– Supreme Decree No. 1876/1995 (“Reglamento del sistema nacional de control de productos farmacéuticos y alimentos de uso médico”), enacted by Chilean Wealth Ministry.
– Laws No. 19.996 and 20.160, which modified Law No. 19.039, published in the Official Gazette of March 11, 2005, in force as of December 1, 2005.
– Decree No. 236 of December 1, 2005, on Regulation Rules of Law No. 19.039, modified by Laws No. 19.996 and 20.160.

Data protected: undisclosed data on security and effectiveness of a new pharmaceutical or chemical-agricultural product not authorized before by ISP (Chilean National Health Office) or by SAG (Chilean National Agricultural and Cattle Office). In order to join protection, the applicant of a marketing authorization must indicate in the application that data are undisclosed. 

Data exclusive right: is granted by ISP or by SAG, which are obliged to keep the data confidential, and not use them in other register proceedings, until the term expires or the applicant allows the revelation. According to Supreme Decree No. 1876/1995 scientific data requested by ISP in order to allow the commercialization of a pharmaceutical product must be kept strictly confidential. It could be revealed by ISP, if competent public offices so request, only by the purpose of evaluating the documents filed in order to obtain the registration of the product. 

Marking requirements: to enjoy the data protection rights, it is necessary to notify in the application for registration of sanitary registration the character of non-disclosed information. 

Duration: “data exclusive right” related to pharmaceutical products lasts five years as from the date of first ISP authorization. “Data exclusive right” related to chemical-agricultural products lasts ten years as from the date of first SAG authorization.

Registration: “data exclusive right” is not a registrable right. It is innate to filing of data to the ISP or to SAG. However, the Public Health Institute (ISP) is enabled to qualify when a health application is filed whether the corresponding data deserves protection.

Ceasing of protection: a judgment of Antitrust Court that declares that protected data have been used in a way not compliant with free competition rules; public health reasons, national security reasons, public no commercial use, national emergency and other extremely urgent circumstances; the pharmaceutical product to which the data are related is submitted to a compulsory license; the pharmaceutical product has not been commercialized in Chile during twelve month, since the sanitary registration is granted; the pharmaceutical product has obtained a foreign authorization, in force during more than twelve months before being filed in Chile. 

Penalties: no penalties are established in case of infringement of the right by ISP or SAG. So civil remedies contemplated in the law should be applicable and also general criminal proceeding regarding the lack of fulfillment of  confidential information by the authorities.