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
- a new product authorisation through mutual recognition.
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 have a dialogue with the evaluating member state.
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.
If you are the holder or represent a holder of an authorisation you may need to apply for an administrative prolongation of your product authorisation.
Product authorisations for plant protection products are time-limited and depend on the approvals of the active substances. It is the EU Commission that decides the peroids of approval for active substances. If the EU Commission has decided to prolong the approval for the active substance you can apply for an administrative prolongation of your product authorisation. The application of an administrative prolongation can be submitted as soon as the EU Commission has taken their decision.
If you are the holder or represent a holder of a product authorisation and want to withdraw your product authorisation, you must inform The Swedish Chemicals Agency about that. Please, do so by sending an email to email@example.com to tell us which product you would like to withdraw. You must also tell the reasons why you want the product authorisation to be withdrawn.
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).
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.
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.
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.
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.
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.
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.
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.
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.