SPOR

Objectives

The objectives of SPOR include streamlining processes by storing and modifying master data about medications in one location and facilitating data reuse. This is achieved through the use of four "Data Management Services": Substances, Products, Organizations, Referentials. These services provide information about all medications approved or part of clinical trials in the EU/EEA.

SPOR will:

• Enhance European pharmacovigilance and facilitate cross-border e-prescriptions
• Simplify European and national management of medication shortages
• Facilitate the implementation of safety information measures
• Aid in the execution of recalls via Rapid Alert

SPOR services are built in accordance with ISO-IDMP. See the SPOR web interface.

Access webinar recordings and other informational videos from EMA - Implementation of ISO IDMP and SPOR

Information available in the databases

• SMS - Substances: A register of all substances found in medicinal products in Europe, both active ingredients and excipients. The industry submits new substances here, and national competent agencies (NCA) submit translations. As of March 2023, the service is not public and is presented as a downloadable Excel or CSV file on the website. The Norwegian Medicinal Products Agency (NOMA) approves Norwegian substance names according to SMS guidelines.
• PMS - Products: A register of all marketed products in Europe. Information on drug form, strength, packaging, marketing status, MA holder, and more can be found here. As of March 2023, this is not operational. For veterinary products, the Union Product Database (UPD) was launched in January 2022:
• Veterinary medicines in Norwegian (External link)
• OMS - Organizations: A register of organizations that develop, own, or manufacture medications (e.g., manufacturer's name, address, overview of manufacturing sites and distribution centers, etc.). This solution is operational.
• RMS - Referentials: Overview of lists containing all valid, proposed, and expired terms describing, for example:
  • Product properties (e.g., drug forms, countries, packaging, administration units, presentation units, etc.)
  • ATC code registry
  • Terminology related to MA processes
  • Terminology related to supervision activities
  • Terminology related to adverse reactions

RMS is operational, and NOMA strictly adheres to these lists. Norwegian translations are prioritized and implemented for important lists.

Description of ISO IDMP

The purpose of the standards is twofold:

• To specify data elements, structure, and relationships between data elements necessary for the unique and secure identification of medicinal products
• To define terms for all data elements necessary for the unique and secure identification of medicinal products

The standards are mandatory in Norway (NS-EN-ISO). National competent authorities (NCAs) and the pharmaceutical industry are required through the medicinal products directive (2001/83) to comply with these standards. The standards have been developed based on a global need for harmonized medication specifications. They are intended to support NCAs regulatory tasks related to the development, registration, and lifecycle of medications. Monitoring of medications, including monitoring adverse reactions and risk management, is part of this. At a minimum, the standards should support information exchange between:

• Different NCAs
• Pharmaceutical industry and NCAs
• Sponsor of clinical trials and NCAs
• NCAs and other stakeholders
• NCAs and global data sources

Message specifications have been incorporated into the ISO-IDMP standards to ensure the desired information exchange capability. The ISO-IDMP standard has been developed in accordance with the "Common Product Model (CPM)" and "Structured Product Labeling (SPL)" in HL7. HL7 V3 message exchange should be used for information exchange between the parties during the standard's implementation.