Update on the review of active substances (Meeussen) ( 880Kb)
Download
Report
Transcript Update on the review of active substances (Meeussen) ( 880Kb)
Regulatory Conference - ECCA & ECPA
12-13 March 2014
Update on the review of
active substances
Jeroen Meeussen
European Commission
DG SANCO
Health and
Consumers
The AIR programmes
AIR-1 – 7 substances – 14 MS
AIR-2 – 31 substances – 21 MS
AIR-3 – 150 substances – 28 MS
Health and
Consumers
Current situation (AIR-1)
All decisions on Annex I Renewal (AIR-1).
substances have been taken - 7 substances
Regulation is applicable from: 1 January 2012.
Re-authorisation of products: 31 December 2015.
Expiry of approval: 31 December 2021.
Health and
Consumers
Current situation (AIR-2)
Regulation (AIR-2) has been published in
December 2010: (EU) No 1141/2010.
Guidance Document has been noted
(SANCO/10387/2010 - rev. 8).
31 substances: 29 dossiers have been
received; peer-review is ongoing.
Expiry of approval: 31 December 2015.
Health and
Consumers
Current situation (AIR-3)
Regulation ("AIR-3") with the general
procedure: Reg. (EU) No 844/2012.
List of RMS & Co-RMS for substances
expiring by 31/12/2018: Reg. (EU) No
686/2012.
Guidance Document has been noted
(SANCO/2012/11251 - rev. 1.2).
Health and
Consumers
Renewal Timelines (Reg. 844/2012)
Activity
- Dossier submission:
- Admissibility check:
- Renewal Assessment Report (RAR):
- RAR circulated to MS and applicant:
- Public Commenting (incl. MS & applicant):
- EFSA peer-review:
- Stop the clock:
- COM decision:
Max Total
-6-
Health and
Consumers
•
•
•
•
•
•
•
•
•
Time
0
1 month
11 months
1.5 months
2 months
5 months
3 months
6 months
• 29.5 months
Underlying
principles
Health and
Consumers
1. A workable programme
Health and
Consumers
2. Stepwise implementation
The extension of the approvals will be done in
batches.
Condition: application submitted within the
deadline.
If no dossier submitted back to old expiry
date.
Health and
Consumers
3. Data requirements
The new data requirements should apply to all
substances.
Starting date for submission of dossiers: after 1
January 2014 (related to the new data
requirements).
Health and
Consumers
AIR-3 substances
Expiry date
No of
substances
Extension
1
< 14 June 2014
40
until 1/2017
Reg. 823/2012
2
July 2014 –
November 2015
27 (23)
until 7/2017
Reg. 1197/2012
3
February 2016 –
November 2017
55
until 7/2018
4
> 31 July 2018
28
In principle
no extension
Health and
Consumers
Extension only if
application
submitted within
deadlines
GROUP 1 : 40 substances expiring before 14 June 2014
Reg. 823/2012 extending the expiry dates
Application
Dossier
submission
Extended
E-date – 3 y
Extended
E-date – 2.5 y
Extended expiry date
Batch 1: 31/1/2014
31/7/2016
31/10/2016
31/01/2017
Health and
Consumers
Group 1
Batch No
AS
New expiry
date
Date of
application
Dossier
submission
31/7/2013
31/1/2014
1
15
31/7/2016
(12)
2
14
31/10/2016 31/10/2013 30/4/2014
(11)
3
11
31/1/2017
31/1/2014
Health and
Consumers
31/7/2014
Reg. 186/2014
Reg. voted
GROUP 2: 27 substances expiring 7/2014 – 11/2015
Reg. 1197/2012 extending the expiry dates*
Application
Application
(using
format Reg.
844/2012)
Original
E-date – 3 y
Extended
E-date – 3 y
Received for
23 substances
Applicable to
23 substances
Dossier
submission
Extended
E-date – 2.5 y
30/4/2017
31/7/2017
* Only if application
requesting renewal was
received (23 substances)
Extended expiry date
Health and
Consumers
GROUP 3: 55 substances expiring 2/2016 – 11/2017
Extend expiry date only if application received
Application
(using format
Reg. 844/2012)
Current
E-date – 3 y
Dossier
submission
Extended expiry date
Extended
E-date – 2.5 y
31/10/2017
31/1/2018
30/4/2018
Adopt regulation as
regards extended
expiry dates
Health and
Consumers
GROUP 3: 55 substances expiring 2/2016 – 11/2017
Several Regulations extending the approval
Regulation (EU) No 533/2013;
Regulation (EU) No 762/2013;
Regulation (EU) No 1136/2013;
Regulation (EU) No 85/2014;
…and more to follow.
Condition: the application has been submitted
Extension to be adopted before the dossier submission
Message for industry: submit the application as soon
as possible
Health and
Consumers
GROUP 4: substances expiring as from 31/7/2018
No extension
Application
Dossier
submission
E-date – 3y
E-date – 2.5 y
Expiry date
Health and
Consumers
Overview Documents (1)
Health and
Consumers
Overview Documents (2)
Health and
Consumers
New Data Requirements
Apply from 1 January 2014;
Commission Regulations (EU) No 283/2013 and
No 284/2013 of 1 March 2013 (published OJ on
03/04/2013);
Commission Communications 2013/C 95/01 and
2013/C 95/02.
Health and
Consumers
New Data Requirements
Active Substance:
- for all applications submitted under Regulation
844/2012;
Products:
- Not to AIR-1 and AIR-2 as long as applications
for re-authorisation are submitted before
31 December 2015;
- Applicable to all re-authorisations AIR-3.
Health and
Consumers
Conclusions
Legal framework for AIR-3 has been adopted.
Extensions only possible if an application has
been submitted.
Submit applications as soon as possible.
Challenge to cope with the deadlines.
Urgent need to address a number of issues for
renewal of authorisations.
What about submissions after AIR-3?
Health and
Consumers
Workload
Health and
Consumers
Thank you for your attention
Any questions?
Health and
Consumers