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| ARTICLE 11: | Joint submission of data by multiple registrants |
1. When a substance is intended to be manufactured in the Community by one or more manufacturers and/or imported by one or more importers, and/or is subject to registration under Article 7, the following shall apply.
Subject to paragraph 3, the information specified in Article 10(a)(iv), (vi), (vii) and (ix), and any relevant indication under Article 10(a)(viii) shall first be submitted by the one registrant acting with the agreement of the other assenting registrant(s) (hereinafter
referred to as the lead registrant).
Each registrant shall subsequently submit separately the information specified in Article 10(a)(i), (ii), (iii) and (x), and any relevant indication under Article 10(a)(viii).
The registrants may decide themselves whether to submit the information specified in Article 10(a)(v) and (b) and any relevant indication under Article 10(a)(viii) separately or whether one registrant is to submit this information on behalf of the others.
2. Each registrant need only comply with paragraph 1 for items of information specified in Article 10(a)(iv), (vi), (vii) and (ix) that are required for the purposes of registration within his tonnage band in accordance with Article 12.
3. A registrant may submit the information referred to in Article 10(a)(iv), (vi), (vii) or (ix) separately if:
(a) it would be disproportionately costly for him to submit this information jointly; or
(b) submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive
and is likely to cause him substantial commercial detriment; or
(c) he disagrees with the lead registrant on the selection of this information.
If points (a), (b) or (c) apply, the registrant shall submit, along with the dossier, an explanation as to why the costs would
be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment or the nature of
the disagreement, as the case may be.
4. A submission for registration shall be accompanied by the fee required in accordance with Title IX.
- Referred by:
- ARTICLE 4: General provision
- ARTICLE 21: Manufacturing and import of substances
- ARTICLE 22: Further duties of registrants
- ARTICLE 41: Compliance check of registrations
- ARTICLE 74: Fees and charges
- ARTICLE 77: Tasks
- ARTICLE 114: Classification and labelling inventory
- ARTICLE 117: Reporting
- ARTICLE VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10