Generic plant protection product in the Netherlands (article 34)

Is it possible to apply for the authorisation of a generic plant protection product based on article 34 of regulation 1107/2009? Which application type should be used and which data have to be submitted in addition to the composition data?

This question refers to an application for the authorization of a plant protection product based on data for which data protection has expired (generics). In Europe this is a debated subject and a harmonized approach shared by all member states is not expected in the short term.

The Regulation holds no basis for an authorization without a dossier. It is therefore not possible to apply for authorization by referring to a reference product with open data, without submitting a dossier. It is always compulsory to submit a dRR. It is possible for the applicant to refer, in the dossier, to studies with open data, which do not have to be submitted according to article 34. When the dossier is complete the Ctgb will accept the dossier.

The risk-evaluation will be done according to the current assessment framework. It is the opinion of the Ctgb that the application procedure of generics cannot be reduced to an administrative procedure which uses the results of the risk evaluation of the reference product. Because under the current assessment framework dossier requirements may be applicable  which differ from dossier requirements of the assessment framework under which the reference product was assessed, it may be that the studies in the reference product dossier are insufficient to identify a safe use. The result of which will be that additional studies are required for a complete dossier.  

The application can be submitted as a zonal application with the Netherlands as ZRMS. Extension to other member states may be effected by adding Concerned Member States in the zonal application process, or after authorization, through mutual recognition. With our tool 'How to apply?' you can find information and the relevant application form.

Frequently asked Questions:

Article 34 allows applicants to refer to studies which are no longer protected. Is there a dedicated form or procedure for dossiers in which reference is made to studies which are no longer protected?

No, the zonal procedure and zonal application form should be used.

Is a standalone dRR required for dossiers in which reference is made to studies which are no longer protected?

Yes, a standalone dRR is required.

Can reference be made to parts of a dossier of a reference product, under article 34?

No, article 34 allows applicants to refer to unprotected studies only, not to parts of dossiers.  

Does Ctgb accept applications for mutual recognition based on a reference authorisation in which dossier reference was made to unprotected studies, according to article 34?

This is possible only if the dossier of the reference authorisation is a complete dossier. A dossier which contains only references is not acceptable as a basis for a mutual recognition in the Netherlands.