MIP-0016-E
Application - Amendment or
withdrawal of an authorisation
(plant protection product)
According to Regulation (EC) No 1107/2009
Application
The numbers in the drop down list refers to the numbers in the price list with application fees for plant protection products.
No.
Information
1
Type of product
Type of amendment (only one amendment per application)
<Choose alternative>
<Choose alternative>
Proposed zonal rapporteur
Member state, zRMS
Product information
If the product contains GMO, please contact the Swedish Chemicals Agency for more information
If the product contains nematodes, insects or arachnids, please use application form MIP-0007-E.
If the application regards extension of product authorisation for minor uses, please use application form MIP-0023-E.
No.
Information
2
Name of the product
Authorisation no.
Low-risk product1
<Choose...>
Signature2
3
Applying company
Date
Signature
Printed name
Payment4:
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-0016-E, 3
/26/2013
Send the documentation3 to:
Swedish Chemicals Agency
Box 2
SE-172 13 Sundbyberg, Sweden
or to: [email protected]
According to article 47 in Regulation (EC) No 1107/2009.
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.
3 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.
4 According to Ordinance (2013:63) on Pesticide Fees.
1
2
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
[email protected]
SE202100388001
MIP-0016-E
Application - Amendment or
withdrawal of an authorisation
(plant protection product)
Swedish Chemicals Agency
According to Regulation (EC) No 1107/2009
Applicant
Current authorisation holder or the permanent representative
No.
Information
4
Name
Company´s registration no. (see no. 5 below)
Address
Telephone no. (incl. country code)
Postal code and town
Contact person
Country
E-mail address
5
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 representative5 (if applicable)
Representing the authorisation holder (i.e. the applicant in no. 4 above) only during the application procedure
No.
Information
6
Company name
Company´s registration no.
Address
Telephone no. (incl. country code)
Postal code and town
Contact person
Country
E-mail address
7
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
8
Application fee will be paid by
Authorisation holder
Temporary representative
Permanent representative
Invoicing address
Contact person (name/e-mail/tel)
Postal code and town
Country
The authorisation holder is fully responsible for the placing of a plant protection product on the MS market. The representative cannot
hold the authorisation.
5
2 (6)
MIP-0016-E
Application - Amendment or
withdrawal of an authorisation
(plant protection product)
Swedish Chemicals Agency
According to Regulation (EC) No 1107/2009
Type of amendment
Amendment of use or conditions for use
An application for amendment may require a new assessment, where the same requirements as for an authorisation, have to be met.
If the application regards extension of product authorisation for minor uses, please use application form MIP-0023-E.
No.
Information
9
Crop(s)
10
Dose/ha
11
Growth stage at application (BBCH)
12
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.(6)
13
Instruction for use
Pest(s)
Dose active substance/ha
Number of applications
Time between applications (days)
Post harvest interval (PHI)
GAP-table is attached
Complete instruction for use, with both present and new use areas (in national language) is attached
Amendment of source and/or manufacturing process for active substance
requiring assessment of equivalence
No.
Information
14
Type of amendment
15
Documentation
New source
Amendment in the manufacturing process
Complete documentation for the assessment of equivalence
Amendment of composition
If formulants are included in the product, the full composition of those formulants has to be stated. If the formulant composition is
unknown, the applicant must contact the manufacturer and ask them to send the full composition directly to KemI. When the
information is submitted it shall be stated which product and application the information relates to. KemI will treat all information
regarding composition as confidential.
An application for amendment may require a new assessment, where the same requirements as for an authorisation, have to be met.
No.
Information
16
Composition
17
If new co-formulants are added, safety data sheets and specification should be submitted
Complete composition statement for the current formulation is attached
Complete composition statement for the new formulation is attached
Safety data sheets for the new co-formulant(s) are attached
Safety data sheet, updated for the product, is attached
(6) 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 (6)
MIP-0016-E
Application - Amendment or
withdrawal of an authorisation
(plant protection product)
Swedish Chemicals Agency
According to Regulation (EC) No 1107/2009
Other amendments
Change of manufacturer and/or site of manufacturing for the active substance (assessment of
equivalence available) or/and the plant protection product.
No.
Information
18
Amendment
19
If amendment of manufacturers/sources/sites of manufacturing, contact information should be submitted
Changed/additional manufacturer of the active substance
Changed/additional source of active substance, equivalence report available on CIRCA
Changed/additional manufacturer of the product
Changed/additional site of manufacturing for the product
Complete addresses to the manufacturers/sources/sites of manufacturing are attached
Amendment of packaging
No.
Information
20
Amendment
21
Attached documentation
New packaging material
New packaging size/type
Packaging specifications for new and current packagings are attached
Two years storage stability study is attached
Accelerated storage stability study is attached
Amendment of authorisation holder/permanent representative
No.
Information
22
The contact information below refers to a new
23
Company name
Company´s registration no.
Address
Telephone no. (incl. country code)
Postal code and town
Contact person
Country
E-mail address
Authorisation holder
Permanent representative
24
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.
25
A representative should prove the appointed level of representation by the applicant, in original.
Company´s/corporation´s certificate is attached
Power of attorney as permanent representative is attached
Amendment of product name
No.
Information
26
New product name
4 (6)
MIP-0016-E
Application - Amendment or
withdrawal of an authorisation
(plant protection product)
Swedish Chemicals Agency
According to Regulation (EC) No 1107/2009
Other amendment
No.
Information
27
Describe the amendment
Withdrawal
No.
Information
28
Withdrawal date
29
Reason to withdrawal
dd <Choose month> yyyy
Reason for the withdrawal is attached
5 (6)
MIP-0016-E
Application - Amendment or
withdrawal of an authorisation
(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
5
Applying company´s/corporation´s certificate
7
Power of attorney – temporary representative
12
GAP-table
13
Complete instruction for use
15
Documentation for equivalence assessment
16
Composition – current formulation
16
Composition – new formulation
17
Safety data sheet(s) – new co-formulants
17
Safety data sheet – updated for the product
19
Address to manufacturer/ source/ site of
manufacturing
21
Packaging specification, new and current
packagings
21
Two years storage stability study
21
Accelerated storage stability study
24
Company´s/corporation´s certificate – new holder
or repr.
25
Power of attorney – permanent representative
29
Reason for the withdrawal
Comments
Attached?
Yes
6 (6)
No
Annex No