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Aug 3, 2015

Can the Minimum Period of 5 years Established by NAFTA for Regulatory Data Exclusivity be Extended in Mexico for Biological Medical Products?

In Mexico, there is no specific body of legislation governing data protection exclusivity (DPE), also known as regulatory exclusivity, for chemical drugs, biological medical products and new indications. The authority responsible for enforcing the regulatory framework for drugs, biological medical products and medical devices, is the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which […]
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