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.