Guidance and help - Article

Release version 2024/12/02

Overview

This release is the next iterative version of the Product Management Service (PMS). This version includes new enhancements to security and access management for NCAs in PMS APIv3, as well as ISO IDMP-related improvements. Additionally, some bug fixes for reported incidents have been solved.

Enhancements

ID	Description
F-209888	Change grouping criteria for LU products During the initial migration from XEVMPD to PMS, a wrong business rule was applied to the migration of these products: the MA number was used as a grouping element. The PMS team was notified later that this is not correct for these products, and the same approach as the one followed for the products in Belgium should be followed. Not all products from Luxemburg are impacted, only those where different pack sizes were submitted with different MA numbers.
F-194208	Access to PMS API V3 for NCAs Access to PMS API PROD H&V NCA is now granted to PMS API V3 for H&V NCAs. Refer to the Chapter 1 - Registration requirements section 3.2.1.1. Temporary arrangements for H&V NCAs for guidance on the registration process.
US-217422	For certain products there may not be a shared "root" MA number across all packaged medicinal products, therefore, MA number will remain empty so that the identifiers at the medicinal product and package level are accurately represented and maintained.

Description

F-209888

Change grouping criteria for LU products

During the initial migration from XEVMPD to PMS, a wrong business rule was applied to the migration of these products: the MA number was used as a grouping element. The PMS team was notified later that this is not correct for these products, and the same approach as the one followed for the products in Belgium should be followed. Not all products from Luxemburg are impacted, only those where different pack sizes were submitted with different MA numbers.

F-194208

Access to PMS API V3 for NCAs

Access to PMS API PROD H&V NCA is now granted to PMS API V3 for H&V NCAs. Refer to the Chapter 1 - Registration requirements section 3.2.1.1. Temporary arrangements for H&V NCAs for guidance on the registration process.

US-217422

For certain products there may not be a shared "root" MA number across all packaged medicinal products, therefore, MA number will remain empty so that the identifiers at the medicinal product and package level are accurately represented and maintained.

Bug fixes

ID	Description
BUG-217817	For products with multiple names (BE, LU and FI), PMS is currently taking 1 name when updates are submitted from XEVMPD.

Known issues pending to be fixed

ID	Description
BUG-220463	During the initial migration from XEVMPD to PMS, in some cases when dates were with only month/year, those were incorrectly migrated to PMS.
BUG-217096	For Split products in SIAMED, when packages moved to the new medicinal product, packages linked to the old medicinal product can still show as active due to an integration issue between SIAMED and PMS.
BUG-202000	Combined pharmaceutical dose form field can contain a value from incorrect RMS list of Authorised pharmaceutical dose.
BUG-218655	Some dates coming from SIAMED such as the EBD or procedure start date might reflect the day before the one is captured in SIAMED (e.g., instead of 9 March 1990, in the Product UI users will see 8 March 1990).
BUG-209254	All Finnish products are referring to an inactive organisation of the Finnish Medicines Agency.
F-193958	From XEVMPD only the attachment EV code present during the initial load has been migrated to PMS. The physical document has not been migrated. Therefore, the URL present in the Product UI is not working as the document was not migrated. Moreover, since the initial migration, the attachment section has not been maintained in PMS. Therefore, any new document submitted to XEVMPD has not been migrated in PSM and therefore will not be present neither in the Product UI nor in the PMS API.
BUG-202110	Some CAP products in PMS are showing duplicated presentations.
US-199606	In PMS it has been identified that multiple PMS CAP Medicinal Products have the same EU number. The expectation is that an EU number is only on one non-nullified CAP.
BUG 205134	The values in the Package Item Quantity and Manufactured Item Quantity are currently populated with a placeholder value of 1.

PMS release notes