- Preparation for dossier submission - guidance on how to compile a dossier in support of an active substance under BPD including UK CA guidance on what data are required.
- Invoices and charges - details of when the completeness check fee needs to be paid.
- Completeness check - details of what a dossier completeness check involves.
- Evaluation process - details of who is involved and when.
- EU discussion - brief details of what happens to applications in Europe. For further information see also ‘What happens to applications in Europe’
- Product/provisional authorisation - details of the different types of authorisations and exemptions.
- Data Protection - lists data protection durations for active substances and biocidal products.
- Guidance for data sharing - suggestions for applicants to achieve data sharing in the UK for the BPD/BPR.
Before considering the submission of a dossier for the inclusion of an active substance on to Annex I it is necessary to establish whether the active substance is:
- a new active substance if it was not on the EU market before or by 14 May 2000 and/or is not notified, eg is not currently being supported in the review programme for an appropriate product type;
- an existing active substance if it has been notified for the correct product type and is currently part of the BPD review programme. In this instance, it may be possible to:
- contact the current participant and discuss the option of data sharing; or
- wait for the outcome of the review and see if the active substance gets inclusion on to Annex I; or
- submit a dossier providing you are either within the time period for the submission of dossiers for that product type given in the Second Review regulation, 2032/2003, or are taking up the role of participant for an existing substance for a specific product type which is no longer being supported, within the defined time period for picking up the substance.
Summary tables of the dossier submission deadlines are available on our biocides question and answer pages.
Details of the current status of the review programme for existing substances are available from the EU Commission and background information is available from the biocides question and answer pages