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During the approval/authorisation process for active substance or biocidal product, the applicant has to provide comments within 30 days to ensure that documents subject to dissemination according to Article 67 of the BPR (the SPC, assessment report, Document III-A, Decisions/authorisation document and Opinion) do not contain confidential information. Once an authorisation, a renewal or a change on request is approved in R4BP 3, you can verify the correctness of the following R4BP 3 information disseminated on the ECHA website as available in your asset:
- The summary of product characteristics (SPC) in XML format. Note: information on the function of other substances or of substances of concern will not be made publicly available.
- Documents under the “Documents” tab with access level ‘Public’:
- Active substance/product assessment report.
- Product authorisation/decision documents.
- Active substance Document IIIA.
- Active substance/Union authorisation Opinion.