On June 30th, 2021 the European Medicines Agency (EMA) released updates to its process for implementing the ISO standards for the Identification of Medicinal Products (IDMP). Here, Calyx’s Karen Harry, a member of the IDMP SPOR Task Force, provides a review of the updates and their impacts on Marketing Authorization Holders as the industry prepares to adopt IDMP.
The Updates
Following the release of version 2.0 of the EU implementation guidance in February 2021, EMA are planning two minor version updates in 2021:
Version 2.1
- Released in June 2021
- Focused on updates to the data related aspects of the guidance
Version 2.2
- Targeting release in October 2021
- Will focus on processes for the submissions for CAPs
“At Calyx, we’re committed to understanding all relevant IDMP updates to support our clients’ compliance when the new standards go into effect, beginning 2022.”
– Karen Harry, Director of RIM, Calyx
Chapter 2 introduces numerous new fields, including:
- Additional need to track “shortage of supply,” “reasons for the shortage,” and the expected return to market (restore) date for prescription and non-prescription medicinal products for each EU market
- Additional information on the composition of medicinal products is also required, with a new requirement to identify genetically modified products, and options to record the origin of substances
- Requirements to submit the Certificates of suitability for the active substance and TSE certificates of suitability with associated details
- Where certification of an Active Substance Master File, Vaccine Antigen Master File, or Plasma Master File has been provided these must also be submitted with associated details
Impact for Marketing Authorization Holders
As they look toward their IDMP readiness, MAHs need to locate the source(s) for the information on shortage of supply, reasons why, and dates for re-introduction of the medicinal product. RIM teams will likely be reliant on local affiliates, commercial teams, and the supply chain to monitor and provide this information on a routine basis. Ongoing collaboration with these stakeholders will be critical.
Moreover, MAHs need to identify the products impacted by the new certificate master file requirements and ensure they have the relevant certificates and numbers, together with the submission date, date of last update, and the manufacturer (where required for CEP, ASMF and PMF).
Impact for vendors
As a vendor providing software to support our clients for IDMP, Calyx are planning to integrate these additional fields into our IDMP solution and we will need to take an agile approach as we look toward future evolving requirements for additional data capture.
Chapter 3 includes updates to the process for electronic submissions.
The four new annexes provide additional clarity on requirements for PMS submissions (eCTD vs API and Full FHIR vs Delta) and which of the newly updated provenance reasons to select for:
- An initial MAA
- Life cycle operations
- Managing the final submission for variations that do not require the submission of a closing sequence
- Managing data enrichment activities for full or partial submissions following the migration of data from Article 57 and other EMA databases
Impact for Marketing Authorization Holders
The additional clarity provided in Chapter 3 positions MAHs to start defining business processes in support of IDMP for different scenarios. By working with their internal stakeholders and RIM vendors, MAHs can now begin to formalize their data capture and processes, in preparation for compliance in 2022.
Impact for vendors
From a vendor perspective the additional clarity in Chapter 3 with respect to the different scenarios has been helpful as Calyx looks to ensure our clients’ submission capabilities. Specifically,
- Where updates to PMS are required
- Whether these updates should be made via inclusion of the FHIR message in the working folder of the eCTD or direct to PMS via the API
- Which provenance reason to use
Check back regularly, as we’re committed to sharing all relevant IDMP updates to help ensure your compliance when the new standards go into effect, beginning 2022.
