Article 34

Date: 27 April 2020

The Article 34 of REGULATION (EC) No 1107/2009 deals with the exemption from the submission of studies when applying for authorisations of plant protection products in accordance with Article 33(3) [see Academy Article “Zonal approach”].

Here some pre-requisites are necessary:
The applicant either needs access to the studies (Letter of access) still data protected or the respective data protection period of the studies has expired. In addition, the plant protection product must be comparable to an authorised reference plant protection product in the respective Member state, which was evaluated in accordance with the currently valid uniform principles.

Unfortunately, there is no harmonised approach for an application in accordance with Article 34. Some Member states insist on a full dossier. For other Member States reduced requirements are possible. In the latter case only some specific dRR parts must be submitted. In a very limited number of cases an administrative process (without dossier) is possible.

Karin Lauber