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PSD Application Form - DOC

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PSD Application Form

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									Chemicals Regulation Directorate          Telephone: 01904 640500 (International: (+44) 1904 640500)
Mallard House, Kings Pool,                Fax: 01904 455763; (International: (+44) 1904 455763
3 Peasholme Green,                        Email: applicant-enquiries@hse.gsi.gov.uk
York, YO1 7PX,                            Website: www.pesticides.gov.uk
UK

                       Application Form CRD2
     Administrative application for approval of a plant protection
                               product
    Control of Pesticides Regulations 1986 (as amended) or Plant Protection
                    Products Regulations 2005 (as amended)

                                    When to use this form
Applications for approval of a plant protection product via the Administrative Stream where
no technical assessment is required.

                                  When not to use this form
Applications for approval of a plant protection product as follows:
 Commercial or Experimental Approval via No-Data, Data, Data-Plus or Major Change
   Streams (use Form CRD1).
 Specific Off-Label/ Extension Of Use (use Form CRD3).
 Parallel Import (use Form IDI1).
 Administrative Experimental Approval, (use form AEA).
Applications for Official Listing of an Adjuvant (use form CRD4).
Applications for biocidal product approval (see http://www.hse.gov.uk/biocides/index.htm)

                                  How to complete this form
   Complete all parts of A to E as appropriate.
   No sections of the form are protected. Take care not to delete or amend existing text.
   To check ‘tick boxes’, double click on the box, select ‘checked’ and press ‘ok’.
   ‘Copy and paste’ to add additional rows/tables in Part D.
   For questions about this form, contact applicant-enquiries@hse.gsi.gov.uk.

                                   Where to send this form
Save a copy of your completed form and submit it to CRD with all other relevant supporting
information/data at:
 applications@hse.gsi.gov.uk; or
 Applications Sift, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3
    Peasholme Green, York YO1 7PX)




Form CRD2 ver. 1.2 (16/11/2009)               1
                                              1
            Chemicals Regulation Directorate
            Application for approval of a plant protection product- Administrative Stream


Part A – Applicant details
1    Applicant            Contact name                                                Title
                         Company name
                                 Address
                              Telephone
                                   E mail
2    Address for          Contact name                                                Title
     invoicing (if       Company name
     different)                  Address
                              Telephone
                                   e mail
3      Purchase order number (if needed)

4    Tick the box that describes your application
4a   Application for 1 product                                Complete Parts A to E
4b   Application for 5 or more products that can be           Complete Parts A, E and Appendix 1
     processed as a ‘blanket amendment’

Part B – Product identity
5    Proposed details that will appear on new approval –must always be completed
5a                         Product name
5b              MAPP number (if known)
5c   Approval            Company name
     holder                       Address
                             Co. Reg. No.
5d   Marketing           Company name
     company (if                  Address
     different)              Co. Reg. No.

6    Current approval(s) NANUM(s)
7    Active substance(s) and content (list
     all)



8    Legislation                              COPR       PPPR




Form CRD2 ver. 1.2 (16/11/2009)                     2
                                                    2
            Chemicals Regulation Directorate
            Application for approval of a plant protection product- Administrative Stream


9    Current identity if different to 5 above- to be completed only if changes are required to the existing
     approval
9a                           Product name
9b                           MAPP number
9c   Approval               Company name
     holder                         Address
                               Co. Reg. No.
9d   Marketing              Company name
     company (if                    Address
     different)                Co. Reg. No.

Part C – Type of application
Tick either 10 or 11 below as appropriate to your application

10   Approval of a new product                                                           Specify below


     10a Identical to existing approved product (specify below); or
     10b Identical to ongoing application for another product (specify below)
     Product name                         MAPP no.                   NANUM or ongoing COP no

     Give details of any other changes to be made to the conditions of the above approval (include
     details of ‘current’ and ‘proposed’ conditions


11   Change to an existing product approval (as specified in 6 above)                    Specify below


     11a    Change in product tradename (details as in 5 and 9 above)
     11b    Change in Approval Holder (details as in 5 and 9 above)
     11c    Change in Marketing Company (details as in 5 and 9 above)


     11d    Extension to data submission deadline/expiry date
            (specify below including need and justification)


