REACH: Use of full study reports for registration purposes – Legitimate possession and reference rights according to Article 10 of REACH
The REACH Regulation includes various obligations for cooperation between registrants. In particular, REACH relies on the principle of data sharing. Registrants are obliged to cooperate with each other to some degree. In certain situations they have to provide each other with substance-specific data available in their own companies. The various items of information can be gathered and used for registration purposes. The main objective of the relevant rules is to avoid duplication of vertebrate animal tests. Furthermore, cooperation – which includes the described form of data sharing – can reduce costs for registrants.
I. Introduction
II. Definition of “Full study reportâ€
III. Definition of “Legitimate possessionâ€
IV. Copyright to the full study report
1. Use of study reports for registration purposes
2. Summary of the full study report
V. Reference right
VI. Consequences of faulty possession
VII. Exemptions from the requirements of Article 10 (a), last sentence
VIII. Conclusion
Autor(en)
Dominik Jaensch
Contentpartner
© Lexxion Verlagsgesellschaft mbH
Publikation
StoffR 03 / 2009 (Juli 2009)
Verkaufspreis
€ 25,00