SPOR Data Management.
Keeping all of your relevant data current.

What is SPOR Data Management and its relationship to IDMP standards?

The regulatory requirement and IDMP.

The European Union (EU) has a regulatory requirement to adhere to ISO IDMP (Identification of Medicinal Products) standards, which are designed to facilitate the consistent and robust exchange of information related to medicinal products by establishing a universal product terminology.

The ISO IDMP framework encompasses five distinct standards: ISO 11238 (Substances), ISO 11239 (Dosage, Units, Packaging, etc.), ISO 11240 (Units of Measurement), ISO 11616 (Regulated pharmaceutical product information), and ISO 11615 (Regulated medicinal product information).

While the primary goal of implementing IDMP is to augment Pharmacovigilance and expedite responses, as well as enable electronic prescription of medications within the EU, it also serves other crucial objectives such as ensuring the authenticity of medicines, facilitating substance identification across different regions, and addressing medication shortages.

Click for more information from the EMA on ISO IDMP standards.

The need for SPOR Data Management.

In response to the EU regulations and the oversight of master data linked to the IDMP implementation, the European Medicines Agency (EMA) has introduced a structured program – SPOR (Substance, Product, Organisations and Referential Management Services).

SPOR includes a dedicated data portal designed for the registration and continual update of pertinent information across four key data management services. These services, along with the data they relate to, are:

Substance Management Services (SMS).
Providing consistent data and definitions to uniquely identify the constituents and materials composing a medicinal product.

Product Management Services (PMS).
Offering standardized data and descriptions to exclusively pinpoint a medicinal product by leveraging regulatory details such as marketing authorization, packaging specifications, and medicinal product information.

Organisations Management Services (OMS).
Managing data pertaining to the names, locations, addresses, and other relevant details of Marketing Authorization Holders (MAHs), sponsors, regulatory authorities, manufacturers, and related entities.

Referential Management Services (RMS).
Lists of controlled terms used to describe various product attributes, including units of measurement, lists of dosage forms, routes of administration, and more.

It is important to recognize that while the ISO IDMP standards primarily pertain to Human Medicinal Products, SPOR also extends its application to Veterinary Medicinal Products (VMPs).

Both human and veterinary medicines will utilize the same SMS, OMS, and RMS services, ensuring uniformity in data, format, and processes for submitting and maintaining master data.

To facilitate the adoption of IDMP standards, the implementation of SPOR is divided into two phases:

RMS and OMS.
These phases establish the fundamental data infrastructure required.

PMS and SMS.
These phases conclude the full deployment, ensuring comprehensive data management and compliance.

Click for more information from the EMA on SPOR.

Why use Aegisana’s SPOR Data Management Services?

Ready for now, & tomorrow.

Our Pharmacovigilance and Veterinary Pharmacovigilance experts are fully aligned with the EMAs SPOR implementation and can assure the accurate management of all your data within the framework to ensure full compliance.

Understanding your products.

Aegisana is committed to understanding all the nuances of your product/portfolio, and our transparent system-based approach instills confidence in our capability to offer rigorous control and oversight of your Pharmacovigilance (PV) systems and patient/animal safety.