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.
Similarly, we advise our clients regarding compliance with the provisions of the General Health Law, its Regulations, Official Mexican Standards, and the Pharmacopeia of the United Mexican States.
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.
Some of our services:
- Processing, monitoring and obtaining permits and authorizations before the Federal Commission for Protection Against Health Risks ("COFEPRIS") and other relevant health regulators.
- 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.
- Procedures followed in the form of a trial before administrative authorities.
- Contentious administrative and constitutional processes against resolutions of health authorities.
- Complaints and procedures before the Inter-American System of Human Rights.
Relevant transactions
- Strategy and legal defense for obtaining an orphan drug registration 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.
- Preparation of distribution contracts for pharmaceutical products imported to Mexico for an English laboratory.
- Voluntary product recall procedure for a US company in the cosmetic industry.
- Procedure and negotiation of voluntary product recall for a French food company.
- Procedure and negotiation of voluntary recall of cosmetic products for Peruvian company.
- Advisory and execution for the transfer of Class II medical device registrations for a Dutch company with operations in Mexico.
- Advisory services for a Korean company for the distribution of tobacco products in Mexico.
