* Information submitted in a process of regulatory approval is protected against unfair commercial use and disclosure.Source: circular from From Olivares & Cía., S.C., Mexico, from whom further information and comment may be obtained.
* Five years maximum protection is available, during which no one can use information provided by the innovator for the commercialization of the drug.
* COFEPRIS will grant approvals for generics once the five years of protection lapses, unless the generic drug manufacturer proves the safety and efficacy of its product independently of the data supplied by the innovator.
* Protection will be given to undisclosed and unpublished experiments and information, with an exception for publication of data necessary to protect the public or when confidentiality measures have been taken to protect unfair commercial use.
Friday, 22 June 2012
COFEPRIS (the agency in charge to grant marketing authorizations in Mexico) published on its website an internal decree providing guidelines to observe and protect data packaging exclusivity for (DPE) for pharma product innovators. The main points include the following: