Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.ages.at

Current situation - Article 43

Christian ProhaskaAustrian Agency for Health and Food Safety (AGES)ECPA-ECCA Conference 2014, Brussels

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Overview

• 1 - General considerations

• 2 – Current situation

• 3 - Outlook

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1 – General considerations

Re-newal of products

Source: MeBeFree

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1 – General considerations

Renewal according to Article 43 of 1107/2009:

- Application – 3 months after Commission´s decision (entry into force) of renewal of the active- Compliance check (step I) and assessment (step II) by zRMS – 6 months (-> zonal RMS`s RR)- Decision on renewal of authorisation by all concerned MS in the zone - 3 months

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1 – General considerations

According to the Regulation (Article 43.3), the RMS "co-ordinates" step 1 and 2 within the corresponding zone

- Short timelines (3 months for preparing a complete dossier, 6 months for evaluation incl.

commenting)

- High number of products and products with >1 active

- New data requirements for products

- New endpoints for the active

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2 – Current situation

Source: Benthehack

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2 – Current situation

-> Meetings on “Renewal and Re-authorisation procedures” with COM, EFSA, ECPA, ECCA, IBMA, MS

- 30 October 2012 Brussels

- 12 December 2012 Brussels

- 14 March 2013 Brussels

- 16 September 2013 Brussels

- 10 and 11 March 2014 (PAI meeting, Brussels)

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2 – Current situation

•1 - Application

•2 - Compliance check

•3 - Assessment

•4 - Mixed products (products containing >1 active)

•5 - Data protection

•6 - Next steps

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2 – Current situation

1 - Application

Source: Kimdille

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2 – Current situation

• A number of submissions (applications for renewal of the product) needs studies which take >3 months time to be completed

Cat. 1 – “Formal” studies which do not impact the safety of the product (i.e. storage stability, validation of analytical methods)

Cat. 2 – Confirmatory information (approval regulation)

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2 – Current situation

Cat. 3 – Confirmatory information for AIR 2 substances (could be according to new data requirements)

Cat. 4 – Studies in order to fulfill new end points and time is too short to produce the studies required

(mesocosm studies, residue trials)

Cat. 5 – Data gaps related to new data requirements/new guidance documents

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2 – Current situation

Studies of cat. 1: not related to safety issues – no reason for extension

Studies of cat. 2, 3 and 5: confirmatory information -> renewal of the product without CI!

Studies of cat. 5: studies which are NOT confirmatory information – to be provided within 3 months

Studies of cat. 4: delay possible

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2 – Current situation

Studies of cat. 4 (remarks, questions):

- One assessment only (once all studies are provided)?

- When to be submitted?

- dRR to be provided? Once all studies are available?

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2 – Current situation

•Interpretation of Article 43(6): “reasons beyond the control of the authorisation holder”

If it is not possible for the applicant to provide studies in time (“new end point”) – no legal justification according to legal service´s opinion

- Applicant may justify the lack of data- MS may find it justified to apply Art. 43.6 and delay the re-authorisation- MS has the responsibility for ensuring that the protection standards are respected (“case by case”)

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2 – Current situation

• -> MS may grant extension of the concerned authorisation [cat 4 studies only]

• To be legally implemented

Proposal: a general statement in the substance renewal decision (approval regulation):“product authorisations should be extended for the time necessary to generate and evaluate the data needed “

Status? Not yet considered!

