(2002; 77 pages) [Spanish]
2. Protected data
The subject matter of the protection under this article is written material which details the results of scientific health and safety testing of drugs and agrochemicals, in relation to human, animal and plant health, impact on the environment and efficacy of use. The provision covers tests and other data that may be required by the authorities. These "other" data may include, for instance, manufacturing, conservation and packaging methods and conditions, but only to the extent that submission of this information is necessary to obtain marketing approval.