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A Checklist for Winning Marketing Authorization in Latin America
June 8, 2016 @ 08:00 - 17:00 UTC+0
Argentina, Brazil, Columbia and Mexico are four of the top five economies and pharmaceutical markets in Latin America, making them prime spots for drugmakers to do business. These four countries also have four of the seven agencies of reference of the Pan American Health Organization.
Fernando Ferrer, head of global consulting in business and operations in life science at Multinational Partnerships LLC, and Silvia Bendiner, director of Latin American regulatory affairs at Mapi Group, provided several strategies for obtaining marketing authorization in these countries during an April FDAnews webinar.
The following tips for individual countries are excerpted from the webinar:
Submission forms must be in Spanish; English is acceptable for certain technical documents.
Product release testing must be conducted locally.
Label texts, package inserts and outer labeling must be submitted on paper in three versions.
Phase 3 clinical trials for new chemical entities must be conducted locally.
Common Technical Document must be submitted as five separate reports.
Foreign manufacturers require mandatory GMP inspection by ANVISA.
Safety and efficacy, technical and legal documentation are required in three consecutive applications.
A Certificate of Pharmaceutical Product from the country of origin must be presented.
A GMP certificate from the foreign product manufacturer must be presented.
Contract authorized third party contractors to assess submission documentation.
Meet with COFEPRIS prior to filing for a market authorization.
Dossier should include process validation data.
Contact Silvia Bendiner at [email protected].