Clarification of the information required to support applications for the authorisation of generic plant protection products based on data held by HSE – Article 34 of Regulation No. 1107/2009
Regulatory Update: 05/2015
Issued: 31st March 2015
This Regulatory Update is to confirm how HSE will handle applications for the authorisation of generic plant protection products based on data that are held by CRD, ie applications based on Article 34 of Regulation No. 1107/2009.
This confirms that applicants need only submit information to demonstrate technical equivalence of the active substance and comparability of the product formulation. They will not need to submit data and revised risk assessments for all other areas of the application. It also advises that only one reference product may be referred to in an application,
HSE's position regarding the assessment of applications made in accordance with the provisions of Article 34 has been confirmed following further consideration of the meaning of Article 36 and Article 34 by EU member States and the Commission.
Article 34 of Regulation No. 1107/2009 states that applicants shall be exempted from supplying the test and study reports referred to in Article 33(3) where the Member State to which an application is made has the test and study reports concerned and the applicants demonstrate that they have been granted access in accordance with Article 59, 61 or 62, or that any data protection period has expired.
For these applications, the only assessment required is to determine the equivalence of the active substance and the comparability of the formulation. Both of these assessments will be made in line with the latest guidance. In line with Article 34 (2) (c), the comparability assessment will only be made in relation to a single reference product, not two as previously.
The applicant does not need to provide new data for the other elements of the risk assessment because HSE will base the authorisation on the tests and study reports of the original, reference product. As no data are being submitted, there is no requirement to carry out a new risk assessment.
When does this apply?
HSE will apply these arrangements to new Article 34 based applications for generic products received after 1 April 2015.
If you have any questions relating to this Regulatory Update, please contact us.