EFSA: Statement on the FERA guidance proposal (2012) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments
27 July 2015
Sanco 12184 (14 July 2015) on emissions of PPP from protected crops to environment
30 July 2015
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 |
What to submit? |
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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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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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. |
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.
Lynxee consulting’s team is at your disposal to manage the renewal process of your products.
Contact us! https://lynxee.consulting/en/contact/
