4. If you have your own file, which documents should you use to demonstrate its compliance?
When inspected by local authorities, the two basic elements used to verify compliance are :
It is important to note that an authorization dossier includes an evaluation phase, at the end of which no update of the CSR is required. The CSR drawn up and submitted by the authorization applicant is analyzed by ECHA's expert committees. This is followed by a phase of exchange and discussion, during which it may be requested to revise the conditions described in the CSR. A summary of the evaluation is then presented in the consolidated opinion of the ECHA committees (RAC...
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If you have your own file, which documents should you use to demonstrate its compliance?