The subject is in news again. Some important documents/ views are:
TRIPs provision
“Members when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the 2 ntroduction origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”
Report on Steps to be taken by Government of India in the context of Data Protection Provisions of Article 39.3 of TRIPS Agreement by Mrs Satwant Reddy, Secretary Department of Chemicals & Petrochemicals Ministry of Chemicals & Fertilizers Government of India and Mr Gurdial Singh Sandhu, Joint Secretary Department of Chemicals & Petrochemicals Ministry of Chemicals & Fertilizers Government of India , 31st May, 2007.
Test Data protection: WIPO perspective
Protection of Regulatory Data, position paper by CropLife America.
TRIPs provision
“Members when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the 2 ntroduction origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”
Report on Steps to be taken by Government of India in the context of Data Protection Provisions of Article 39.3 of TRIPS Agreement by Mrs Satwant Reddy, Secretary Department of Chemicals & Petrochemicals Ministry of Chemicals & Fertilizers Government of India and Mr Gurdial Singh Sandhu, Joint Secretary Department of Chemicals & Petrochemicals Ministry of Chemicals & Fertilizers Government of India , 31st May, 2007.
Test Data protection: WIPO perspective
Protection of Regulatory Data, position paper by CropLife America.
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