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You are in: Applicant Advice » Pesticide Approvals » Pesticides Registration » Applicant Guide » The Applicant Guide: Revocations Of Approvals

The Applicant Guide: Revocations Of Approvals

When will my approval be revoked?

An approval can be revoked under the following circumstances:

  1. If there are significant safety or efficacy concerns with an approved product or a specific use; or,
  2. If a requirement for the submission of data to continue with the approval of the product or a specific use is not met; or,
  3. If the data submitted in support of an application do not support the continuing approval of the product or a specific use; or,
  4. If an approved product or a specific use is commercially withdrawn; or,
  5. At the final commission deadline for all active substances in a COPR approved product; or
  6. If false or misleading information was submitted to support an approval.

In addition, if we issue a new approval(s) for a commercially approved product, we will automatically revoke the current approval(s) for that product to ensure that a product does not have a number of extant approvals at the same time.

When we revoke an approval it will receive either a ‘phased’ or ‘immediate’ revocation period. A phased revocation will usually allow the approval holder a certain amount of time to place stocks of their product, approved under that specific approval, into the supply chain and a certain amount of time for stocks of the product to be safely used up.

An immediate revocation will not allow the approval holder to place any stocks of their product, approved under a specific approval, into the supply chain, nor will anybody else be able to market or use the stocks of that product already in the supply chain.

We sometimes refer to revocation periods as ‘wind down’ periods.

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What type of revocation period will my commercial approval receive?

24+ 24 phased revocation (S3 in the attached table)

This revocation period will be specified when approvals have been revoked purely for 'house keeping' reasons.

This revocation allows:

  • an approval for advertisement, sale or supply by any person for 24 months; and
  • approval for storage and use by any person for 48 months (i.e. a further 24 months).

'12+12' phased revocation (S2 in the attached table)

This revocation period will be specified where an approval has been replaced by a newer approval, such that there are no safety concerns with the previous approval, but the newer updated approval is more appropriate in terms of reflecting the latest regulatory standard.

This revocation allows:

  • an approval for advertisement, sale or supply by any person for 12 months; and
  • an approval for storage and use by any person for 24 months (i.e. a further 12 months).

'0+6+12' phased revocation (P2 in the attached table)

This revocation period will be specified when there is a need for tighter control of the withdrawal from the supply chain, e.g.failure to meet data submission deadlines, a phased revocation will be implemented to ensure an orderly sell-out and use-up of stocks in the supply chain.

This revocation allows:

  • immediate revocation for advertisement, sale or supply for any person holding an approval;
  • approval for 6 months for advertisement, sale or supply by 'others'; and
  • approval for storage and use by any person for 18 months (i.e. a further 12 months)

This revocation period applies when:

  1. Approvals of products or uses are revoked for failing to meet a data submission deadline; or,
  2. Approvals of products or uses are commercially withdrawn and the approval holder has confirmed that they have no remaining stocks of the product, but there are stocks of product still in the supply chain; or,
  3. COPR approvals for non-compliance at the Step 1 deadline; or,
  4. COPR approvals at the final commission deadline; or,
  5. Approvals of products or uses are revoked due to a safety or efficacy concern (but see (a) under '0+0 immediate revocation' below).

'6+12' phased revocation (S1 in the attached table)

This revocation period will generally be applied to COPR approvals in respect of EU non-inclusion decisions, but may be used in other instances where the level of concern justifies a shorter sell out period for the approval holder

This revocation period allows:

  • an approval for advertisement, sale or supply by any person for 6months; and
  • an approval for storage and use by any person for 18 months (i.e. a further 12 months).

'0+0' immediate revocation

This revocation period will be applied when:

  1. Approvals of products or uses are revoked due to a significant safety concern. If necessary we will initiate enforcement action to recall existing stocks in the supply chain; or,
  2. Approvals of products or uses are commercially withdrawn and there are no stocks of the product in the supply chain.
  3. A new approval has been issued that does not change any of the conditions in the existing approval (e.g provisional to full approval)

Where an immediate revocation is given, No further stocks of the product can be placed in the supply chain and stocks already in the supply chain cannot be used up. Where there are stocks in the supply chain that are subject to a product recall, an approval for storage only by anyone will be issued for 3 months to allow for disposal of the product (see I1 in the attached table)

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Action following Blanket Amendment

Where there are no safety concerns, the standard revocation period for products has now been extended to 48 months (24+24). Following a blanket application change, we will now automatically revoke the 'old' approvals using the extended wind-down periods, as this should be sufficient to ensure that all stocks in the supply chain can be used safely.

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Applying Revocation Periods where earlier expiry dates already apply

In some cases the extended revocation periods may result in a later expiry date than can actually be granted, for example, where an expiry date has been set following an EC decision. In these cases, the revocation period will have to be reduced to ensure that approval does not continue beyond the date already set.

  • Where a product’s final expiry date (including a 12 month period of grace for use up) following an EC decision is between 36 and 48 months after the issue of the revocation, we will reduce the wind down period for advertisement, sale and supply by the necessary amount to ensure that the final expiry date remains in line with the applicable EC decision. Approval for storage and use will continue for 24 months after the first expiry date.
  • Where a product’s final expiry date (including a 12 month period of grace for use up) following an EC decision is between 24 and 36 months after the issue of the revocation, the wind down period for advertisement, sale and supply will be 12 months, and the period for storage and use will be reduced accordingly so that the final expiry date is in line with the applicable EC decision. Approval for storage and use will therefore continue for at least 12 months after the first expiry date.
  • Where a product’s final expiry date (including a 12 month period of grace for use up) following an EC decision is less than 24 months after the issue of the revocation, the wind down period for advertisement, sale and supply will be reduced to comply with the EC decision, and approval for a further period of 12 months for storage and use will be granted.

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Can I request a longer revocation period?

If you are submitting an application that is likely to result in a change to your product label and your application has a target date for completion midway through the use season, this may mean that the standard revocation periods may not be sufficient to allow stocks approved under the previous approval to pass through the supply chain. To avoid this, you may make a case for a longer revocation period as part of your application. Alternatively, if your approval has already been revoked, you can seek an extension to the sell-out period by submitting an Admin Stream application (see the guidance document for requirements for Admin Stream applications).

However, we will not be able to allow any longer revocation periods, where we are revoking COPR or PPPR approvals at re-registration (see the guidance document for re-registration applications) or where there are particular concerns.

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What type of revocation period will my Experimental or Specific Off-Label Approval receive?

As Experimental Approvals and Specific Off-Label Approvals are only given for storage, supply and use (Experimental) and use (Specific Off-Label), these approvals are not given a phased revocation. Where necessary, approvals are revoked immediately or at a particular date depending on the appropriate circumstances.

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Can my approval be suspended?

In certain circumstances we will suspend an approval to allow the submission and evaluation of additional data following a review or to impose a penalty on the approval holder for failing to address a specific requirement.

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Further Information

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