Revision as of 21:13, 17 October 2018

TecMonterrey_GDL

Legal Aspects

What's necessary?

We spoke with a representative of COFEPRIS (The organism that protects against sanitary risks) to ask the necessary steps for the launch of Lactobachill in Mexico; they showed us the required steps which are the following:

Steps

1. Fill the format of authorizations, certificates, and visits

This document is filled with data of the project representative, data of the physical place where Lactobachill is produced, product specifications (classification, common international denomination, measure unit, therapeutic indications, concentration, usage instructions, etc), sanitary registry of supplies for health and export and import information.

2. Gather enough information to prove the safety of Lactobachill in humans

This is accomplished via toxicological studies (acute, chronic, study of the constituents of food that might be affected due to the genetic modification) preclinical studies, clinical studies, allergenicity studies, any interaction that might occur between the modified organism and the food matrix, nutrimental equivalent study as well as all the important parameters for the genetic modification.

3. Payment

The payment is for the request for authorization for commercialization and importation for the marketing of genetically modified organisms After the previous steps a special committee deliberates whether the product is suitable for commercialization.

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