Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.ages.at Current situation - Article 43 Christian Prohaska Austrian Agency for Health and Food Safety (AGES) ECPA-ECCA Conference 2014, Brussels

Overview 1 - General considerations 2 – Current situation 3 - Outlook

1 – General considerations Re-newal of products Source: MeBeFree

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

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

2 – Current situation Source: Benthehack

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)

2 – Current situation 1 - Application 2 - Compliance check 3 - Assessment 4 - Mixed products (products containing >1 active) 5 - Data protection 6 - Next steps

2 – Current situation 1 - Application Source: Kimdille

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)

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

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

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?

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 and delay the re-authorisation - MS has the responsibility for ensuring that the protection standards are respected (“case by case”)

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!

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]

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

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

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)

2 – Current situation 2 – Compliance check Source: Bemthehack

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

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 1 st approval

2 – Current situation 3 - Assessment Source: themonsterinmyhead

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)

2 – Current situation 4 - Mixed products Source: rogueshollow

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 2 nd substance is renewed [Note: application after the 1 st 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 1 st substance renewal

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 1 st 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

2 – Current situation 5 – Data protection Source: themonsterinmyhead

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!

2 – Current situation 6 – Next steps Source: themonsterinmyhead

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

3 – Outlook Source: RegularWeirds

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)

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

The horror is watching you! Source: Terrorama.com.br 35