NEW REQUIREMENTS TO OBTAIN A HEALTH REGISTRATION OF MEDICINES. INCREASED PENALTIES FOR COUNTERFEIT MEDICINES

28/04/2010
Contact:
Jorge Mario Sánchez-DeVanny
jsd@sanchezdevanny.com
Turenna Ramírez-Ortiz
tramirez@sanchezdevanny.com
Daniel Maldonado-Alcántara
dmaldonado@sanchezdevanny.com
Eduardo Sotelo-Cauduro
esotelo@sanchezdevanny.com
Cecilia Curiel-Piña
ccuriel@sanchezdevanny.com

NEW REQUIREMENTS TO OBTAIN A HEALTH REGISTRATION OF MEDICINES. INCREASED PENALTIES FOR COUNTERFEIT MEDICINES

On April 27 an amendment to articles 222 and 464 Ter of the General Health Law was published in the Official Gazette of the Federation (OGF). The most important aspects of such amendment are as follows:

a) Article 222, adds the requirement obtaining a Health Registration as a medicine. The Mexican Health Secretariat, prior to granting the registration, will verify compliance with good manufacturing practices and the quality, efficiency and safety manufacturing procedures, as well as the certification of active ingredients of the medicine to be registered.

It is also established that certificates of active ingredients issued by foreign authorities will be accepted and recognized as long as acknowledgement agreements exist between the Mexican Health Secretariat and the competent authorities of the corresponding country.

Clearly this amendment adds requirements to obtain a Health Registration as a medicine. In our opinion, such addition will make the process of requesting the registration of medicines, even more cumbersome. Therefore, we recommend pharmaceutical companies anticipate said situation before such amendment becomes effective on October 23, 2010.

b) Article 464 Ter, increases the applicable penalties up to fifteen years imprisonment for individuals who counterfeit, alter or adulterate drugs. Also, it increases the applicable penalty up to nine years of imprisonment for those individuals who falsify or adulterate or allow the falsification of materials used for packaging of drugs, labeling, legends, or the information or identification numbers thereon, or for those individuals who sell counterfeit or adulterated drugs or drugs with altered or modified packaging or with counterfeit labels.

These new penalties will become effective on May 26, 2010.

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