What must you know when it comes to additional PCN notification fees?

Certain EU/EEA countries mandate additional PCN notification fees, including Hungary, Italy, Ireland, and Belgium. 

The expenses associated with Hungary, Italy, Ireland, and Belgium are borne by the company, given that these fees are specific to the company (VAT-specific). 

Please be careful, as each state has its own distinct procedure, as listed below.

For Hungary: 

• The fee is 16,000 HUF per notification (roughly 42€ per notification). 
• The fee shall be paid by bank transfer to the National Centre for Public Health and Pharmacy (NCPHP) as soon as the notification receives a submission number. 
• You can read more about where and how to pay here. 

For Italy: 

• The fee is 50€ per year, regardless of the number of notifications, and will be valid for 1 year.
• The whole process of Terms of payment is stated on the website step by step. 

For Ireland: 

• The fee if 650€ per company, with no time limit on validity of the notification, with no notification limit.  
• The whole process is listed on this website.  

For Belgium: 

• The person responsible for placing a hazardous mixture on the Belgian market must pay a one-time fee (i.e. he must pay only once) for each notified mixture or group of equivalent mixtures.
• The fee is 200€ per notification, with no time limit on validity of the notification. 
• All the bank information is listed here.  
• The payment of the fee must happen before the notification.  Proof of payment has to be included in the notification file sent to the Poison Centre. In the case of a notification made through the ECHA’s PCN Portal, it is unfortunately not possible to upload the proof of payment directly in the technical dossier of the PCN. We therefore ask you to send your proof of payment directly to the Poison Centre.  The notification to the Poison Centre is legally not admissible without payment of this fee.

If you have any other questions regarding PCN notification, the process or the fees, feel free to contact me at spela.hudobivnik@bens-consulting.eu.