Impact analysis from the Plant Protection Regulation
Do you know whether, and to what extent, you are affected by plant protection legislation? Have you checked whether your product is considered a plant protection product and requires authorisation? And which authority will you have to submit your documents to? And what test results will you need?
We would be glad to serve as your consultant to clarify these and other questions. In doing so, think not only about your current range of products, but also the products you want to offer in the future.
Things need to be right now and the future must be well prepared
With regard to your existing range of your plant protection products, we assume that you have already sufficiently clarified which regulations apply and that you are in compliance. But if you are not sure, we will be pleased to work with you to clarify whether you still have things to do.
For your current range, please note that the required approvals and authorisations are time-limited. Make sure to apply for renewals well in advance as required by Article 43 of the Plant Protection Regulation. If during the renewal process you decide you want to change or extend your previous authorisation, this is only possible to a very limited extent within the renewal process. Usually, you will need to make a separate application for these changes.
Questions that can help clarify your situation
For new products, the number of tasks you’ll need to complete is much bigger. We have put together a few questions to help you clarify how you might be affected by plant protection product legislation:
- Which active ingredient(s) are present in my formulations?
- What is the status of these in the renewal process?
- What kind of authorisation do I want (new authorisation, mutual recognition)?
- Do I have access to the required data about the active ingredient(s)?
- Is my active ingredient equivalent to the EU active substance source?
- What type of formulation do I plan?
Your goals and the path to successful marketing
We recommend creating a plan of action for new developments as well as when you are revising your existing product portfolio. It should roughly look like this:
- Clarify the goals you want to achieve, i.e. products
- On the basis of which active ingredients
- For which applications
- In which countries
- This is followed by regulatory consequences:
- Possible purchase of data
- Possibly generating new data with appropriate tests
- Meeting deadlines
- Preparing documents for submission to the authorities
- Submitting the documents, consulting with the authorities, adding other documents as necessary, receive the authorisation
- Start/continue sales
Very important: planning resources
Estimating the amount of work involved is not easy. Often all that has to be done only becomes clear once the process is underway. A cost estimate and schedule is thus your first project.
If you have the necessary experts in sufficient numbers in-house, then you are probably not reading this site. But if you do not have all the experts you need on staff or they’re already overloaded with work, it can be very advantageous to use external support. If you would like a recommendation for such support, just ask. ⇒ Contact