Article 7 Procedure for minor changes of products

The authorisation holder, or its representative, shall submit F1... an application complying with Article 5.

F2The competent authority shall inform the applicant of F3the appropriate fee. If the applicant fails to pay the fee within 30 days, the F4competent authority shall reject the application and inform the applicant F5... accordingly. Upon receipt of the fee, the 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 F7competent 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 F8... accordingly.

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

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

F9Subject to paragraph 4A, within 90 days of validating an application, the competent 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 F10... to the applicant.

Where an application is validated before 2nd October 2027, the competent authority must, before 31st December 2027—

F12Subject to paragraph 5A, where it appears that additional information is necessary to carry out the evaluation, the competent 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 competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant F13... 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.

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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.