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Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.ages.at
Lessons learned and improvement of the zonal system
Christian ProhaskaAustrian Agency for Health and Food Safety (AGES)ECPA/ECCA Conference 2015, Brussels
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Expectations
- One MS´s assessment on behalf of other MS
- Speeding up of authorisations
- Increase the level of harmonisation between MS
- Keeping the timelines
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The zonal system? – Worth thinking about!
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Create an update of 1107/2009 would be an option
How long would that take?
Danger of making things worse than they are
Focus on the existing system only…
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Complaints? Expectations?
Timelines/capacities
Harmonisation (procedural and technical)
Article 40 (mutual recognition)
Article 43 (renewal of the products)
Article 51 (minor uses)
And many much more…
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Capacities/timelines
Submitted and intended applications for new products (2012 – 2014)
Date: December 2014
To be considered: different structures of the authorities, number of experts, history, agriculture….
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Capacities/timelines
Keeping timelines (new applications according to 1107/2009 considered only) – e.g. AT as zRMS
* 5 days – 3 months** 25 days – 2 months
Time Total number of authorizations (AT acting as zRMS)
On time Delay
July 2011 – July 2012 17 3 14*July 2012 – July 2013 11 5 6**
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Capacities/timelines
It becomes more and more obvious, that every MS failed/will fail to keep the timelines
Additional workload to be considered
- Comparative assessment
- Article 43 applications
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Capacities/timelines
Why is everybody complaining about capacities? - We are in the same situation as under Directive 91/414/EEC (number of applications, work load….)
- Hypothesis: For the new system, every MS tries/tried to keep the timelines, but….
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Capacities/timelines – solutions?- Increase the number of experts (will not solve the problem)?
- Reflect on the organisation in each MS (one body instead of several numbers of bodies) – political issue in MS!
- Process improvement (authorities; procedural and assessment)
- Increase work-sharing within the zone and between zones (without complicating the system, like e.g. additional commenting phase)?
- Zonal secretariat? Will not solve the issues with technical assessments!
- Harmonisation!
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Harmonisation - Aim
Increase the level of knowledge of experts (because of increase of scientific exchange)
Increase the level of trust between MS (in order to simply rely on the zRMS´s assessment)
Preconditions: Follow the agreed guidance (even if not
in favour)!
Harmonisation means the will for compromise!
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Harmonisation – procedure/examples
Substance data – when to be used (product assessment)?
- Use of new substance data only if needed in order to show a safe use and/or flagged by the applicant as “adverse data” -> otherwise, use existing LoEPs only!
- Data gaps identified in EFSA conclusion
If data gaps substantial -> no approval of the active or confirmatory information (to be dealt with at EU-level!)
If not that substantial – to be assessed for renewal of the active
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Harmonisation – procedure/examples
Guidance on Article 34
- Composition of the PPP is comparable to the reference product (in the sense of GD on significant and non-significant change) and data are out of protection
- No new studies needed – no new assessment (part A and C only!)
- To be further elaborated if products are not comparable in the sense of the GD on significant and non-significant change
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Harmonisation – procedure/examples
Label extensions (Article 33 applications)
- If new use fall within the risk envelope approach for existing uses (even 91/414 registrations are concerned)
Need to assess new studies only (e.g. residues, efficacy)
No need to re-assess the existing uses and/or the existing risk assessment
Every MS to follow the approach?
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Harmonisation – technical issues
Harmonisation Workshops
- Toxicology (Berlin, June 2014; follow up in Vienna, June 2015) – interzonal
- Ecotoxicology (Wageningen, June 2014; follow up in Vienna, April 2015) – central zone only
- Fate and behaviour (Vienna, November 2014) – central zone only
- Risk harmonisation under BTSF? COM to consider!
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Harmonisation – technical issues
Harmonisation Workshops – critical remark
- Accumulation of worst case assumptions? - Will/possibility for harmonisation?
Supervising body needed:
“Director´s meeting” at zonal level (established for the central zone):
- Safeguard for the harmonised issues to be followed by MS- If no decision at experts level, the directors will decide
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Harmonisation – technical issues
National addendum vs core assessment
Do not use national specifics in thecore dRR
Use EU-agreed methodology in the coredRR, e.g. Focus model for fateassessment!
Harmonisation workshops needed in order to reduce und understandthe national specifics
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Harmonisation – technical issues
Technical GD (EFSA Guidance)
Development of GD:
- All stakeholders to be taken on board (industry)- Transitional measures/periods to be considered- Feasibility/practicability of the GD for regulatory purposes to be considered
Examples:Operator exposure GD??Guidance on dermal absorption
Note: It is still a MS/zonal issue, when to use what for product evaluation
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Article 40 – Mutual recognition- Accelerated procedure (120 days for “real” 1107/2009
registrations)- Precondition: same uses and same GAPs as the reference MS- Registration not to be refused because on efficacy grounds only
- Do really all MS follow? - Some MS refuse application if efficacy not assessed in the corresponding EPPO zone
Recommendation:Not to include MS in Article 33 application (cMS) – rather go for Article 40 – at least for MS who follow the rules
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Article 43 – Renewal of the products
• Preconditions for application according to Article 43:
- GAPs remain unchanged (what if the GAP has to be changed because of new end-points?)- No new uses!- No new cMS (for which the product is new)!- No formulation change! (except: non-significant change according to GD SANCO/12638/2011)
If preconditions are not fulfilled -> Article 33 application
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Article 43 – Renewal of the products
MS may grant extension of the concerned authorisation until studies are made available [valid for cat 4 studies only]
Cat. 4 studies are:
- Studies in order to comply with new end points and time is too short to produce the studies required (e.g. mesocosm studies, residue trials; efficacy trials if necessary because of changed end points -> lowering of amount active/ha)
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Article 43 – Renewal of the products
• For the time being: Interpretation of Article 43(6): “reasons beyond the control of the authorisation holder”
To be considered in the Guidance Document “Renewal, Withdrawal and Amendment of Authoristaion” (“sake of harmonisation”!)
• For the “near” future: Change of the wording of Article 43.2 and/or Article 43.6?
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Article 43 – Renewal of the products
Mixed products (containing > 1 active) Consequently, for the individual sections only product data to be considered:
- section physchem properties (Storage stability only)- section analytical methods (no need to be looked at)- section toxicology (toxicity data of the product including dermal
adsorption)- section residues (no need to be looked at)- section fate (no need to be looked at)- section ecotox (e.g. bees, arthropods, earthworms, plants, aquatic organisms) - part C (composition of the product only)
Once the 2nd substance is renewed, there is no need to look at the 1st substance again
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Article 51 – Minor uses
• Zonal system applies as well• Accelerated procedure possible
(no efficacy, residue trials only*))• Grower´s associations may/should
look for cooperation across the border- Identification of common minor uses in different MS- Joint generation of residue data needed
• Implication of comparative assessment:Candidate products with minor uses – not to perform a comparative assessment at all - Increased motivation for application holders to increase the level of investment for minor uses-----------------------------*) If new use is within the risk envelope
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The house is damaged, but still possible to make it worth living in!
Source: Steffi A.
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