Team:Tec-Monterrey/Humanresources

From 2010.igem.org

Tec de Monterrey

Importing Genetic Material into Mexico

Our Experience

While we were developing our project, we encountered several difficulties along the way -including a war and a hurricane- but undoubtedly the biggest problems we had to deal with was our inexpertise in the field of imports and exports and the complicated Mexican bureaucracy involved in the process. We were surprised when we realized Mexican regulations don’t include a defined protocol for the importation of this material. In top of that, a high percentage of the Mexican population is not familiarized with biologic language, so the communication between our team and the Mexican authorities was very difficult. The consequences of such circumstances were degraded genetic material and dead cells which were a major setback for our project. That’s why we present a guide on how to import genetic material into the country with several useful tips that will hopefully provide a valuable resource to future Mexican teams interesting in the fields of synthetic biology.

Contribution: Due to our experience, we decided that it would be a good idea to create a document with a series of basic steps to facilitate the biological material importation process to Mexican teams that would like to participate in subsequent years.

Idea: To promote biological language among Mexican authorities that is related to importation and/or management of biological material. The target is to make the importation process more feasible in our country.

Documents required

If you are a Mexican team from a public or private university and want to obtain an import from iGEM, which is considered as a donation, then you must begin by obtaining health permission for importation of med destined for donation within three months in advance to avoid setbacks. It is important to know that the responsible of this permission is Cofepris which is the Federal Commission for the Protection against Sanitary Risks in Mexico.

The code of this permission is: COFEPRIS-01-010-E. To get such a permission, the following documents are required:

Donation letter given and signed by the donor with recent date. This document must be sent on letterhead paper.
Acceptance letter of the donation given and signed by the responsible of your team in your university. This document must be sent on letterhead paper with recent date and it should contain a statement of no commercialization.
Copy of professional license of the doctor responsible for the donation.
Letter that establishes and notifies clearly the use of the product that you want to import.
Application form named “Solicitudes”.

To get started with this process you must fill out properly the application form “Solicitudes”, which is in the web page: www.cofepris.gob.mx

Particularly you must fill the next numbers in the application form “Solicitudes”:

Step 1

Step 2

Step 3

This section is regarding product information. The fields that must be filled out are: 1, 2, 3, 4, 5, 6, 7, 8, 10,11, 15, 17, 18, 35, 36, 37.

Step 4

This section is regarding import registry.

Step 5

Regulations in Mexico related to General Health Law

Overview

The General Health Law assigns the Mexican Ministry of Health (Secretaría de Salud) with the responsibility of issuing regulations related to human health. In the case of importations, the importer must show all the required documentation under implemented regulations by the General Health Law, and must include a health certificate issued by authorities in the country of origin. The Ministry may also randomly sample and inspect imported products to ensure compliance with Mexican requirements. Mexican regulations related to human health are issued through the Ministry of Health’s regulatory agency, by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS); its website www.cofepris.gob.mx.

General requirements for labeling importation samples

There are two options for labeling:

The original English container can be used as long as a Spanish sticker is attached that contains all the labeling requirements. Stickers are permitted as long as they remain attached to the container.
The product can be packaged for the local Mexican market using Spanish.

Biotechnology labeling

Currently there is not a specific NOM (Mexican Official Norm or standards) for labeling GMO’s or products containing GMO’s. However, the industry has agreed that yellow corn must be identified as such in the package. These products are subject to general labeling requirements.

Regulations and Requirements Based on Public Health Risks (SSA or SALUD)

The Federal Commission for the Sanitary Risk Protection (COFEPRIS) is the regulatory agency in charge of the control and surveillance of food and beverages, food supplements, tobacco, plant nutrients, toxic or dangerous substances, biotechnology products, and pesticides among others types of products.

The “Accord that establishes the classification and codification of products, the importation of which is subject to regulations from the Mexican Ministry of Health SSA”, issued on September 27, 2007, and last updated on June 25, 2009, lists the tariff numbers of the products that are subject to SSA regulation. These products require either an import permit “PERMISO Sanitario de Importación” or simply an import notification “AVISO Sanitario de Importación” to COFEPRIS.

The most important thing for the U.S. exporter is to determine the exact tariff classification number. This number will define the regulatory agency and all the documentation necessary to get import approval.

The importer of products subject to SSA regulations must be registered with SALUD and is responsible for securing all the necessary documentation for a well done import process.

Import Procedures

Collaborations

We collaborated with…