This guidance document, updated on 14 July 2015, has been developed to elaborate the procedures for the renewal of authorisations of PPPs according to Article 43 of Regulation (EC) No. 1107/2009.
The procedures described only apply to renewals of authorisations based on active substances for which approval is renewed under the Regulation (EC) No. 1107/2009, and where safe uses have been demonstrated.
Lynxee consulting focuses on the key steps of the renewal of the authorisation of a PPP according to Article 43:
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Steps
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What to submit?
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When to submit?
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Notification of the application
to each MS where renewal of authorisation is seek
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By the deadline for the submission of the supplementary dossier for the renewal of the active substance
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First step application
to the zRMS and cMS
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updated template of the notification form;
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indication of agreement on the studies which are needed and where possible an expected timeframe,
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indication on which parts of the risk assessment need updating (preferably agreed in pre-submission meetings with zRMS);
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a “data matching list” regarding references relied upon (where relevant).
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2 months following the publication of the EFSA conclusions
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Second step application
to the zRMS and cMS
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a copy of the authorisation;
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any new information required as a result of amendments in data requirements, and criteria (changes to endpoints arising from the active substance renewal);
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evidence/justification that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval;
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any information to demonstrate that the product complies with the requirements (conditions and restrictions) set out in the Regulation on the renewal of the approval of the active substance;
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a report on the monitoring information, where the authorisation was subject to monitoring;
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a complete updated draft Registration Report in which the changes to the risk assessment are highlighted;
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a list of intended uses including a statement that no significant changes compared to previous authorisations (in the zone) exists.
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a justification for each data point for which not all information is available as specified in Article 43(2) (outstanding data)
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a comparative assessment for products containing candidates for substitution (to be assessed by each MS)
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Within 3 months from the date of entry into force of the decision of renewal of the approval of the active substance.
At the same time the
application should be included into the EU PPP Application management System.
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Data protection
The applicant may seek advice by the individual MS about the status of protected/non-protected studies.
The data generated because they were necessary for the renewal of the authorisation benefit from a data protection period of 30 months from the applicability of the decision of renewal of the authorisation.
New information related to active substance renewal
The applicant shall take into account the list of “old” and “new” studies and the list of critical endpoints that have been changed during the active substance renewal procedure in order to build the updated draft Registration Report of the PPP renewal.
Outstanding data at the 3 months deadline
Five circumstances can result in data being outstanding.The applicant must provide an appropriate justification for each situation where data is missing at the three months deadline.
The data directly related to a (new) endpoint as listed in EFSA conclusion and for which the time is too short to produce the requested study should be submitted as soon as possible taking into account the time necessary to conduct the studies (generally within 2 years).
Timelines
The zonal RMS should complete its assessment of the new information 6 months after receipt of the information (this period includes a 3 week commenting time for the applicant and the MSs of the relevant zone(s)). And then this allows 3 months for the other MSs to conduct comparative assessment (if necessary) and to decide on the renewal of their authorisations.
After every step in the procedure the EU PPP Application management System should be updated respectively by the applicant or by the concerned MS.
Products containing more than one active substance
For products containing two or more active substances the applicant shall apply for a renewal of authorisation after the renewal of each active substance contained in the PPP.
However, if the PPP contains two or more active substances and the approval of the second active substance expires within 12 months of the first one, zRMS and MSs should evaluate the data submitted for both active substances after the data for the second active substance are submitted.
http://ec.europa.eu/food/plant/pesticides/approval_active_substances/guidance_documents/docs/gd_renewal_1107-2009_rev_13.pdf
Lynxee consulting’s team is at your disposal to manage the renewal process of your products.
Contact us! http://lynxee.consulting/en/contact/
