Belgium Adds New Fee for PCN Updates

Just when you thought the Belgian PCN system was predictable, here’s a fresh alert for companies:

Belgium now charges €35 for every updated PCN notification.

That’s right – beyond the annual fees and first submissions, any change to an existing PCN now comes with an extra cost.

An updated PCN can be triggered by:

• Formulation changes

• Product name changes

• Certain administrative adjustments

• Any modification that requires a resubmission to the Poison Centre

Each update = €35 - For companies managing multiple products, these fees can add up quickly.

Why this matters?

Belgium is making it clear: managing your PCNs isn’t just about compliance, it’s about cost efficiency.

Example scenarios:

• 20 updates/year = €700

• 50 updates/year = €1,750

And that’s on top of your annual PCN fees.

What you should do?

Plan changes strategically – avoid unnecessary updates
Bundle changes when possible
Align internal teams (Regulatory, R&D, Marketing)
Factor update fees into your Belgian compliance budget

In short, every update counts – literally.

If you’re unsure how these new fees impact your Belgian product portfolio, we can help you assess and optimize your PCN strategy.

Got questions or need a quick portfolio check? Email us at spela.hudobivnik@bens-consulting.eu – we’ll help you optimize your Belgian PCNs.