Article 1Amendments to Implementing Regulation (EU) No 686/2012
Implementing Regulation (EU) No 686/2012 is amended as follows:
- (1)
Article 1 is replaced by the following:
Article 1
For the purposes of the renewal procedure, the evaluation of each active substance set out in the first column of the Annex is allocated either to a rapporteur Member State, as set out in the second column of that Annex, and to a co-rapporteur Member State, as set out in the third column of that Annex, or to a group of Member States acting jointly as rapporteur Member State, as set out in the fourth column of that Annex, where applicable. In the latter case, no co-rapporteur is appointed.
- (2)
The Annex is amended in accordance with the Annex to this Regulation.
Article 2Amendments to Implementing Regulation (EU) No 844/2012
Implementing Regulation (EU) No 844/2012 is amended as follows:
- (1)
Paragraph 1 of Article 1 is amended as follows:
- (a)
the first subparagraph is replaced by the following:
Without prejudice to the fourth subparagraph, an application for the renewal of an approval of an active substance shall be submitted by a producer of the active substance to the rapporteur Member State, as set out in the second column of the Annex to Commission Implementing Regulation (EU) No 686/20124 and to the co-rapporteur Member State as set out in the third column of that Annex, or to 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, no later than three years before the expiry of the approval.
- (b)
the following fourth, fifth and sixth subparagraphs are added:
Where a group of Member States jointly assumes the role of the rapporteur Member State as set out in the fourth column 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, 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)
- (2)
in Article 11(2), point (h) is replaced by the following:
(h)
the points on which the co-rapporteur Member State did not agree with the assessment by the rapporteur Member State, where relevant, or, where applicable, the points where there is no agreement between Member States forming a group of Member States acting jointly as rapporteur Member State.
- (3)
the following Article 13a is inserted:
Article 13aFees and charges
Member States may require payment of fees and charges in accordance with Article 74 of Regulation (EC) No 1107/2009 to recover the costs associated with any work they carry out within the scope of this Regulation.
Article 3Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 May 2019.
For the Commission
The President
Jean-Claude Juncker