In our country, pharmaceutical and health regulation has evolved with the participation of various actors such as the Ministry of Health (“Secretaría de Salud”) and the Federal Commission for the Protection against Health Risks (“Comisión Federal para la Protección contra Riesgos Sanitarios”).
In a contextual way, we must understand that pharmaceutical regulation has as its main objective the safe and effective use of Medicines; available when needed; that there are no barriers to access them; that the expense is optimal (including the adequate use by mexican citizens); as well as promoting the introduction to the market of new therapeutic alternatives.
Health regulation in our country is in charge of the Federal Commission for the Protection against Sanitary Risks (hereinafter “COFEPRIS”) which is a decentralized body of the Ministry of Health. COFEPRIS, whose constitution and entry into operation dates from 2001, has powers in matters of regulation, control and health promotion, under the terms of the General Health Law and other applicable legislation.
Throughout these years, the regulation imposed by COFEPRIS has been relevant and defining for the pharmaceutical industry as well as for the food industry in our country, since modifications have been made in the following areas: (i) Renewals of Health Records; (ii) the elimination of the plant requirement; (iii) policies to promote generic medicines; (iv) the Certificate of Good Manufacturing Practices; and (v) recognition by international organizations such as the Pan American Health Organization and the World Health Organization.
However, it is important to mention that pharmaceutical industries and retail pharmacies nationwide should consider having an agenda in terms of health compliance to comply with the obligations, permits, licenses and authorizations established by law and that are required by COFEPRIS, and thus avoid falling into breaches of the provision and be the object of closure of the establishments and administrative fines, in accordance with the above mention we believe it is important to follow these recommendations.
- Maintain an order in the compliance documentation of the pharmaceutical industry, example. Health Licenses, Notice of Operation, Permits and Authorizations issued by the Health Authority.
- File in a timely manner the requests for Registries, Health Licenses and Notices before COFEPRIS, in order to perform the necessary functions for the operation of the Industry.
- Train personnel for the management and sale of Controlled Drugs in compliance with the provisions established by the General Health Law and COFEPRIS.
- Conduct periodic audits of the necessary and mandatory compliance documentation in accordance with the General Health Law for the operation and function of the Industry, in order to detect anomalies or unforeseen events and correct themselves before receiving an administrative sanction or Closure by COFEPRIS.
- Comply with the provisions stipulated by the General Health Law and by the ordinance and requirements by the COFEPRIS.