Mexico defines orphan drugs, but questions remain; US patent deal
Earlier this year, on January 31, new provisions of the Mexican General Health Law (GHL) came into force, containing for the first time a definition of orphan drugs, explains law firm Olivares & Cia in a posting on the IP Tango blog.
Under Article 224 bis of the GHL, an orphan drug is defined as a drug to diagnose, treat, or prevent a rare disease, affecting no more than five in 10,000 individuals. This definition, which was previously contained in the Mexican Pharmacopeia, is now a matter of Federal Law.
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