Mexico
Reform of RIS: supplementary protection certificates, data protection, biotechnological drugs and extensions
Key aspects
- The definition of new molecule is updated, and the participation of the New Molecules Committee (resolution in 180 days) is established.
- The supplementary protection certificate is introduced due to unreasonable delays in the health registration, and validity is for up to five years.
- The relationship between the Mexican Institute of Industrial Property (“IMPI” in its Spanish acronym) and the Federal Commission for Protection against Sanitary Hazards (“COFEPRIS” in its Spanish acronym) is strengthened, with tacit approval implied if the IMPI does not answer within 10 business days.
- Data protection of new molecules for five years; generic molecules will require the holder’s consent.
- The first extension of health registrations is extended from five to 10 years.
- The regulatory framework for innovative biotechnological drugs and biosimilars is reinforced with specific study requirements.
- The reform complements the Federal Industrial Property Protection Act (“LFPPI” in its Spanish acronym).
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