Freyr provides regulatory services and solutions in Mexico to comply with COFEPRIS for pharma, medical device, cosmetics and food supplement manufacturer companies.

The “Comision Federal para la Proteccion Contra Riesgos Sanitarios” (COFEPRIS) is the key Drug Regulatory Authority in Mexico. Drug department of the COFEPRIS is responsible for handling and licensing of the manufacture, import, export, distribution, promotion,...Read more

Freyr provides regulatory services and solutions in Mexico to comply with COFEPRIS for pharma, medical device, cosmetics and food supplement manufacturer companies.

The “Comision Federal para la Proteccion Contra Riesgos Sanitarios” (COFEPRIS) is the key Drug Regulatory Authority in Mexico. Drug department of the COFEPRIS is responsible for handling and licensing of the manufacture, import, export, distribution, promotion, advertising, and pharmaceutical product registration. COFEPRIS is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and for monitoring the quality & safety of marketed medicinal products.

Classification of Medicinal Products

Medicinal products are classified into following categories.

Chemical Synthesis Drugs (New Drug/ New Chemical Entityand Generic Drug)

Biological(New Entity and Generic Drug)

Biotechnological (New entity and biosimilar)

Herbal Medicines