* PRC-registered professional acting as representatives may transact with PRC upon presentation of Authorization Letter and his/her professional ID. renewal. That we shall display the approved License to Operate in a conspicuous place of my establishment; 4. Accomplished and duly notarized Petition Form and Joint Affidavit of Undertaking; List of products to be distributed, identified by generic names and brand names intended for use; Copies of Pharmacist Board Registration Certificate, PRC ID, valid PTR, ID picture, and Duties and Responsibilities; Certificate of Attendance of owner or pharmacist to an FDA seminar on Licensing of Drug Establishments; Certificate of Registration with SEC and Articles of Incorporation/Partnership (for corporations or partnerships); Certificate of Business Name Registration with DTI (for single proprietorships); Locational plan and floor plan (office and storage room) with dimensions; and. P 5,000.00 S-5I (Importer) License to import specified (a supplemental options on said requirements. Photocopy of the business/mayor’s permit or SEC/DTI registration of the facility. Contact Us : +63 (02) 8551 9012-13. print it on a long bond paper, back-to-back) 2. Foreign Agency Agreement (FAA) from each supplier, duly authenticated by the Territorial Philippine Consulate, Certificate of Registration of manufacturer and its conformity with the Good Manufacturing Practices From Health Authority authenticated by the Philippine Consulate, Valid current contract with FDA licensed supplier/manufacturer, Certificate of product registration from FDA, Philippine National Drug Formulary (latest edition), R.A. 3720: Foods, Drugs, Devices & Cosmetics Act, R.A. 6675: Generics Act of 1988 and Relevant Implementing Rules and Regulations, R.A. 5921: Pharmacy Law as amended and Relevant Implementing Rules and Regulations, Latest edition of United State Pharmacopoeia/National Formulary (USP/NF), or Remington’s Pharmaceutical Sciences, or Goodman & Gilman’s The Pharmacological Basis of Therapeutics. For a company to be able to import, distribute, market, advertise or manufacture their products here in the Philippines. For initial/renewal application, fee paid shall be forfeited when the facility fails to comply with the licensing requirements within 60 days upon proper notice from the CDRRHR. Dela Costa Street Salcedo Village, Makati City 1227 PRE-PERMIT REQUIREMENTS: ISSUING OFFICE/AGENCY/ ADDRESS: 1. �suo��]��/�(� ~�{�7#-ra`;|F�$������&��@(�؍!S�|�}K���G0M�;iD����1��-�+��d9��>> #�����u�V��2+|B�e3��wjU�T^U�7;I�=`(��Q,@����`�{Wo6��?۽�덓횵Ӽ�x� �� �\�R�f�ܵ#���"��(iqj�գ|��/.�8�̭#d�x�C����+[�g�)�2*(�Z��ISV��創�qnop��(��e��� ��@?i�u؉��x�+�!���]��!==^�#����APn��I7�o�4�8�3>~��C�2Ż�Pd��\��!^��X�)V �5f�Ʌ^ +��ǡ�6���t��.�Ge�� License to Operate is an Establishment License of medical device enterprise issued by Philippines government. <> Dela Costa Street Salcedo Village, Makati City 1227 endobj Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION Alabang, Muntinlupa City Tel. Product Importation and Registration in the Philippines. “An application for renewal of an LTO received after its date of expiration shall be subject to a surcharge or penalty equivalent to twice the renewal licensing fee and an additional 10% per month or a fraction thereof of continuing non-submission of such application up to … 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. Frequently Asked Questions for Bookkeeping in the Philippines August 2, 2020; FDA-Approved Food Supplements in the Philippines: A Quick Guide (Part 1) May 25, 2020; FDA CPR Certificate of Product Registration Requirements and Application Process in the Philippines April 26, 2020 License to Operate (LTO) Application Goes Electronic. <>>> (Section 5 item no. Establishments under industries requiring a License to Operate as manufacturer, importer, distributor, wholesaler, or exporter: Requirements for verification during inspection: 12F Sagittarius Building, The government agency in the Philippines tasked to issue licenses and permits to individuals who are qualified to drive is the Land Transportation Office or more commonly called as