A toxikológiai központ értesítésének (PCN) portálja

The ECHA Submission portal is an online tool that allows industry to prepare and submit a dossier for a poison centre notification (PCN). To start preparing a PCN dossier, click on the ECHA submission portal button below. Check our Guide to dossier preparation and submission for more details.

What is a PCN dossier? Check our ECHA-term bank of multilingual chemical terminology in the related links below.

Currently, only Germany, Estonia, Denmark and Lithuania are accepting submissions made through the ECHA Submission portal.

ECHA Submission portal logo

 

It is also possible to prepare a dossier offline using IUCLID 6 – the dossier can be then uploaded later to the portal. Users need to download the latest version of IUCLID from the IUCLID 6 website.

Companies can now upload and submit notifications in the test environment as if they were in the official ECHA Submission portal. The full user experience allows different submission scenarios to be tested and full validation checks to be done for dossiers. Now with the test environment, companies can check how the portal works without appointed bodies and poison centres receiving misleading data.

 

The ECHA submission portal facilitates the submission process, however further information on national submission systems, fees, acceptance criteria and timelines are at the discretion of each Member State. For more details, see the key document Overview of Member States’ decisions in relation to implementation of Annex VIII to the CLP Regulation.

 

Languages required for notifications

According to Annex VIII to the CLP Regulation, submissions have to be made in the official languages of the Member States where the mixture is placed on the market, unless the Member State has specified otherwise.

The list of accepted languages for each Member State can be found in the Overview of Member States’ requirements for language(s) of notifications.

In your PCN dossier, indicate all the relevant languages. Free text fields will become available for the languages specified, for:

  • toxicological information; and
  • some classification and labelling information, e.g. affected organs.

For more information on how to prepare a dossier in multiple languages, see Poison centre notifications: Guide to dossier preparation and submission.

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