Increasing Importance of DMFs for U.S. Exporters to Mexico

Proper submission and regular maintenance of Drug Master Files are gaining a new level of importance for any company that wants to successfully supply the Mexican pharma market.




Until most recently, anyone selling pharmaceuticals in Mexico was legally required to have a laboratory (i.e., pharmaceutical production facility) in Mexico. A major change to articles 168 and 170 of the Healthcare Products Law (Reglamento de Insumos para la Salud; RIS) was published on August 5, 2008. The presidential decree removes the current rule, opening up Mexico to any exporters. The Mexican Secretary of Health has stated that COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios; aka the Federal Comission for the Protection Against Sanitary Risks), will determine that exporters comply with regulations. This is a major change of huge importance, and drug master files (DMFs) are going to play a critical role. Article 168 of the law was modified as follows:

“To become the holder of the sanitary registration of a medicine, it is required to hold a sanitary license of manufacturer or laboratory for medicines or biological products for human use. For the case of foreign manufacturers, it is required to hold a license, certificate, or any document that accredits that the enterprise has the permit to manufacture medicines, issued by the competent authority in the country of origin.”

Paragraph III of article 170 was also modified accordingly. It specifies the need for a document that accredits a legal representative domiciled in Mexico.

The first transitory article provides the deadlines for such accreditation to occur:

The day following the publication (i.e., Aug. 6, 2008): antiretrovirals.

After six months: vitamins, vaccines, sera, blood derivatives, antitoxins, biological hormones, homeopathic medicines, and herbal medicines.

After 12 months: biotechnological medicines and biological products not included in the previous paragraph.

After 18 months: medicines containing narcotics and over-the-counter (OTC) drugs.

After 24 months: all other medicines.

More is yet to come. For example, by competent authority in the case of the United States, Mexico only acknowledges FDA as the license-issuing source. Therefore, problems are to be anticipated, owing to lack of correspondence for all those products that FDA does not control or regulate, such as vitamins and dietary supplements.

Montesino Associates, a Wilmington, DE–based consulting company that caters to pharmaceutical packaging and component suppliers as well as their clients, is addressing the changed rule and its implications. It will hold a full-day seminar in Mexico City in December 2008. The course will address DMF III holders (component and packaging suppliers), as well as packaging professionals in pharmaceutical, biotech, and medical companies (Type II DMFs). Speakers Peter J. Schmitt and Angela Roggenhofer will discuss fundamentals of the U.S. concept of drug master files, DMF creation and maintenance, key pitfalls to avoid in regards to content and structure, and how to deal with deficiency letters and other frequent issues.

For more information, contact Montesino Associates at 973/665-2050 or at


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