Enc. 2.2 rev 2
CZSC September 2014
CZSC January and April 2015 Bullet Points:
· What to be assessed for Article 43 applications (efficacy)
Since the assessment of applications according to Article 43 is necessary following the re-newal of the active, the czSC is considering to what extent the re-assessment of products has to be performed.
The following preconditions are to be applied for Article 43:
- No formulation change [exception: non-significant change according to GD SANCO/12638/2011]
- No change in the authorized GAPs [remark: the change of GAPs necessary because of the new endpoints has to be elaborated separately]
- No additional use/crop as originally authorized
- No cMS included for which the product is new
Where any of these pre-conditions are not met, an Article 33 application will be required.
Assessment of efficacy:
Already discussed and concluded for the situation, if the GAPs remain unchanged:
No assessment of efficacy except “Possible development of resistance or cross-resistance” (OECD KIII6.2.8). Therefore, all that is required is:
v need for a new resistance risk analysis
v need for a dRR (Section B 7) addressing resistance (OECD KIII6.2.8) only
v GAP table including all uses to be renewed
· CIRCA Pilot newsgroup
A expert forum “Newsgroup” has been taken up as a tool for consultation, information exchange and agreement by Experts in all Zones
The Newsgroup forum is a tool where opinions can be sought and information can be exchanged between experts.
The objective is facilitation of harmonisation between experts in the EU Zones.
Each type of expertise has its own forum.
A spin-off may be adaptation of guidance documents/development of guidance documents.
· Harmonization of the clock stop
As has become clear in discussions of Central Zone Steering Commitee, about every member state has their own way of dealing with the ‘stop the clock’.
Table was prepared, in which the specific ways of working for all MS are included.
Clock is stopped / Name MSAfter a completeness/validity check and the dossier is not complete / NL, SK, SI, HU, CZ, BE, AT, IE,
After the first evaluation of all aspects, resulting in a request for more information/studies / NL, SI, HU, CZ, BE, AT, DE, UK
After evaluation of a single aspect only, resulting in a request for more information/studies / UK
During evaluation of a single aspect, when it appears that the dRR is not correctly drafted by applicant, and needs to be updated by applicant. / NL, SI, SK, HU, CZ,
Whenever considered necessary / AT, Sl, IE, PL
Clock starts again
If we ascertained that the information received is correct and answers the request, then the clock stops from the moment the information arrived in the post room/email box (if not correct, than clock keeps ticking and the applicant will be informed within 3 weeks from receipt of information) / NL, SK, SI, HU, CZ, AT
When the requested information has arrived in the post room / email box / BE, UK, PL
When the requested information has arrived in the post room / email box and the applicant has declared this to be the last submission / DE
As long request does not take longer than 6 months, we don’t have a formal way of clocking it / IE
Clock doesn’t start if application very clearly incomplete / UK
How often stop-clock?
As often as necessary until the 6 months are used up / NL, SK, SI, HU, CZ, BE, AT, IE, PL
Only once / DE
Once per specialist area / UK
· Literature research
All Member States agreed that for national authorisations MS don’t require open literature research. Literature research is reserved for renewal of actives and for procedure of approval of new actives substances.
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