MIP-0017-E Application Form

MIP-0017-E Application Form

Swedish Chemicals Agency / 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 / Name of the parallel trade product ([1]) in Sweden
2 / 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 / Type of product
<Choose alternative>Chemical (no. 26)Biological (no. 39) / Function
<Choose alternative>AC - AcaricideAT - AttractantBA - BactericideDE - DesiccantEL - ElicitorFU - FungicideHB - HerbicideIN - InsecticideMO - MolluscicideNE - NematicideOT - Other treatmentPA - Plant activatorPG - Plant growth regulatorPruningRE - RepellantRO - RodenticideST - Soil treatmentVI - Virus inoculation / Additional function (if applicable)
<Choose alternative>AC - AcaricideAT - AttractantBA - BactericideDE - DesiccantEL - ElicitorFU - FungicideHB - HerbicideIN - InsecticideMO - MolluscicideNE - NematicideOT - Other treatmentPA - Plant activatorPG - Plant growth regulatorPruningRE - RepellantRO - RodenticideST - Soil treatmentVI - Virus inoculation
5:1 / Active substance/organism 1 / CAS no./Strain and culture collection 1
5:2 / Active substance/organism 2 / CAS no./ Strain and culture collection 2
5:3 / Active substance/organism 3 / CAS no./ Strain and culture collection 3

Signature[2]

6 / Applying company / Date
Signature / Name
Send the documentation[3] to:
Swedish Chemicals Agency
Box 2
SE-172 13 Sundbyberg, Sweden
or to: / 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.

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 / Company name / Organisation no. (for companies registered in Sweden)
Address / Telephone no. (incl. country code)
Postal code and town / Contact person
Country / E-mail address
8 / 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 / Company name / Company´s registration no.
Address / Telephone no. (incl. country code)
Postal code and town / Contact person
Country / E-mail address
10 / 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 / Company name / Company´s registration no. (see no. 12 below)
Address / Telephone no. (incl. country code)
Postal code and town / Contact person
Country / E-mail address
12 / 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
13 / A representative should prove the appointed level of representation by the applicant in original
Power of attorney as permanent representative is attached

Invoicing address for application fee

No. / Information
14 / 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

Authorisation holder in the Member State of origin

No. / Information
15 / Company name / Company´s registration no.
Address / Telephone no. (incl. country code)
Postal code and town / Contact person
Country / E-mail address
16 / Indicate in which Member State of origin
AT Austria BE Belgium BG Bulgaria CY Cyprus CZ Czech Republic
DE Germany DK Denmark EE Estonia EL Greece ES Spain
FI Finland FR France HU Hungary IE Ireland IS Iceland
IT Italy LT Lithuania LU Luxembourg LV Latvia MT Malta
NL Netherlands NO Norway PL Poland PT Portugal RO Romania
SE Sweden SI Slovenia SK Slovakia UK United Kingdom

Further documentation required

No. / Information
17 / 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
18 / 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.

Annexes

See No. / Issue / Comments / Attached? / Annex no.
Yes / No
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

1 (4)

[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 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

[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.