What documentation will I receive once the application is completed?
If you have applied for a commercial or experimental level of approval or a Specific Off-Label Approval ( SOLA ) and:
If your application is partially or completely successful
You will receive:
- A letter which specifies the type of approval given, any changes required to the draft product label (except for a SOLA); 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 a SOLA) and any other additional information of which you will need to be aware; and,
- A ‘Notice of Approval’ detailing the governing legislation (COPR or PPPR), the level and scope of the approval; the product identity (including the product’s unique MAPP number); a reference to the product’s formulation details (except for a SOLA); the approval holder and marketing company; relevant deadlines for the submission of confirmatory data; 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 Approval can be found in the guidance document on the structure of a Notice of Approval.
- For PPPR approvals where the application was accepted after 22 November 2007, a copy of the Registration Report will be released to the applicant on completion of the assessment. The Registration report supplied to the applicant will not contain Section C (confidential information section) because, in some instances, there may be data provided from parties other than the applicant/approval 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 approvals in this way) or by First Class delivery through the mail.
If your application is unsuccessful
We will send you a detailed letter explaining the reasons why your application has been refused and specifying what data requirements you need to address if you wish to make a further attempt to obtain an approval.
When will my approval expire?
Product expiry dates are set on approvals to allow approval for storage or use to continue beyond the expiry date for the sale of the product. Consequently, two expiry dates will be set on most approvals to reflect the expiry dates for sale and storage or use.
The expiry dates for these products will generally be set in the following format:
- All persons after which they cannot advertise, sell off supply stocks;
- All persons after which they cannot use and store stocks.
This will apply to all approvals issued under COPR (full and provisional), and both provisional and interim standard approvals issued under PPPR. This format will also apply to blanket amendment notices.
Standard approvals will be issued with a single expiry date.
What obligations do I have as the approval holder once my application is completed?
Changes to the conditions of the approval
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 approval (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
The approval given for your product may have associated data requirements which will need to be addressed by the data submission deadline specified on the approval. 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 approval for your product, or the affected use, will be revoked.
Data requirements can be addressed in a number of ways. Further information on data submission deadlines can be found in the guidance document on data submission deadlines.
Reviews of existing pesticides
All pesticides used in products for plant protection purposes that were on the market within Austria, Finland, Iceland, Liechtenstein, Norway or Sweden on or before 1st July 1994, or in other states within the European Economic Area on or before 26 July 1993, are subject to review within the framework of Council Directive 91/414/EEC. Such pesticides are regulated under national rules (e.g. COPR in Great Britain) prior to their inclusion in Annex I of the Directive. Once an active substance is included in Annex I, you will need to take action to maintain your approvals and also to apply for approval of your product, and associated uses, under PPPR. This process is known as re-registration (further information can be found in the guidance document on re-registration).
If a UK review is initiated which affects your product, you will need to comply with any requests for the submission of data by specified deadlines. You may also need to consider any amendments to the conditions of use that are required following the completion of a review.
What are ‘adverse data’ and what are my obligations?
As an approval 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 Approval.
For further information on adverse data and procedures for submitting these data can be found in the guidance document on adverse data.
Why would my approval be revoked?
Your approval can be revoked in the following circumstances:
- If there are significant safety or efficacy concerns relating to the product, or the active substance (following a review), or following the submission of adverse data.
- If the deadline for the submission of a data requirement for confirmatory data and/or information is not met.
- If data and/or information submitted to meet a data requirement do not support continuing approval.
- If a product or use is commercially withdrawn.
- If false or misleading information was supplied concerning the facts on the basis of which the approval was granted.
In addition, we will revoke an approval for a product upon issue of a new Notice of Approval (e.g. following a new application). Further information on revocations of Notices of Approval can be found in the guidance document on the revocation of approvals.
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 approval 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 (i.e. they are ‘outwith’ the data protection system).
Further information on data protection and data protection periods can be found in the guidance document on the protection of data.
What if I want to take my approved 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 approval can be formally revoked, 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 document on commercial withdrawals.
Approval 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 document on commercial withdrawals).
Commercial withdrawal of uses
If you wish to formally remove a use from the label of an approved product and discontinue the approval for that use for a commercial reason, you will need to submit an application for a commercial withdrawal of the use, as a new approval will need to be issued for your product. Details of how to apply for a commercial withdrawal of a use can be found in the guidance document on commercial withdrawals.
You should be aware that the revocation periods given following the commercial withdrawal of a use will differ from the revocation period following the revocation 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.
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