How To Fix Complications with UUID Numbers in eCTD

Acorn Regulatory’s publishing team is staffed by eCTD experts.  We have assisted many companies in their eCTD projects in recent years.  Many visitors to our website submit questions on regulatory issues. Issues with UUID numbers arise time and again and we are consistently advising companies on the issue.  Eileen Ryan, our Regulatory Publishing Manager has written a brief article suggesting a way to overcome UUID number issues when working in eCTD.

What is a UUID?

The revised guide for the implementation of EU Module Specification 1.0, version 3.0 says that a UUID must contain the new attribute containing a Universal Unique Identifier (UUID). This UUID should be generated when the first sequence in eCTD format will sent to generate a unique identifier of a dossier. This UUID will be kept as a reference for
subsequent submissions.  A UUID is a hexadecimal number in the form of 8-4-4-4-12, including 32 digits and 4 hyphens. UUIDs are formally defined by ISO/IEC 11578:1996 and ITU-T Rec X.667 ISO/IEC 9834-8:2005. UUIDs are represented as follows:

• String of digits separated by hyphens: 25635f23-a3a4-4ce0-9994-99c5f074960f 596

UUID number complications

UUID numbers can be generated quite easily; therefore, extreme caution should be used not to regenerate a UUID number for a dossier already submitted to the authorities. Some of the current validator tools can catch this error before submission by running a check against the UUID number to the sequence previous.  However, when the submissions are submitted close together, then it is possible to have a valid submission on the last sequence if the UUID number was changed two sequences prior.

Solution: What can be done if a UUID number was changed and submitted to the authorities in error?  The authorities should be notified immediately of the UUID number problem and to discuss what can be done to correct the issue.  In many cases, the sequence that had the incorrect UUID number can be amended with the correct UUID number and resubmitted to the authorities to upload.

Acorn Regulatory Can Help

We can provide a range of eCTD services that could assist you in the transition to eCTD.  We have a dedicated electronic publishing team that can help with any of your eCTD publishing requirements or queries.  Talk to us today by calling 00353(0)52 61 76706 or completing the webform below.