Important Update: Belgian Poison Centre Now Actively Requesting PCN Fees

For many years, companies have used the EEA PCN (European Economic Area Poison Centre Notification) to cover all EEA countries in a single submission. This approach is practical and cost-effective, especially because most countries within the EEA do not charge state fees for PCN notifications.

However, there are four exceptions:

• Belgium
• Italy
• Hungary
• Ireland

Until recently, even when these countries were included in the EEA PCN, competent authorities did not actively request payment of the fees. Because of this, many companies chose to include all countries—believing they would only pay state fees if and when they began selling in those markets. This helped them finalise their compliance in one step.

What Has Changed?
Belgium has now started actively sending reminders for PCN fees.
Belgian fee: 200 EUR per formulation
For companies that have been submitting PCNs across their full product range over several years, the total amount can come as a surprise. Some may now face invoices covering an entire portfolio accidentally notified for Belgium—even if they never placed those products on the Belgian market.

What To Do If You Receive a Payment Request from Belgium
If you are selling in Belgium
Check your portfolio, make sure which products do you sell or plan to sell to Belgium and pay the requested fees, as the notification is required for market access.
If you are not selling in Belgium (and have no plans to)
You can reply to the Belgian authority simply informing them that:
“These products are not placed on the Belgian market and there are no plans for future distribution in Belgium.”
A polite reply is recommended rather than ignoring the request.

Our Recommendation Going Forward
If your products are not intended for Belgium, Italy, Hungary, or Ireland, you may wish to exclude these countries from future EEA PCN requests to avoid unnecessary fees.
If you are unsure about your past submissions or market plans, we can review your PCN portfolio and advise you on the best approach.

If you have received such a notice from Belgium and need help drafting a response or clarifying whether payment is required, feel free to contact us.

Staying compliant doesn’t need to be complicated—just informed.
If you need support, our team is here to help.