MIP-0031-E

Application for authorisation of a new plant protection product

According to article 33 in Regulation (EC) No 1107/2009

Application for authorisation of a new plant protection product

The first page of this application form shall be submitted as a signed original. All other documents, including the remainder of this application form may be submitted in digital form, preferably through any cloud service.

Signature

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, shall be submitted.

Product name	Product code
Applying company	Date
Signature
Name

Postal address

Swedish Chemicals Agency
Box 2
SE-172 13 Sundbyberg
Sweden
Delivery address

Swedish Chemicals Agency
Löfströms Allé 5
SE-172 66 Sundbyberg
Sweden

Submission of documentation

Please use a safe file share service to submit the remainder of the documentation. If you wish to use our file share service, please contact kemi@kemi.se. You may also submit the documentation on, for example, CD. In that case, please use the above address.

Application overview

Product name	Product code
Type of product (more than one option may be applicable) Chemical Microorganism Low-risk product	Type of application Interzonal Northern zone	Proposed zRMS
The application is based on a product currently authorised in Sweden, a so-called clone authorisation Please state Swedish reference product registration no:
Active substance approved as Candidate for substitution Low risk substance
Total cultivated area available for the product in Sweden < 3000 ha? If yes, a justification of the statement shall be submitted Yes No

Applicant

Future authorisation holder, i.e. the party responsible for placing the plant protection product on the market

Name	Company´s registration no.
Address	Telephone no. (incl. country code)
Postal code and town	Contact person
Country	E-mail address
A company/corporation certificate shall be submitted by applicants that have not previously submitted an application to the Swedish Chemicals Agency. A company/corporation certificate is also required, if there has been changes since the previous certificate was submitted. Company´s/corporation´s certificate is attached

Temporary representative (if applicable)

Representing the authorisation holder (i.e. the applicant above) only during the application procedure. The authorisation holder is fully responsible for placing the plant protection product on the market.

Company name	Company´s registration no.
Address	Telephone no. (incl. country code)
Postal code and town	Contact person
Country	E-mail address
A representative shall prove the appointed level of representation by the applicant. Power of attorney as temporary representative is attached

Permanent representative (if applicable)

Representing the authorisation holder (i.e. the applicant above) during the authorisation period (“ombud” in Swedish).

Company name	Company´s registration no.
Address	Telephone no. (incl. country code)
Postal code and town	Contact person
Country	E-mail address
A company/corporation certificate shall be submitted by applicants that have not previously submitted an application to the Swedish Chemicals Agency. A company/corporation certificate is also required, if there has been changes since the previous certificate was submitted. Representing company’s/corporation’s certificate is attached
A representative shall prove the appointed level of representation by the applicant in original. Power of attorney as permanent representative is attached

Invoicing information for application fee

On our website, there is a tool and a list that can give you an estimate of the application fee.

Company name	VAT no.
Invoicing address	Contact person (name/e-mail/tel)
Postal code and town	Country
Peppol-invoice	Peppol-invoice no.
Invoice reference (purchase order no./your reference)

Product information

Function	Additional function (if applicable)
Active substance/organism 1	CAS no./Strain and culture collection 1	Concentration (in g/kg, g/L or %)
Active substance/organism 2	CAS no./Strain and culture collection 2	Concentration (in g/kg, g/L or %)
Active substance/organism 3	CAS no./Strain and culture collection 3	Concentration (in g/kg, g/L or %)

Concerned Member States

Is the application submitted to other Member States in the Northern zone? Yes No If yes indicate to which Member State(s): DK – Denmark EE – Estonia FI – Finland IS – Iceland LT – Lithuania LV – Latvia NO – Norway SE – Sweden
Is the product intended for use in green house, pre- or post harvest, in storage rooms or as seed treatment? Yes No If yes indicate to which Member State(s): 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 HR Croatia 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

Intended uses, label, and user category

Intended uses – GAP Complete zonal GAP, including indication of relevant Member States, is attached Zonal core GAP (risk envelope GAP) is attached (if relevant)
Label Proposed national label(s) is/are attached Draft master label is attached
User category Professional Non-professional

Active substance no. 1: <Name of the active substance>

If the product contains more than one active substance, please duplicate this section for each substance.

Sources of active substance

Have all sources been evaluated? Yes No If yes all relevant equivalence reports shall be submitted If no all relevant documentation shall be submitted

Active substance data

Do you refer to a data matching dossier? Yes No If yes Report on data match shall be submitted

Active substance data

Is data submitted in support of the application protected in Sweden and not owned by you? Yes No If yes A letter of Access shall be submitted

New studies

Are studies on vertebrates included? Yes No If yes justifications of new vertebrate studies and/or information of efforts reaching an agreement shall be submitted

Product documentation

Data access

Is data submitted in supported of the application protected in Sweden and not owned by you? Yes No If yes A Letter of Access shall be submitted

Vertebrate studies

Are new studies on vertebrates included? Yes No If yes justifications of new vertebrate studies and/or information of efforts reaching an agreement shall be submitted

Request that certain information should be treated confidential

You may request that certain parts of the information submitted with the application should be treated as confidential. The form to be used is available in the Guidance document on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009, SANCO/13169/2010 Rev. 11.

A form requesting that certain parts of the information submitted with the application should be treated as confidential is submitted. Yes No

According to Ordinance (2013:63) on Pesticide Fees