The Applicant Guide: Withdrawal of Authorisations and Permits
When will my authorisation/permit be withdrawn?
A decision may be taken to withdraw an authorisation/permit under the conditions specified in Regulation 1107/2009 as it applies in Great Britain / Northern Ireland . These may include the following:
- The active substance(s) contained in the product are withdrawn or restricted from the list of approved active substances
- Significant safety or efficacy concerns are identified with the product or a specific use
- A product or a specific use is commercially withdrawn
- Products are not adequately supported during the renewal process
- False or misleading information was submitted to support an authorisation/permit
- Changes to MRLs where a use is no longer accommodated
- For housekeeping purposes: if we issue a new authorisation/permit for a product, we will automatically withdraw the previous authorisation(s) to ensure that a product does not have a number of extant authorisations at the same time
When we withdraw an authorisation/permit it will receive either a 'phased' withdrawal with an appropriate grace period or an immediate withdrawal.
The grace period allows a time for existing stocks authorised/permitted under that specific authorisation/permit number to be placed on the market, with a further period for existing stocks of the product to be used safely.
An immediate withdrawal does not allow the authorisation/permit holder to place any stocks of their product authorised/permitted under that specific authorisation/permit onto the market, nor will anybody else be able to market or use existing stocks of that product.
What type of grace period will my commercial authorisation/permit receive?
Grace periods vary depending on the reason for withdrawal and degree of concern. The most common grace periods and the reasons for applying them are set out below.
In some cases, the relevant grace period is reduced to ensure that the authorisation/permit does not continue beyond the date already set, or that allowed based on the approval status of the active substance.
When an active substance approval is withdrawn, the grace period is likely to be determined as part of the withdrawal decision and is likely to be specific to products containing that active substance.
'24+24' phased withdrawal (S2 in the withdrawal table )
This is applied where there are no safety concerns (including no changes in required assessment standards or amendments to the label) and where the expiry date for the active substance approval allows. There are limitations on expiry dates extending beyond the expiry date of the any of the authorisations/permits active substances (article 32 – Duration and article 46 grace period). If the phased withdrawal would extend beyond these limits then the withdrawal period will be shortened accordingly..
This grace period allows:
- 24 months for sale and distribution of existing stocks
- 48 months for disposal, storage and use of existing stocks (ie a further 24 months)
This grace period may apply when:
- Authorisations/permits are withdrawn for house-keeping purposes and changes have been made that affect the authorisation conditions or the label
- Where an authorisation/permit has been replaced by a new one and there are no safety concerns.
'0+6+12' phased withdrawal (P in the withdrawal table )
This grace period will be specified when there is a need for tighter control of withdrawal of the product from the supply chain or where the authorisation/permit holders are aware of the impending deadlines.
This withdrawal allows:
- Immediate withdrawal for sale and distribution for any person holding an authorisation/permit;
- 6 months for sale and distribution of existing stocks by persons other than the authorisation/permit holder
- 18 months for disposal, storage and use of existing stocks by any person (that is a further 12 months)
This grace period may apply when:
- Products or uses are commercially withdrawn and the authorisation/permit holder has confirmed that they have no remaining stocks of the product, but there are stocks of product still in the supply chain
- Products or uses are withdrawn due to safety or efficacy concerns (but also see (a) under '0+0 immediate withdrawal' below).
'0+0' immediate withdrawal (I in the withdrawal table )
This is applied when:
- Products or uses are withdrawn due to a significant safety concern. If necessary, we will initiate enforcement action to recall existing stocks in the supply chain;
- Products or uses are commercially withdrawn and there are no stocks of the product in the supply chain;
- A new authorisation/permit has been issued that does not change any of the conditions in the existing authorisation/permit (for example continuing authorisation).
- A product has additional active source details added (or modified, such as a source removed and replaced by another source) but no other conditions of authorisation change.
Where an immediate withdrawal is implemented, no further stocks of the product in line with the withdrawn authorisation can be placed on the market and existing stocks in the supply chain cannot be used up. Where there are stocks in the supply chain that are subject to a product recall, an authorisation/permit for storage only may be issued to allow for disposal of the product. Individual withdrawal dates may also be set to reflect the severity of the concern.
'6+12' EU standard withdrawal (S1 in the withdrawal table )
In line with Article 46 of Regulation (EC) 1107/2009, the standard withdrawal period of 6 months for sale and distribution and a further 12 months for storage, use and disposal, will be applied where required as a result of a decision.
Status of marketing companies with respect to persons other than the authorisation holder
Notices of Authorisation refer to both the 'Authorisation Holder' and the 'Marketing Company' where the latter is declared by the applicant to be a different company as identified by the company registration number. It is recognised that there is a significant range of commercial relationships between Authorisation Holders and Marketing Companies. It is also recognised that the Marketing Company position in the supply chain will also vary. In some cases, Marketing Companies will sell their product on to distributors and other agents for sale to the end user, and in other cases will sell direct to the end user themselves. It is difficult to cover all eventualities and it must also be recognised that those higher in the supply chain must take some responsibility for ensuring others have adequate time to sell out their stocks.
HSE 's interpretation is that the 'Marketing Company' as named on the Notice of Authorisation is not considered to be a person holding an authorisation (ie the 'Authorisation Holder') and therefore falls into the category 'persons other than the Authorisation holder', and is entitled to the additional sell out period allocated to this group.
When the Authorisation Holder and Marketing Company is the same, the Notice of Authorisation refers to the Authorisation Holder only. In this case the Marketing Company, which is also the Authorisation Holder, can be considered a 'person holding an authorisation' and therefore is not entitled to the additional sell out period which, in this case, is intended for persons further down the supply chain.
Blanket amendments only amend the current authorisation/permit – they do not replace/revoke the previous notices (for example expiry date / additional technical specification)
Can I request a longer grace period?
Where a grace period has been given for safety reasons, it cannot be extended. An extension would also not normally be granted following application of the standard 24 + 24 grace period.
However, if a shorter grace period was originally requested by the authorisation/permit holder when commercially withdrawing a product or use, it may be possible to extend this to the maximum grace period of 24 + 24 months. You can request such an extension by submitting an Admin stream application (see the guidance for requirements for Admin Stream applications).
What type of grace period will my Permit for Trials Purposes or extensions of authorisation for minor use receive?
As Permits for Trial Purposes and Extensions of authorisations do not authorise the placing of products on the market, they do not require a phased withdrawal. Where necessary, permits for trial purposes and Extensions of authorisation are withdrawn immediately or at a specific date as circumstances require.