| ARTICLE 20: |
Duties of the Agency |
2. The
Agency shall undertake a completeness check of each
registration in order to ascertain that all the elements required under Articles
10 and
12 or under Articles
17 or
18, as well as the
registration fee referred to in Article
6(4), Article
7(1) and (5), Article
17(2) or Article
18(2), have been provided. The completeness check shall not include an assessment of the quality or the adequacy of any data
or justifications submitted.
The
Agency shall undertake the completeness check within three weeks of the submission date, or within three months of the relevant
deadline of Article
23, as regards
registrations of
phase-in substances submitted in the course of the two-month period immediately preceding that deadline.
If a
registration is incomplete, the
Agency shall inform the registrant, before expiry of the three-week or three-month period referred to in the second subparagraph,
as to what further information is required in order for the
registration to be complete, while setting a reasonable deadline for this. The registrant shall complete his
registration and submit it to the
Agency within the deadline set. The
Agency shall confirm the submission date of the further information to the registrant. The
Agency shall perform a further completeness check, considering the further information submitted.
4. The
Agency shall notify the competent authority of the relevant Member State within 30 days of the submission date, that the following
information is available in the
Agency database:
(c) the result of the completeness check; and
(d) any request for further information and deadline set in accordance with the third subparagraph of paragraph 2.
The relevant Member State shall be the Member State within which the manufacture takes place or the
importer is established.
If the manufacturer has production sites in more than one Member State, the relevant Member State shall be the one in which
the head office of the manufacturer is established. The other
Member States where the production sites are established shall also be notified.
The
Agency shall forthwith notify the competent authority of the relevant Member State(s) when any further information submitted by
the registrant is available on the
Agency database.
5. An appeal may be brought, in accordance with Articles
91,
92 and
93, against
Agency decisions under paragraph 2 of this Article.
6. Where additional information for a particular substance is submitted to the
Agency by a new registrant, the
Agency shall notify the existing registrants that this information is available on the database for the purposes of Article
22.