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Cerfa No. 15722 concerning marketing authorisation for a plant protection product, an adjuvant or a mixed product, Cerfa No. 15723 on declaration regarding a marketing authorisation or trial permit, Cerfa No. 15721 on parallel trade permits and the associated explanatory notes No. 52173, No. 52174 and No. 52172 have just been updated.
The main changes are:
– For applications regarding a marketing authorisation
- New methods for entering product packaging and manufacturing sites, consistent with data entry on the Dphy platform;
- Addition of adjuvant substances in section 5;
- Removal of identity statement for paper / electronic documents;
- Important clarifications regarding marketing authorisation by mutual recognition, namely the possibility to submit additional information to the reports provided to the reference member state. This additional information can only be taken into account if the time necessary to evaluate it is compliant with the timelines of Art. 42 of Regulation (EC) No. 1107/2009. If the time required for evaluation is not compatible with EU regulatory timeline, and in case of refusal of the authorisation, this additional information may be submitted as part of a new marketing authorisation application, according to Art. 33 of Regulation (EC) No. 1107/2009, which benefits, when submitted within 6 months following the refusal, from accelerated processing as well as a reduced fee.
– For declarations relating to a marketing authorisation
- New methods for entering product manufacturing sites, consistent with data entry on the Dphy platform;
- Introduction on section 7 of a category of products, for which a first marketing authorisation demand is in progress;
- Removal of identity statement for paper / electronic documents;
- Introduction of explanations to fulfil demand “1.3 Management of manufacturing site of an authorised product” on the Dphy platform.
– For requests regarding a parallel trade permit
- Removal of the renewal demand;
- Addition of the “origin extension” section;
- New methods for entering product packaging.
– And finally, update of the “Dossier preparation” section in the explanatory notes and addition of the preferred submission method via the Dphy platform.
These Cerfa forms and their explanatory notes are available through hypertext links in the general note on dossier submission to Anses, updated on 09/04/2024.
To download (in French):
General note on dossier submission (Cerfa forms and notices to be used) (09/04/2024)
Cerfa N° 15722*04 Marketing authorisation request
Explanatory note 52173*04 Marketing authorisation request
Explanatory note N° 52174*03 Declaration
Cerfa N° 15721*02 Parallel trade permit
Explanatory note N° 52172*02 Parallel trade permit
See also our previous article:
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