The Mexican Association of Pharmaceutical Laboratories (AMELAF) denounced that the federal health authorities, through COFEPRIS, establish more flexible criteria in the authorization of health records for foreign companies, significantly affecting the national pharmaceutical industry.
In a press release, AMELAF denounced in the Agreement of the Ministry of Health in its first article it indicates that it corresponds to COFEPRIS to resolve the origin of the requests for sanitary registration of medicines and supplies that come from abroad, within a period of five business days; while for the national industry, they will continue to apply the Health Supplies Regulation that indicates 180 calendar days for generics and 240 calendar days for new molecules.
Therefore, AMELAF questioned, preferential treatment is given to foreigners, in addition to the fact that there has not been a similar agreement to modify the times of attention to their procedures, which have been waiting for authorization for a long time, a fact that does not give the possibility to compete evenly. As is the Agreement published in the Official Gazette of the Federation, “puts Mexican manufacturers at a disadvantage.”
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