The UK regulatory authority has issued details of the procedures to be adopted for the renewal of product authorisations following the renewal of approval of an active substance.
The process for renewal of product authorisations is described in Article 43 of Regulation EC No 1107/2009 and is further explained in the EU Guidance document SANCO 2010/13170. UK specific guidance has been developed to explain what is required by HSE and how HSE will charge for this work.
What action is required by authorisation holders?
Within 3 months of renewal of the approval of an active substance, authorisation holders for Plant Protection Product’s (PPPs) containing that active substance must apply to have those authorisations renewed.
Voluntary changes in the formulation or Good Agricultural Practice (GAP) of a product cannot be considered under an Article 43 renewal application. Any change to the formulation or authorised must be submitted under a separate Article 33 application. If a change in GAP is unavoidable (e.g. it is driven / triggered by a change in end points and/ or guidance documents) then this should be highlighted in the overview. A justification for each use/change is required.
For information on how this may impact on your business, or further information on the registration of plant protection products, biocides or general chemicals, contact JSC on +44 (0)1423 520245, email@example.com
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