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Marketing authorization for pharmaceutical products to foreign applicants

por Agustín Azcatl

Managing Intellectual Property, June2011

Under the amendment made to the Articles 168 and 170 of the Health Supplies Regulation, about the omission of the requirement for a manufacturing plant, last May 5, 2011, the Mexican Government granted the first Marketing Authorization (drug licensing) through the Health Ministry (The Federal Commission for Protection against Sanitary Risk COFEPRIS) to international foreign manufactures (Takeda International Company Limited and Amgen).

The plant’s requirement for marketing a pharmaceutical product was in force since August 5, 2008. Actually, a foreign applicant may manufacture its pharmaceutical product in his country and then export it to Mexico. The requirements set by the Mexican Health authority to foreign applicants to carry out this transaction are the following: authorization issued by a health Ministry or an equivalent thereof in  the country where the pharmaceutical product has been manufactured, legal representation address in Mexico conferring the same a general power of attorney for acts of administration, in accordance with the second paragraph of Article 2554 of the Civil Code (Código Civil para el Distrito Federal.), sanitary licenses to warehouse and distribution, and notice of sanitary representative, agreement with contract manufacturers, service providers for packaging, storage and/or analysis, and medicament labeling.

The new conditions allow the management of the foreign product without the need of sharing the confidential information about the product with a third party, and using the patent linkage system.

The applicant for a Marketing Authorization in Mexico shall comply with all regulations, including concepts such as the good manufacturing practices (NOM-059-SSA1-2006), pharmacovigilance (NOM-220-SSA1-2002), stability of the product (NOM-073-SSA-2005), bioequivalence (NOM-177-SSA1-1998),as well as any applicable statute.

In conclusion, nowadays there is a possibility to do business in México without having a manufacturing local plant and foreign manufacturers can manage their own policies and conditions in the marketing of pharmaceutical products.