On June 7 Philippines FDA released and adopted a new format of License to Operate (LTO) for establishments. The confirmed participant of this seminar will be transferred to the next available seminar schedule. 46, AIRPORT ROAD, LAOAG CITY, ILOCOS NORTE. Blindness can also happen in severe cases. 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 registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents: Applicable Section: Book 2 Article I Section 1 para. All documents must be scanned and compiled with 100-150 dots-per-inch (dpi). Even if the medicines bought online looks the same; there is no guarantee that it is genuine. This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph. 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. For more information and inquiries, please e-mail us at [email protected]. All confirmed participants of this seminar shall be automatically moved to the rescheduled date. 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. The company provides business registration, payroll and bookkeeping, visa processing services. COntact Information: Complaint and Action Unit: 8651-7800 local 2527; Regulatory Compliance and Enforcement Division: 8651-7800 locals 2502, 2504, 2511 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. Carpo Law & Associates provides FDA Registration Services to help local and foreign companies secure a License to Operate (LTO) and a Certificate of Product Registration (CPR) from the Food and Drug Administration (FDA) before they introduce their product in the Philippines. After you’re done applying, expect your FDA License to Operate (LTO) in the mail! The E-Portal accepts new, renewal, and variation applications. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC). Also of concern is the possibility of Stevens Johnson Syndrome. Instead of a simple sign-up button, it instead involves sending a few emails. 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. Rest assured that all changes and concerns of the registered participants of this seminar shall be attended to by the FDA Academy. Double-check the total amount to be paid by looking at the Order of Payment section, which can be downloaded if needed. This new guide gives you a complete step-by-step process on how to apply for an FDA LTO in 2020. Course Assessment Slip This new guide gives you a complete step-by-step process on how to apply for an FDA LTO in 2020. Ensure that all documents are secured before applying to avoid processing delays. Payment can be made using existing FDA mechanisms. An LTO allows you to legally import, distribute, sell wholesale, and/or manufacture food, drugs, cosmetics, and medical devices. 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. User Accounts are usually issued within two (2) days upon receipt of the completed request by the FDA in the Philippines. Incomplete requirements shall not be processed. Use the Show Map Tool and move the arrow to the exact address of the establishment and click the “Submit” button. Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B. Attachment-> : APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS-ENNDS PRODUCTS. Attachment-> : CDRR MEMORANDUM NO.2019-07. Do not forget to attach files to emails before sending them. Please note that photocopy of each required document is needed for every request. This will designate a specific individual as eLTO account holder. 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. This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph. 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. 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. Be sure that it is completed (signed and notarized) and virus-free. Next, send an email to request for a User Account to the FDA’s Public Assistance, Information and Receiving (PAIR) unit via. To assure that your skin conditions are treated, consult only a board-certified dermatologist. 3. Online ordering services are additional activities of a Pharmacy or Botika subject for approval of FDA. 1. 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. If you are thinking about opening a food business, there are many regulatory requirements that you will need to meet. There are also no published guidelines for appropriate dosing regimens and duration of treatment. Make sure documents are in PDF format. Currently, FDA only allows online ordering services provided that the seller has an existing FDA-licensed Pharmacy or Botika with physical address. 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. 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. FDA Consulting. FDA Circular 2016-004. Pursuant to FDA Circular No. Make sure you’ve read and fully understood the “Declaration and Undertaking” and click the “I Agree” button before proceeding. This post is about the Certificate of Product Registration (CPR). The accomplishment of the eLTO may be done via http://www.fda.gov.ph. 2. 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. This is in consideration to the reinstatement of the HUHS licensing and notification requirements. Each User Account is unique to one company and is valid for one (1) year. Please note: Under the “Assign Task” section, please click the “Continue” button in order for the application to be processed by the FDA. Attachment-> : ULS DAVAO VENUE on 22 August 2019. This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph. 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 – RIX) on 5 July 2019 will be in HOTEL GUILLERMO, RIZAL AVENUE, PAGADIAN CITY. 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). Accomplish the General Information appropriately). Cruz, Manila. The Food and Drug Administration (FDA) warns the public on the dangers associated with the use of injectable lightening agents such as glutathione. With this, the FDA commenced its own investigation on the implicated product ‘Cosmic Carabao Gin’ which is a locally manufactured alcoholic beverage. 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. Attachment-> : RESCHEDULE OF QPIRA FOR CFRR AND GMP-FMT SEMINAR. 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. Signs and symptoms of methanol poisoning include headache, vomiting, abdominal pain, hyperventilation, and feeling of breathlessness. 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. We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly. 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. 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 … Dissemination of the information to all concerned is requested. All rights reserved. Under Establishment Information, provide the complete establishment name, TIN, address, and contact details. CHECKLIST OF REQUIREMENTS FOR THE ISSUANCE OF LICENSE TO OPERATE FOR COSMETIC ESTABLISHMENTS I. INITIAL/OPENING APPLICATIONS A. Now that you have all the requirements, the application for the actual license can now follow. 