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2 – Current situation

• Application according to the timelines given in the regulation (i.e. 3 months after EIF of the approval regulation) – even if cat 4 studies are ongoing

• To be applied by all authorisation holders (i.e. notifying and non-notifying companies)[Note: no application means the authorisation to be revoked]

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2 – Current situation

• The application of dossiers (cat 4 studies ongoing) should contain

- All necessary studies available at the time of application

- List of studies to be generated, i.e. cat. 4 studies (including time table for study submission and justification – to be accepted by zRMS)

- dRR

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2 – Current situation

• The application of “incomplete” dossiers should NOT contain

- data related to additional uses (not yet authorised in the zone); those data are subject to extension of use, i.e. Article 33 application

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2 – Current situation

NOTE:

Source: Frater Tecum

•All authorisation holders (i.e. notifying and non-notifying companies to apply for renewal of the product within 3 months period – otherwise authorisation revoked)

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2 – Current situation

2 – Compliance check

Source: Bemthehack

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2 – Current situation

•Compliance with the conditions and restrictions of the active renewal/equivalence check if necessary after each substance´s renewal

•Compliance check to be performed by the individual MS having authorisations

•Equivalence check(s) to be performed by the RMS for the active renewal

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2 – Current situation

•Reference specification:

According to GD SANCO/10387/2010 rev 8 reference specification should not be changed unless a relevant impurity is to be included

Implications of a possible change- All equivalence checks (completed and ongoing) to

be reconsidered- A new specification would mean that different

material used in the tox/ecotox studies supporting the 1st approval

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2 – Current situation

3 - Assessment

Source: themonsterinmyhead

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2 – Current situation

•Assessment to be performed by the zRMS- One evaluation only once all cat. 4 studies are provided?- Assessment of sections for which all studies are made available first? Followed by an assessment when all cat. 4 studies are made available?

•Based on the dRR provided by the applicant (as for Article 33 applications)

•“new” consideration of the risk envelope approach (worst case GAP for one product – other products covered – applicable at least for sections residues and fate)

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2 – Current situation

4 - Mixed products

Source: rogueshollow

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2 – Current situation

• If 2 substances are renewed within a short timeframe (with a maximum of 1 year), the renewal of the product(s) will wait until the 2nd substance is renewed[Note: application after the 1st active is renewed!]

• To be considered:- What about substances which are renewed within e.g. 1 year and 1 month?- Sometimes not easy to anticipate, if the renewal of the second substance is delayed, which is not known after the 1st substance renewal

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2 – Current situation

• If the product contains > 2 actives:

Proposal of the expert´s group:

- if the approval of the substances is expiring in a short time frame, full evaluation of the product 5 years after the 1st substance is renewed (max. time period)

- 2 substances expiring earlier in a short period and 2 in the same (close) period later -> grouping

Not mentioned in the GD; same rules as for products containing 2 actives may apply

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2 – Current situation

5 – Data protection

Source: themonsterinmyhead

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2 – Current situation • Data protection (substance and product data) of 30

months starts at the date of renewal of the product (including studies which are provided later)

• If authorisation is extended (see chapter 1. application), data protection of 30 months starts once the authorisation is renewed

• Successive renewal of a product containing 2 actives may trigger 2 starting points for data protection (every time MS decide on the renewal of the product)

• For generics (products): MS should suspend for 30 months the authorisation of the product allready on the market (unless a LoA is available) – but application within 3 months necessary!

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2 – Current situation

6 – Next steps

Source: themonsterinmyhead

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2 – Current situation

•To be legally implemented

Proposal: a general statement in the substance renewal decision (approval regulation):“product authorisations should be extended for the time necessary to generate and evaluate the data needed “[still under consideration by COM]

•Amendment of the relevant GD SANCO/2010/13170 (conclusion of the expert´s meeting was implemented to some extent only due to legal service) – Standing Committee

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3 – Outlook

Source: RegularWeirds

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3 - Outlook

• How to coordinate the work between MS (zonal SC)

• “New” consideration of the risk envelope approach (worst case GAP for one product – other products covered!)

• In order to plan the work: information by applicants to MS about products to be renewed (2 years in advance to expected re-authorisation at the latest) – new notification sheet (implemented in the GD SANCO/2010/13170)

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3 - Outlook

• Worksharing of MS (interzonal, within the zone)

• Pre-submission meeting for renewal of the active – renewal of the PPP to be discussed as well

• Quality of the dRR prepared by the applicant

• Comparative assessment to be considered

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The horror is watching you!

Source: Terrorama.com.br

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