Applications for authorisation of a plant protection product shall include a risk assessment for both human health and the environment. The applicant must demonstrate that the product is effective and can be used safely. This is done by submitting scientific documentation and a risk assessment for the product and the intended use.
We evaluate each application individually
We evaluate each application that is submitted to us. The evaluation of a product is based on legislation and its associated guidance documents. Often, the guidance documents have been developed within the EU. The basis for our evaluation is the applicant's information on how the product is to be used and other submitted documentation. In some cases, other government agencies are also involved in the evaluation process, for example, the Swedish Board of Agriculture and the National Food Agency.
It is important that your application is as complete as possible when you submit it to us. You must also pay an application fee.
Processing of cases
When an application is received by the Swedish Chemicals Agency, we register it as a case. The case is then given a registration number based on the type of case. Each type of case has its own queue which is processed on the basis of the date on which we received the application or, alternatively, the date when supporting documentation was received. A case is processed in three different steps:
- Queue: A case in a queue is waiting to be distributed for processing.
- Distributed: A case that has been distributed has a date planned for processing to start and has been distributed to a processing team.
- Processing in progress: A case that is being processed has a planned decision date and a case officer who is the contact person.
Important that the application is complete
Be sure to follow the guidelines and templates provided, for example, the guide for the northern zone. If information is waived, you will need to explain why. Take into account all relevant available data, for example, data from the EU evaluation of the active substance.
The risk assessment must be based on the dose and use stated in the application. The overall effect of the product must be taken into account if it contains several active substances since the effects of the various substances must be added together. The risk assessment must be relevant for the product, the zone and the member states where the product will be used. If the risk assessment is not relevant, the processing time may be prolonged.
Principles of order
Our basic principle for the processing of cases is first-in-first-out. This means that the case we receive first will be processed first, when there are two cases of the same type. Sometimes we may need to deviate from this principle. To be more effective, we sometimes process similar cases at the same time. The order may also be affected by the date of expiry of either the product’s authorisation or the active substance’s authorisation. In addition, we sometimes need to wait for an applicant to complete an application before processing can begin.
The starting date for a case is normally the date we receive an application. This applies to cases where Sweden is the evaluating country (zonal Rapporteur Member State, zRMS). This also applies to cases that needs less extensive risk assessment, i.e. applications for extension of product authorisation for minor use (UPMA), amendments of conditions, derogations and parallel trade permits. For cases where Sweden is a concerned member state of another country's evaluation (cMS), the queue time will start on the date we receive the documentation needed for our evaluation (registration report and decision support).
Priority is given to the processing of extended product authorisations under Article 43 of the EU PPP Regulation No 1107/2009. This applies to both zRMS and cMS cases. We also give priority to the processing of the small number of applications that still fall under the former regulation (91/414) and applications for mutual recognition.
Cases that are applications for administrative extension because the authorisation of the active substance has been granted administrative extension are usually processed when the expiry date of the authorisation for the product in question is drawing near.
Different types of extended authorisations
If a product authorisation needs to be renewed, an application must be submitted to us on the basis of the specific requirements of Article 43 in the EU Plant Protection Product Regulation. Among other things, this means that the application for renewal of a product authorisation must be submitted at the latest three months after the authorisation of the active substance has been renewed.
If you have applied for the renewal of a product authorisation and we are not able to process the case before the product authorisation expires, we will extend the product authorisation without you having to submit another application.
If you are not able to apply for a renewal of the product authorisation because the review of the active substance is not completed, you should apply for administrative extension of your product authorisation instead.
We will stay in touch with you
It is quite common for us to receive applications where there is missing documentation or data or where documents have not been signed. Applicants must then complete the application and submit the required documentation. This will delay the processing of your case. We will contact you if there are any problems regarding your application.
If, after the evaluation, we decide authorisation should be denied, we will inform you before we take the decision. This also applies if we decide the product should be authorised with stricter conditions than those you applied for. You will then be given a certain period of time during which to put forward any views.
Deciding a case
When we have evaluated your application, we will decide the case. If we authorise the product, the decision will state what conditions apply for the product and how it may be used. If we have evaluated your application and are unable to see how the product can be used safely and effectively, we will not be able to authorise it. In that case, you will be sent a decision that authorisation has been denied.
After your case has been decided, the Swedish Chemicals Agency will send a copy of the signed decision by email. After you have received the decision, the Agency requires confirmation by email that you have been informed of the decision.
As of 30 November 2017, signed originals are no longer sent out by regular mail. This amendment is part of the Agency’s digitalisation and simplification management. A paper copy of the decision can still be sent out but only after a special request is made.
How long does it take to process a case?
EU legislation for plant protection products stipulates how long the processing of applications may take. You can find these deadlines in the Plant Protection Product Regulation.