PCN validation rules – meaning and differences

Published On: 18 January 2021By Categories: PCN

The European product notification (PCN) framework has already begun and of course, there are initial hurdles to overcome, such as the PCN validation rules. Perhaps you, like many of our users contacting support, are wondering about these business rules and quality rules in the notifications.

Where do PCN validation rules apply?

When you upload a PCN to the ECHA portal or start a validation using the IUCLID program, errors may occur: these are abbreviated using “BRXXX” or “QLTXXX”. “XXX” represents a numerical code used to precisely identify the error. The abbreviation “BR” stands for business rule, “QLT” stands for quality rule.

What differentiates these two kinds of errors?

In principle, the errors differ in one important point: If a business rule has not been complied with (BR failure), your notification will be rejected by the portal. This means that notification is not complete and you cannot place your products on the market yet. The next step is to eliminate all errors and upload a notification without a BR Failure. Quality rules are not as clear-cut as business rules. If a quality rule has not been complied with (QLT failure), the notification is not automatically rejected.

However, the QLT Failure will provide you with information concerning areas in your PCN which need improvement or which could lead to queries from authorities. But quality rules are also used to indicate rules that are not always clearly incorrect. As a result, it is possible that a quality rule will be displayed for your specific case, but everything is still fine with the notification. During validation, all the identified validation rules are displayed. If several areas require correction, the report should provide you with a good overview of how to proceed.

Report and portal-specific PCN validation rules

In our GeSi³ software, the report-specific business rules and quality rules are evaluated directly when the dossier is created and potential solutions are presented. But there are other checks for which the results can only be seen in the portal. One typical example is if a UFI has already been notified or if the UFI of a supplier (MiM) is not available for the specified countries.

How can I determine if there is a need for action?

It goes without saying that there is an urgent need for action if the notification has been rejected. This is indicated in the portal under the “Submission status”. If “Failed” is displayed, the notification has been rejected. If the status is set to “Succeeded” but validation rules are mentioned, you have a bit more leeway when deciding whether updating the data would be beneficial.

Business rules: Deviations in designation

There are some quality rules currently in place which used to be business rules in the past. These are also currently highlighted in orange in the ECHA documentation. As a result, you may be able to successfully upload your notification even though one of the messages starts with “BR“.

Where can I get more information about validation rules?

On the ECHA Poison Centres website, the business rules are also listed under the “PCN format” tab. Information about the error messages is also provided there. The error checks relevant to the different PCN dossier types are also outlined. Because the notifications are still at an early stage, it is highly likely that there will still be considerable activity in future regarding the automatic PCN dossier validation in the form of PCN validation rules.   Sources: Website of the Poison Centres of the European Chemicals Agency (ECHA)18 Guidance on harmonised information relating to emergency health response, Version 3.0, ISBN: 978-92-9481-578-1

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