What Happens Once My Application Is Completed
What documentation will I receive once the application is completed?
If you have applied for a commercial level of authorisation, trials permit or an Extension of Authorisation for Minor Use (EAMU) and:
If your application is partially or completely successful
We will send you:
- a letter which specifies the type of authorisation given, any changes required to the draft product label (except for an EAMU and trials permit); details of any confirmatory data required; details of any proposed uses and/or proposed label claims that have been refused; comments on the protection status for the data submitted in support of your application (except for an EAMU and trials permit) and any other additional information that you will need to be aware of;
- a Notice of Authorisation detailing the governing legislation, the level and scope of the authorisation, the product identity (including the product's unique Ministerially Authorised Pesticide Product (MAPP) number); a reference to the product's formulation details (except for an EAMU); the authorisation holder and marketing company, relevant dates of expiry; the statutory conditions of use for the product and any additional advisory information. Further information on the format of a Notice of Authorisation can be found in the guidance on the structure of a Notice of Authorisation.
- where relevant, a copy of the Registration Report on completion of the assessment. The Registration Report supplied to the applicant will not contain Part C (confidential information section) because, in some instances, there may be data provided from parties other than the applicant/authorisation holder. The Registration Report will not distinguish between the different data owners and the complete evaluation will be released.
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.
If your application is unsuccessful
We will send you a detailed letter, and if relevant, a copy of the Registration Report explaining the reasons why your application has been refused and specifying the data requirements to be addressed if you wish to make a further attempt to obtain an authorisation.
When will my authorisation expire?
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' dates reflect the maximum duration and grace period specified in Regulation (EC) 1107. With the exception of permits for trial purposes (Article 54), EAMUs (Article 51) and where confirmatory data requirements have been set, the 'authorisation end' dates are as follows:
- [1 year from expiry date of earliest active] except as set out in (b) and (c)
- [Date (a) plus 6 months] for sale and distribution of existing stocks
- [Date (b) plus 12 months] for the disposal, storage and use of existing stocks
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 an authorisation is withdrawn or amended or is not renewed, a grace period may be granted which shall not exceed 6 months for the sale and distribution, with 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 are not renewed on the list of approved active substances, then these expiry dates may be reduced and a shorter phased withdrawal period applied.
Expiry dates for authorisations issued in accordance with the Control of Pesticides Regulations, (full and provisional), interim standard and most blanket amendment notices will generally be set in the following format:
- a final date for the sale and distribution of existing stocks by any persons
- a final date for the disposal, storage and use of existing stocks by any person
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, then expiry dates may be reduced and a shorter phased withdrawal period applied.
When will my Extension of Authorisation for Minor use (EAMU) expire?
All EAMUs are issued with the following phrase:
This Extension of authorisation ends: on the final expiry date of use for the authorised product (unless otherwise stated)
How can I check the actual EAMU expiry date?
The EAMU search results screen gives the expiry date for that notice 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.
What if the EAMU has a shorter expiry date than the authorised product?
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 standard phrase. This may occur for example where the EAMU has been withdrawn.
What happens when a product or EAMU is withdrawn?
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.
What obligations do I have as the authorisation holder once my application is completed?
Changes to the conditions of the authorisation
You may remove uses from your product label without the need to submit an application. If you wish to have these uses removed from your authorisation you will need to submit an application in line with the commercial withdrawal procedure. 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.
Meeting data requirements
Any associated data requirements must be addressed by the data submission deadline or within 12 months of the expiry date 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 or within 12 months of the expiry date, otherwise authorisation for your product, or the affected use, will expire or be withdrawn.
Data requirements can be addressed in a number of ways. Further information on data submission deadlines and data requirements for continuing authorisation can be found in the guidance on data submission deadlines and data requirements for continuing authorisation.
Renewals of active substance approval
When an active substance has its approval renewed under Regulation (EC) 1107, 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. These need to be updated and an assessment carried out to the renewal end points and current guidance.
What are 'adverse data' and what are my obligations?
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.
Further information on adverse data and procedures for submitting these data can be found in the guidance on adverse data.
Why would my authorisation be withdrawn?
Your authorisation can be withdrawn in the following circumstances:
- when active substances are included or renewed on the list of approved active substances (a.s.) but products containing the a.s. are not successfully renewed
- the active substance(s) contained in the product are withdrawn from or not renewed on the list of approved active substances
- there are 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
- false or misleading information was submitted to support an authorisation/permit.
In addition, we will withdraw an authorisation for a product upon issue of a new Notice of Authorisation (for example following a new application). Further information on withdrawal of Notices of Authorisation can be found in the guidance on the withdrawal of authorisations.
Are my data protected?
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 (meaning 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.
What if I want to take my authorised product or use off the market?
Commercial withdrawal of products
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).
Commercial withdrawal of uses
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 requirement, or the period following the renewal 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.