactions will resume on Monday, 19 August 2019. Also of concern is the possibility of Stevens Johnson Syndrome. Businesses involved in the importation, exportation, trading, and distribution of food, drinks, drugs, pharmaceuticals, cosmetics, or medical devices in the Philippines need to obtain a license to operate (LTO) and a certificate of product registration (CPR) from the Food and Drug Administration (FDA). The manufacturing facility of Juan Brewing, Inc. shall be inspected and investigated for any possibility of adulteration specifically the addition of methanol during processing. Interested in FDA LTO application (License to Operate from the Philippine Food and Drug Administration) but don’t know where to start? This new guide gives you a complete step-by-step process on how to apply for an FDA LTO in 2020. 3. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. (Each primary activity has its applicable sub-options. Important Reminder: Only residents of the Philippines (either Filipino citizens or alien holders of resident visas) and majority Filipino-owned companies may apply for LTO. Tip 3: Get assistance from DAYANAN Business Consultancy! https://ww2.fda.gov.ph/attachments/article/330042/FDA%20Circular%20No.%202016-004.pdf, The Complete FAQ Guide on How to Renew Your Business Permit in the Philippines for 2020, Here’s Why You Should Retire in the Philippines, Fees and Requirements for FDA-Approved Food Supplements in the Philippines (Part 2), Frequently Asked Questions for Bookkeeping in the Philippines, FDA-Approved Food Supplements in the Philippines: A Quick Guide (Part 1), FDA CPR Certificate of Product Registration Requirements and Application Process in the Philippines. Attachment-> : Cascading on 7 and 9 August 2019 by CCRR. Proof of Payment, VENUE FOR UNIFIED LICENSING SEMINAR ON 3 & 4 JULY 2019. 11232), Special Visa for Employment Generation (SVEG), Tips to make application easier and faster. This will designate a specific individual as eLTO account holder. Filling up the forms and uploading the documents can now be done via the portal. The Food and Drug Administration (FDA) warns the public on significant risks associated with the growth of the internet’ sales of medicines. Below is a sample email provided by the FDA: Please take note that the User Account details will be sent to the company email address provided in the body of the email, not to the original sender’s email address. While there are quite a few articles online on FDA LTO application, they are mostly outdated. Under Establishment Information, provide the complete establishment name, TIN, address, and contact details. Ensure that all documents are secured before applying to avoid processing delays. Please note that photocopy of each required document is needed for every request. Injectable glutathione is sometimes paired with intravenous Vitamin C. Vitamin C injection may form kidney stones if the urine is acidic. Photocopy of any of the following ID’s:  A Document Request Form (DRF) must be accomplished by the Client (Owner/President/Manager/Head of the company or the Authorized Representative) and submit to the Releasing Officer together with the required document/s mentioned above. 2016-003 “Guidelines on the Unified Licensing Requirements and Procedures” (See CL news on May 6 2016). 3 License To Operate (LTO) All cosmetic establishments shall first secure the LTO or authorization from FDA prior to engaging in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertisement and for sponsorship of any … One major change to the process is that it is now done online via https://eportal.fda.gov.ph (the integrated application form may be found here). It is also a requirement before you can obtain a Certificate of Product Registration (CPR), a seal of approval which indicates that your product complies with health, safety, and technical standards set by the FDA in the Philippines. In a previous post, I wrote about the Philippine Food and Drug Administration (FDA) and the requirements and how to procure a License to Operate (LTO) for food establishments.. This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph. 2019-308 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device "INFECTIGUARD KID'S STERILE BANDAGES", VENUE FOR UNIFIED LICENSING SEMINAR (ULS-NCR) ON 1 OCTOBER 2019, APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS-ENNDS PRODUCTS, ADVISORY-RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC), RESCHEDULE OF QPIRA FOR CFRR AND GMP-FMT SEMINAR, VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RIX) ON 5 JULY 2019, CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019, Presentation of IRR of RA10620: Toy and Game Safety Labeling Act of 2013, LTO Application for E–Cigarette Establishment Documentary Requirements and Other Reminders. Dissemination of the information to all concerned is requested. For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected] (for ENDS/ENNDS-related concerns) or [email protected] (for HUHS, HUP, PCO and Toy-related concerns). DBC was founded in 2011. An LTO allows you to legally import, distribute, sell wholesale, and/or manufacture food, drugs, cosmetics, and medical devices. Photocopy of the certificate of all the radiologist/s for being a Fellow of the Philippine College of Radiology (FPCR) or Diplomate of the Philippine Board of Radiology (DPBR). 