April 29, 2014

Food and Drug Administration (FDA) Philippines ensures that products circulating in the country have undergone a wide range of tests to determine if they are of best quality and are safe for consumers. Recently, there is a case of an eye product called CMD that is being marketed at Php 120.00 per 15 mL bottle in the Metro Manila and some provinces having claims that the product is FDA registered with Registration No. FR-98502. The said product calls in it’s indication to be the “best for astigmatism, cataracts, pterygium, glaucoma, sore eyes, eye stress, red and itchy eyes, blurry ‘computer’ vision and more”.

According to FDA, after conducting a verification of the sample’s authenticity, it is confirmed it to be unregistered. FDA authorities ordered to seize unregistered CMD Eye Drops from all outlets or establishments where they are found or offered for sale or use.

1- Product registration plays a vital role in the path of a product that is on its way to the market. Without it, even the best of the best products out there cannot and would not reach its potential clients.

2- Establishments which are marketing or selling unregistered commodities that are used for human consumption will face necessary sanctions as stated at the Republic Act 9711 .

3- If FDA found your unregistered product, it will issue a cease and desist order removing the products from the market. You will have to register the product plus pay a large amount for penalty and charges.

In the registration of health regulated products, FDA Philippines provides standard requirements that should be duly prepared by the distributor and/or manufacturer. These standards are being used for testing the product if it conforms and if it can be used by human consumption.

If you are a manufacturer or a distributor and you need for product registration or licensing of the establishment, Triple i Consulting is headed by one of the most experienced FDA consultants in the country. Our Pharma Division is able to provide you suitable guidance in the preparation of documents to avoid rejection and minimize submission of incomplete application requirements for all FDA regulated products and regulatory approvals.

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