What is IDMP?
IDMP is a suite of five standards developed within the International Organization for Standardization (ISO). These standards provide an internationally accepted framework to uniquely identify and describe medicinal products with consistent documentation (including labeling), coding and exchange of product information between global regulators, manufacturers, suppliers and distributors.
How does Kallik help with IDMP?
Kallik helps pharmaceutical manufacturers prepare for IDMP compliance by preserving labelling content as structured data. Because Veraciti stores, indexes and versions every piece of labelling content ever created and maintains a record of which labels use which content, the risk of downstream labelling becoming out of alignment with submission data is greatly reduced.
- Captures and manage the relationship between the data elements that form part of the package description and the underlying data that forms part of the labelling content
- Establishes a single source of labelling ‘truth’ that all market-facing product information and materials flow from
- Facilitates the reliable exchange of structured regulatory content contained within product and package labeling in a robust and consistent manner
Timeline of Updates
2012: IDMP standards published by ISO
The ISO IDMP standards specify the use of standardized definitions for the identification and description of medicinal products for human use. They were developed in response to a worldwide demand for internationally harmonized specifications for medicinal products. The group of five standards provide the basis for the unique identification of medicinal products.
2016: Date set by EMA for IDP compliance
Original date set for which manufacturers will be required to adhere to a new set of regulations that govern the way their products must comply with industry standards. The Identification of Medicinal Products (IDMP) regulations will require all pharmaceutical products to be identified according to a set of data standards defined by the International Organization for Standardization (ISO).
2017: ISO publishes revised IDMP standards
The revision was a consequence of the development of IDMP implementation guides. The overall standard remanded largely unchanged but gained in usability for implementers. By developing implementation guides, it was possible to move some information from the standard itself to its corresponding implementation guide.
2018: EMA publishes revised timelines for IDMP implementation
Unlike its eXtended EudraVigilance Medicinal Product Directory (XEVMPD) predecessor, EMA’s initial implementation of IDMP includes packaging and labelling and hence is broader in scope.
2021: Submissions to PMS begin
Beginning Q3 2021, organizations can start submitting product data to the EMA IDMP Master Data Management (MDM) platform via SPOR (Substances Products Organizations and Referentials) data services.
2022: Submissions to PMS are mandatory
From Q3 2022, submission of product data to the EMA IDMP (MDM) becomes mandatory, whilst xEVPRM messages can no longer be submitted from this date.
How to be compliant
Getting started now with building a repository of structured labelling content will remove one key item from the critical path toward achieving IDMP compliance
Facilitate process efficiencies in regulatory activities (e.g. submission of medicinal product information, regulatory application forms and variations) by adopting a structured data approach to content related to packaged products
Eliminate multiple siloed systems by moving to a centralized cloud-based solution will improve visibility, control and co-ordination making it easier to capture and prepare data for IDMP submission
Unite dispersed teams and eliminate disjointed processes resulting from use of spreadsheets, documents, emails and localized desktop solutions that otherwise compromise the integrity of labelling content
Be better prepared for further world adoption of IDMP regulations by implementing a scaleable, robust and transparent solution to secure your supply chain and deliver globally compliant labeling
Capture and manage labeling content within a single controlled environment to unify data ahead of its dispersal to regulatory, manufacturing and submission systems and processes