Process and support on applications for authorisations

Transcription

1 Process and support on applications for authorisations Seminar on Applications for Authorisation June 2015 Sanna Henrichson Risk Management Implementation Unit European Chemicals Agency 06 July

2 Outline 1. Timelines 2. Submission windows 3. Notification and Pre-submission information sessions ( PSIS ) 4. Where to find information and get additional support? 2

3 Other factors affecting the application 1. decision Timelines Compiling an application might still require significant staff and other resources The application fee is not insignificant and only guarantees an opinion, not authorisation Authorisation is temporary application costs have to be incurred again and again, and justifying the authorisation 3

4 Timeline: the main steps Broad Information on use published Comments and responses published Final opinions published Submission Applicant can comment Draft opinions Commission Decision PSIS 6-9 months earlier 8 weeks Public consultation «Trialogue» ~ month 3 Final opinions 2-3 months Invoice paid = date of receipt max10 months RAC and SEAC develop opinions 1-4 months 4

5 Initial processing Broad Information on use published Comments and responses published Applicant can comment Draft opinions Final opinions published Commission Decision Submission 8 weeks «Trialogue» ~ month 3 Final opinions Public consultation 2-3 m Invoice paid = Date of receipt Max 10 months 1-4 months RAC/SEAC develop opinions 5

6 Initial processing timeline Submission (via REACH IT) Comments on 1 st "brief wording" Payment chrome://flags/#enable-npapi ~3 wk ~3 wk 2+1 wk (submission fails) BR check outcome 1 st "brief wording" for BIU Final "brief wording" + Invoice Date of receipt (Art. 64(1)) ~ months Public consultation Committees start work on conformity check and opinion 6

7 Other factors affecting the application 2. decision Submission windows Compiling an application might still require significant staff and other resources The application fee is not insignificant and only guarantees an opinion, not authorisation Authorisation is temporary application costs have to be incurred again and again, and justifying the authorisation 7

8 Submission windows (1/2) Specific periods for submission of applications to ECHA (announced on ECHA web pages; every 3 months) synchronisation with scheduled Committees meetings, for effective preparation of opinions submission windows Date of receipt 10 months Draft opinion

9 Submission windows (2/2) Most of the latest application dates fall in a submission window but not all You can benefit from the transitional arrangements of Art. 58(1)(c)(ii) of REACH, if you submit your applications to ECHA during any of the submission windows before the substance s latest application date. This means that you can continue using the substance after the sunset date, while waiting for the Commission s decision. If the application does not pass the Business Rules check and you need to re-submit after the latest application date, you will not benefit from the transitional arrangements. To benefit from the transitional arrangements, ECHA advises to submit before the latest submission window 9

10 Other factors affecting the application 3. decision Notification and Presubmission information sessions ( PSIS ) Compiling an application might still require significant staff and other resources The application fee is not insignificant and only guarantees an opinion, not authorisation Authorisation is temporary application costs have to be incurred again and again, and justifying the authorisation 10

11 Pre-submission information session («PSIS») (1/2) Objective: address case-specific questions on regulatory/procedural aspects clarify critical elements for the public consultation on alternatives and facilitate the development of the "broad information on use NOT to provide consulting services or advice. The assessment of the application only starts once ECHA has received the application for authorisation (fee received) Logistics: Notify ECHA and request a PSIS at least 8 months before the planned submission of the application Documents to send to ECHA and further details on: 11

12 Pre-submission information session («PSIS») (2/2) Mutual learning process! PSIS considered very useful by the (potential) applicants: Helps to clear some misunderstandings Highlights and clarifies important aspects Very useful for ECHA too: Better understanding of what is not clear or what worries potential applicants We know what is likely to come better planning 12

13 Other factors affecting the application 4. decision Where to find information and get support? Compiling an application might still require significant staff and other resources The application fee is not insignificant and only guarantees an opinion, not authorisation Authorisation is temporary application costs have to be incurred again and again, and justifying the authorisation 13

14 ECHA support ECHA s website is main information source New AfA support pages: Q&As Seminars & workshops Pre-submission information sessions ( PSIS ) Helpdesk (primary contact point for questions) Make suggestions too! Send an to: applications-authorisation [at] echa.europa.eu

15 New AfA support page Q&As: several issues addressed, updated regularly. Stay up to date! Subpages with more information about each step, including relevant links 15

16 Subpages with more information Link to the Autorisation List 16

17 Subpages with more information Submission windows to facilitate time planning Links to find out more about potential partners, application fees etc. 17

18 Subpages with more information Formats for the application Guidance on SEA, AoA, ES etc. Useful tips, reference DNELs, justification for length of review period etc. 18

19 Subpages with more information 19

20 Subpages with more information Technical instructions 20

21 Subpages with more information 21

22 Subpages with more information 22

23 Subpages with more information 23

24 Take home Check ECHA s website regularly and start from here: Request a Pre-submission information session Submit during the submission windows Make suggestions too! 24

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