Biocidal products require pre-marketing authorization before they can be sold within the EU market. The governing legislation is referred to as "harmonized legislation". The Biocidal Products Regulation (EU) 528/2012 is the currently governing document for authorization of the biocidal products and other parameters of the product such as safety, efficacy, composition, etc.
The first step is the approval of the "active substance" used within the biocidal product, the second step is the market authorisation of the "biocidal product" itself.
Thewa Innovation is ready to assist you with a full package of services to successfully and efficiently acquire authorization for your biocidal products within the EU market:
- Analysis of available data and identification of any gaps,
- Assisting with classification and labelling,
- Create technical documentation in the correct way, and submit it to the relevant authorities,
- Evaluation of scientific study on the subject and monitor its evolution,
- Support to align your important "claims" with EU legislation,
- On your behalf, manage communication with the relevant authorities,
- Guiding and advising in strategy
In case the regulation changes, and this will certainly occur, we are well equipped to track and identify the potential impact of any such change for your products. Our customers benefit from our professionalism and efficiency, which allows them to focus on product, market and revenue while we take care of the regulatory side very efficiently and timely.
If you are looking for someone to assist you in regulatory issues for your biocidal products efficiently, timely, and in a cost-effective manner, feel free to contact us (click).