MIP-0017-E Parallel trade permit

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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)

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