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:
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.
This is the CRD standard grace period, and will be applied in most cases.
This grace period allows:
This CRD standard grace period may apply when:
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 The existing authorisation will be withdrawn and a new authorisation will be issued.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.
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:
This grace period may apply when:
This will be applied when:
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.
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.
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.
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.
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.
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).
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.