Articol

Why planning is key for PMS readiness

Karl-Heinz Loebel

Find out how companies can plan for Product Management Service (PMS) data requirements and consider implementing dedicated software systems to better embed PMS data handling into their overall database and process landscape.

The current and future implications of the Product Management Service (PMS) are becoming increasingly apparent. A key part of the European Medicines Agency’s (EMA) four-part SPOR master data program, PMS contains detailed structured and validated information on authorized European Economic Area (EEA) medicinal products.¹

As previously explored in “Preparing the PMS," it is intended to be a single source of truth for medicinal product data. At the time of writing, PMS was limited to the data that was imported by EMA from XEVMPD, but in the longer run it will be extended to encompass a larger share of the Identification of Medicinal Products (IDMP) model, though the full extent was not yet clear.²

Understanding PMS requirements

October 2026 update: The enrichment function of the PMS user interface has been live since February 3, 2025, and EMA has adjusted their deadlines: June 2026 for ULCM products, December 2026 for manufacturer data, and June 2027 for structured pack sizes.^9,10

To prepare for PMS activities, it is advisable for companies to start strategic planning to ensure that data cleansing and additions to XEVMPD are performed efficiently. How they go about this depends on how they handle XEVMPD data submissions: using either EMA’s free EVWEB tool4 or in-house systems if their XEVMPD data is organized in a regulatory information management (RIM) system or another dedicated tool.

These activities may require additional resources, especially for the XEVMPD cleansing and extension activities, and when considering the February 2025 deadline for some of these activities on the European Shortages Monitoring Platform (ESMP) relevant products.⁵

Possible next steps

Reviewing entries for the Organisation Management Services (OMS) for Marketing Authorization Holders (MAHs) and Manufacturers.
Checking SMS (Substance Management Services) data used to describe the composition of products and performing corrections as needed. This also includes checking the substances’ current Substance Validation Group (SVG) assessment status and may require assigning different substance terms to products.⁶
Making sure products have been migrated correctly and completely from XEVMPD to PMS.

Once the enrichment function in the PMS PUI has been enabled (which is expected by early 2025), the structured pack size information and additionally the information on manufacturers should be completed for ULCM products by the end of 2025 and for other products by the end of 2026, as shared by EMA during various sessions. There will also be the option to submit data carrier ID for both centrally authorized and non-centrally authorized products using the PUI.

Companies are advised to wait for more information from the national authorities with regards to the data carrier ID, since at the time of writing there appeared to be a lack of consensus on how this should be addressed. However, there will likely be the potential to reuse the data and have the connections in place for logistics and serialization. Furthermore, the EMA is committed to cooperating with the national competent authorities (NCAs) so they can reuse the data, for example to streamline regulatory processes. At the moment, though, the NCAs’ focus also lies on the ULCM products and the input they have to provide to ESMP. National stock and expected future demand need to be reported by NCAs into the shortages monitoring platform and therefore be aligned and matched with the data on products coming from PMS.⁸

Other near-term activities companies will need to commit to include looking into their current XEVMPD data maintenance processes, checking for improvements and, where necessary, allocating additional resources.

Another near-term activity that companies will need to address is the inclusion of any product needed in web-based electronic application forms (such as homeopathic and herbals).

Planning strategies for the future

Now that the PMS user interface enrichment functionality is available, companies can consider preparing and performing the first enrichment of PMS data beyond the scope of XEVMPD data. This includes adding structured pack size information and adding manufacturers.

Looking further into the future, companies might consider implementing dedicated software systems to better embed PMS data handling into their overall database and process landscape, with the potential to also cover non-EU products and activities such as enterprise resource planning (ERP) or labeling and artwork. But the extended scope of data in PMS (compared to XEVMPD) may lead even smaller companies with less complex product portfolios to consider investing in additional or more complex software solutions.

Precizare:
Informațiile furnizate în acest articol nu constituie consultanță juridică. Cencora, Inc. încurajează insistent cititorii să revizuiască informațiile disponibile legate de subiectele discutate și să se bazeze pe propria experiență și expertiză în luarea deciziilor legate de acestea.