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||Joint submission of data on isolated intermediates by multiple registrants
1. When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in the Community
by one or more manufacturers
and/or imported by one or more importers
, the following shall apply.
Subject to paragraph 2 of this Article, the information specified in Article 17
(2)(c) and (d) and Article 18
(2)(c) and (d) shall first be submitted by one manufacturer or importer
acting with the agreement of the other assenting manufacturer(s) or importer
(s) (hereinafter referred to as "the lead registrant").
Each registrant shall subsequently submit separately the information specified in Article 17
(2)(a), (b), (e) and (f) and Article 18
(2)(a),(b), (e) and (f).
2. A manufacturer or importer
may submit the information referred to in Article 17
(2)(c) or (d) and Article 18
(2)(c) or (d) separately if:
(a) it would be disproportionately costly for him to submit this 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 manufacturer or importer
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.
3. A submission for registration
shall be accompanied by the fee required in accordance with Title IX.