1. Anticoagulant rodenticides: adaptation of products not subject to an on-going renewal (Art. 48)
Some questions from Industry:
Conditions specified for the active substance:
Which conditions? Those in the AS renewal that are not currently implemented
Commonly interpreted by MS? Yes. If not, Article 48(3) provides for referral to the CG
“Margin for discretion” vs. proposed timelines: avoid different conditions in different MSs (dual-label):
If a timeline is agreed, it should be followed by all MSs (particularly by the refMSs)

2. Anticoagulant rodenticides: adaptation of products not subject to an on-going renewal (Art. 48)
Some questions from Industry:
When and how the label should be updated:
Following the amendment of the authorisation (e.g. by March 2018), Art. 52 applies:
current product can be made available on the market for 6 months (e.g. until Sept 2018) and used for 6 additional months (e.g. until March 2019).
After Sept new labels are mandatory for any making available on the market (i.e. in new batches placed on the market or in remaining stocks in the supply chain - by re- labeling).

3. Anticoagulant rodenticides: adaptation of products not subject to an on-going renewal (Art. 48)
Some comments from NL:
Tools to make the authorisation holder change his SPC:
Voluntary cooperation (footnote 5)
Submission to CA by the end of August 2017
If no submission, CA to produce the draft SPC

4. Anticoagulant rodenticides: adaptation of products not subject to an on-going renewal (Art. 48)
Some comments from NL:
Tools to make the authorisation holder change his SPC:
Voluntary cooperation (footnote 5)
If not, CAs to do it
Timelines:
AH provides draft SPC to CA by the end of August 2017
CA provides revised draft SPC to AH for comments by the end of October 2017
AH comments on the revised draft SPC by the end of November
CA amends the SPC/authorisation by the end of December 2017

5. Anticoagulant rodenticides: adaptation of products not subject to an on-going renewal (Art. 48)
Some comments from NL:
Consequences in case of non-compliance:
Following the amendment of the SPC/authorisation and period of grace:
 Enforcement of Article 17(1)
 National legislation on penalties