The federal government will allow from this Tuesday the import of medicines, from countries such as India or China, that have health registration in Mexico or not.
To avoid drug deserving, the Ministry of Health made amendments to the law to purchase medicines, and although it will not be mandatory for them to have the Mexican health registry endorsed by the Federal Commission for the Protection of Health Risks (Cofepris), it must be a drug authorized by international regulatory authorities.
In the Official Journal of the Federation specifies that it must be a drug regulated by the Swiss Therapeutic Products Agency-Swissmed, the European Commission, food and drug administration of the United States of America, Ministry of Health canada, Australian Therapeutic Products Administration, PAHO/WHO Reference Regulatory Agencies; prequalified by the World Health Organization’s Prequalification Program for Medicines and Vaccines or Regulatory Agencies members of the Pharmaceutical Inspection Cooperation Scheme.
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“In the event that the Secretariat, through the Federal Commission for the Protection of Health Risks, determines that medicines registered in Mexico do not comply with the quality, safety, efficacy and good manufacturing practices, the Secretariat and Dependencies related to the National Supply and Internment to the National Territory of Health Inputs, shall determine to initiate the process of importation of raw materials or finished products that have or do not have a health registry in Mexico, in accordance with Article 132 Health Supplies Regulations,” details.
The Ministry of Health recognized only the technical procedures of the United States, Australia, Switzerland, Canada and the European Union as equivalent to those of Mexico.
Now, with the agreement, expand this recognition to the World Health Organization’s (WHO) Drug and Vaccine Preclassification Program, so Mexico could receive medicines that are manufactured in India and some in China
Also from Turkey, South Africa, Argentina, Ukraine, Malaysia, Indonesia, Thailand and South Korea, whose medicines are regulated by the agencies of the member countries of the Pharmaceutical Inspection Cooperation Scheme, known as PIC/S.
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In order to avoid drug deserving, the decree states that “the Secretariat, through the corresponding legal instruments, will be coordinated with IMSS, ISSSTE, Pemex, Insabi, Sedena, Senar or CCINSHAE, in order to determine the importation of those medicines and inputs necessary for the correct and timely provision of health services”.
Imported medicines that do not have a health record in Mexico, will have five working days from that import to begin the registration process with Cofepris, which in turn will have 60 working days to resolve.
In the case of medicinal products that have been imported without registration into Mexico and have not initiated the registration process with Cofepris, they may not be considered in subsequent imports under this scheme.
It is further stated that in accordance with article 84 of the General Law on Regulatory Improvement, “holders of Federal Public Administration units are empowered to simplify the procedures and services provided for in laws, regulations or any other provision issued by the Holder of the Federal Executive, through general agreements published in the Official Journal of the Federation, which provide, among other measures, shorter response times than the maximum provisions, as well as not as well as not. require the submission of data and documents.”
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