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Procedures for the renewal of product authorisations – Article 43 of Regulation 1107/2009

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.

  • A product renewal application must be submitted for every product containing a renewed active (either alone or in mixture).
  • The zonal Rapporteur Member State (zRMS) for the product renewal assessment must be agreed in advance.  The application must be made to all MSs in which the product is being supported (the zRMS and the ‘concerned Member States’ (cMS)).
  • Products not supported at the 3 month deadline will expire 1 year after the expiry of the previous approval of the active substance.  A subsequent 18 month grace period, comprising of 6 months sale period plus 12 months storage and use, will normally apply.

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, enquiries@jsci.co.uk

Published 28th January 2016
Categories Agrochemicals, News
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