MIP-0017-E
Application - Parallel trade permit
(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.
No. Information
1
2
Name of the parallel trade product (1) in Sweden
Name of the reference product in Sweden Authorisation no. in Sweden
3 Name of the product in the Member State of origin Authorisation no. in MS of origin
4
5:1
5:2
5:3
Type of product
<Choose alternative>
Active substance/organism 1
Active substance/organism 2
Active substance/organism 3
Function
<Choose alternative>
Additional function (if applicable)
<Choose alternative>
CAS no./Strain and culture collection 1
CAS no./ Strain and culture collection 2
CAS no./ Strain and culture collection 3
Signature 2
6 Applying company
Signature
Send the documentation 3 to:
Swedish Chemicals Agency
Box 2
SE-172 13 Sundbyberg, Sweden or to: kemi@kemi.se
Date
Name
Payment 4 :
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.
1 A parallel trade permit is an authorisation for import of a plant protection product that is authorised in another Member State and is identical to a product already authorised in Sweden. Plant protection products are considered as being identical to the reference product when the following applies: a) they have been manufactured by the same company or by an associated undertaking or under license in accordance with the same manufacturing process; b) they are identical in specification and content to the active substance(s), safeners and synergists, and in the type of formulation; and c) they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human health or the environment
2 If the signature is done by someone other than the applying company, a power of attorney confirming the right to sign the application
3 on behalf of the applicant should be submitted.
The first page of this application form and Letter of Access should be submitted as signed originals. All other documents, including
4 the remainder of the application form, can be delivered on CD or in another digital form.
According to Ordinance (2013:63) on Pesticide Fees
Swedish Chemicals Agency
Mailing address
Box 2
SE-172 13 Sundbyberg
Sweden
Visit & delivery
Esplanaden 3A
SE-172 67 Sundbyberg
Sweden
Invoicing address
FE 124
SE-838 80 Hackås
Sweden
Phone & fax
Phone +46 8 519 41 100
Fax +46 8 735 76 98
Internet www.kemi.se kemi@kemi.se
VAT No
SE202100388001
Swedish Chemicals Agency MIP-0017-E
Application - Parallel trade permit
(plant protection product)
According to Regulation (EC) No 1107/2009
Applicant
Intended permit holder, i.e. the party responsible for the parallel trade of the plant production product on the Swedish market
No. Information
7
8
Company name
Address
Organisation no. (for companies registered in Sweden)
Telephone no. (incl. country code)
Postal code and town
Country
Contact person
E-mail address
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 5 (if applicable)
Representing the intended permit holder (i.e. the applicant in no. 7 above) only during the application procedure
No. Information
9
10
Company name
Address
Postal code and town
Country
Company´s registration no.
Telephone no. (incl. country code)
Contact person
E-mail address
A representative should prove the appointed level of representation by the applicant in original.
Power of attorney as temporary representative is attached
Permanent representative (if applicable)
Representing the intended permit holder (i.e. the applicant in no. 7 above) during the duration of the permit (“ombud” in Swedish)
No. Information
11
12
13
Company name
Address
Postal code and town
Company´s registration no. (see no. 12 below)
Telephone no. (incl. country code)
Contact person
Country E-mail address
A company/incorporation certificate should be submitted by all companies that have no previously authorised plant protection product in Sweden. Company/incorporation 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.
Representing company´s/incorporation´s certificate is attached
A representative should prove the appointed level of representation by the applicant in original
Power of attorney as permanent representative is attached
5 The permit holder is fully responsible for the placing of a plant protection product on the MS market. The representative cannot hold the authorisation.
2 (4)
Swedish Chemicals Agency MIP-0017-E
Application - Parallel trade permit
(plant protection product)
According to Regulation (EC) No 1107/2009
Invoicing address for application fee
No. Information
14 Application fee will be paid by
Authorisation holder
Temporary representative
Permanent representative
Invoicing address
Postal code and town
Contact person (name/e-mail/tel)
Country
Authorisation holder in the Member State of origin
No. Information
15 Company name
Address
Postal code and town
Country
Company´s registration no.
Telephone no. (incl. country code)
Contact person
E-mail address
16 Indicate in which Member State of origin
AT Austria
DE Germany
BE Belgium BG Bulgaria
DK Denmark EE Estonia
FI Finland
IT Italy
FR France
LT Lithuania
HU Hungary
CY Cyprus
EL Greece
IE Ireland
LU Luxembourg LV Latvia
NL Netherlands NO Norway
SE Sweden SI Slovenia
PL Poland
SK Slovakia
CZ Czech Republic
ES Spain
IS Iceland
MT Malta
PT Portugal RO Romania
UK United Kingdom
Further documentation required
No. Information
17
18
Label and instruction for use
Label and instruction for use, in the Member State of origin, is attached
Original label and instruction for use, translated to English or Swedish, is attached
Proposed Swedish label and instruction for use, in Swedish, is attached
Product sample
A product sample, i. e. information of package size, material and form, is attached
A photo or an empty sample of the container may also be attached.
3 (4)
Swedish Chemicals Agency MIP-0017-E
Application - Parallel trade permit
(plant protection product)
According to Regulation (EC) No 1107/2009
Annexes
See
No.
Issue Comments
8 Applying company´s/corporation´s certificate
10 Power of attorney – temporary representative
12 Representing company´s/corporation´s certificate
13 Power of attorney – permanent representative
17 Label and instruction for use – MS of origin
17 Original label and instruction for use – translated
17 Proposed label and instruction for use – SE
18 Product sample
Attached?
Yes No
Annex no.
4 (4)