The Applicant Guide: Withdrawal of Authorisations and Permits
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
When will my authorisation/permit be withdrawn?
A decision may be taken to withdraw an authorisation/permit under the conditions specified in Regulation (EC) No 1107/2009. These may include the following:
- When active substances are included or renewed on the list of approved active substances(a.s.) included in Regulation (EU) No 540/2011 but products containing the a.s. are not successfully re-registered.
- The active substance(s) contained in the product are withdrawn from/not renewed on the list of approved active substances included in Regulation (EU) No 540/2011;
- Significant safety or efficacy concerns with the product or a specific use;
- A requirement for the submission of data to continue with the authorisation of the product or a specific use is not met;
- Data submitted in support of an application do not support the continuing authorisation of the product or a specific use;
- A product or a specific use is commercially withdrawn;
- For products not authorised/permitted to uniform principles, at the final commission deadline for re-registration of all active substances in the product;
- False or misleading information was submitted to support an authorisation/permit.
In addition, if we issue a new authorisation/permit(s) 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' or 'immediate' withdrawal grace period. A phased withdrawal will usually allow a certain amount of time for existing stocks authorised/permitted under that specific authorisation/permit number to be placed on the market, and a certain amount of time for existing stocks of the product to be used safely.
An immediate withdrawal will 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?
'24+24' phased withdrawal (S2 in the attached table)
This is the CRD standard grace period, and will be applied in most cases.
This grace period allows:
- 24 months for sale and distribution of existing stocks; and
- 48 months for disposal, storage and use of existing stocks (ie a further 24 months).
This CRD standard grace period may apply when:
- Authorisations/permits are withdrawn for house-keeping purposes;
- Where an authorisation/permit has been replaced by a new one and there are no safety concerns, including product re-registration* where no new MAPP number is issued.
In most cases, a new MAPP number will be issued at re-registration. If there are no safety concerns, the old MAPP number will be subject to the standard grace period. However, if this standard grace period would extend the old MAPP number beyond the Step 2 final commission deadline, then the '0+6+12' Step 2 phased withdrawal will be applied as detailed below.
In a few cases, a new MAPP number may not be required at re-registration. The existing authorisation will be withdrawn and a new authorisation will be issued. This new authorisation will retain the same MAPP number, but will reflect any changes required following assessment to Uniform Principles. As this is an amendment to the existing authorisation, the standard grace period will be applied to the earlier version. However, if this standard grace period would extend the old authorisation beyond the Step 2 final commission deadline, then the '0+6+12' Step 2 phased withdrawal will be applied as detailed below.
'0+6+12' phased withdrawal (P in the attached 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 phased withdrawal is implemented to ensure an orderly sell-out and use-up of existing stocks. Individual withdrawal dates may also be set to reflect the severity of the concern.
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 holder; and
- 18 months for disposal, storage and use of existing stocks by any person (ie a further 12 months)
This grace period may apply when:
- Authorisations of products or uses are withdrawn for failing to meet a data submission deadline;
- 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).
- Authorisations/permits are withdrawn for non-compliance at the Step 1 re-registration deadline
- Existing national authorisations/permits are withdrawn at the final Step 2 commission deadline for re-registration;
- Active substances approvals are withdrawn or not renewed
'0+0' immediate withdrawal (I in the attached table)
This will be 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 (eg continuing authorisation).
Where an immediate withdrawal is implemented, No further stocks of the product 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 by anyone 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 attached table)
In line with Article 46 of Regulation (EC No 1107/2009), the EU 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 an EU decision.
Status of marketing companies with respect to persons other than the authorisation holder
Notices of Authorisation issued in the UK 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.
CRD '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.
Action following Blanket Amendment
Where there are no safety concerns, the standard grace period for products is 48 months (24 months for sale and distribution and a further 24 months for disposal, storage and use). Following a blanket application change, we will automatically withdraw the 'old' authorisations/permits using the CRD standard grace period, unless earlier decisions are in force which will take precedence over the CRD standard grace period.
Applying Grace Periods where earlier expiry dates already apply
In some cases the standard grace period may result in a later expiry date than can actually be granted, for example, where an expiry date has been set following an EU decision. In these cases, the grace period will be reduced to ensure that authorisation/permit does not continue beyond the date already set.
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 document 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.