BPR AS Review Programme - Actions agreed at the 77 th CA meeting. 77 th CA meeting March 2018

Transcription

1 BPR AS Review Programme - Actions agreed at the 77 th CA meeting 77 th CA meeting March

2 A. Applicants / Stakeholder associations 1. Applicants: Respect procedures and duties set in the BPR, both during the eca evaluation and during the BPC review BPC These are clearly set in: the BPR, in particular Articles 6 to 8, Article 90(2) the Review Regulation (EU) No 1062/2014 CA meetings clarifications : in particular, CA-Sept13-Doc.3.0 Final, CA-March14- Doc.4.1 Final, CA-Nov14-Doc.4.5 Final, CA-May15-Doc.6.1 Final the operating procedures agreed by the BPC for the peer review : BPC documents "Introducing new information during the peer review process of active substance approval", "Applicability of new guidance and guidance-related documents", Agreed at BPC 13, 20 January Applicants: Keep the eca informed about the progress in the realisation and submission of missing data requested by the eca 3. Applicants: for substances subject to exclusion, anticipate and prepare the justifications for a possible derogation to exclusion, and submit them in due time (CA-Nov14-Doc Final - Processus Art 5(1)&(2)) 4. Applicants/Stakeholder associations: identify if there are key missing technical guidance, and contact ECHA on the matter 5. Stakeholder associations: remind their affiliates about BPR rules and procedures 2

3 Key reminders to applicants about BPR rules and processes: All needed data should be present at the submission of its application The eca has the responsibility to decide if additional data are needed/requested to carry out the evaluation, not the applicant. To do so, the eca may consult the ECHA's BPC Working Groups to ensure more harmonisation and advise on difficult cases The eca has no obligation to accept additional data that it has not requested (ie. the request for data are only foreseen in the BPR at the initiative of the eca, not the applicant) The failure to submit the requested data in the requested timeframe may lead the eca to conclude that the applicant has withdrawn its application (Article 11(d) of Regulation No 1062/2014) Commenting periods are foreseen in the procedures to submit written comments, not new data or plans to submit new data (ex: in Article 8(1) of the BPR when the eca sends its draft report to the applicant prior to submitting it to ECHA). 3

4 For the peer review at ECHA's BPC level (Article 8(4) of the BPR, BPC13 document) : No submission of additional data is foreseen in the BPR during this phase, the BPC should normally conclude on the basis of the data already available in the application and the evaluation report from the eca. Therefore, additional data may be considered only in limited and exceptional cases : o The decision on the need or acceptance of new data already generated/available that the applicant may want to submit is in the remit of the relevant BPC WG. If required, data must submitted within 10 days after the WG o Exceptionally and in duly justified cases, additional data may generated during the peer review process if agreed/requested by the relevant BPC WG. This should, a priori, only concern the evaluation under the new ED criteria (see Article 90(2) of the BPR, document CA-March14-Doc.4.1 Final, document CA-Jan18-Doc.7.3b) 4

5 B. Member States : 1. Have a higher commitment to apply agreements, procedures, and priority lists 2. Remind applicants about the rules in the BPR, the Review Regulation, and the procedures in the ECHA's BPC 3. Improve the management of suspensions in accordance with Article 6(5) of the Review Regulation (or Article 8(2) of the BPR for applications outside the review programme), and use the provisions of Article 11(1)(d) of the Review Regulation where necessary (de-facto withdrawal of an applicant in absence of submission of requested data) 4. Make pro-active checks of exclusion/substitution criteria, specifications of active substances, limit the quest for finding safe uses 5. Inform ECHA of difficulties as early as possible, and provide frequent updates to ECHA 6. Consult the BPC WGs during evaluation on difficult issues 7. Improve the communication with applicants on the progress of evaluation (ex: on progress, issues of concern, early discussions in WG on their case etc.) 8. Do not postpone dossiers in WG/BPC meetings when the evaluations can be concluded 9. Show more consistency in commenting on draft CARs from other MS with their own evaluations 5

6 C. ECHA 1. Anticipate, identify missing guidance and emerging technical issues, consult the BPC (and the CA meeting when needed) on priorities, provide regular overviews to the CA meeting on on-going development of guidance 2. Consider whether the principles on the application of new/revised guidance need to be rediscussed by the BPC (ie. timing of application of new/revised guidance during AS review) 3. Improve the coordination (in particular on late dossiers, complex cases like in situ, CLH / PBT / ED process when needed), monitor the stop of the clocks 4. Improve the management of BPC WGs in decision-taking and expert judgement D. Commission 1. Continue to monitor progresses and delays 2. On late dossiers, initiate/continue trilateral discussions with ECHA and MS on appropriate actions 3. Consider sending letters to Member States, and more formal actions where necessary 6