New procedure for extending authorisations of plant protection products during the renewal process
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Regulatory Update: 16/2016
Issued: 23 November 2016
This Regulatory Update outlines the new procedure for extending authorisations of plant protection products (PPP) underdoing renewal under Article 43 of Regulation (EC) No 1107/2009.
Current PPP authorisations include a specific expiry date, which is set at 12 months after the expiry date of the related active substance. This is to allow for completion of the product renewal process under Article 43. Where a renewal decision has not been taken by the expiry date, Article 43.6 allows current authorisations to be extended to allow time for consideration of the renewal application to be concluded.
The timescales involved in considering product renewals is such that HSE is routinely extending product authorisations under Article 43.6. Where the authorisation for a product is extended, HSE also has to extend the authorisations of all associated back-to back and parallel products.
Two common scenarios which will trigger a delay in the renewal process and hence the need to extend authorisations are:
- the citing of ’Cat 4’ studies which need to be generated before the renewal submission can be made, and
- the agreement that the renewal submission for mixed active products should be delayed until the renewal of a second active, where the actives expire within a 12 month period (so requiring only one renewal assessment to be carried out).
Under the current arrangements, HSE estimates when the consideration of the Article 43 renewal application is likely to be completed in order to set an expiry date for the extended authorisation. Under the new procedure, HSE will simply extend the authorisation until a decision is taken following the completion of the Article 43 renewal application (unless an earlier decision is taken for other reasons).
The current dates will be replaced by the following text:
This authorisation remains extant until a regulatory decision is taken under the ongoing application for renewal of this product under Article 43 of Regulation (EC) No 1107/2009 (and upon the condition that a complete dossier is supplied by the submission date agreed by HSE) unless an earlier decision is taken . Upon expiry of this authorisation there will an additional 6 month grace period for the sale and distribution of existing stocks and a further 12 month grace period for the disposal, storage and use of existing stocks. When this decision is taken, a withdrawal notice specifying the grace period will be published.
The text in bold would only be included where a submission deadline had been set for the submission of the complete renewal draft Registration Report (dRR) for the renewal application. If no submission is made by the agreed date, the authorisation will be immediately withdrawn (subject to the Article 46 grace period).
When does this apply?
HSE will apply these new arrangements for extensions of authorisations under Article 43 of 1107/2009 with immediate effect.