Europe – Chapter 1 : Implementation of ISO standards for the identification of medicinal products in Europe

Chapter 1: Registration requirements

Registration requirements

Before submission of medicinal product information is initiated by an industry organisation, that organisation must be registered with the EMA Account Management portal (IAM).

Users may log into the SPOR web portal and use all the available services only after they create an account in IAM and register one or more user roles. The user registration and management of the SPOR user roles is managed through the above-mentioned EMA Account Management portal.

The ‘SPOR User Registration Manual’ provides a comprehensive step-by-step manual which describes all existing SPOR user roles and authorisation process flow. In addition, it provides detailed instructions on how to register and manage SPOR roles. The ‘SPOR User Registration Manual’ will be updated in version 2 of the EU Implementation Guide (EU IG) with additional information with PMS specific user roles with different level to access to product information or system functionalities.

In addition, a governed process to access SPOR programmatically through SPOR application
programming interface (API) will be developed. Additional information will be included in version 2 of the EU IG…