1. Authorization letter in company letterhead; Photocopy of valid ID of the Company’s Owner/President/Manager/Head; and. Don’t forget to attach a scanned Authorization Letter in PDF format. Please note: Under the “Assign Task” section, please click the “Continue” button in order for the application to be processed by the FDA. Methanol is a widely available chemical that has many industrial applications and is also found in household products and fuel for aircraft. Currently, this product is not registered with the FDA. Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. For more information and inquiries, please e-mail us at [email protected]. Even if the medicines bought online looks the same; there is no guarantee that it is genuine. Higher concentrations of methanol in alcoholic drinks can happen when methanol is deliberately added to alcoholic drinks. Provide needed information under “Details of the Authorized Officer” and “Details of the Applicant.”Upload the required documents (depending on LTO type). Please be informed that the venue of the Unified Licensing Seminar (ULS – RV) on 19-20 June 2019 will be in LA VENEZIA HOTEL & SPA, INC., RENAISSANCE GARDENS, WASHINGTON DRIVE, LEGAZPI CITY, ALBAY. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email at [email protected]. The new mandatory format requirement is a supplement to the Order No. Appropriate regulatory action shall be imposed on those non- compliant establishments found violating current standards, rules, and regulations. On June 7 Philippines FDA released and adopted a new format of License to Operate (LTO) for establishments. The applicant shall submit the documentary requirements specified in DOH AO 2016-0003 when applying for a License to Operate and variations as applicable. We hope these tips answer your queries on how to apply for an FDA LTO. This new guide gives you a complete step-by-step process on how to apply for an FDA LTO in 2020. By virtue of FDA Personnel Order No. Releasing Officer releases the Authorization/s to Client. Cruz, Manila. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. It is alarming that they also offer services such as intravenous drip or infusion using skin lightening agents including reduced glutathione, vitamin C and other injections. The confirmed participant of this seminar will be transferred to the next available seminar schedule. All Local Government Units and Law Enforcement Agencies are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. Instead of a simple sign-up button, it instead involves sending a few emails. Before you can access the E-portal, you must first create a User Account, the application for which is not as straightforward as what you may be used to. Attachment-> :  VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019. Consistent with this national policy, the Congress of the Philippines passed 3 landmark legislations namely: RA No: 9502 (Universally Accessible Cheaper & Quality Medicine Act of 2008), RA No: 9711 (FDA Act of 2009) and RA No: 10611 (Food Safety Act of 2013), for the promotion and protection of public health and welfare. Upon receipt of DRF, the Releasing Officer checks on the files for release. Companies may also apply at the respective FDA regional field office in their location. 7 J.P LAUREL AVENUE, LANANG, DAVAO CITY, DAVAO DEL SUR. The public is warned to exercise extreme caution in purchasing or consuming alcoholic beverages and advised to purchase and consume only those which are registered with the FDA. Here’s how to create a new User Account for the FDA E-Portal System: SUBJECT: Request for eLTO User AccountBODY: a. E-mail address (preferably company email address) b. Under the General Information tab, select the appropriate Product Type, Primary Activity, and Type of Application from their respective drop-down menus. If caught, your LTO may be suspended, revoked, canceled, or disapproved upon renewal. Submit files in PDF format and ensure that there are no bugs, viruses, or anything that can jeopardize the system of the FDA. After filing, the FDA will evaluate all LTO applications to determine whether to grant the license or not. In addition, all establishments covered under the FDA may be inspected anytime by the agency to ensure proper compliance with its set rules and regulations. Likewise, existing licenses that were not renewed after one-hundred twenty (120) days from the date of expiration will be automatically canceled by the FDA. License to Operate (LTO) Application Goes Electronic. VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RV) ON 19-20 JUNE 2019, on APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS/ENNDS PRODUCTS, VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019, Please be informed that the venue of the Unified Licensing Seminar (ULS – RI) on 31 July 2019 and 1 August 2019 will be in, We