Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1
- Training .................................................................................................................................................... 13
Product Management Service (PMS) - Implementation of International Organization for
Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
Europe
EMA/676105/2019Page 2/13
Summary of changes
Following the publication of version 2 in February 2021, the following sections were updated:
?PMS Registration requirements;
?
Access to data;
?
Training.
- Scope of this document
This document has been developed with the goal of facilitating the maintenance and accessibility to
data on medicinal products for human use in the EU. - Scope of PMS
The scope of PMS is to have harmonised data and definitions to uniquely identify a medicinal product
based on regulated information (e.g. - Therefore, users shall read this chapter in
conjunction with the 'On-boarding of users to Substance, Product, Organisation and Referentials
(SPOR) data services' document. - In order to start this process the user has to confirm the registration of the relevant organisation in
Organisation Management Service (OMS). - Product Management Service (PMS) - Implementation of International Organization for
Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
Europe
EMA/676105/2019Page 4/13
User can check whether the relevant organisation is in OMS by searching using 'Request Access for
Organizations' at EMA account management. - Product Management Service (PMS) - Implementation of International Organization for
Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
Europe
EMA/676105/2019Page 10/13
Is the user Organisation
in OMS? - For further information on how data are classified please refer to EU IG
Chapter 5 and Annex A to Chapter 5. - Product Management Service (PMS) - Implementation of International Organization for
Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
Europe
EMA/676105/2019Page 12/13
5.
- Additional information on the location of the training materials
will be made available in future updates of this chapter. - At the time of the PMS go live foreseen in Q2 2024, users will have read-only privileges in PMS.
- The
enabling of the write privileges will be released for specific set of PMS data elements at later stage in
Q4 2024. - Product Management Service (PMS) - Implementation of International Organization for
Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
Europe
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