Philippine Legal Advice

Securing a License to Operate with the Food and Drug Administration in the Philippines

Securing a License to Operate with the Food and Drug Administration in the Philippines: What is a License to Operate and When is it Needed?

What is a License to Operate (“LTO”)? 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,

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How to Apply for Variations with the Food and Drug Administration

E-Portal: Filing and Application for a License to Operate (LTO) as a Cosmetic / Drug /Medical Device / Food Manufacturer, Importer Or Distributor with the Food and Drug Administration of the Philippines

The LTO Application Process Is Now Streamlined On 02 May 2016, the Food and Drug Administration (“FDA”) adopted a new application process and form for a License to operate (“LTO”). The application process is now navigable and accessible through the electronic portal found at the FDA website (www.fda.gov.ph). The electronic process for LTO application has

E-Portal: Filing and Application for a License to Operate (LTO) as a Cosmetic / Drug /Medical Device / Food Manufacturer, Importer Or Distributor with the Food and Drug Administration of the Philippines Read More »

Taxes and Transfer of Stocks Listed and Traded thru the LSE - nicolas and de vega law offices image

Taxes and Transfer of Stocks Listed and Traded through the Local Stock Exchange

New Tax Rates on Stock Transfers This article discusses the tax involved in the transfer of stocks which are listed and traded through the Local Stock Exchange. In stock transfers, the tax to be paid is called a Percentage Tax, which is a business tax imposed on stock transfer transactions such as the sale, barter,

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PROHIBITED CLAIMS IN FOOD PRODUCTS - nicolas and de vega law offices

Prohibited Claims in Food Product Labels under FDA Regulations and Philippine law

Purpose of the Law To protect the public against dishonest or misleading advertising or promotion, and to ensure that every consumer acquires sufficient knowledge to be an informed consumer, particularly in the choice of the consumer products that he or she wishes to purchase or consume, the Food and Drug Administration (“FDA”) issued Administrative Order

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What are the FDA Mandatory Label Information for Food Products?

Mandate of the Food and Drug Administration Republic Act No. 3720, or otherwise known as the Food, Drug, and Cosmetic Act, is the law creating the Food and Drug Administration (“FDA”), which is under the Office of the Secretary of the Department of Health. The FDA is tasked by law to prescribe standards, guidelines, and

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FDA Requirements for the Issuance of an Authorization for the Sale, Manufacture, Importation or Distribution of a Medical Device in the Philippines

What is a medical device? The regulations issued by the Food and Drug Administration (FDA) of the Philippines defined a ‘medical device’ as any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used alone, or in combination, for human

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HOW TO MAINTAIN PRODUCT INFO FILE - nicolas and de vega law offices image

An FDA Requirement: How to Maintain a Product Information File?

FDA Issuance Requiring a Product Information File With the end in view of ensuring safety, quality and/or efficacy of the cosmetic products that companies are placing in the market, the Food and Drug Administration (FDA) issued FDA Circular No. 2018-001, which requires a Marketing Authorization Holder (MAH) to keep and maintain a Product Information File.

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New Procedure: How to Liquidate a Closed Bank in the Philippines

The Supreme Court enacts New Rules of Procedure on Liquidation of Closed Banks  The Supreme Court recently enacted new rules of procedure for the liquidation of closed banks in the Philippines. Scheduled to take effect on April 16, 2020, A.M. No.19-12-02-SC governs the Rules on Liquidation of Closed Banks (Rules). The Rules apply to local

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