DR-SoftWare, Inc.

ChemGes provides an End-to-End Solution, automating everything from the UFI to the PCN notification

DR-Software’s powerful solution to the CLP Annex VIII requirements for Poison Center Notifications, is as always, automatic and simple, ensuring full compliance with little effort.

With the implementation of CLP Article 45 and its PCN requirements, companies are facing increased information requirements.  The first deadline has already passed on January 1st, 2021.

 

“What matters to our customers now, is ease and efficiency.  As always, we have distilled the compliance requirements down to a few simple steps, ChemGes does all the work.”

Christopher Radlinger, Senior Executive Programming (2020)

Every possible aspect of the PCN notification is fully integrated into ChemGes, allowing for efficient dossier generation.  No need to purchase a separate module or pay extra fees.  All users with a valid maintenance contract have access to these features.  The full integration of this module allows the user to access all data and functionalities to assist in the new notification requirements.

Instructional videos on our YouTube channel

UFI and PCN Notification with ChemGes (or: brief description)

Group handling for the PCN notification

• The UFI generator is built into ChemGes, thus providing optimal speeds. 
• All possible combinations of data are covered.  These include but are not limited to, multiple manufacturers, mixes of multiple manufacturers for the same preparation, substance variants. 
  
• ICGs (Interchangeable component groups) and SFs (Standard formulas) can be easily managed and notified.
  
• MiMs (with or without UFI) are easily maintained as intermediate preparations and PDFs to send with your dossier can be saved with a substance
• Variants, phrases and addresses, that have always been standard features are part of the dossier data
• ChemGes identifies all manner of changes automatically, removing the need for manual involvement. 
• EuPCSs, packaging, market placement and even colour, can be automatically allocated to dossiers, and ChemGes will output the ECHA required terminology
• ChemGes provides for the fully automatic upload of single and bulk notifications, directly to the PCN portal.  Of course, manual notification is also available, if desired.

Data between ChemGes and ECHA, is easily managed with options such as the:

• Import or Export of the ECHA legal entity
  
• Import and the test of the S₂S key
  
• Direct links to ECHA webpages, portals and documents.
  

The effort necessary to create a dossier is negligible, once the minor task of allocations and import of any ECHA provided data, is completed. 

As always, our support team is ready to provide assistance in using this aspect of ChemGes. 

Links

• Information on UFI, EuPCS and PCN

• ECHA Poison Centres - Tools
  
• ECHA "My Legal Entity" Applications
• ECHA Submission portal
• ECHA Poison Centres - System-to-System service
• ECHA Support - How to join ECHA's system-to-system integration service
• ECHA CLP contact form for S₂S key request
• ECHA Applications for access to S₂S keys

UFI Decoder