For applications for the authorisation of generic plant protection products based on data that are held by CRD, i.e. applications based on Article 34 of Regulation No. 1107/2009; 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. 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. 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.
HSE will apply these arrangements to new Article 34 based applications for generic products received after 1 April 2015.
For further information on how to submit applications for generic plant protection products or any other any other regulatory issues, please contact JSC on +44 (0)1423 520245, email@example.com
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