Article 5 Submission of the application for renewal
United Kingdom
An application for renewal shall be submitted electronically via a central submission system using the format as set out in Article 7 by a producer of the active substance no later than three years before the expiry of the approval.
The rapporteur Member State as set out in the second column of the Annex to Commission Implementing Regulation (EU) No 686/2012f1 or each of the Member States in a group of Member States acting jointly as rapporteur Member State as set out in the fourth column of that Annex, the co-rapporteur Member State as set out in the third column of that Annex, the other Member States, the Authority and the Commission shall be informed via the central submission system referred to in Article 7.
Where a group of Member States jointly assumes the role of the rapporteur Member State, as set out in the fourth column of the tables in Part B and Part C of the Annex to Implementing Regulation (EU) No 686/2012, no co-rapporteur Member State shall be appointed. In this case, all references to ‘the rapporteur Member State’ in this Regulation shall be deemed to be references to ‘the group of Member States acting jointly as rapporteur Member State’.
Prior to the expiry of the deadline for submission of the application for renewal, the Member States acting jointly as rapporteur Member State shall agree on the repartition of all tasks and workload.
Member States forming part of the group of Member States acting jointly as rapporteur Member State shall endeavour to reach consensus during the evaluation.
A joint application for renewal may be submitted by an association of producers designated by the producers.
Where there is more than one applicant requesting the renewal of the approval of the same active substance, those applicants shall take all reasonable steps to submit their dossiers jointly. Where contrary to the advice of the Authority as referred to in Article 4 such dossiers are not submitted jointly by all the applicants concerned, the reasons for that shall be set out in the dossiers.
Annotations
Footnotes
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Commission Implementing Regulation (EU) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of the active substances (OJ L 200, 27.7.2012, p. 5).