What is SPOR?

by Alessia Rossi, Senior Pharmacovigilance Consultant @PQE Group

To make a long story short, SPOR (Substance, Product, Organization and Referential) is the European Medicines Agency’s (EMA’s) requirement to implement the standards on data for medicines, the so-called ISO IDMP1 standards (IDentification of Medicinal Products), in the European Union. The purpose of IDMP standards is to allow for the exchange of medicinal product information in a consistent and robust manner. 

In order to comply with the ISO IDMP standards, as mandated by Commission Implementing Regulation (EU) No. 520/2012 (articles 25 and 26), the EMA is delivering four SPOR data management services for the centralized management of master data: 

Substance Management Services (SMS): Harmonized data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product. 

Product Management Services (PMS): Harmonized data and definitions to uniquely identify a medicinal product based on regulated information (e.g. marketing authorization, packaging and medicinal information). 

Organization Management Services (OMS): Data comprising the organization name and location address, for organizations such as marketing authorization holders, sponsors, regulatory authorities and manufacturers. 

Referential Management Services (RMS): List of terms (controlled vocabularies) to describe attributes of products, e.g., lists of dosage forms, units of measurement and routes of administration. 

After an extension of the original deadline, pharmaceutical companies are invited to start to replace their current data submission format in the Article 57 Database from the eXtended EudraVigilance Product Report Message (XEVPRM2) format to the new ISO IDMP compatible format (HL7 FHIR3). 

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In this respect, EMA has established a SPOR portal that provides various data management services including viewing, searching and exporting SPOR data (an important feature to import SPOR data into other documents/systems) in order to allow Marketing Authorization Holders (MAHs) to register and enter or update their related SPOR data. 

What do Marketing Authorization Holders have to do at this stage? 

First of all, MAHs with authorized MA(s) need to check their data in the Article 57 database (xEVMPD4) to ensure it is accurate and up to date.   

Subsequently, in order to maintain an effective linkage of the entire European medicines regulatory network and pharmaceutical industry, EMA has made it mandatory for applicants and MAHs of medicinal products to complete corporate information (i.e. organization names, location and address details, contact information for location: Email, address, telephone number, etc.). 

On 1st November 2021, for Centrally Authorised Products (CAPs), the use of OMS data in the current electronic application forms (eAF5) became mandatory. This means that when filling out one of the (fillable) EU electronic application forms (e.g., electronic Application Form (eAF) or electronic Variation Application Form (VAF)), OMS data must be directly imported from the SPOR portal into the fillable forms provided and it is only possible if the applicant had previously registered on the SPOR portal and entered the related data. 

Mandatory use of OMS for National Authorized Products (NAPs) is still under discussion. However, with the progressive replacement of the current eAF forms with web-based application forms over the next year, OMS will de-facto become a requirement for NAPs as well. This is because web-based application forms are the same for CAPs and NAPs by design. Even though there are no official dates for National Procedures, it is recommended that companies begin to register their information as soon as possible in SPOR. 

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