QLT Rules 101: The Basics

When you're handling Poison Centre Notification (PCN) processes, quality rules — or QLTs — can be a real headache.

You’re not alone; many submitters hit the same challanges, so we’re here to clear things up. We launched this QLT series because companies were crying out for help, unsure of how to tackle these surprise challenges.

Welcome to QLT Rules 101: The Basics. Let’s dive in.

What is a Quality Rule (QLT)?

• QLTs are quality checks applied to the data in your PCN dossier to ensure it’s accurate, complete, and consistent before the Poison Centres in the EU accept it. Remember, these rules don’t prevent you from making a successful submission—they just help ensure your data meets the required standards.

Does the QLT impact the timeline for PCN submission?

• If your data fails the QLT checks, you'll need to correct it and resubmit the dossier. In this case, your PCN notification is NOT VALID until you resubmit.
• However, if your data passes with warnings, the dossier will still be sent to the relevant authorities along with a "Validation Assistant Report" outlining the QLTs. Here, your PCN notification is considered VALID.

What are common reasons for QLT issues in PCN notifications?

• Common reasons include using the same UFI for multiple formulations, incorrectly marking a submission as "initial," failing to comply with EU regulations, or not providing sufficient justification for voluntary submissions of non-hazardous mixtures.
• Issues can also arise if UFIs are not unique or if the legal entities in your supply chain don't match EU requirements.

How can companies ensure their PCN data passes QLT checks?

• Follow the guidelines from ECHA carefully and use their tools, like the UFI Generator, correctly.
• We’ve also gathered all the necessary data you will need for a successful PCN notification, here.

What should you do if a PCN notification fails the QLT check?

• Review the feedback, correct any errors or inconsistencies, and resubmit your PCN notification.

Are there tools to pre-check PCN data for QLT compliance?

• Yes! ECHA offers tools like the PCN Validation Assistant to help you pre-check your data for potential issues before making a final submission.

How do changes to a mixture formulation affect QLT compliance?

• Significant changes require a new initial submission. For smaller changes, an update to the existing PCN notification will suffice. Remember, any updated data must also pass QLT checks, so make sure all modifications are correctly reflected.

Can QLT rules differ between EU member states?

• While the QLT rules are generally harmonized across the EU, there can be slight variations in how member states enforce them. Always check for any national-specific requirements.

What are the consequences of not complying with QLT?

• Non-compliance can delay your product from reaching the market, incur additional fees, potential fines, or, in severe cases, product recalls.

How often are QLT rules updated, and how can companies stay informed?

• QLT rules can be updated periodically as regulations evolve. Stay informed by regularly checking updates from ECHA and other regulatory bodies.
• You can also follow us on social media—we frequently post updates and changes to EU regulations on our blog and LinkedIn page.

Mastering the QLT process can feel like a daunting task, but with the right knowledge, you’re already ahead of the curve.

Remember, we’re here to make your journey easier. If you’re short on time or need a helping hand, don’t do it alone — reach out to us. Our team is ready to support you every step of the way, ensuring your submissions are smooth and compliant.