Reform to the Health-Care Regulations
On October 19,2011, the "Decree by which various provisions of the Health-Care Regulations were reformed and added" was published in the field of biotechnological drugs. In this decree some terms are defined that are related to biotechnological drugs, health information the label must contain such as the acronyms that mark the difference between innovative biotechnological drug (B.M.) and the bio-equivalent (M.B.B.) as well as the requirements for obtaining the health registration thereof, such as the scope of the bio-equivalent clinical trials, among others.
Furthermore, it was established that the Bolar clause for bio-equivalent biotechnological drugs will be of eight years. The Bolar clause implies that one may apply for the registration of a bio-equivalent drug with respect to a biotechnological drug protected by a patent, in order to carry out studies, tests and corresponding experimental production, within the eight years prior to the patent expiration. In which case, the health registration will only be granted at the end of the patent's term.
It should be mentioned that this reform to the Health-Care Product Raw Materials Regulations, reflects the need to regulate the provisions of article 222 bis of the General Health Law.
For more information check the Official Federal Gazette of October 19, 2011.