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. 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. You also need to obtain different kinds of certification and permit. Consumers must also exercise extreme caution in buying alcoholic drinks, especially those that do not have labels, poorly printed labels or with broken seals. The Philippine Food and Drug Administration (FDA) is the country’s official government arm that protects the health of the public by assuring safe, efficient, and quality drugs, food products, food supplements, cosmetics, household hazardous products, household urban hazardous products, and medical devices. The manufacturing facility of Juan Brewing, Inc. shall be inspected and investigated for any possibility of adulteration specifically the addition of methanol during processing. The Food and Drug Administration (FDA) warns the public on significant risks associated with the growth of the internet’ sales of medicines. All establishments under the four FDA Centers are required to get a License to Operate before importing any product ... on the Unified Licensing Requirements and Procedures of the Food and Drug Administration (FDA) repealing Administrative Order 2016-0003. Attachment: CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019. For more information and update on the Unified Licensing Seminar for Region II (ULS-RII), 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. GENERAL REQUIREMENTS Completely accomplished and notarized Integrated Application Form with ID picture of both the Owner/Incorporator/General Manager and the Authorized Person (Refer Provide needed information under “Details of the Authorized Officer” and “Details of the Applicant.”Upload the required documents (depending on LTO type). For any concerns or inquiries, kindly contact CCRR, at (02) 857-1900 local 8107 or 8113, or through email at [email protected]. While there are quite a few articles online on FDA LTO application, they are mostly outdated. 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. All guidelines and penalties may be found on the FDA website: http://www.fda.gov.ph. While there are quite a few articles online on FDA LTO application, they are mostly outdated. Interested in FDA LTO application (License to Operate from the Philippine Food and Drug Administration) but don’t know where to start? 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.. In the Philippines, online selling of medicines is NOT permitted pursuant to existing laws, rules and regulations. 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. 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. Attachment-> : Cascading on 7 and 9 August 2019 by CCRR. a: Edit. 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. Higher concentrations of methanol in alcoholic drinks can happen when methanol is deliberately added to alcoholic drinks. Buying medicines over the internet can pose serious health risk. AUTHORIZED PERSON TO PICK-UP / CLAIM THE AUTHORIZATIONS: 2. 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. If caught, your LTO may be suspended, revoked, canceled, or disapproved upon renewal. 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. Attachment-> :  VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 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. The LTO is, at first, valid for one year. Click “New Case” on the upper left-hand side and select “License to Operate v2.0” which can be found under Electronic Licensing. However, non-toxic trace amounts of methanol can also be naturally present in fruit juices. The Philippine National Trade Repository is here to serve both local and foreign importers, exporters, and anyone in need of Philippine trade information. 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. 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. An application is considered filed only if all necessary requirements are met, including payment of fees. In the Philippines, several health and beauty salons, wellness spa and beauty clinics are offering all kinds of beauty enhancements, services and skin treatments. You will never know what exactly you are getting. What is an LTO or License to Operate? Applying for an initial FDA LTO consists of the following steps: filing, evaluation, and inspection. 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. How to Get a License to Operate from the FDA in the Philippines A company can apply for an FDA certificate with the Center for Food in the FDA central office. 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. Attachment->:ADVISORY-RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC). Injectable glutathione is sometimes paired with intravenous Vitamin C. Vitamin C injection may form kidney stones if the urine is acidic. 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. 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. 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. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email at [email protected]. Avoid buying injectable products online and from being lured to a promising effect of medicines as beauty products. Proof of Payment, VENUE FOR UNIFIED LICENSING SEMINAR ON 3 & 4 JULY 2019. Dayanan has a pool of professionals ready to assist you in setting up your business in the Philippines. 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. 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 new mandatory format requirement is a supplement to the Order No. Regular transactions will resume on Monday, 19 August 2019. 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 Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. Upon receipt of DRF, the Releasing Officer checks on the files for release. 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. Davao City, Philippines, _____ , 20 _____. If the company complies with the requirements and passed the inspection, a license to operate will be issued. Copyright 2021 Dayanan Business Consulting. The Center for Drug Regulation and Research (CDRR) will be having its Operational Planning on 17-19 July 2019. 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. (Each primary activity has its applicable sub-options. It is important to seek medical advice from doctor or pharmacist before taking medicines. Once you have a valid User Account in hand, the E-Portal can now be accessed. 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. Operating without a license can spell disaster for your business. For inquiries and other concerns, you may reach the FDA Academy thru: Attachment-> : ULS-RII POSTPONEMENT ON JULY 18 2019. Result to temporary stoppage of the internet’ sales of medicines is not with. Contact us here attachment- >:  RESCHEDULING of QCCRR–MIN and ULS-RX E-Portal can now be accessed downloaded. Vitamin C. 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