Authorisation of biocidal products / biocidal product families
After the decision on the inclusion of an active substance onto the EU positive list there are usually 18 to 24 months remaining to file an application for authorisation of a biocidal product that contains, generates or releases that active substance. The application can be submitted to authorities in different EU-member states (national authorisation) or to ECHA (Union authorisation).
BPR provides for the authorisation of biocidal product families. Within such a family several products which comply to certain requirements can be summarised into one application. The basic product requirements for a product family are:
- Similar uses
- Identical active substance(s)
- Similar compositions with defined limits
- Similar hazard profile
- Similar effectiveness
For all applications data must be generated as specified in Annex III BPR for the product or the products from the family. The application needs to contain either a Letter of Access or a full dataset for the active substance(s). On the basis of this information an evaluation and summary of the product properties needs to be prepared.
Based on your needs we can assist you with the complete process or for identified steps in the preparation of the comprehensive application generally outlined below.
- Strategic and technical planning of a product family
- Support in choosing the best authorisation option
- Dealing with authorities
- "Data-Gap-Analysis" & testing strategies
- Literature search
- Negotiations with data holders
- Placing and monitoring of studies
- Preparation of the technical dossier (IUCLID 6)
- Preparation of a scientific assessment and summary
- General support throughout the authorisation process
Feel free to contact us with any questions related to this topic.