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 any concerns or inquiries, kindly contact CCRR, at (02) 857-1900 local 8107 or 8113, or through email at [email protected]. The confirmed participant of this seminar will be transferred to the next available seminar schedule. After filing, the FDA will evaluate all LTO applications to determine whether to grant the license or not. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC). 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. We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly. 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. 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). Double-check the total amount to be paid by looking at the Order of Payment section, which can be downloaded if needed. To assure that your skin conditions are treated, consult only a board-certified dermatologist. Attachment:->VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RIX) ON 5 JULY 2019. The applicant shall submit the documentary requirements specified in DOH AO 2016-0003 when applying for a License to Operate and variations as applicable. Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. 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. Incomplete requirements shall not be processed. 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: Filling up the forms and uploading the documents can now be done via the portal. This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph. 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. 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. Upon receipt of DRF, the Releasing Officer checks on the files for release. For more information and update regarding FDA seminars, please visit the FDA website, www.fda.gov.ph. 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. AUTHORIZED PERSON TO PICK-UP / CLAIM THE AUTHORIZATIONS: 2. 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 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 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. 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