Article by José Luis Duarte Cabeza and José Antonio Pérez Estrada

Just before February 25, 2005, Article 376 of the General Health Law provided that sanitary registrations before the Ministry of Health to which medicaments, stupefacient, psychotropic substances and products containing such,; medical equipment, prosthesis, functional assistances, diagnostic agents, deontological use materials, surgical and healing materials and hygiene products; as well as pesticides, nutrient vegetables and toxic or hazardous substances are subject had an indefinitely validity.

On February 24, 2005 it was published in the Official Gazette of the Federation the Decree by which Article 376 of the General Health Law is reformed, which will become in force on February 25, 2005 (the day after its publication) indicating that the sanitary registrations previously referred will have a validity of 5 years. Furthermore, these sanitary registrations can be renewed for equal terms, which in contrary the authority will have the capacity to proceed with its cancellation.

Article Third Transitory of the Decree that reforms Article 376 of the General Health Law, imposes to the holders of sanitary registrations of medicaments and other health materials granted for indefinitely terms, those granted prior to the effectiveness of the reform (February 25, 2005), the obligation to submit to review its registrations before the sanitary authority. The foregoing with the purpose of achieving the renewal of such registrations for periods of up to 5 years. These renewals will only be granted when the Ministry verifies the therapeutic safety and effectiveness of the health materials pursuant to the current sanitary provisions, which in contrary shall be deemed as revoked.

We consider that the Article Third Transitory previously mentioned, violates the non retroactive law guarantees provided in Article 14 of the Constitution by affecting the situations or rights created pursuant to Article 376 of the General Law Health reformed which arises the opportunity of filing an "amparo" trial which effects would be the elimination of the obligation to submit to review the sanitary registrations granted prior to February 25, 2005 and, therefore, to maintain such with an indefinitely validity.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.