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France: Article 43 evaluation grouping for products containing more than one active substance

Anses has published a note detailing the requirements for grouping article 43 renewal applications in accordance with Regulation (EC) No.1107/2009.

It is noted that the applicant shall apply for a renewal of authorisation within 3 months of the renewal of each  active substance contained in the product. When the product contains more than one active substance, evaluations of the renewal dossiers of the product can be grouped, if the approval expiry dates of the substances are spaced by less than 12 months. The decision of grouping is granted by the zonal Rapporteur Member State (zRMS). When evaluations are grouped, only one fee is requested. The fee can also be adjusted  in some cases.

To download:

Gestion d’une demande de renouvellement d’AMM pour un produit phytopharmaceutique comportant au moins deux substances actives dont les dates de fin d’approbation sont espacées de moins d’un an (in French – Version dated  10 April 2019)

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FRANCE – ANSES: Management of PPPs applications following the renewal of active substances approval

ANSES published on 18.10.2018 a memo describing the management of applications for PPPs authorisation following the renewal of active substances approval. This memo recalls the regulatory context of the active substances renewal in the framework of Regulation (EC) No. 1107/2009 and describes the consequences of the active substances renewal for the applications for PPPs authorisation before and after the active substance renewal, in the case of applications for new PPPs authorisation as well as in the case of PPPs already approved (Article 43).

Applications related to PPPs for which the authorisation is being renewed under article 43 are classified into three categories described in the memo: applications essentially administrative that may be processed during the process of authorisation renewal, applications that cannot be processed by ANSES during the period of evaluation of the authorisation renewal (frozen period) and applications that may be processed in parallel with the renewal authorisation, for which the evaluation cannot be finalised before  the renewal evaluation is complete.

Finally, the theoretical timelines for the renewal of PPP authorisations pursuant to Article 43 of Regulation (EC) No.1107/2009 and to the Guidance document on the Renewal of Authorisations is set out in appendix and details on the definition of the frozen period are given.

 

To download:

Gestion des demandes relatives à la mise sur le marché de produits phytopharmaceutiques suite au renouvellement de l’approbation de substances actives (in French)

 

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EUROPE: Update of GD on Renewals according to Art. 43

This new revision (Rev. 14) of SANCO/2010/13170 on renewals according to Article 43 replaces revision 13 dated July 2015.

The update is based on the first experience gained regarding: notifications, list of studies relied upon, lists of end-points, data matching and specification checks, Cat. 4 data processes.

It should be applied from 1st January 2017 onwards.

 

To download:

SANCO/2010/13170 rev. 14, 7 October 2016, Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009

 

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FRANCE: Memo on the composition of renewal dossiers (art. 43)

ANSES published a memo and a form specifying the pieces necessary to the constitution of renewal dossier under Article 43.

The memo takes into account 3 cases:

1- Application for renewal of a plant protection product: Category 4 without on-going study

2- Application for renewal of a plant protection product for which Category 4 studies are on-going

3- Application for renewal of a plant protection product containing two active substances whose renewal date is spaced less than one year (with or without on-going Category 4 study)

As a reminder, these dossiers must be submitted within 3 months after the renewal of approval of active substances, safeners or synergists.

 

Memo and form: COMPOSITION OF RENEWAL DOSSIERS (article 43 of regulation (EC) No. 1107/2009) (in French)

 

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European Commission: Questions and Answers for renewal according to Article 43

The European Commission has published a list of questions and answers that has been conceived as a clarification note of the Commission Services to the Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No.1107/2009 (SANCO/2010/13170 rev. 13, 14 July 2015).

Several key issues are covered and updates to the renewal guidance document are suggested such as the demonstration of data access or the submission of data waivers, the process for data matching work and decision on Cat.4 studies, the change of reference source during the review, the agreement of the cMSs following the decision of the zRMS, the product compliance with conditions and restriction in the active substance regulation, the impact of new scientific guidances on dRR revision, the justification of changes from the registered GAP, the evaluation of minor uses (Article 51), the requirements for the efficacy part.

Legal clarification is still needed regarding the evaluation of ongoing zonal applications following renewal of approval: registration obtained in zRMS before date of application of active substance (a.s.) renewal but not yet in cMSs; registration obtained in zRMS after a.s. renewal date of application but before Article 43 submission date; submission of dRR >18 months prior to the date of application of a.s. renewal but no decision before Article 43 submission.

For download:

Questions and Answers on the Renewal of Authorisations according to Article 43 of Regulation (EC) No.1107/2009 (8 March 2016)

Our previous article:

Sanco 13170 (14 July 2015) on Renewal of the Authorisation of PPP according to Article 43

Lynxee consulting’s team is at your disposal to manage the renewal process of your products.

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Sanco 13170 (14 July 2015) on Renewal of the Authorisation of PPP according to Article 43

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:

Steps

What to submit?

When to submit?

Notification of the application

to each MS where renewal of authorisation is seek

  • notification form

By the deadline for the submission of the supplementary dossier for the renewal of the active substance

First step application

to the zRMS and cMS

  • updated template of the notification form;

  • indication of agreement on the studies which are needed and where possible an expected timeframe,

  • indication on which parts of the risk assessment need updating (preferably agreed in pre-submission meetings with zRMS);

  • a “data matching list” regarding references relied upon (where relevant).

2 months following the publication of the EFSA conclusions

Second step application

to the zRMS and cMS

  • a copy of the authorisation;

  • any new information required as a result of amendments in data requirements, and criteria (changes to  endpoints arising from the active substance renewal);

  • 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;

  • 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;

  • a report on the monitoring information, where the authorisation was subject to monitoring;

  • a complete updated draft Registration Report in which the changes to the risk assessment are highlighted;

  • a list of intended uses including a statement that no significant changes compared to previous authorisations (in the zone) exists.

  • a justification for each data point for which not all information is available as specified in Article 43(2) (outstanding data)

  • a comparative assessment for products containing candidates for substitution (to be assessed by each MS)

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.

 

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/