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Legal entity

B. Legal entity change

How can I download the dossier that I acquired via a legal entity change?

You can use the ‘Request IUCLID file’ functionality to download the dossier in REACH-IT. The IUCLID file can be downloaded from the REACH-IT submission report page. You can get to the submission report page, by clicking --> Menu --> Search --> Submissions.

request IUCLID file

When a legal entity change (LEC) takes place, a new submission number is created and assigned to each transferred asset. This is done for technical reasons to keep track of the legal entity transfer, and is not linked to any new submission.

Therefore, when the legal successor submits a request for a dossier download, they should request the download for a submission that is linked to an ‘Initial submission’ or a ‘Submission update’, and not to the Event ‘Legal entity change’. The submission numbers with the related Events can be checked at the Reference number page, ‘Reference number history section’

You can get to the Reference number history section, by clicking Menu → Search → Reference number → click on the reference number displayed in the results page to open the Reference number page → click on the Reference number history section → click on the submission number under ‘Initial submission’ or ‘Submission update’. (see screenshot below)

Reference number history

Please note that it is not possible to download a NONS registration under Directive 67/548/EEC that was successfully claimed if no registration dossier update has been submitted. The owner of the NONS registration needs to contact the appropriate Member State competent authority to receive the files in IUCLID 5 format if the successfully claimed NONS registration needs to be updated. The list of MSCA contact details is available at National Helpdesks page.

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