Guide for application – plant protection products

If you want to import, sell or in some other way supply a plant protection product that is either a chemical product or consists of microorganisms, you need to apply for an authorisation from the Swedish Chemicals Agency. For such products you must apply in accordance with the EU Plant Protection Products Regulation. This guide provides guidance on different types of applications.

If you want to place a plant protection product on the Swedish market, the product must be authorised by the Swedish Chemicals Agency.

To obtain an authorisation for a plant protection product, you can apply for

  • a new product authorisation through zone work sharing
    or
  • a new product authorisation through mutual recognition.

Use the form MIP-0012-E to apply for a new product authorisation through zone work sharing or through mutual recognition (DOC 376 kB)

You can find a template and instructions here on how to do your application.external link

You can find further information here on how to apply for a new product authorisation.

If you are the holder or represent a holder of a product authorisation you may need to apply for a renewal of a product authorisation.

Product authorisation for a plant protection product is limited in time and the authorisation of the product is depending on the approval of the active substance in the EU. You must therefore apply for the renewal of your product authorisation before it expires so you can continue to have your product on the Swedish market. The application must be made within three months after the renewed approval of the active substance, but already before your application it is important to make a pre-notification and to have a dialogue with the evaluating member state.

Use the form MIP-0012-E to apply for renewal of a product authorisation (DOC 376 kB)

Here you can read more about the pre-notification and the application for a renewal of a product authorisation according to the guidelines provided.

If you are the holder or represent a holder of a product authorisation and need to amend the product authorisation of your plant protection product, you must apply for an amendment. Examples of such amendments could be the addition or removal of an area of use, or ...

Use the form MIP-0016-E to apply for amendment of a product authorisation (DOC 200 kB)

If you are the holder or represent a holder of a product authorisation and want to withdraw your product authorisation, you must apply to do so. In the application, you must state the reasons why you are requesting the product authorisation to be withdrawn.

Use the form MIP-0016-E to apply for a withdrawal of a product authorisation (DOC 200 kB)

If the product is already authorised, but not for the use in question, it is possible to apply for an extension of a product authorisation for minor use (UPMA).

Use the form MIP-0023-E to apply for UPMA (DOC 142 kB)

You can find further information here about UPMA

If your product is authorised in another member state within the EU and it is identical to a product that is already authorised in Sweden, it is possible to apply for a parallel trade permit in Sweden.

Use the form MIP-0017-E to apply for a parallel trade permit (DOC 167 kB)

You can find further information here about parallel trade permits.

If you want to claim data protection along with your application for product authorisation, you must submit a list specifying for which test and study reports that data protection is claimed. You can use the template for the reference list when preparing your claim for data protection.

Template for the reference list (DOCX 54 kB)

When claiming data protection, you must provide the following information:

  • The reasons that submitted test and study reports are necessary for the authorisation.
  • Certificates that the test and study reports are compliant with the principles of good laboratory practise (GLP) and good experimental practise (GEP).
  • A confirmation that a period of data protection never has been granted before.

In connection with your application for authorisation, you must justify the steps taken in order to avoid animal testing and duplication of test and study reports on vertebrate animals. This applies to all test and study report concerning vertebrates.

Test and study reports that benefit from a valid period of data protection, or has benefited from a period that has expired, cannot be granted another period of data protection. This also applies to data protection granted in accordance with the previous legislation of EU directive 91/414/EEC.

Here you can read more about data protection for test and study reports.

In certain cases, the Swedish Chemicals Agency can make an exception from the requirement for authorisation of a plant protection product. You can apply for a permit for experimental use of plant protection products for research and development purposes.

Use the form MIP-0020-S to apply for a permit for research and development (DOC 58 kB, currently available in Swedish only).

You can find further information here on how to apply for a permit for research and development.

In certain cases, the Swedish Chemicals Agency can grant a derogation from the requirement for authorisation of a plant protection product. You can apply for a derogation for an emergency situation.

Use the form MIP-0019-E to apply for a derogation in an emergency situation (DOCX 49 kB)

Guidance on applying for a derogation in an emergency situation (PDF 217 kB, in Swedish)

You can find further information here on how to apply for a derogation for an emergency situation.

If you want to apply for an approval of an active substance in a plant protection product you can find information about the procedure at the website of the EU Commission.

You can find information about applying here at the EU Directorate General for Health and Consumer Protection.external link

You can find further information here about active substances in plant protection products.

There are a number of different fees for pesticides. For example, if you apply to have a pesticide assessed for authorisation, you must pay a fee for the assessment. You must also pay an annual fee based on the volume of your sales of the pesticide.

Help with calculating your application fee.external link

You can find further information here about fees for pesticides.

We evaluate each application and carry out an evaluation which includes a special assessment. The assessment of a product is based on legislation and its related guidance documents which are in many cases produced at EU-basis.

The supporting material for our assessment is the information given by the applicant on how the product shall be used and the documentation submitted. In some cases several other authorities participate in the assessment, such as the Swedish Board of Agriculture and the National Food Agency, Sweden.

You can find further information here on how we process your application.

Last published 18 September 2020