Update on the review of active substances (Meeussen) ( 880Kb)

Report
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

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