Article 43 of Regulation 1107/2009 - Procedures for the renewal of product authorisations
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
Regulatory Update: 02/2016
Issued: 26th January 2016
To provide guidance on the UK requirements for Article 43 product renewal applications and associated charging.
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. If you wish to make a change to the formulation or authorised uses then this must be submitted under a separate Article 33 application. If a change in GAP is unavoidable (eg 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.
Links to relevant guidance are provided below.
If you have any queries concerning the contents of this Regulatory Update, please contact HSE: Link to Contact Details Page.