MIP-0023-E Application form

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MIP-0023-E
Application - Extension of
authorisation for minor uses
(plant protection product)
According to Regulation (EC) No 1107/2009
Product information
The numbers in the drop down list refers to the numbers in the price list with application fees for plant protection products.
If the product contains GMO, please contact the Swedish Chemicals Agency for more information
If the product contains nematodes, insects or arachnids, please use the application form MIP-0007-E.
No.
Information
1
Name of the product
2
Type of product
Function
Additional function (if applicable)
<Choose alternative>
<Choose alternative>
<Choose alternative>
3:1
Active substance/organism 1
CAS no./Strain and culture collection 1
3:2
Active substance/organism 2
CAS no./Strain and culture collection 2
3:3
Active substance/organism 3
CAS no./Strain and culture collection 3
Authorisation no.
Signature1
4
Applying company
Date
Signature
Printed name
Payment3:
The Swedish Chemicals Agency makes a decision on the
application fee and sends the decision together with an invoice.
The invoice states the amount to be paid and how to pay it.
A list of application fees is available at KemI’s website. There is
also a tool that helps you estimate the fee.
Mall-id: MIP-0023-E, 3
/26/2013
Send the documentation2 to:
Swedish Chemicals Agency
Box 2
SE-172 13 Sundbyberg, Sweden
or to: kemi@kemi.se
If the signature is done by someone other than the applying company, a power of attorney confirming the right to sign the application
on behalf of the applicant should be submitted.
2 The first page of this application form and Letter of Access should be submitted as signed originals. All other documents, including
the remainder of the application form, can be delivered on CD or in another digital form.
3 According to Ordinance (2013:63) on Pesticide Fees
1
Swedish Chemicals Agency
Mailing address
Visit & delivery
Invoicing address
Phone & fax
Internet
VAT No
Box 2
SE-172 13 Sundbyberg
Sweden
Esplanaden 3A
SE-172 67 Sundbyberg
Sweden
FE 124
SE-838 80 Hackås
Sweden
Phone +46 8 519 41 100
Fax +46 8 735 76 98
www.kemi.se
kemi@kemi.se
SE202100388001
MIP-0023-E
Application - Extension of
authorisation for minor uses
(plant protection product)
Swedish Chemicals Agency
According to Regulation (EC) No 1107/2009
Applicant
Application for extension for minor uses may be submitted by official or scientific bodies involved in agricultural activities,
professional agricultural organisations and professional users. The application may also be submitted by the authorisation holder or
their permanent representative.
No.
Information
5
Name
Company´s registration no. (see no. 6 below)
Address
Telephone no. (incl. country code)
Postal code and town
Contact person
Country
E-mail address
6
A company/corporation certificate should be submitted by all companies that have no previously authorised plant protection
product in Sweden. Company/corporation certificates can also be required if there have been changes since the last product
authorisation or if more than 6 months has elapsed since the last application was filed.
Applying company´s/corporation´s certificate is attached
Temporary representative (if applicable)
Representing the authorisation holder (i.e. the applicant in no. 5 above) only during the application procedure
No.
Information
7
Company name
Company´s registration no.
Address
Telephone no. (incl. country code)
Postal code and town
Contact person
Country
E-mail address
8
A representative should prove the appointed level of representation by the applicant in original.
Power of attorney as temporary representative is attached
Invoicing address for application fee
No.
Information
9
Application fee will be paid by
Authorisation holder
Temporary representative
Permanent representative
Official or scientific bodies involved in agricultural activities/ professional agricultural
organisations/ professional users
Invoicing address
Contact person (name/e-mail/tel)
Postal code and town
Country
2 (4)
MIP-0023-E
Application - Extension of
authorisation for minor uses
(plant protection product)
Swedish Chemicals Agency
According to Regulation (EC) No 1107/2009
Description of application
An application for label extension may require a new assessment where some or all of the data requirements for an application for
authorisation/re-authorisation of a plant protection product have to be met.
No.
Information
10
Extended crop(s)
11
Dose/ha
12
Growth stage at application (BBCH)
13
When submitting data required according to sections 3.1 – 3.8, Regulation (EU) No 545/2011, please use a GAP-table in
accordance with the guidance on draft Registration Reports.(4)
14
Instruction for use
Extended pest(s)
Dose active substance/ha
Number of applications
Time between applications (days)
Post harvest interval (PHI)
Estimated cultivated area of the
crop
GAP-table is attached
Complete instruction for use, with both present and extended use areas (in national language)
is attached (if the applicant is the same as the holder)
Instruction for use with only the extended use areas (in national language)
is attached (if the applicant is another party than the holder)
(4) Guidance document on the presentation and evaluation of dossiers according to annex III of Directive 91/414/EEC in the format
of a (draft) Registration Report - Annexes (doc. SANCO/6895/2009)
3 (4)
MIP-0023-E
Application - Extension of
authorisation for minor uses
(plant protection product)
Swedish Chemicals Agency
According to Regulation (EC) No 1107/2009
Annexes
Please observe that all of the studies referred to in this application must be made available to the Swedish Chemicals Agency in full
text, including those where access is provided through a Letter of Access. A Letter of Access should in relevant cases be attached to
this application.
Data requirements according Regulation (EU) No 545/2011 must be met either by new documentation or by a justification showing
that the original assessment covers the intended amendment.
See
No.
Issue
6
Applying company´s/corporation´s certificate
8
Power of attorney – temporary representative
13
GAP-table
14
Complete instruction for use
14
Instruction for use, extended use areas
Comments
Attached?
Yes
4 (4)
No
Annex No
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