Implementation of the 9th ATP to anticoagulant rodenticides (estimates based on a publication date by 10/06/2016) New product authorisations.

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Presentation transcript:

Implementation of the 9th ATP to anticoagulant rodenticides (estimates based on a publication date by 10/06/2016) New product authorisations All the products on the market labelled according to the new CLH New ATP (e.i.f.) e.g. 30/06/16 New ATP (e.i.a.) e.g. 31/12/17 Transitional period = 18 months According to the current C&L According to the new CLH 2016 2017 2018 2019 Period of grace Deadline to implement the new CLH / to notify the grouped administrative changes1 1 I.e. implementation of the new CLH and, where relevant, removal of the user category "general public" (as per paragraph (11) in document CA-Nov15-Doc.4.1-Final). ONLY Use (up to 30/06/2018) Earlier implementation of the new CLH / notification of the grouped administrative changes2 2 E.g. by 01/01/2017, also as per paragraph (11) in document CA-Nov15-Doc.4.1-Final. Making available Use (up to 30/06/2017) + (up to 31/12/2017) Changes to existing products: where relevant, removal of the general public

Implementation of the 9th ATP & renewals process New product authorisations All the products on the market labelled according to the new CLH New ATP (e.i.f.) e.g. 30/06/16 New ATP (e.i.a.) e.g. 31/12/17 Transitional period = 18 months According to the current C&L According to the new CLH 2016 2017 2018 2019 Deadline to implement the new CLH and, where relevant, the removal of the user category "general public" (notified as grouped administrative changes1) 1 As per paragraph (11) in document CA-Nov15-Doc.4.1-Final. Earlier implementation & notification is also possible. Period of grace2 after renewal 2 Provided that the new CLH has been implemented (and where relevant, the user category "general public" removed from the authorisation). Making available Use (up to 30/06/2018) + (up to 31/12/2018) End of renewal process by CAs: SPCs with CLH (H&P statements) and the new RMMs Changes to existing products & renewal process

Implementation of the 9th ATP to anticoagulant rodenticides (estimates based on a publication date by 10/06/2016) New product authorisations All the products on the market labelled according to the new CLH New ATP (e.i.f.) e.g. 30/06/16 New ATP (e.i.a.) e.g. 31/12/17 Transitional period = 18 months According to the current C&L According to the new CLH 2016 2017 2018 2019 Period of grace Deadline to implement the new CLH / to notify the grouped administrative changes1 1 I.e. implementation of the new CLH and, where relevant, removal of the user category "general public" (as per paragraph (11) in document CA-Nov15-Doc.4.1-Final). ONLY Use (up to 30/06/2018) 2 See Article 8 of the changes Regulation. The change cannot be implemented until it is agreed by the relevant CA. Application for a major change  AS < 0,003% (max. 18 months2) Major change agreed by CAs Preparatory work Changes to existing products: case 2 – major change to maintain the general public