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Procedures to apply for / establish grace periods

Grace periods only apply in case of WG restrictions

  • the entire authorization is withdrawn/expiring.
  • amendments in which the use according to the new WG is in at least one aspect restricted compared to the previous WG, e.g., use/claim withdrawn, more strict mitigation, higher PHI, lower frequency, or dose, etc.
  • amendments in which the new WG contains a combination of restrictions and extensions.
  • Where the new WG only contains extensions and no restrictions relevant for the existing uses as defined by the previous WG, grace periods do not apply.

Restriction in the conditions for use as stated in the WG can be triggered by a Ctgb evaluation, an EU evaluation or by request from the applicant. In all cases grace periods can be applied for.

Changes in classification or other changes in the authorization do not trigger grace periods.

Grace periods may also apply to previous WG versions

  • It is not uncommon that an authorization has more than 1 valid WG version when no grace periods applied to pre-previous WG versions. If then the newest WG is restricted compared to the previous WG, the grace periods set for the previous WG version automatically apply to all still valid pre previous WG versions.
  • When the new WG is restricted because of a significant risk and short grace periods are set, it may happen that this risk is also relevant for a pre previous WG version with a still valid grace period. In those cases, it may be necessary to shorten the grace period for the pre previous WG-version as well.

Which grace period applies to which WG version can be traced back in the individual decisions in appendix I (BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING), and the Ctgb database will also be updated with grace periods specified per WG version (W-code).

WG changes in existing authorizations- W-code

The use of the product is legally defined in the conditions for use – in Dutch ‘Toepassingsvoorwaarden’ and ‘Overige Toepassingsvoorwaarden’ - stated in the Legal Instructions for Use – in Dutch ‘Wettelijk Gebruiksvoorschrift’ (WG). When a plant protection product is authorized for the first time, the WG does not receive a suffix W-code (=W0). However, any following Board decision on that authorization may have consequences for the use of the product as defined in the WG. Each newly authorized version of the WG is marked by a code W(x+1) that is 1 higher than the previous version Wx. With publication of the Ctgb Board decision in the Staatscourant, the new WG becomes the Legal instruction for Use. The previous version of the WG may attract grace periods.

Procedures to apply for / establish grace periods

In administrative applications for (voluntary) restriction of the use or withdrawal of the authorization

Tthe applicant can state the desired grace periods in the application form WI. The argumentation why grace periods are needed can be added in the form or in an appendix for more elaborate reasoning. An application for voluntary withdrawal of the product authorization can be used e.g., in case authorizations expire due to expiration of the active substance approval, restrictions of product use because of a new condition in the active substance approval, or the applicant not supporting the art 43 renewal of a product authorization. Proactive application of the applicant is appreciated to inform users. In such cases, the Board decision on grace periods will not be jeopardized by the lesser degree of surprise.

In case the risk assessment in an ongoing application (e.g., applications for amendment  article 33, article 45 or renewal article 43), results in a restriction compared to the old WG

The applicant will be contacted by our project manager in the finalizing stages of the concept decision. The applicant will be requested to submit argumentation for grace periods tuned to the actual situation, which will be used in determining the grace periods in the decision.
 

In case the applicant does not actively request for grace periods

The grace periods will be set to zero (no grace periods), even if there is no risk involved. It is the responsibility of the applicant to timely request grace periods.

Grace periods may be limited by EU implementation regulations

EU-decisions ending or amending active substance approvals may contain specific clauses for transitional periods and grace periods that are often set shorter than the maximum grace periods in article 46. In such cases, Ctgb will generally follow the EU-considerations for these shorter maximum terms. However, shorter terms may not always leave room to finish the ongoing or upcoming application season or even a logic period for sales and distribution.

Grace periods on derived trade permits and parallel trade permits

The same principles as set out for original authorizations apply to derived trade permits and parallel trade  permits. Derived trade permits and parallel trade permits shall be withdrawn by the Ctgb upon expiration or withdrawal of the mother authorisation. The authorisation holder of the mother authorization is obliged to actively inform the holders of the derived trade permits about the intention to request withdrawal. A grace period is possible in case the holder of the derived or parallel trade permit timely submits a withdrawal on request with a substantiated argumentation for grace periods. Grace periods for derived or parallel trade permits may differ from the grace period for the  mother authorization or reference product as stock and market situations may differ, e.g., the mother authorization is not marketed and needs no grace periods as the product is solely marketed and used through a derived trade permit.

Ctgb policy on grace periods

The Ctgb policy on grace periods is based on articles 20 and 46 of Regulation (EU) 1107/2009 and is laid down in a special board decision: Besluit Beleidsregel Respijttermijnen voor Gewasbeschermingsmiddelen (in Dutch. Published in the Staatscourant of August 31, 2016). As required by Dutch law, the text of the document is in Dutch, but the most important elements are explained below.

  • As a precondition for granting grace periods by the Board, applicants must actively request for grace periods with a sound argumentation for the reason why and the length applied for. See below under procedures.
  • Maximum grace periods are 6 months for distribution and sales and an additional 12 months for use, storage and removal as based on article 46 of PPPR (EU) 1107/2009, in case the restriction of use is not triggered by risk for humans, animals or the environment.
  • As far as the reason for restriction, withdrawal or expiration is related to the risks for human, animals and environment, the Board weighs possible risks against the interests of the producer and user, e.g., the surprise element, agronomical factors, economic factors, etc. Grace periods will be set shorter in case of heavier, acute, and more concrete risks. When unacceptable (acute) risk is foreseen, the Board may decide to no grace periods.
  • Risk permitting, Ctgb will time the end of the grace period to for use with the end of the current or soon-to-start application season.