french feed back about air 2 & air3 léa riffaut, jérémy pinte
TRANSCRIPT
FR scheme for AS
• Splitting between scientific evaluation and decision making: Anses vs. Ministry of Agriculture
• A single desk: Anses (DPR)• Anses: scientific evaluation and
administrative checks (CoC) → MAAF• MAAF: regulatory issues (data
protection), risk mitigation & decision making → COM, EFSA, MSs, Notifier
FR Outcomes of AIR2
• AIR2: 31 AS, 31 RMS, 31 co-RMS• FR AIR2: 6 AS, 5 as RMS, 1 as co-RMS• As RMS: different worksharing options
tested– RMS drafting, co-RMS review (3)– RMS and co-RMS co-drafting (2)
• As co-RMS: review of RMS' assessment
FR Outcomes of AIR2
• Assessment at FR level: approx. on time
• Now at EU assessment level– 3 after 'additional information' step– 1 before 'additional information' step– 1 about to be fully evaluated by EFSA
FR Outcomes for AIR2
• RMS and co-RMS usually agreed. – Few disagreements listed in Vol1/Lev3
• FR conclusions on the assessment– Proposal of non-approval due to higher
protection goals– Proposal of approval• Change of end-point(s)• Change of EU-harmonised classification
FR Outcomes of AIR2
• As RMS with a co-RMS co-drafting the RAR– Interesting and valuable exchanges– (Little) Extra work due to
• Co-ordination of evaluator's workload and cross commenting of conclusions of assessment
• Interdependance of sections: need of detailed scheduling of the evaluation in order not to await some input values from the other MS/section.
FR Outcomes for AIR2
• Communication at every step– Between RMS and co-RMS– Within RMS– Between RMS, co-RMS and EFSA (in
case of worksharing and co-drafting)
• Hard point: referring to the existing DAR vs. drafting a stand-alone RAR– Renewal is not assessment of a NAS
FR Outcomes for AIR3
• Pre-notification steps• Some pre-submission meetings• …
• Some delays for decisions for pre-notifications
FR Outcomes for AIR3
• Prenotifications– Some negative decisions
• Uncomplete prenotifications• On-going discussions between parties
– Challenging pending questions• Notification of studies:
– Partial list (possible amendment?)– Not fully own data package (physical
availability / decision making before getting the letter of access)
– Old studies not peer-reviewed
FR Outcomes for AIR3
• Some meetings before supplementary dossier submission– Interesting and valuable steps
• With co-RMS and industry• Workscheduling (pending studies,
worksharing)
– EU harmonised classification:• No existing classification• Existing classification challenged
FR Outcomes for AIR3
• Communication– For every step, as early as possible
• With(in) industry and with (co-)RMS
• Quality of (finalised) prenotifications• Homogeneous treatment of notifiers
FR worries for AIR3
• Access to data for very old dossiers• New procedure
– New template for the RAR (stand-alone RAR & retyping paper copies of ancient DARs)
– Changing deadlines for end of approval
• Change of MS as RMS between approval and renewal
• Workload: no spare evaluation time, difficulties for 2015 → delayed RARs? Postponed end of approval?
Conclusions
• Full implementation of R(EC)1107/2009
• Heavy workload– Starting with dossiers of ASs
– Which will feed the art. 43 PPP re-authorisation: RMS for AS → zRMS for PPPs
– Impact on periods of approval for AIR3 ASs.
• Need of planification, communication
• Experiencing a new procedure with AIR3