The Mexican Foreign Trade Receipt System (VUCEM) is an integral service platform that facilitates access to pre-approved customs clearance procedures to Mexico, simplifying foreign trade operations. It is a solution that allows users to send information electronically through a web page, for several types of procedures for different regulations issued by 10 areas of the Government, including COFEPRIS. The system is available at www.ventanillaunica.gob.mx and also as a mobile application.

As of September 25, 2019, all submissions for health licenses requests for the importation of products regulated by COFEPRIS may be petitioned electronically through VUCEM.

To access the system, it is necessary to have a Mexican electronic signature (Firma Electrónica Avanzada – FIEL), entering it as the license applicant and using its password. The user may be a physical or legal person.

In order to make an authorization request, after selecting COFEPRIS as the process regulator, you must select the desired type of procedure and fill in the application with the required fields.

All procedures regulated by COFEPRIS for importation are listed, and relate to registered products, investigational products, pharmaceutical ingredients, controlled products, among others.

The filling of the application form consists of 4 steps:

1. Identify the request, with data from the applicant, establishment, product, country of origin, and fee payment data. After saving the information from this first step, a transaction number is generated, and it will be used to retrieve the petition while it is in progress.

2. Complete the requirements by indicating which documents will be attached in support of the request.

3. Attach the documents indicated in the previous step.

4. Sign off the request with the digital certificate.

After the signature has been confirmed in the last step, the procedure is completed and a protocol number is generated. This protocol number will be used for petition tracking.

All process movements generate alerts that are communicated by e-mail, according to the registered data of the user whose digital signature was used in the request.

The deadline for submission of the procedure is at 6pm, local Mexico time. If completed later, the protocol date is considered as the next business day.

Through the system, it is also possible to browse the pending tasks page and change or renew previously submitted procedures.

Count on Vita to assist your company in developing drug products registration and post-registration projects in Latin America.

Contact us: info@vitaraconsulting.com.

Sources:

Video tutorial (in Spanish): https://bit.ly/2mAab3d

VUCEM Website: https://www.ventanillaunica.gob.mx/vucem/ventanillaunica.html

COFEPRIS LinkedIn: https://www.linkedin.com/feed/update/urn:li:activity:6578014439738531840/