To assure that your skin conditions are treated, consult only a board-certified dermatologist. 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. This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph. Accomplish the General Information appropriately). Do not forget to attach files to emails before sending them. By virtue of FDA Personnel Order No. It is important to seek medical advice from doctor or pharmacist before taking medicines. Each User Account is unique to one company and is valid for one (1) year. With the goal of increasing transparency, accessibility, and efficiency of the process, this decision has been especially beneficial for businesses based outside Metro Manila. 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. Don’t forget to attach a scanned Authorization Letter in PDF format. 2016-003 “Guidelines on the Unified Licensing Requirements and Procedures” (See CL news on May 6 2016). 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. Attachment-> : RESCHEDULING OF QCCRR–MIN AND ULS-RX. Ensure that all documents are secured before applying to avoid processing delays. This will designate a specific individual as eLTO account holder. 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. Please note: Under the “Assign Task” section, please click the “Continue” button in order for the application to be processed by the FDA. The FDA will also ensure that adequate coordination with the Law Enforcement Agencies shall be done to facilitate their own investigation. The manufacturing facility of Juan Brewing, Inc. shall be inspected and investigated for any possibility of adulteration specifically the addition of methanol during processing. For any concerns or inquiries, kindly contact CCRR, at (02) 857-1900 local 8107 or 8113, or through email at [email protected]. This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph. On June 7 Philippines FDA released and adopted a new format of License to Operate (LTO) for establishments. Next, send an email to request for a User Account to the FDA’s Public Assistance, Information and Receiving (PAIR) unit via. 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. Thru the use of an electronic portal (e-portal), you can submit an LTO application and wait for the approved LTO to be mailed to your designated address. 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. 2. 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. Online ordering services are additional activities of a Pharmacy or Botika subject for approval of FDA. 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. Make sure you’ve read and fully understood the “Declaration and Undertaking” and click the “I Agree” button before proceeding. A License to Operate or LTO is a license which must be secured in order to operate or establish an establishment prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable the use, testing, promotion, advertisement, and/or sponsorship of food, drugs, cosmetics, health products, and other medical products and devices. Incomplete requirements shall not be processed. 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. 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. Attachment-> : Cascading on 7 and 9 August 2019 by CCRR. The company is given sixty days to comply with all the deficiencies. Applicable Section: Book 2 Article I Section 1 para. Releasing Officer releases the Authorization/s to Client. ‘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; …’” Cruz, Manila. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. 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. The confirmed participant of this seminar will be transferred to the next available seminar schedule. a: Edit. The applicant shall submit the documentary requirements specified in DOH AO 2016-0003 when applying for a License to Operate and variations as applicable. Upon receipt of DRF, the Releasing Officer checks on the files for release. All rights reserved. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. COntact Information: Complaint and Action Unit: 8651-7800 local 2527; Regulatory Compliance and Enforcement Division: 8651-7800 locals 2502, 2504, 2511 To date there are no published clinical trials that have evaluated the use of injectable glutathione for skin lightening. The Center for Drug Regulation and Research (CDRR) will be having its Operational Planning on 17-19 July 2019. 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. Please be informed that the venue of the Unified Licensing Seminar (ULS – RI) on 31 July 2019 and 1 August 2019 will be in NORTHVIEW HOTEL, BRGY. Provide needed information under “Details of the Authorized Officer” and “Details of the Applicant.”Upload the required documents (depending on LTO type). Be sure that it is completed (signed and notarized) and virus-free. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. For more information and inquiries, please e-mail us at [email protected]. Renewal Application of LTO Center for Food Regulation and Research - Drug Establishment Licensing Requirements Self Assessment Toolkits for Drugstores - FDA drugstore application form for renewal The LTO is, at first, valid for one year. However, non-toxic trace amounts of methanol can also be naturally present in fruit juices. The FDA has not approved any injectable products for skin lightening. 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. 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. Requests for replacing the authorized company representative as well as account reactivation must be sent to pair@fda.gov.ph at least three (3) months before the expiration of the User Account. There are also no published guidelines for appropriate dosing regimens and duration of treatment. Please be informed that the conduct of ULS-RII in Isabela (Course Code:ULS-RII) scheduled on 18 July 2019 shall be postponed due to Typhoon Falcon that is expected to land in Northern Luzon this week. Attachment->:ADVISORY-RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC). The company provides business registration, payroll and bookkeeping, visa processing services. 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. Course Assessment Slip 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. Applying for an initial FDA LTO consists of the following steps: filing, evaluation, and inspection. While there are quite a few articles online on FDA LTO application, they are mostly outdated. If caught, your LTO may be suspended, revoked, canceled, or disapproved upon renewal. Consumers must also exercise extreme caution in buying alcoholic drinks, especially those that do not have labels, poorly printed labels or with broken seals. FDA Consulting. Higher concentrations of methanol in alcoholic drinks can happen when methanol is deliberately added to alcoholic drinks. The new mandatory format requirement is a supplement to the Order No. If the company complies with the requirements and passed the inspection, a license to operate will be issued. 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. 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. 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. You also need to obtain different kinds of certification and permit. All registered participants to this seminar shall be automatically moved to the reschedule date of the seminar. The Philippines’ Food and Drug Administration (FDA), formerly the Bureau of Food and Drugs (BFAD), was created under the Department of Health to license, monitor, and regulate the flow of food, drugs, cosmetics, medical devices, and household hazardous waste in the Philippines. 