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. 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. 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. 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. (Each primary activity has its applicable sub-options. 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. 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. 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. All document file names must be less than 40 characters, should not contain the following characters: \ ? 7 J.P LAUREL AVENUE, LANANG, DAVAO CITY, DAVAO DEL SUR. 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. 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. Proof of Payment, VENUE FOR UNIFIED LICENSING SEMINAR ON 3 & 4 JULY 2019. For inquiries and other concerns, you may reach the FDA Academy thru: Attachment-> : ULS-RII POSTPONEMENT ON JULY 18 2019. FDA Consulting. If the company complies with the requirements and passed the inspection, a license to operate will be issued. 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. An LTO allows you to legally import, distribute, sell wholesale, and/or manufacture food, drugs, cosmetics, and medical devices. After filing, the FDA will evaluate all LTO applications to determine whether to grant the license or not. 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. Procedures on the Use of the New Application Form for License to Operate thru the FDA Electronic Portal (For All Establishments Regulated by FDA) For more information and update on the Unified Licensing Seminar for Region II (ULS-RII), please visit the FDA website, www.fda.gov.ph. Make sure documents are in PDF format. 2. With our FDA Consulting services, you would no longer have to stress and fret over the LTO application process. 4. The E-Portal accepts new, renewal, and variation applications. Next, send an email to request for a User Account to the FDA’s Public Assistance, Information and Receiving (PAIR) unit via. The applicant shall submit the documentary requirements specified in DOH AO 2016-0003 when applying for a License to Operate and variations as applicable. 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). All registered participants to this seminar shall be automatically moved to the reschedule date of the seminar. 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. For more information and inquiries, please e-mail us at [email protected]. The Food and Drug Administration (FDA) warns the public on the dangers associated with the use of injectable lightening agents such as glutathione. Interested in FDA LTO application (License to Operate from the Philippine Food and Drug Administration) but don’t know where to start? For any concerns or inquiries, kindly contact CCRR, at (02) 857-1900 local 8107 or 8113, or through email at [email protected]. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. 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. Requests received after 5:00 pm on regular working days, holidays, Saturdays, and Sundays shall be processed on the next working day. 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. 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. Attachment:->VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RIX) ON 5 JULY 2019. Blindness can also happen in severe cases. 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. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. All guidelines and penalties may be found on the FDA website: http://www.fda.gov.ph. Releasing Officer releases the Authorization/s to Client. CHECKLIST OF REQUIREMENTS FOR THE ISSUANCE OF LICENSE TO OPERATE FOR COSMETIC ESTABLISHMENTS I. INITIAL/OPENING APPLICATIONS A. The FDA will also ensure that adequate coordination with the Law Enforcement Agencies shall be done to facilitate their own investigation. Attachment-> : RESCHEDULE OF QPIRA FOR CFRR AND GMP-FMT SEMINAR. – Surrender original / old License to Operate and COC / CTR The following are the License to Operate requirements for initial and renewal applications. 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. 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. Once you have a valid User Account in hand, the E-Portal can now be accessed. Dissemination of the information to all concerned is requested. Attachment-> : RESCHEDULING OF QCCRR–MIN AND ULS-RX. 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 … Attachment-> : Cascading on 7 and 9 August 2019 by CCRR. Attachment-> : APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS-ENNDS PRODUCTS. Be sure that it is completed (signed and notarized) and virus-free. 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. Filling up the forms and uploading the documents can now be done via the portal. If caught, your LTO may be suspended, revoked, canceled, or disapproved upon renewal. You will never know what exactly you are getting. This post is about the Certificate of Product Registration (CPR). 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. 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 manufacturing facility of Juan Brewing, Inc. shall be inspected and investigated for any possibility of adulteration specifically the addition of methanol during processing. 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: 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). 11232), Special Visa for Employment Generation (SVEG), Tips to make application easier and faster. If you would like to avail of our FDA consulting services, you may contact us here. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC). For more information and update regarding FDA seminars, please visit the FDA website, www.fda.gov.ph. 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. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. This will designate a specific individual as eLTO account holder. ‘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; …’” Attachment-> : CDRR MEMORANDUM NO.2019-07. 