EUROPE : Marketing authorisations with exemption of studies in Southern Zone Member States

The Southern Member States Steering Committee (SMS-SC) has released on 8 November 2023 a document on the procedures of the SMSs for the placing on the market or amendment of authorization of a plant protection product (PPP) in accordance with the exemption from the obligation to submit studies included in Article 34 of Regulation (EC) 1107/2009 of the European Parliament and of the Council.

The document sets out (1) the EU data requirements and guidelines and (2) the national requirements. These are presented using flowcharts and information on the specific procedures to be followed for submitting PPP authorisation applications using the provisions of Article 34, for each Southern Zone Member States (with the exception of Malta). Applications submitted under Article 33 using the exemptions of Article 34 may only be based on a single reference PPP, designated by the applicant, which has been evaluated in accordance with Uniform Principles under either Directive 91/414/EEC or Regulation (EC) No. 1107/2009 and for which a registration report (RR) is available. The authorization of the reference product must not be in the process of being renewed according to Article 43 of Regulation (EC) No. 1107/2009.

The applicant must prove that he has access to the reference product studies or demonstrate that data protection has expired. Furthermore, at the request of the zRMS, the applicant must be able to provide information demonstrating that the new PPP has effects comparable to those of the reference PPP. The comparison of the composition of the new product with the reference PPP is based on the guidance document SANCO 12638/2011 (rev. 2) on significant and non-significant changes. 

To download: 

Procedures of the SMSs for the placing on the market or amendment of authorization of a plant protection product (PPP) in accordance with the exemption from the obligation to submit studies included in Article 34 of Regulation (EC) 1107/2009 of the European Parliament and of the Council – Version 1.1 – 08/11/2023 

See also our previous articles: 

EUROPE : Update of Working Document on the Work-Sharing of the Southern Zone Member States

EUROPE: New Schedule for Southern Zone Guidelines for Protected Crops

EUROPE: New Guidelines for Southern Zone Member States

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