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. Regular transactions will resume on Monday, 19 August 2019. Authorization letter in company letterhead; Photocopy of valid ID of the Company’s Owner/President/Manager/Head; and. 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). Signs and symptoms of methanol poisoning include headache, vomiting, abdominal pain, hyperventilation, and feeling of breathlessness. AUTHORIZED PERSON TO PICK-UP / CLAIM THE AUTHORIZATIONS: 2. 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. Attachment-> : CDRR MEMORANDUM NO.2019-07. First, accomplish an authorization letter for the eLTO User Account Application. 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. For more information and update on the Unified Licensing Seminar for Region II (ULS-RII), please visit the FDA website, www.fda.gov.ph. 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 shall be rescheduled to 3-4 October 2019. We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly. Buying medicines over the internet can pose serious health risk. DBC was founded in 2011. Please note that photocopy of each required document is needed for every request. Davao City, Philippines, _____ , 20 _____. 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. Copyright 2021 Dayanan Business Consulting. This process is done in conjunction with the human drug registration process. Companies may also apply at the respective FDA regional field office in their location. Attachment: CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019. 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 … This post is about the Certificate of Product Registration (CPR). 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. Requests received after 5:00 pm on regular working days, holidays, Saturdays, and Sundays shall be processed on the next working day. Use the Show Map Tool and move the arrow to the exact address of the establishment and click the “Submit” button. This is also a product of natural fermentation and is found in both alcoholic and non-alcoholic fermented beverages. 11232), Special Visa for Employment Generation (SVEG), Tips to make application easier and faster. 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. 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. 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 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). This is of particular concern when non-medical practitioner administers this treatment or done in a non-sterile facility. Attachment-> : ULS DAVAO VENUE on 22 August 2019. 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. We hope these tips answer your queries on how to apply for an FDA LTO. 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: Under the General Information tab, select the appropriate Product Type, Primary Activity, and Type of Application from their respective drop-down menus. 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. Operating without a license can spell disaster for your business. Methanol is a widely available chemical that has many industrial applications and is also found in household products and fuel for aircraft. Photocopy of the VALID Professional Regulation Commission (PRC) license of all the radiologist/s and radiologic/x-ray technologist/s. Payment can be made using existing FDA mechanisms. 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. The Food and Drug Administration (FDA) warns the public on significant risks associated with the growth of the internet’ sales of medicines. 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. Also, these medicines may not be stored correctly in accordance with its appropriate storage conditions. In order to have an efficient and orderly releasing of FDA Authorizations at the Food and Drug Action Center (FDAC), the following guidelines shall be strictly implemented: A. The following are the License to Operate requirements for initial and renewal applications. 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). Procedures on the Use of the New Application Form for License to Operate thru the FDA Electronic Portal (For All Establishments Regulated by FDA) Click “New Case” on the upper left-hand side and select “License to Operate v2.0” which can be found under Electronic Licensing. 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. Proof of Payment, VENUE FOR UNIFIED LICENSING SEMINAR ON 3 & 4 JULY 2019. 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. For more information and update regarding FDA seminars, please visit the FDA website, www.fda.gov.ph. 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. Once you have a valid User Account in hand, the E-Portal can now be accessed. Upon validation, Releasing Officer hands-over to Client the second copy as FDA’s receiving copy indicating the printed name, signature, date and time of receipt. 3. 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. The Food and Drug Administration (FDA) Philippines (previously called Bureau of Food and Drugs) is responsible for safeguarding public health and safety through enforcing its standards on all products relating to food, drugs, cosmetics, medical devices, and household hazards that are available in the Philippine market. 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. Dissemination of the information to all concerned is requested. Double-check the total amount to be paid by looking at the Order of Payment section, which can be downloaded if needed. 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. Non-compliance will result to temporary stoppage of the selling of medical devices. If you are thinking about opening a food business, there are many regulatory requirements that you will need to meet. Lastly, a pre-opening inspection shall be conducted for manufacturers. Injectable glutathione is sometimes paired with intravenous Vitamin C. Vitamin C injection may form kidney stones if the urine is acidic. The E-Portal accepts new, renewal, and variation applications. Attachment-> :  VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019. 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. Currently, FDA only allows online ordering services provided that the seller has an existing FDA-licensed Pharmacy or Botika with physical address. The accomplishment of the eLTO may be done via http://www.fda.gov.ph. For a related entry, please read Food and Drug Administration – Philippines. 7 J.P LAUREL AVENUE, LANANG, DAVAO CITY, DAVAO DEL SUR. In the Philippines, online selling of medicines is NOT permitted pursuant to existing laws, rules and regulations. 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 … Blindness can also happen in severe cases. – Surrender original / old License to Operate and COC / CTR 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. / : * ” > <. All documents must be scanned and compiled with 100-150 dots-per-inch (dpi). For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email at [email protected]. Completed Application Form with Declaration and Undertaking, Site Master File (for manufacturers of drugs, devices and cosmetics), Log-in to the e-Portal using the User Account provided by FDA at. Interested in FDA LTO application (License to Operate from the Philippine Food and Drug Administration) but don’t know where to start? 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: 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. 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).