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. Injectable glutathione is sometimes paired with intravenous Vitamin C. Vitamin C injection may form kidney stones if the urine is acidic. Please note that photocopy of each required document is needed for every request. Double-check the total amount to be paid by looking at the Order of Payment section, which can be downloaded if needed. On June 7 Philippines FDA released and adopted a new format of License to Operate (LTO) for establishments. This is also a product of natural fermentation and is found in both alcoholic and non-alcoholic fermented beverages. Dayanan has a pool of professionals ready to assist you in setting up your business in the Philippines. Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B. 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. While there are quite a few articles online on FDA LTO application, they are mostly outdated. The accomplishment of the eLTO may be done via http://www.fda.gov.ph. Don’t forget to attach a scanned Authorization Letter in PDF format. 46, AIRPORT ROAD, LAOAG CITY, ILOCOS NORTE. 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. Attachment-> : ULS DAVAO VENUE on 22 August 2019. 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. 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. Each User Account is unique to one company and is valid for one (1) year. The company provides business registration, payroll and bookkeeping, visa processing services. This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph. Under the General Information tab, select the appropriate Product Type, Primary Activity, and Type of Application from their respective drop-down menus. 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! The Food and Drug Administration (FDA) warns the public on significant risks associated with the growth of the internet’ sales of medicines. 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. The FDA recommends purchase of medicines from licensed pharmacies near you and seek advice from your community pharmacist on the proper and safe use of medicines. Cruz, Manila. 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. 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. It is important to seek medical advice from doctor or pharmacist before taking medicines. 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). Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. 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. Incomplete requirements shall not be processed. Why would you need one? 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. / : * ” > <. Upon receipt of DRF, the Releasing Officer checks on the files for release. This new guide gives you a complete step-by-step process on how to apply for an FDA LTO in 2020. If you are thinking about opening a food business, there are many regulatory requirements that you will need to meet. Now you can apply for a LTO from Food and Drug Administration in the comfort of your own home. All confirmed participants of this seminar shall be automatically moved to the rescheduled date. First, accomplish an authorization letter for the eLTO User Account Application. 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.. 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. The confirmed participant of this seminar will be transferred to the next available seminar schedule. Online ordering services are additional activities of a Pharmacy or Botika subject for approval of FDA. The Philippine National Trade Repository is here to serve both local and foreign importers, exporters, and anyone in need of Philippine trade information. 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. Avoid buying injectable products online and from being lured to a promising effect of medicines as beauty products. AUTHORIZED PERSON TO PICK-UP / CLAIM THE AUTHORIZATIONS: 2. Lastly, a pre-opening inspection shall be conducted for manufacturers. 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. 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. Copyright 2021 Dayanan Business Consulting. 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. By virtue of FDA Personnel Order No. Authorization letter in company letterhead; Photocopy of valid ID of the Company’s Owner/President/Manager/Head; and. 2019-0523, please be advised that the Center for Cosmetics Regulation and Research (CCRR) will conduct a Cascading-Workshop on the new Administrative Orders on the Regulation of Electronic Nicotine Delivery Systems (END/ENDDS), Household Pesticide and Their Active Ingredients, Operators of Pest Control, Certification of Pesticide Handlers and Accreditation of Their Training Providers, Reinstatement of Licensing and Registration and or Notification of Household Urban Substances and Implementing Rules and Regulations of RA10620 on 15 to 16 of August 2019.On such dates, CCRR will not be able to entertain clients. Attachment-> :  VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019. The Revised Corporation Code of the Philippines (R. A. To assure that your skin conditions are treated, consult only a board-certified dermatologist. User Accounts are usually issued within two (2) days upon receipt of the completed request by the FDA in the Philippines. 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 1. Currently, this product is not registered with the FDA. With the goal of increasing transparency, accessibility, and efficiency of the process, this decision has been especially beneficial for businesses based outside Metro Manila. This process is done in conjunction with the human drug registration process. 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. This is of particular concern when non-medical practitioner administers this treatment or done in a non-sterile facility. Appropriate regulatory action shall be imposed on those non- compliant establishments found violating current standards, rules, and regulations. Now that you have all the requirements, the application for the actual license can now follow. 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. Applicable Section: Book 2 Article I Section 1 para. 3. Also, these medicines may not be stored correctly in accordance with its appropriate storage conditions. Higher concentrations of methanol in alcoholic drinks can happen when methanol is deliberately added to alcoholic drinks. 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