Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement
(2002; 77 pages) [Spanish] View the PDF document
Table of Contents
View the documentTHE SOUTH CENTRE
View the documentFOREWORD
View the documentEXECUTIVE SUMMARY
View the documentINTRODUCTION
View the documentI. DATA REQUIRED FOR THE REGISTRATION OF PHARMACEUTICALS
Open this folder and view contentsII. THE RATIONALE FOR DATA PROTECTION
Close this folderIII. CONDITIONS OF PROTECTION UNDER TRIPS
View the documentA. Protection of test data under the TRIPS Agreement
Close this folderB. The Article 39.3 conditions of protection
View the document1. Data necessary for marketing approval
View the document2. Protected data
View the document3. Undisclosed data
View the document4. New chemical entities
View the document5. Considerable effort (investment)
View the documentIV. NON-DISCLOSURE OBLIGATION
Open this folder and view contentsV. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE
View the documentVI. MEANS OF PROTECTION AGAINST UNFAIR COMMERCIAL USE
View the documentVII. THE EXCLUSIVITY APPROACH
View the documentVIII. THE HISTORY OF THE TRIPS NEGOTIATIONS
View the documentIX. CONCLUSIONS
View the documentANNEX I. EXCLUSIVE USE OF DATA AND COMPENSATION UNDER THE U.S. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT (FIFRA)
View the documentBIBLIOGRAPHY
View the documentBACK COVER
 

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.

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