Mexico

Simplified steps with COFEPRIS announced by President Felipe Calderon on August 17th 2010

24 Jun 2013

To avoid unnecessary costs and to facilitate the access to cutting-edge products and technology services, Mexican President Mr. Felipe Calderon has announced six measures that will benefit Mexican citizens and foreign pharmaceutical, cosmetic and food industries as well.

The six measures announced are:

  • Over the counter drugs marketed in the USA and Canada with demonstrated safety and efficacy will be approved through a fast track process in Mexico.
  • The extension of allopathic registrations will be carried out through a digital file, based on the good practices established by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
  • Aiming at the marketing in Mexico of cutting-edge medical devices, the evaluation process of those products with marketing authorization in the USA and Canada will be significantly simplified in order to accelerate the granting of the Mexican sanitary registration.
  • There will be a direct interconnection between the Tax Administration Service (SAT in Spanish) and COFEPRIS for real-time transfers of importing sanitary permissions hence particulars will have lower storage costs and a quicker release of their products from Customs. Currently there are transfers of food and insecticides importing permissions, and from October 2010 psychotropic drugs and narcotics will count with this real-time transfers as well.
  • The use of authorized third parties will be promoted to help in the verification process of requirements established by COFEPRIS for drug products, medical devices and food.
  • Operation and sanitary responsible licenses of the sites regulated by COFEPRIS can be submitted through the website www.tuempresa.gob.mx, avoiding the traveling to different official agencies and the costs related. This measure will positively affect 216 industries such as food, health and cleaning products, medical devices and more.

Notes:
Author: Andrea Robles, Lawyer. Regulatory Affairs Department
Verified by Marta Pentz, Head of Moeller Regulatory Affairs Department
Special thanks for their contribution to Ms. Luz Gabriela Hernandez and Grupo Estrategico de Soluciones Corporativas & Outsourcing Internacional, S.C.




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