Application Form CRD2 Administrative application for authorisation of a plant protection product

Chemicals Regulation Directorate
Mallard House, Kings Pool,
3 Peasholme Green,
York, YO1 7PX,
UK
Telephone: 01904 640500 (International: (+44) 1904 640500)
Fax: 01904 455763; (International: (+44) 1904 455763
Email: pesticides&[email protected]
Website: www.hse.gov.uk/CRD
Application Form CRD2
Administrative application for authorisation of a plant protection
product
Regulation (EC) No 1107/2009
When to use this form
Applications for authorisation of a plant protection product via the Administrative Stream
where no technical assessment is required.
When not to use this form
Applications for authorisation of a plant protection product as follows:
 Commercial authorisation or permit for trial purposes via No-Data, Data or DataPlus Streams (use Form CRD1).
 Extension of authorisation for a minor use of a plant protection product (use Form
CRD3).
 Permit for Parallel Trade (use form CRD5 or CRD6 [own-use]).
 Administrative permit for trial purposes, (use form CRD7).
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
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Complete all parts of A to D 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 pesticides&[email protected]..
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:
 [email protected]; or
 Applications Sift, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3
Peasholme Green, York YO1 7PX)
Form CRD2 ver. 2 (September 2011)
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5
Chemicals Regulation Directorate
Application for authorisation of a plant protection product- Administrative Stream
Part A – Applicant details
1
Applicant
Contact name
Company name
Address
Telephone
E mail
Date
Title
3
I confirm that the information given in this application form
is true to the best of my knowledge, information and belief.
(please tick to confirm)
Address for
Contact name
Title
invoicing (if
Company name
different)
Address
Telephone
e mail
Purchase order number (if needed)
4
4a
Tick the box that describes your application
Application for 1 product
4b
Application for 15 or more products that can be
processed as a ‘blanket amendment’ (only applies to
changes which do not require a new MAPP number to
be issued)
2
Complete Parts A to E
Complete Parts A, E and Appendix 1
Part B – Product identity
5
5a
5b
5c
5d
6
7
Proposed details that will appear on new authorisation –must always be completed
Product name
MAPP number (if known)
Authorisation
Company name
holder
Address
Co. Reg. No.
Marketing
Company name
company (if
Address
different)
Co. Reg. No.
Current authorisation(s) NANUM(s)
Active substance(s) and content (list
all)
Form CRD2 ver. 2 (September 2011)
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Chemicals Regulation Directorate
Application for authorisation of a plant protection product- Administrative Stream
8
8a
8b
8c
8d
Current identity if different to 5 above- to be completed only if changes are required to the existing
authorisation
Product name
MAPP number
Authorisation
Company name
holder
Address
Co. Reg. No.
Marketing
Company name
company (if
Address
different)
Co. Reg. No.
Part C – Type of application
Tick either 9 or 10 below as appropriate to your application
9
Specify below
Authorisation of a new product
9a
Identical to existing authorised product (specify below); or
9b
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 authorisation (include
details of ‘current’ and ‘proposed’ conditions
10
Change to an existing product authorisation (as specified in 6 above)
10a
Change in product tradename (details as in 5 and 9 above)
10b
Change in Authorisation Holder (details as in 5 and 9 above)
10c
Change in Marketing Company (details as in 5 and 9 above)
10d
Extension to data submission deadline/expiry date
(specify below including need and justification)
10e
Commercial withdrawal of use(s) (specify below)
Form CRD2 ver. 2 (September 2011)
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Specify below
Chemicals Regulation Directorate
Application for authorisation of a plant protection product- Administrative Stream
10f
Change(s) to this product authorisation based on the authorisation of another
product (specify below); or
Change(s) to this product authorisation 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 authorisation based on the other
product (include details of ‘current’ and ‘proposed’ conditions
10g
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 authorisation
11
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
authorisation holder?
Yes
No
Specify all ownership below
Letters of Access
Enclosed Refer to
Sent
Not neededprevious
separately unprotected
letter
data
Data owner(s)
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. 2 (September 2011)
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Chemicals Regulation Directorate
Application for authorisation of a plant protection product- Administrative Stream
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Formulation/Annex III (add additional rows if necessary)
Are all data owned by the authorisation holder?
Data owner(s)
Yes
No
Specify all ownership below
Letters of Access
Enclosed Refer to
Sent
Not neededprevious
separately unprotected
letter
data
Specific type of data (e.g.
residues, efficacy) or ‘all
data’
‘Copy and paste’ additional rows above if necessary
Using personal data
HSE is under a legal duty to protect any personal information we collect and we will only use that
information in accordance with the law, including the Data Protection Act 1998, the Freedom of
Information Act 2000 and the Environmental Information Regulations 2004. We meet our
obligations as part of UK Government to safeguard data and prevent any unauthorised access to it
through use of technical, personnel and procedural controls. More details on Government
security may be found on the Gov.UK Web site
[https://www.gov.uk/government/collections/government-security]. In order to carry out our
functions and respond to enquiries effectively, we will sometimes need to share information with
other government departments, the emergency services, law enforcement agencies, public
authorities (such as local authorities and the Environment Agency) and organisations acting on
our behalf. However, we will only do this where it is required or permitted by law.
Form CRD2 ver. 2 (September 2011)
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Chemicals Regulation Directorate
Application for authorisation of a plant protection product- Administrative Stream
Appendix 1 Details of ‘blanket amendment’ application
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This Appendix must be completed for applications for a ‘blanket amendment’ authorisation for the same or similar changes for 15 or more products
(usually changes to authorisation holders , pack sizes within an existing range, additional source of active substance, extensions to expiry datesacceptability 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/authorisation holders - delete/amend columns as appropriate
Current
tradename/MAPP
no *
Proposed
tradename
Current
authorisation
holder/ Co.Reg.
No,*
Proposed
authorisation
holder/ Co.Reg.
No,
* information in this column is always required.
Form CRD2 ver. 2 (September 2011)
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Current marketing
company/ Co.Reg.
No.*
Active
substance(s) *
A.s./Annex II data
owner(s) (access letters
submitted?) *
Formulation/Annex III
data owner(s) (access
letters submitted?) *
Chemicals Regulation Directorate
Application for authorisation of a plant protection product- Administrative Stream
Example 2- applications for other changes - delete/amend columns as appropriate
Current product identity
Tradename and MAPP
no. *
Active substance(s) *
Authorisation holder/
Co.Reg. No. *
* information in this column is always required.
Form CRD2 ver. 2 (September 2011)
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Marketing company/
Co.Reg. No. *
Data ownership
A.s./Annex II data
owner(s) (access letters
submitted?) *
Proposed change
Formulation/Annex III
data owner(s) (access
letters submitted?) *