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TITLE-III: DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING
CHAPTER-2: Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered
ARTICLE 26: Duty to inquire prior to registration
| ARTICLE 26: | Duty to inquire prior to registration |
1. Every potential registrant of a non-phase-in substance, or potential registrant of a phase-in substance who has not pre-registered in accordance with Article 28, shall inquire from the Agency whether a registration has already been submitted for the same substance. He shall submit all the following information to the Agency with the inquiry:
(a) his identity as specified in Section 1 of Annex VI, with the exception of the use sites;
(b) the identity of the substance, as specified in Section 2 of Annex VI;
(c) which information requirements would require new studies involving vertebrate animals to be carried out by him;
(d) which information requirements would require other new studies to be carried out by him.
2. If the same substance has previously not been registered, the Agency shall inform the potential registrant accordingly.
3. If the same substance has previously been registered less than 12 years earlier, the Agency shall inform the potential registrant without delay of the names and addresses of the previous registrant(s) and of the relevant
summaries or robust study summaries, as the case may be, already submitted by them.
Studies involving vertebrate animals shall not be repeated.
The Agency shall simultaneously inform the previous registrants of the name and address of the potential registrant. The available studies shall be shared with the potential registrant in accordance with Article 27.
4. If several potential registrants have made an inquiry in respect of the same substance, the Agency shall inform all potential registrants without delay of the name and address of the other potential registrants.
- Referred by:
- ARTICLE 12: Information to be submitted depending on tonnage
- ARTICLE 27: Sharing of existing data in the case of registered substances