With EMA’s publication (slide 25) of their current plan to facilitate the implementation of the International Organization for Standardization (ISO) identification of medicinal products (IDMP) standards as with Article 57(2) of Regulation (EU) 726/2004 and considering that EMA has communicated that the first iteration implementation of the Product Management System (PMS) will mainly include xEVMPD data – the Substance Management System seems to be the part that contains the most complexity in getting ready for the first submission of IDMP data.
Currently the plan seems to be to use the GInAS system for the definition and submission of substance data to comply with the ISO 11238 standard Data elements and structures for the unique identification and exchange of regulated information on substances.
The group in charge of developing the GInAS application is publiching all information on their web site. The web site contains a lot of presentations and video’s from early meetings that can be used to get introduced to the GInAS application.
If you need a fast guide for setting up your own cloud GInAS system just follow the guides and links below and that will give you a fast introduction to the GInAS application.
- Download lates software package from the GInAS web site
- Install GInAS via Amazon Web Services (follow the guide)
- Login to GInAS username: admin ; password: adminginas
- If needed you can watch the following video’s to get familiar with the application:
Best of luck getting started using the GInAS application and preparing your company for the first submission of IDMP data.