... 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. The
Agency shall
reject the
registration if the
registrant fails to complete his
registration within the deadline set. The
registration fee shall not be reimbursed in such
cases. ...
ARTICLE-21: Manufacturing and import of substances [
go to this ARTICLE]
ARTICLE-61: Review of authorisations [
go to this ARTICLE]
... 1. Authorisations
granted in
accordance with
Article 60 shall be regarded as
valid until the
Commission decides to
amend or
withdraw the authorisation in the
context of a
review, provided that the holder of the authorisation submits a
review report at least 18
months before the
expiry of the
time-limited
review period. Rather than re-submitting all elements of the
original application for the current authorisation, the holder of an authorisation may submit only the
number of the current authorisation,
subject to the second, third and fourth subparagraphs. A holder of an authorisation
granted in
accordance with
Article 60 shall submit an update of the
analysis of alternatives referred to in
Article 62(4)(e),
including information about any
relevant research and
development activities by the
applicant, if appropriate, and any substitution
plan submitted under
Article 62(4)(f). If the update of the
analysis of alternatives shows that there is a suitable alternative available taking into
account the elements in
Article 60(5), he shall submit a substitution
plan,
including a timetable for proposed
actions by the
applicant. If the holder cannot demonstrate that the
risk is adequately controlled, he shall also submit an update of the
socio-economic analysis contained in the
original application. If he can now demonstrate that the
risk is adequately controlled, he shall submit an update of the
chemical safety report. If any other elements of the
original application have changed, he shall also submit updates of these element(s). When any updated
information is submitted in
accordance with this paragraph, any
decision to
amend or
withdraw the authorisation in the
context of the
review shall be taken in
accordance with the
procedure referred to in
Article 64 applied
mutatis mutandis. ...