CA-July17-Doc.4.6
Overview of the referrals discussed at the Coordination Group
30/06/20171 (6)
Overview of the referrals discussed at the Coordination Groupas of30June2017
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 Withdrawn by iCMS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
No / Kind of referral / iCMS[4] / RMS / PT / Date of notification / CG meeting discussion / Area of disagreement / Outcome
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
13 / 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 / 14 / 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
No / Kind of referral / iCMS[5] / RMS / PT / Date of notification / CG meeting discussion / Area of disagreement / Outcome
22 / Formal / DE / FR / 18 / 14/4/2016 / CG-17 / RMM / Closed. CG agreement
23 / Formal / NL / LV / 1,2 and 4 / 11/5/2016 / CG- 17 &
CG-18 / Efficacy / Closed. CG agreement
24 / Formal / FR / UK / 18 / 23/5/2016 / CG-18 / Efficacy / Closed. CG agreement
25 / Formal / DE / IT / 14 / 8/6/2016 / CG-18 / RMM / Closed. CG agreement
26 / Formal / FR / DE / 18 / 22/8/2016 / CG-19 / Efficacy / Closed. CG agreement
27 / Formal / FR / DE / 18 / 22/8/2016 / CG-19 / Efficacy / Closed. CG agreement
28 / Formal / DK / NL / 19 / 4/11/2016 / CG-20 & CG-21 / Human health risk assessment / Closed. CG agreement
29 / Formal / DK / NL / 19 / 4/11/2016 / CG-20 & CG-21 / Human health risk assessment / Closed. CG agreement
30 / Formal / DK / NL / 19 / 4/11/2016 / CG-20 & CG-21 / Human health risk assessment / Closed. CG agreement
31 / Formal / FR / UK / 18 / 22/11/2016 / CG-21 / RMMs / Closed. CG agreement
32 / Formal / UK / DE / 8 / 14/12/2016 / CG-21 / Efficacy / Closed. CG agreement
33 / Formal / UK / EL / 18 / 20/12/2016 / CG-21 / Efficacy/ RMMs / Closed. CG agreement
No / Kind of referral / iCMS[6] / RMS / PT / Date of notification / CG meeting discussion / Area of disagreement / Outcome
34 / Formal / LV / IT / 14 / 10/01/2017 / CG-21 / Classification and labelling / Closed. CG agreement
35 / Formal / FR, DE / CZ / 8,
14,18 / 9/1/2017 / CG-21 & CG-22 / Efficacy/ RMMs / Closed. CG agreement
36 / Formal / UK, DE, SE / BE / 19 / 15/02/2017 / CG-22 & CG-23 / Human health risk assessment / Efficacy / Closed. Referred to Commission under Art 36 BPR
37 / Formal / UK, DE, SE / BE / 19 / 15/02/2017 / CG-22 & CG-23 / Human health risk assessment/ Efficacy / Closed. Referred to Commission under Art 36 BPR
38 / Formal / UK, DE, SE / BE / 19 / 15/02/2017 / CG-22 / Human health risk assessment / Closed. CG agreement
39 / Formal / DE, DK / HU / 18 / 20/02/2017 / CG-22 / Efficacy / Closed. CG agreement
40 / Formal / DE / SE / 18 / 20/02/2017 / CG-22 & CG-23 / Substance identity / Closed. Referred to Commission under Art 36 BPR
41 / Formal / PL / CZ / 8 / 10/03/2017 / CG-22& CG-23 / Environmental exposure assessment / Closed. CG agreement
42 / Formal / FR / DE / 8 / 17/03/2017 / CG-23 / Phys-Chem properties, Efficacy, Human health andenvironmental risk assessment / Closed. CG agreement
No / Kind of referral / iCMS[7] / RMS / PT / Date of notification / CG meeting discussion / Area of disagreement / Outcome
43 / Formal / NL, DK, FR, ES / SE / 18 / 29/03/2017 / CG-23 / Efficacy / Closed. CG agreement
44 / Formal / NL, FR / SE / 18 / 29/03/2017 / CG-23 / Efficacy / Closed. CG agreement
45 / Formal / SE / NL / 18 / 12/04/2017 / CG-23 / Phys-Chem properties / Closed. CG agreement
46 / Formal / SE, DE, DK, ES / FR / 18 / 03/05/2017 / CG-23 &
CG-24 / Phys-Chem properties, Efficacy, Human health and environmental risk assessment, Instruction of use. / Under discussion
47 / Formal / DE / FR / 18 / 04/05/2017 / CG-23 / Efficacy, Instruction of use / Pending agreement via written procedure
48 / Formal / FR / UK / 18 / 05/05/2017 / CG-23 / Packaging size / Closed. CG agreement
50 / Formal / DK / LV / 2 / 11/05/2017 / CG-24 / Clasiffication and labelling / Under disucssion
No / Kind of referral / iCMS[8] / RMS / PT / Date of notification / CG meeting discussion / Area of disagreement / Outcome
51 / Formal / FR, DE, ES / UK / 18 / 17/05/2017 / CG-24 / Use instruction, Package size, RMM, Efficacy,
Human health and environmental risk assessment. / 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.
[5]iCMS: Initiating concerned MS that starts the referral process under a mutual recognition procedure.
[6]iCMS: Initiating concerned MS that starts the referral process under a mutual recognition procedure.
[7]iCMS: Initiating concerned MS that starts the referral process under a mutual recognition procedure.
[8]iCMS: Initiating concerned MS that starts the referral process under a mutual recognition procedure.