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Patent Law

: Patent Docs

COFEMER and AMELAF Comment on Biotech Regulations in Mexico

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

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By Juan Serrano -- Following up on the note for future regulations to approve biotechnological drugs in Mexico (see "Mexico to Issue Regulations for Approval of 'Biocomparable' Drugs"), documents with comments have been uploaded to the official website of the Federal Commission for Regulatory Improvement (COFEMER). The first of these documents is an official communication from COFEMER to COFEPRIS (the authority which oversees approvals) referring to the regulatory impact that the provisions will have, which was made public on August 9, 2010. COFEMER is requesting, amongst other things, the following: - A justification for the elimination of the 3-year period...

Full post as published by Patent Docs on August 17, 2010 (boomark / email).

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