If you have applied for a commercial or experimental level of authorisation or an Extension of Authorisation for Minor Use (EAMU) and:
We will send you:
This information may be provided electronically via our website and the e-approvals system (where you have chosen to receive your authorisation in this way) or by First Class delivery through the mail.
We will send you a detailed letter explaining the reasons why your application has been refused and specifying what data requirements must address if you wish to make a further attempt to obtain an authorisation.
Product expiry dates are set on authorisations to allow authorisation for storage or use to continue beyond the expiry date for the sale of the product. Consequently, different expiry dates will be set on most authorisations to reflect the expiry dates for sale and storage or use.
Standard authorisations will be issued with three expiry dates. The ‘authorisation end’/’permit end’ dates reflect the maximum duration and grace period specified in Regulation (EC) No 1107/2009. With the exception of provisional authorisations which cannot exceed 3 years (Article 30), permits for trial purposes (Article 54) and where changes/amendments have been made to existing authorisations ahead of the full Annex III assessment, the ‘authorisation end’/’permit end’ dates are as follows:
The (a) date comes from Article 32 (Duration) which states that the duration of an authorisation shall be set for a period not exceeding 1 year from the date of the expiry of the approval of the active substance. The (b) and (c) dates then come from the Grace Period (Article 46) which states that where a Member State withdraws or amends an authorisation or does not renew it, it may grant a grace period which shall not exceed 6 months for the sale and distribution and an additional maximum of 1 year for the disposal, storage and use of existing stocks.
However, if the active substance(s) contained in the product are withdrawn from or not renewed on the list of approved active substances included in Regulation (EU) No 540/2011, then these expiry dates may be reduced and a shorter phased withdrawal period applied.
Expiry dates for authorisations issued in accordance with previous national rules, (full and provisional), provisional and interim standard authorisations issued under PPPR and most blanket amendment notices will generally be set in the following format:
However, these dates may also change. For example, when a decision is taken as to whether the active substance(s) contained in the product can be included on the list of approved active substances included in Regulation (EU) No 540/2011 then expiry dates for products authorised in accordance with previous national rules may be reduced and a shorter phased withdrawal period applied.
In the past EAMU documentation included a specific expiry date. However, this meant that if products had their final expiry dates extended, each extension also had to be individually re-issued to reflect the new expiry date. To streamline this process and remove the need to re-issue many notices unnecessarily, all EAMUs are now issued with the following phrase:
|This Extension of authorisation ends:|| |
on the final expiry date of use for the authorised product
The EAMU search results screen remains unchanged, so that the expiry date for that notice can easily be found in the results table.
The final use date for the authorised product can also be found on the product Authorisation documents available on the product searches on our web site.
Where the EAMU has a shorter deadline than the final use date for the authorised product, this date will be specified in place of the new phrase. This may occur for example where the EAMU had a specific data requirement, or where the EAMU has not been supported through re-registration.
Whenever an amendment is made to an EAMU which shortens the expiry date, a new notice will be issued which contains the revised expiry date. This may arise, for example, because of a change in condition of use or because a product or EAMU is withdrawn. The reason for the re-issue of the Extension will be found in the Explanatory Notes section of the EAMU. The new date will also appear in the search results screen.
You may remove uses from your product label via the commercial withdrawal procedure without the need to submit an application. Otherwise you can only market your product in line with the conditions specified on the authorisation (including any label amendments). These cannot be changed unless you submit a new application. Further information on how to change these conditions can be found in the checklists for the requirements for different types of applications.
Any associated data requirements must be addressed by the data submission deadline specified on the authorisation. These data requirements may relate to either your product as a whole or to a use specified on the label. Suitable data and/or information must be submitted to address these requirements by the data submission deadline otherwise authorisation for your product, or the affected use, will be withdrawn.
When an active substance has its approval renewed under Regulation (EC) 1107/2009, you will need to take action to renew your authorisations in accordance with Article 43 of the Regulation Data packages (or dossiers) previously submitted in support of these products need to be updated and an assessment carried out to the EC harmonised standards.
As an authorisation holder you have an on-going obligation to submit immediately any new data and/or information on the potentially dangerous effects of an active substance and/or product. These data are known as ‘adverse’ and your obligations are specified on your Notice of Authorisation.
For further information on adverse data and procedures for submitting these data can be found in the guidance on adverse data.
Your authorisation can be withdrawn in the following circumstances:
In addition, we will withdraw an authorisation for a product upon issue of a new Notice of Authorisation (eg following a new application). Further information on withdrawal of Notices of Authorisation can be found in the guidance on the withdrawal of authorisations.
Where appropriate all the data submitted in support of your application and used to make a regulatory decision will be protected in line with the provisions in the legislation under which your application was processed. The data will be protected for a period of time based on the date of issue of the original authorisation for your product and whether you change your product’s formulation and/or use.
A third party can request that we access such data in support of their application if they refer to these data and the protection date (the ‘data protection period’) for these data has passed. Any data that you submit and are not used to support a regulatory decision will not be protected (ie they are ‘outwith’ the data protection system).
Further information on data protection and data protection periods can be found in the guidance on the protection of data.
If you wish to withdraw your product from the market for a commercial reason (a ‘commercial withdrawal’) we would prefer that you contact us so that your authorisation can be formally withdrawn, although you are not under any obligation to do so. Details of how to apply for a commercial withdrawal of a product can be found in the guidance on commercial withdrawals.
Authorisation holders are not required to submit an application for a commercial withdrawal although they should consider their position with regard to liability if they do not do so (see the guidance on commercial withdrawals).
If you wish to formally remove a use from the label of an authorised product and discontinue the authorisation for that use for a commercial reason, you must submit an application for a commercial withdrawal of the use, as a new authorisation will have to be issued for your product. Details of how to apply for a commercial withdrawal of a use can be found in the guidance on commercial withdrawals.
The grace periods given following the commercial withdrawal of a use may differ from the grace period following the withdrawal of a use that could occur because of a failure to meet a data submission deadline, or the period following the review of an active substance. A grace period up to the maximum authorisation period allowed for the product or use may be granted as explained in the section on authorisation expiry dates above.