The client intended to introduce a biocidal product in four European countries. Ramboll assisted with a cost-effective solution for constructing an authorisation dossier compliant with the Biocidal Products Regulation (EU) 528/2012.
Ramboll provided expert advice on different ways to submit the necessary paperwork for authorisation in Europe. We calculated various cost scenarios to find the most affordable option for the client. Our assistance covered everything from gathering necessary data and preparing the required assessments to submitting them. We also helped the client answer questions from authorities and guided them through the review process, giving strategic advice to handle discussions with regulatory groups.
Ramboll designed an optimised and cost-efficient strategy for the client, resulting in the successful submission of their dossier. Following a rigorous evaluation by the reference EU member state, we adeptly navigated the peer-review commentary phase and discussions with the coordination group, including a challenging final phase where disagreement arose between concerned member states and the evaluating member state’s assessment. Consequently, all member states consented to authorise the product, ensuring our client's successful market entry.