FRANCE– ANSES: Implementation of Article 38 of Regulation (EC) No 1107/2009

ANSES released  on 14 March 2024 a Note setting out the criteria it takes into account when allocating specification dossiers between Member States.

Pursuant to Article 38 of Regulation (EC) No 1107/2009, from 1 June 2024, Anses will only assess applications for new origin, new manufacturing site, change of manufacturing process or specification or revision of specifications for an active substance :

– for which it has been Rapporteur Member State (RMS) and has assessed the reference specifications currently in force, or

– which are submitted simultaneously with an application for authorisation of a reference PPP or for renewal of a marketing authorisation for which it is the zonal rapporteur Member State (zRMS) or interzonal rapporteur Member State (izRMS) .

The applications that do not fall within this category will not be assessed by Anses and will be rejected. Within this framework, the applicant should contact the Member States likely to take charge of the assessment, in application of the regulatory provisions of Article 38 of Regulation (EC) No 1107/2009.

To download: 

Anses note of 14 march 2024 – Implementation of Article 38 of Regulation (EC) No 1107/2009 (in French)

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