Transcript (Prohaska) ( 5.48MB)

Current situation - Article 43
Christian Prohaska
Austrian Agency for Health and Food Safety (AGES)
ECPA-ECCA Conference 2014, Brussels
www.ages.at
Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
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 "coordinates" 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
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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
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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
www.ages.at
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
www.ages.at
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
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within 3 months necessary!
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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