2 July 2003
Changes to Approval Documentation
This letter describes various recent changes to Pesticides Safety Directorate (PSD) approval documentation, and introduces a new way of publishing information regarding superseded approvals.
Following a successful application, approval holders receive a paper or electronic copy of the new approval, revocation notices for any superseded approvals, and a covering letter, which puts the approval(s) in context. Most approvals are now published directly onto PSD’s website. Some approval holders have opted to ‘collect’ the documentation from the website rather than receive a paper copy. If you would like to collect your approvals in this way, please contact Rachel Brown for details.
As part of the evaluation process, PSD may consider a draft label and provide the approval holder with any required amendments. These amendments used to be detailed in the notice of approval but are now listed in Annex A of the covering letter. The notice of approval now refers to the draft label supplied by the applicant, cross-referenced to the necessary changes that are listed in Annex A.
Data requirements (confidential to the applicant) are now listed in Annex B of the covering letter. The data submission deadline(s) for Control of Pesticides Regulations (COPR) provisional approvals are listed on the notice of approval cross-referenced to the data requirements given at Annex B. For a Plant Protection Products Regulations (PPPR) approval, Annex B specifies details of data required to complete the dossier and/or gain standard approval. If approval for a particular use has been refused, details of data requirements for approval for that use are given in Annex C of the covering letter.
When a new approval is issued for an existing product, any previous approvals are superseded. Currently PSD provides the applicant with a paper or electronic copy of the revocation notice for the superseded approval(s), at the same time as the new approval is issued. Where a new Ministerially Approved Pesticide Product (MAPP) number is issued for the product, a revocation notice is issued for the old Ministry of Agriculture, Fisheries and Food (MAFF)/ MAPP number. In some instances, only elements of the old approval are revoked (e.g. a particular use or type of packaging).
These revocation notices are issued as a ‘housekeeping’ exercise, to ensure that superseded approvals are formally revoked within an appropriate time-scale. The revocation notices clarify both the type (phased or immediate) and time-scale of the revocation. As noted in PSD’s All Approval Holder Letter 31/2002, from 1 April 2003, revocation periods have been standardised to either:
- Immediate revocation, where approval holders, their agents and users lose the benefit of the approval with immediate effect. This is uncommon, and would usually only follow review action or a commercial withdrawal where it is known all stocks in the supply chain have been used.
- Phased revocation, where approval holders and their agents lose the benefit of the approval with immediate effect, but others may have a period up to 12 months to allow use of existing stocks in the supply chain. This type of revocation is applied e.g. to a failed data submission deadline.
- Phased revocation where approval holders and their agents have a six month sell out period, but others may have an additional period up to 12 months (18 months in total) to allow use of existing stocks in the supply chain.
Paper copies of revocation notices are also issued individually to approval holders when approval is lost for failure to meet a data submission deadline, or when the approval holder wishes to commercially withdraw the product.
Change to current procedures
In most instances PSD will no longer issue a separate paper/electronic copy of the revocation notices to the applicant/approval holder. Revocations will instead be published on PSD’s website shortly after the new approval has been issued. For each product affected, details will be given stating:
- the Notice of approval number(s) which have been superseded, and which are to be revoked.
- the reasons for revocation (e.g. replacement by a new MAPP number, loss of a particular use following an evaluation).
- whether the revocation is phased or immediate and the time-scale of that revocation.
A unique identifier (revocation notice number) will be given to each revocation.
Approval holders should note that where a product/use approval is revoked for safety reasons (e.g. following a review or following the setting of new Maximum Residue Levels (MRLs)), the approval holder will be provided with a paper or electronic copy of the revocation notice, which will also be published in the Pesticides Monitor, and on PSD’s website. You should also note that for the time being, revocations reflecting commercial withdrawals and failed data submission deadlines will continue to be issued in the usual way, and published in the Pesticides Monitor.
These new procedures will take effect from 1 July 2003, the first website lists of revocations appearing shortly after the month end.
If you have any queries concerning the contents of this letter, please do not hesitate to contact Tracy Roberts by telephoning 01904 455818, by fax on 01904 455722 firstname.lastname@example.org, or in writing. You may also contact Rachel Brown (tel. 01904 455719, e-mail email@example.com).