advise our clients to kindly send all queries and concerns via, For more information and inquiries, please e-mail us atÂ, Seek medical attention immediately if you experience any side effects and report it to FDA at, Center for Cosmetics Regulation and Research QPIRA Seminar  for Mindanao (Cagayan de Oro), Unified Licensing Seminar for Region X (Iligan City), Unified Licensing Seminar for Region X (Cagayan de Oro City), For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email atÂ, Please be informed that the conduct of Center for Food Regulation and Research (CFRR) QPIRA Seminar (Course Code: QCFRR-Min) on, Please be informed that the conduct of Center for Cosmetics Regulation and Research (CCRR) QPIRA Seminar for Household and Urban Hazardous Substance (Course Code: QCCRR-HUHS) on 16-17 July 2019 within Muntinlupa City, Please be informed that the venue of the Unified Licensing Seminar (ULS – RIX) on 5 July 2019 will be in, Please be informed that the venue of the Unified Licensing Seminar (ULS – RV) on 19-20 June 2019 will be in, FDA Advisory No. Click “New Case” on the upper left-hand side and select “License to Operate v2.0” which can be found under Electronic Licensing. A company that wishes to engage in such business activities must first obtain a License To Operate (LTO) from the FDA either as an importer or a manufacturer. To assure that your skin conditions are treated, consult only a board-certified dermatologist. Business entities must secure both a License To Operate (LTO) and a Certificate of Product Registration (CPR) from the FDA Philippines before it can engage in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertisement and/or sponsorship of the following products in the Philippines: Copyright 2021 Dayanan Business Consulting. Once done, the company must then apply for a Certificate of Product Registration (CPR) to ensure that its products comply with FDA … Pursuant to FDA Circular No. Also, these medicines may not be stored correctly in accordance with its appropriate storage conditions. Now you can apply for a LTO from Food and Drug Administration in the comfort of your own home. Please be informed that the venue of the Unified Licensing Seminar (ULS – RIX) on 5 July 2019 will be in HOTEL GUILLERMO, RIZAL AVENUE, PAGADIAN CITY. Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 14 August 2019 will be in CORNER ONE EVENTS HUB, CORNER MABINI SUPERHIGHWAY, APLAYA, DIGOS CITY, DAVAO DEL SUR. Why would you need one? The E-Portal accepts new, renewal, and variation applications. Please be informed of the following changes of the FDA Academy QPIRA Seminar for Center for  Cosmetics  Regulation  and  Research  for  Mindanao  Stakeholders  (QCCRR-MIN)  and Unified  Licensing  Seminar   for  Region  X  (ULS-RX) in observance of the local holiday in Cagayan de Oro City on 28 August 2019: Our sincere apologies for any inconvenience this change in seminar schedule have cause. Course Assessment Slip Consumers must also exercise extreme caution in buying alcoholic drinks, especially those that do not have labels, poorly printed labels or with broken seals. Name of the authorized company representative (preferably permanently employed and not merely a consultant) c. Position in the company d. Contact Number e. Company Name. User Accounts are usually issued within two (2) days upon receipt of the completed request by the FDA in the Philippines. Procedures on the Use of the New Application Form for License to Operate thru the FDA Electronic Portal (For All Establishments Regulated by FDA) All concerned regulated establishments are reminded to follow and strictly comply with the FDA’s existing rules and regulations to ensure that only safe and quality products shall be made available to the public. With this, the FDA commenced its own investigation on the implicated product ‘Cosmic Carabao Gin’ which is a locally manufactured alcoholic beverage. Make sure documents are in PDF format. Additional Requirements: – Location Plan / Site (size, location, immediate environment, type of building) – Floor Plan with dimensions (Lay-out of the premises) Changes in Circumstances: – Official letter re: Change of Address / Owner / Business Name and/or etc. In the interest of public protection, the Field Regulatory Operations Office inspectors and Regulatory Enforcement Unit officers of FDA shall seize and/or confiscate all Cosmic Carabao Gin products available in the market. The FDA has not approved any injectable products for skin lightening. / : * ” > <. Once you have a valid User Account in hand, the E-Portal can now be accessed. To report continuous unauthorized sale or distribution of drug products, kindly email us via [email protected], or through the online reporting facility, eREPORT, at www.fda.gov.ph/ereport. LTO Application for E–Cigarette Establishment Documentary Requirements and Other Reminders Guidelines for Manufacturers and Traders Guidelines for Distributors Guidelines for Retailers For any concerns or inquiries, kindly contact CCRR, at (02) 857 … For inquiries and other concerns, you may reach the FDA Academy thru: