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Apply and Register for License to Operate, Certificate of Product Registration, and other FDA Authorizations
Welcome to FDA Verification Portal. This online portal provides a comprehensive list of Establishments and Health Products with License to Operate (LTO) and Certificate of Product Registration/Notification (CPR/NN) respectively.
This FDA Circular is provided to give further guidance on the regulatory flexibilities implemented by the FDA considering the continuing COVID-19 pandemic, specifically on the FDA-issued marketing authorizations.
Human Drugs. × UPDATE! Updated as of 30 September 2024. Formulation: After reconstitution, one dose (0.5 mL) contains 4.0-5.8 log Plaque Forming Units (PFU) live, attenuated, recombinant Japanese Encephalitis Virus.
Application form is downloaded from www.fda.gov.ph. The integrated application form in XLS or XLSX format is used for both License and Registration applications, as well as amendments and other certifications.
6 September 2022. FDA Advisory No.2022-1519 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “SANSURE BIOTECH SARS-COV-2-ANTIGEN TEST CASSETTE”. COVID19-Related, Device Advisories.
1. What is a License to Operate (LTO)? LTO is an authorization issued by the FDA to an establishment to grant permission to undertake a trade or carry out a business activity, such as manufacturing, importation, exportation, sale, offering for sale, distribution, or transfer of food products.
NN-1000007322526. LUSH FRESH HANDMADE COSMETICS YUZU AND COCOA BODY SPRAY. LUSH FRESH HANDMADE COSMETICS. STORES SPECIALISTS, INC. 12 January 2021. 12 January 2023. View. NN-1000005598798. MARVEL KAWAII NOSE MASK (IRON MAN)
To protect and promote the right to health of the Filipino people by ensuring the safety, efficacy, quality, and purity of foods, drugs, devices, and cosmetics, and. To establish and maintain an effective health products regulatory system responsive to the country’s health needs and problems.
Emergency Use Authorization (EUA) is an authorization issued for unregistered drugs and vaccines in a public health emergency. The FDA Director General, by virtue of the Executive Order No. 121 of the President of the Philippines, authorizes the issuance of the EUA. List of COVID-19 Vaccines Authorized by the FDA.