     11e    Commercial withdrawal of use(s) (specify below)




Form CRD2 ver. 1.2 (16/11/2009)                     3
                                                    2
             Chemicals Regulation Directorate
             Application for approval of a plant protection product- Administrative Stream


      11f  Change(s) to this product approval based on the approval of another product (specify
           below); or
           Change(s) to this product approval based on an ongoing application for another
           product (specify below)
      Product name                         MAPP no.                   NANUM or ongoing COP no

      Give details of and justify the changes to be made to this product approval based on the other
      product (include details of ‘current’ and ‘proposed’ conditions


      11g   Other change not covered by above.
            Give details of and justify the changes to be made to this product below (include
            details of ‘current’ and ‘proposed’ conditions)



Part D –Data ownership
No data may be submitted with an Administrative application. However, you must show access
to all previous data supporting the product approval

12     Active substance/Annex II data (if more than one a.s. copy and paste table below)
Active substance(s) names(s)
Are all data on the active substance owned by the           Yes
approval holder?                                            No      Specify all ownership below
                        Data owner(s)                                        Letters of Access
                                                            Enclosed Refer to       Sent        Not needed-
                                                                       previous     separately unprotected
                                                                       letter                   data
Specification and 5
batch analysis data
Other a.s. data



‘Copy and paste’ additional tables above if more than one a.s./data owner




Form CRD2 ver. 1.2 (16/11/2009)                         4
                                                        2
             Chemicals Regulation Directorate
             Application for approval of a plant protection product- Administrative Stream


13       Formulation/Annex III (add additional rows if necessary)
Are all data owned by the approval holder?                    Yes
                                                              No      Specify all ownership below
Data owner(s)               Specific type of data (e.g.                        Letters of Access
                            residues, efficacy) or ‘all       Enclosed Refer to       Sent        Not needed-
                            data’                                        previous     separately unprotected
                                                                         letter                   data




‘Copy and paste’ additional rows above if necessary


Part E Signed declaration
If you are submitting the form electronically, you must provide verification of applicant details
and submitted information (see
http://www.pesticides.gov.uk/applicant_advice_home.asp?id=1721). If you are submitting this
form in hard-copy, you must complete the following declaration:
I confirm that the information given in this application form is true to the best of my knowledge,
information and belief

Signed                                                                dated




Form CRD2 ver. 1.2 (16/11/2009)                           5
                                                          2
                    Chemicals Regulation Directorate
                    Application for approval of a plant protection product- Administrative Stream


       Appendix 1 Details of ‘blanket amendment’ application

          This Appendix must be completed for applications for a ‘blanket amendment’ approval for the same or similar changes for 5 or more products (usually
           changes to product names/approval holders/marketing companies- acceptability of other changes are at our discretion). The following are suggested
           templates which you can reformat as appropriate to your application (they are all ‘unprotected). Additional advice is at in The Applicant Guide
          Add additional rows as necessary (‘cut and paste’ or press the ‘tab’ key with cursor in the bottom right cell.

       Example 1- applications for change in product names/approval holders/marketing companies- delete/amend columns as appropriate

Current               Proposed         Current            Proposed             Current marketing   Proposed             Active           A.s./Annex II data         Formulation/Annex III
tradename/MAPP        tradename        approval           approval holder/     company/ Co.Reg.    marketing            substance(s) *   owner(s) (access letters   data owner(s) (access
no *                                   holder/ Co.Reg.    Co.Reg. No,          No.*                company/ Co.Reg.                      submitted?) *              letters submitted?) *
                                       No,*                                                        No




       * information in this column is always required.

       Example 2- applications for other changes- delete/amend columns as appropriate

Current product identity                                                                           Data ownership                                        Proposed change
Tradename and MAPP       Active substance(s) *    Approval holder/           Marketing company/    A.s./Annex II data         Formulation/Annex III
no. *                                             Co.Reg. No. *              Co.Reg. No. *         owner(s) (access letters   data owner(s) (access
                                                                                                   submitted?) *              letters submitted?) *




       * information in this column is always required.



       Form CRD2 ver. 1.2 (16/11/2009)                                                  Appendix 1

								
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