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Was great the marketing authorization of Nano-Huit.
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Was submit a letter no-commercialization with regarding the period August 01, 2014 to January 30, 2016. On base on the pharmacovigilance regulation mention that if you do not have sales of your products, you must submit a letter no-commercialization to COFEPRIS, but you should wait for 6 months to submit this.
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The first PSUR was submitted to COFEPRIS on October 28, 2016, which covers the period January 31, 2016 to July 31, 2016.