Attachment-> : ULS-RII POSTPONEMENT ON JULY 18 2019. The company is given sixty days to comply with all the deficiencies. Attachment-> : CDRR MEMORANDUM NO.2019-07. ‘Whereas, the general requirements for the issuance of License to Operate include, among others, “a valid Certificate of Registration of the establishment’s Filipino pharmacist issued by the Professional Regulation Commission (PRC)” necessitating the employment of a validly registered pharmacist for each application for a license to operate; …’” There are also no published guidelines for appropriate dosing regimens and duration of treatment. Photocopy of the VALID Professional Regulation Commission (PRC) license of all the radiologist/s and radiologic/x-ray technologist/s. If you are thinking about opening a food business, there are many regulatory requirements that you will need to meet. This is in consideration to the reinstatement of the HUHS licensing and notification requirements. Lastly, a pre-opening inspection shall be conducted for manufacturers. This is also a product of natural fermentation and is found in both alcoholic and non-alcoholic fermented beverages. While there are quite a few articles online on FDA LTO application, they are mostly outdated. Medical devices under class B, C and D, and IVDs which are NOT included in FDA 2014-005 and 005A shall be considered non-registrable. All document file names must be less than 40 characters, should not contain the following characters: \ ? Online ordering services are additional activities of a Pharmacy or Botika subject for approval of FDA. Double-check the total amount to be paid by looking at the Order of Payment section, which can be downloaded if needed. Laboratory testing of the product is also being undertaken to check if the methanol content is compliant.  For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259. Operating without a license can spell disaster for your business. For any concerns or inquiries, kindly contact CCRR, at (02) 857-1900 local 8107 or 8113, or through email at [email protected]. On 30 June 2019, the Food and Drug Administration (FDA) received a report on an incident involving two (2) women who allegedly consumed ‘Cosmic Carabao Gin’ and exhibited signs and symptoms related to methanol intoxication which include headache, vomiting, abdominal pain, and affected vision. Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 22 August 2019 will be in GRAND REGAL HOTEL DAVAO, KM. All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents: For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259. WHEREFORE , the petitioner respectfully prays that she/he be granted License to Operate a drug / cosmetic / medical device establishment after inspection thereof and after compliance with the Bureau of Food and Drugs’ requirements, rules and regulations. The FDA hereby reiterates its previous Advisories following the casualties due to the consumption of unregistered food products including alcoholic beverages that have not gone through this agency’s registration and testing. It is important to seek medical advice from doctor or pharmacist before taking medicines. In light of the developments on the investigation of the Food and Drug Administration (FDA) with regards to the incident involving two (2) women who allegedly consumed ‘Cosmic Carabao Gin’, this Office shall order the seizure and/or confiscation of the product as the samples collected and subjected to FDA analysis were found positive for methanol. FDA Consulting. One of the documents that you need to secure is a license to operate (LTO) from the Food and Drug Administration (FDA), especially if your business involves the production and sale of goods and medicines. For a related entry, please read Food and Drug Administration – Philippines. After you’re done applying, expect your FDA License to Operate (LTO) in the mail! In the Philippines, several health and beauty salons, wellness spa and beauty clinics are offering all kinds of beauty enhancements, services and skin treatments. Tip 1: Follow documentary requirements listed in Administrative Order (AO) 2016-0003 (“Guidelines on Unified Licensing Requirements and Procedures of the Food and Drug Administration”): Tip 2: Make sure to submit all forms completely. An application is considered filed only if all necessary requirements are met, including payment of fees. The Philippines continues to evolve with the ever changing advances in technology and the PNTR is just one part of making trade and industry easier in the Philippines. However, non-toxic trace amounts of methanol can also be naturally present in fruit juices. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. Given that glutathione affects the production of melanin (the pigment that gives the human skin, hair and eyes their color) — there are theoretical concerns about the long term skin cancer risk. Applicable Section: Book 2 Article I Section 1 para. 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An FDA LTO consists of the registered participants of this seminar shall be conducted for manufacturers contact details which.