The authorisation holder, or its representative, shall submit F2... a notification F3to the competent authority complying with Article 5 and F4... pay the F5appropriate fee.

Without prejudice to the second subparagraph, the notification shall be submitted within 12 months following the implementation of the change.

In case of a change referred to in Section 1 of Title 1 of the Annex to this Regulation, the notification shall be submitted before the implementation of the change.

Within 30 days following receipt of the notification, where F6the competent authority disagrees with the change or the relevant fee has not been paid, F7the competent authority shall inform the authorisation holder, or its representative, F8... that the change is rejected and the grounds for the rejection.

If, within 30 days following receipt of the notification, F9the competent authority has not expressed its disagreement, F10it shall be deemed to have agreed with the change.

F11Where the competent authority has not rejected the change in accordance with paragraph 3 F12it shall, where relevant, amend the authorisation of the biocidal product in conformity with the agreed change.

The authorisation holder, or its representative, shall submit F13... an application complying with Article 5.

F14The competent authority shall inform the applicant of F15the appropriate fee. If the applicant fails to pay the fee within 30 days, the F16competent authority shall reject the application and inform the applicant F17... accordingly. Upon receipt of the fee, the F16competent authority shall accept the application and inform the applicant accordingly indicating the date of acceptance.

Where the application is one that has been resubmitted by virtue of Article 95M of Regulation (EU) No 528/2012, paragraph 2 applies as if for “shall inform the applicant of the appropriate fee” there were substituted “shall inform the applicant before 31st December 2027 of the appropriate fee”.

The F19competent authority shall validate the application within 30 days of its acceptance, if it complies with the requirements laid down in Article 5 and inform the applicant F20... accordingly.

In the context of the validation referred to in the first subparagraph, the F19competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

Where the F19competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the application to be completed and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 45 days.

The F19competent authority shall, within 30 days of receipt of the additional information, validate the application if the additional information submitted is sufficient to comply with the requirements laid down in Article 5.

The F19competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant F20... accordingly.

F21Subject to paragraph 4A, within 90 days of validating an application, the F19competent authority shall evaluate the application and draft an assessment report and shall send its assessment report and, where relevant, the revised summary of the biocidal product characteristics F22... to the applicant.

F24Subject to paragraph 5A, where it appears that additional information is necessary to carry out the evaluation, the F19competent authority shall ask the applicant to submit such information within a specified time limit. The period referred to in paragraph 4, shall be suspended from the date of the request until the date the information is received. The time limit given to the applicant shall not exceed 45 days in total unless justified by the nature of the data requested or by exceptional circumstances.

The F19competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant F25... accordingly.

Where paragraph 4A applies and it appears that additional information is necessary to carry out the evaluation, the competent authority must ask the applicant to submit such information within a specified time limit. The deadline of 31st December 2027 referred to in paragraph 4A is to be extended by a period equal to the number of days beginning with the date on which the applicant is asked for additional information and ending with the date on which that information is received by the competent authority. But the deadline may not be extended by more than 45 days in total, unless it is justified by the nature of the data requested or by exceptional circumstances.

The competent authority must reject the application if the applicant fails to submit the requested information within the specified time limit and must inform the applicant accordingly.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Where authorisation of the change is granted, the competent authority shall, within 30 days, amend the authorisation of the biocidal product in conformity with the change.

The authorisation holder, or its representative, shall submit F29to the competent authority an application complying with Article 5.

F30The competent authority shall inform the applicant of the F31appropriate fee. If the applicant fails to pay the fee within 30 days, F32the competent authority shall reject the application and inform the applicant F33... accordingly. Upon receipt of the fee, F32the competent authority shall accept the application and inform the applicant accordingly indicating the date of acceptance.

Where the application is one that has been resubmitted by virtue of Article 95M of Regulation (EU) No 528/2012, paragraph 2 applies as if for “shall inform the applicant of the appropriate fee” there were substituted “shall inform the applicant before 31st December 2027 of the appropriate fee”.

The F35competent authority shall validate the application within 30 days of its acceptance if it complies with the requirements laid down in Article 5 and inform the applicant F36... accordingly.

In the context of the validation referred to in the first subparagraph, the F35competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

Where the F35competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The F35competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirements laid down in Article 5.

The F35competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant F36... accordingly.

F37Subject to paragraph 4A, within 180 days of validating an application, the F35competent authority shall evaluate the application and draft an assessment report and shall send its assessment report and, where relevant, the revised summary of the biocidal product characteristics F38... to the applicant.

F40Subject to paragraph 5A where it appears that additional information is necessary to carry out the evaluation, the F35competent authority shall ask the applicant to submit such information within a specified time limit. The period referred to in paragraph 4 shall be suspended from the date of the request until the date on which the information is received. The time limit given to the applicant shall not exceed 90 days in total unless justified by the nature of the data requested or by exceptional circumstances.

The F35competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant F41... accordingly.

Where paragraph 4A applies and it appears to the competent authority that additional information is necessary to carry out the evaluation, the competent authority must ask the applicant to submit such information within a specified time limit. The deadline of 31st December 2027 referred to in paragraph 4A is to be extended by a period equal to the number of days beginning with the date on which the applicant is asked for additional information and ending with the date on which that information is received by the competent authority. But the deadline may not be extended by more than 90 days in total, unless it is justified by the nature of the data requested or by exceptional circumstances.

The competent authority must reject the application if the applicant fails to submit the requested information within the deadline and must inform the applicant accordingly.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Where authorisation of the change is granted, the competent authority shall, within 30 days, amend the authorisation of the biocidal product in conformity with the change.