NAPs products and the web-based electronic Application Forms (eAFs), the PMS implementation and the ISO IDMP data (March 2024)

You’ll find below some basic information and simple recommendations for the MAHs of NAPs (NP/MRP/DCP authorised products) on the above topics with focus on the managing of the data on medicines.

One of the EMA key deliverable is the release of the medicines data in ISO IDMP format, to use (and re-use) in regulatory activities between regulators and pharmaceutical companies, through many digital applications and systems such as the new web-based eApplication form, the SPOR, the eProduct Information, the IRIS applications and the latest EMA projects: the European shortage monitoring platform (ESMP) and the Antimicrobial Sales and Use platform (ASU).

Objective of the EMA

The purpose of the EMA effort remains to have the digital systems ready for the new pharma legislation requirements, the largest reform in over 20 years.

The products data and relevant documents will be stored and made available from the PMS (Product Management System), expected for the end of 2024. Once fully implemented, the PMS will replace the xEVMPD database.

For this goal, the next step to be achieved by EMA during this year is the migration of the medicines data from xEVMPD to PMS, making at the same time, the data compliant with the ISO IDMP format and available for the use in the new eAF web-based. The data to be uploaded will be those of medicines with status different from “Not Valid – Superseded” or nullified.

As for latest news from the EMA Team, in April 2024 the data migration of Centrally Authorised Products (CAPs) from xEVMPD to PMS is going to take place as well as the simultaneous upload of updated CAPs (now splitted) on the web-based eAF.

Subsequently, EMA will proceed with the same data migration for the NAPs. The NAPs data should be uploaded into the PMS in ISO IDMP format within the end of 2024 and, by approximately early 2025, MAHs of NAPs should be able to use the web-based eAF on voluntary bases.

For some time, the managing of the data (the inserting, the updating and so on) will be carried out by the Industry “as-is” through xEVMPD.

Transition Period between XEVMPD and PMS

During this transition period between XEVMPD and PMS, EMA will maintain the two databases aligned in near real time. During this period, it is very important for companies to maintain high data quality in xEVMPD.

In the near future, when EMA releases the new operating modes (PUI and API), the managing of the data will be carried out by the industry directly on PMS and xEVMPD will be decommissioned.

Another key point for MAHs of NAPs is to be prepared for the data enrichment required to comply the ISO IDMP format.

The PMS will also contain product data partially or not present in xEVMPD, such as the Legal status of supply, the marketing status, detailed data on the authorised packaged medicinal products, the risk of shortage of supply of medicinal products, data on medical devices used in combination with medicinal products and information on certified manufacturers and related manufacturing activities.

The data enrichment will be carried out by the industry, in a near future.

Operational recommendations for NAP holders

What are the operative recommendations for MAHs of NAPS to be implemented during 2024 to be prepared? Below, some of the main ones:

• to maintain XEVMPD aligned with the current status of the products, correcting data if needed.
• to think about the PMS access for the management of the product data and related documents through the Product Lifecycle Management (PLM) portal, by Company users in terms of role and responsibility (administrator, manager, contributor?).
• to prepare for submitting/maintaining manufacturers’ data and pack sizes.

Regarding the manufacturers’ data, it is important to map your manufacturers to OMS and to map manufacturing operations to the terms in the RMS list.

Regarding the package data, you should start compiling your authorised pack sizes on XEVMPD. In the near future, EMA will issue instructions on how to provide pack sizes data on xEVMPD in most granulary format.

Stay tuned for the further news from the Di Renzo Team!

Written by 08/04/2024 by Monica Chiari