LTO. "�������8G(����֌������ License To Own and Possess Firearm (LTOPF) Requirements (Update) Written by FESAGS on 28 April 2015. Occupancy Certificate (clearance) 5. Mayor’s Permit (Business Permit) Registration in the Philippines for New Businesses Before you can start operating your business in the Philippines, you need to secure a Mayor’s Permit or Business Permit from the Local Government Unit (LGU) where your company office is located. All Drug, API and Medical Device establishments registered with FDA must renew their registration annually between October 1st and December 31st. Procedures on the Use of the New Application Form for License to Operate thru the FDA Electronic Portal (For All Establishments Regulated by FDA) No. How Te Get a LTO Non-Professional Driver’s License: Requirements, Qualifications, Procedures – 2020; Driver’s License Requirements: The Definitive Guide 2019; Driver’s License Renewal: LTO Non-professional – 2020; Driving in the Philippines with a Foreign Driver License; How to get an MTOP (Motorized Tricycle Operator’s Permit) 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. Establishments under industries requiring a License to Operate as manufacturer, importer, distributor, wholesaler, or exporter: Food; Drugs Email: info@tripleiconsulting.com. ��>L��6�2x����� Barangay Business Clearance 3. Proceed with interview with the Food and Drug Registration Office (FDRO); Review of completion of requirements and application by the Licensing Department; Receive Order for Payment and complete application; Physical inspection of office and facility by the FDRO. %PDF-1.5 This process is done in conjunction with the human drug registration process. <>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595.4 842] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Documentary Requirements 1) Application Form Nicolas & De Vega Law Offices is a full-service law firm in the Philippines. Contact the FDA Industry Systems Help Desk at furls@fda.gov, toll-free in the USA 1-800-216-7331, or 301-575-0156 if you require additional assistance. .����W�#��� wv��{\��2!�KZXA8�_�v���0�J�����ɻhţJ�s��(4]HG���.�1kY>�C�\�|�;+(n9[���-��X>��|ƣց V�F�o��@Z4��RϠm���H*�!�� Here are the requirements in starting your own drugstore business for prescription and non 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 nowvia the1. 111, H.V. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. Forgot Password: Copyright © 2013-2021 Food and Drug Administration, Philippines. How to Get a License to Operate from the FDA in the Philippines. After obtaining an LTO companies may then proceed to apply for a Certificate of Product Registration (CPR), which states that the product has been evaluated and officially registered with the Philippine FDA. (632) 8651-7800 DOH Call Center Telephone No: (632) 8651-7800 local 5003-5004 (632) 165-364 Mobile No (DOH Main Office): +63919-1601418 Email Address: callcenter@doh.gov.ph p For every three (3) nurses, there must be … Philippines 1003 Telephone No. service provider should be secured as a prerequisite for license to operate. Accomplished Application Form with Declaration and Undertaking; Proof of Business Name Registration; Site Master File (for manufacturers of drugs, devices and cosmetics) Risk Management Plan; Payment of the appropriate filing fee ; For Renewal Application Letter Request for Renewal of Permit/s addressed to EMB Regional Director; Duly accomplished application form for POA/WWDP; and Copy of previous issued POA/WWDP. COntact Information: Complaint and Action Unit: 8651-7800 local 2527; Regulatory Compliance and Enforcement Division: 8651-7800 locals 2502, 2504, 2511 3. – Surrender original / old License to Operate and COC / CTR The new schedule of fees and charges are summarized in Annexes A to G:. The LTO is, at first, valid for one year. V. Requirements for Renewal/Amendment of Wastewater Discharge Permit Letter request for Renewal/Amendment of Permit addressed to EMB Regional Director Duly accomplished and notarized application form Geo-tagged 1. Click here to read more. 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