Guidance on data sharing - ECHA - Europa

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6 <strong>Guidance</strong> on data sharing Version 2.0 April 2012 Version 2 The sub-section covering the right to refer to data and legitimate possession has been updated in order to reflect the latest CARACAL decision and clarify the concepts. April 2012 - A new sub-section covering data sharing disputes according to Article 30(2) and 30(3) and on available legal remedies against ECHA decisions has been created and included in new section 3 on data sharing within SIEFs. - Section 4 on Inquiry process has been revised by eliminating out of date information and amending the text according to the current practice. Information to be submitted in the inquiry and possible outcomes of the process have been added. The stepwise workflow has been extended and better described in order to provide comprehensive set of information to those involved in the inquiry process. A new sub-section addressing the scenario where new co-registrants need to join an existing joint submission has been added. - New sub-section covering data sharing disputes according to Article 27(5) and available legal remedies against ECHA decisions has been created and included in new section 4 on data sharing for non-phase-in substances. - The section on joint submission has been updated to take account of current practice and the information on lead registrant has been merged in section 3. A new sub-section covering post- registration data sharing obligations has been added. - The section on Cost Sharing has been revised in order to correct editorial mistakes and clarify the language without any substantial changes. It has been explained that the section covers the sharing of cost related to studies, but other costs related to SIEF activities need to be considered in cost sharing models. - The section on Forms of Cooperation has been revised in order to correct editorial mistakes and clarify the language. A new example suggesting an alternative form of cooperation has been added. - The section on Competition Law has been revised by replacing the reference to EC Treaty by a reference to the Treaty on the Functioning of the European Union (TFEU). - Deletion of Annex 1 and inclusion of updated charts in the relevant sections of the <strong>Guidance</strong>.
<strong>Guidance</strong> on data sharing Version 2.0 April 2012 7 Version 2 - Deletion of Annex 2 and inclusion of the examples in the relevant sections of the <strong>Guidance</strong>. Only minor changes and corrections have been made. - Deletion of Annex 3 and inclusion of the information relevant for data sharing in the main text. Reference to <strong>Guidance</strong> for Downstream Users made when relevant. April 2012 - Deletion of Annex 5 and inclusion of cost sharing examples in the relevant section. The examples 9 (“Volume factors”) and 10 (“New parties”) have been replaced by new examples. Only minor changes and corrections have been made to the other examples. - Deletion of Annex 6. - Reference to the Data Submission Manuals, REACH-IT Industry User Manuals and Practical Guides published by ECHA. A new annex listing all the documents mentioned in the guidance has been added. - Special “NB boxes” have been added throughout the document to draw the reader’s attention to important concepts and reminders that particular attention should be paid to. - Editorial corrections.
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