CA-May16-Doc.4.4
Overview of the referrals discussed at the Coordination Group
10/05/20161 (2)
Overview of the referrals discussed at the Coordination Group as of 10 May 2016
No / Kind of referral / iCMS[1] / RMS / PT / Date of notification / CG meeting discussion / Area of disagreement / Outcome1 / Informal[2] / ES / UK / 8 / 21/10/2013 / CG-3 / Composition / Efficacy / Closed. Withdrawn by iCMS
2 / Informal / DK / NL / 18 / 25/10/2013 / CG-2 / Efficacy / Closed. Way forward found between iCMS & RMS
3 / Formal[3] / DE / FR / 14 / 11/02/2014 / CG-4 / Efficacy / Closed. CG agreement
4 / Formal / DE / SE / 14 / 29/07/2014 / CG-7 / Dermal absorption / Exposure assessment / Closed. CG agreement
5 / Formal / DE / UK / 14 / 03/09/2014 / CG-8 / Efficacy / Closed. Referred to Commission under Art 36 BPR
6 / Informal / BE / NL / 19 / 06/10/2014 / CG-8 / Risk assessment / Classification / Closed. Way forward found between iCMS & RMS
7 / Informal / DK / FR / 14 / 24/10/2014 / CG-8 / Efficacy / Closed. Taken further as a formal referral
8 / Formal / FR / ES / 14 / 17/12/2014 / CG-9 / Efficacy / Exposure assessment / Closed. Referred to Commission under Art 36 BPR
9 / Informal / AT / DE / 14 / 13/01/2015 / CG-9 / Composition / Closed. Way forward found between iCMS & RMS
10 / Formal / DK / FR / 14 / 19/01/2015 / CG-9 / Efficacy / Closed. CG agreement
11 / Informal / DK / DE / 14 / 16/02/2015 / CG-10 / Risk assessment / Closed. To be taken further as a formal referral
12 / Formal / DE / NL / 19 / 03/03/2015 / CG-10 / Risk assessment / Classification / Closed. Withdrawal of authorisations
CA-May16-Doc.4.4
Overview of the referrals discussed at the Coordination Group
10/05/20161 (2)
No / Kind of referral / iCMS[4] / RMS / PT / Date of notification / CG meeting discussion / Area of disagreement / Outcome13 / Formal / DE / UK / 18 / 20/04/2015 / CG-11&12 / Composition / Risk assessment / Closed. CG agreement
14 / Formal / DE / UK / 8 / 11/05/2015 / CG-11&12 / Identified SoCs / Risk assessment / Closed. CG agreement
15 / Formal / DK / DE / 1 / 22/06/2015 / CG-12&13 / Risk assessment / Closed. CG agreement
16 / Formal / DE / IT / 14 / 23/09/2015 / CG-14 / Efficacy / Closed. CG agreement
17 / Formal / DE / UK / 18 / 26/10/2015 / CG-14, 15 / Environmental risk assessment / Closed. Referred to Commission under Art 36 BPR
18 / Formal / FR / UK / 8 / 18/01/2016 / CG-16 / Phys-chem properties, efficacy and human health risk assessment / Closed. CG agreement
19 / Formal / FR / DE / 8 / 18/01/2016 / CG-16 / Human health risk assessment / Closed. CG agreement
20 / Formal / DE / UK / 8 / 22/01/2016 / CG-16 / Efficacy / Closed. CG agreement
21 / Formal / DE / DK / 8 / 29/01/2016 / CG-16 / Human health risk assessment / Closed. CG agreement
22 / Formal / DE / FR / 18 / 14/04/2016 / CG-17 / Human health risk assessment / Under discussion
23 / Formal / NL / LV / 1,2 and 4 / 11/5/2016 / CG-17/CG-18 / Efficacy / Under discussion
[1]iCMS: Initiating concerned MS that starts the referral process under a mutual recognition procedure.
[2] An informal referral regards the exchange of views between the iCMS, the rMS and the other cMSs as soon as an issue has been identified during the mutual recognition phase.
[3] A formal referral means that the bilateral discussion or the informal referral to the CG has not been successful, or that the 90-day MR period for agreement on the SPC has expired. Therefore the iCMS refers the matters of disagreement to the Coordination Group in accordance with Article 35(2) of the BPR.
[4]iCMS: Initiating concerned MS that starts the referral process under a mutual recognition procedure.