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Commission Implementing Regulation (EU) 2020/1740Show full title

Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012 (Text with EEA relevance)

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Article 12U.K.Comments on the draft renewal assessment report

1.The Authority shall examine whether the draft renewal assessment report received from the rapporteur Member State contains all the relevant information in the agreed format and circulate it to the applicant and to the other Member States at the latest three months after its receipt.

2.Upon receipt of the draft renewal assessment report pursuant to paragraph 1 of this Article, the applicant may, within a period of two weeks, submit a request to the Authority for certain information in the draft renewal assessment report originating from its application to be kept confidential pursuant to Article 63 of Regulation (EC) No 1107/2009 and in accordance with Article 6(7) of this Regulation.

The Authority shall make the draft renewal assessment report publicly available with the exception of the information for which the confidentiality request has been accepted as justified.

3.The Authority shall allow a period of 60 days from the date the draft report is made available to the public for the submission of written comments. Such comments shall be communicated to the Authority, which shall collate and forward those comments, together with its own comments, to the rapporteur Member States or group of Member States acting jointly as rapporteur Member State and where relevant the co-rapporteur Member State. The Authority shall provide its view to the Commission on whether it is not necessary in the light of the comments received to continue the procedure in accordance with Article 13.

4.The Authority shall make the updated renewal dossier available to the public at the same time as making the draft renewal assessment report available in accordance with Article 10.

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