Keep the information up to date

Keep the information up to date

The information contained in a submission made to an appointed body must accurately reflect the product on the market at all time. Whenever your product changes in a way that concerns information requirements, this needs to be reflected in an update of the existing submission.

Develop fit for purpose processes for monitoring and change management and make sure that all information regarding changes to the product portfolio, formulations, and classification and labelling are considered not only for the initial submission, but also for future updates.

In some cases, submission updates will replace outdated information with new information, such as when:

  • you change the 24/7 emergency phone number required for a limited submission;
  • the classification of the mixture has changed.

In other cases, updates will add to the information already provided, which will remain relevant for the poison centre, for example:

  • you rename your product (but the mixture composition remains the same);
  • you repackage your product in a new type of packaging;
  • new toxicological information becomes available.

Should your mixture composition change, you must:

  1. generate a new UFI;
  2. change the UFI on the product; and 
  3. make a submission update reflecting all the changes. 

 

Keep the information up to date - links