Health & Pharmaceutical Industry

Services

We provide regulatory counsel and litigation relating to manufacturing, import, distribution, marketing, labeling and advertising of pharmaceutical products, medical devices, pesticides, fertilizers, cosmetics and household cleaning products, veterinary products, seeds, foods, beverages, alcohol and tobacco.

Basham has a multidisciplinary practice team which consists of lawyers, chemists, and biologists, who ensure a comprehensive vision of client cases and inquiries from a technical, regulatory, and legal point of view, through meaningful collaboration. We also offer industry-specific specialized litigation services at an administrative and constitutional level.

Our legal services include:

• Processing, monitoring and obtaining of permits, licenses and marketing authorizations before the Federal Commission for the Protection Against Sanitary Risks (“COFEPRIS”) and other relevant sanitary authorities and agencies.
• Structuring and execution of complex regulatory projects derived from corporate operations, such as mergers and acquisitions, both local and international.
• Registration of medicines and therapeutic devices.
• Registration of pesticides, fertilizers, and growth catalysts.
• Drafting and negotiation distribution agreements for the pharmaceutical industries.
• Obtaining of advertisement permits in regulated industries.
• Product recall procedures and notices, as well as product liability consulting.
• Management and obtaining authorizations to import and export regulated consumer products, medicines, and therapeutic devices.
• Negotiations with federal and state health and regulatory authorities.
• Advice, analysis, and implementation of Official Mexican Standards.
• Verification of packaging and labelling of regulated products according to applicable regulations.
• Legal support for the inclusion of medicines in the national formulary of the health sector.

REPRESENTATIVE MATTERS

• Strategy and legal defense for the obtaining of a sanitary registry of an orphan drug for a U.S. laboratory.
• Regulatory strategy on Mexico and its execution for the acquisition of a line of medical devices from an international laboratory by a U.S. investment fund.
• Obtaining health registrations of biocides used in industrial processes for a German company in Mexico.
• Drafting of distribution contracts for pharmaceutical products imported into Mexico for the English laboratory.
• Procedure for voluntary withdrawal of cosmetic products for a U.S. company.
• Procedure and negotiation of voluntary withdrawal of food products for a French company.
• Procedure and negotiation of voluntary withdrawal of cosmetic products for a Peruvian company.
• Advice and execution for the transmission of class II medical device health records for a Dutch company with operations in Mexico.
• Advising a Korean company for the distribution of tobacco products in Mexico.