Lonza can help you navigate the complex regulatory environment with our unmatched expertise:

Lonza offers actives substances and  formulated products for medical device applications as well as antimicrobial ingredients for medicinal products / drug-device combinations.

The EU Biocidal Product Regulation (EU) No 528/2012 (BPR) has introduced significant changes in the regulation and authorisation of biocidal products that will impact your product portfolio. Once an active substance has been evaluated as acceptable for inclusion in the Union List of allowable substances, the product authorisation phase of the BPR will become relevant for companies wishing to place and keep biocidal products (including disinfectants) containing listed substances, on the market. Lonza can support you through the complicated authorisation process for your products by:

  • Providing information, analytical methods and advice for our broad portfolio of actives that may be used in your formulations.
  • Providing opportunities to market and/or produce a range of disinfectant formulations that we intend to support through the product authorisation process of the BPR for specified EU Member States. These formulations could easily be added into your product range and marketed under your own trade name.