ARTICLE-9: Exemption from the general obligation to register for product and process orientated research and development (PPORD) [
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... 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. ...
... 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 [
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... 1. A
registrant may start or
continue the
manufacture or
import of a
substance or
production or
import of an
article, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
weeks after the submission
date, without
prejudice to
Article 27(8). In the
case of registrations of
phase-in substances, such a
registrant may
continue the
manufacture or
import of the
substance or
production or
import of an
article, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
weeks after the submission
date or, if submitted within the two-
month period before the
relevant deadline of
Article 23, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
months from that deadline, without
prejudice to
Article 27(8). In the
case of an update of a
registration according to
Article 22 a
registrant may
continue the
manufacture or
import of the
substance, or the
production or
import of the
article, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
weeks after the update
date, without
prejudice to
Article 27(8). ...
... 1. A
registrant may start or
continue the
manufacture or
import of a
substance or
production or
import of an
article, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
weeks after the submission
date, without
prejudice to
Article 27(8). In the
case of registrations of
phase-in substances, such a
registrant may
continue the
manufacture or
import of the
substance or
production or
import of an
article, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
weeks after the submission
date or, if submitted within the two-
month period before the
relevant deadline of
Article 23, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
months from that deadline, without
prejudice to
Article 27(8). In the
case of an update of a
registration according to
Article 22 a
registrant may
continue the
manufacture or
import of the
substance, or the
production or
import of the
article, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
weeks after the update
date, without
prejudice to
Article 27(8). ...
... 1. A
registrant may start or
continue the
manufacture or
import of a
substance or
production or
import of an
article, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
weeks after the submission
date, without
prejudice to
Article 27(8). In the
case of registrations of
phase-in substances, such a
registrant may
continue the
manufacture or
import of the
substance or
production or
import of an
article, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
weeks after the submission
date or, if submitted within the two-
month period before the
relevant deadline of
Article 23, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
months from that deadline, without
prejudice to
Article 27(8). In the
case of an update of a
registration according to
Article 22 a
registrant may
continue the
manufacture or
import of the
substance, or the
production or
import of the
article, if there is no indication to the
contrary from the
Agency in
accordance with
Article 20(2) within the three
weeks after the update
date, without
prejudice to
Article 27(8). ...
ARTICLE-30: Sharing of data involving tests [
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ARTICLE-96: The budget of the Agency [
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