CHAPTER-3: Obligation to register and information requirements for certain types of isolated intermediates
ARTICLE 19: Joint submission of data on isolated intermediates by multiple registrants
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ARTICLE 19: 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.
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