ISO IDMP: EMA‘s Recommendations for Data Migration

In light of the ISO IDMP standards implementation for product information management, the European Medicines Agency (EMA) has recently shared guidance outlining the expectations for Marketing Authorization Holders (MAHs) in the near future. It is anticipated that the Product Management Service (PMS) system will incorporate both centralized authorization procedure (CAP) and non-CAP product data by the second quarter of 2024. To ensure this process runs smoothly, several essential processes are currently under development:

1. SIAMED II Data Mapping and Initial Data Migration. The integration of SIAMED data mappings with other SPOR (Substance, Product, Organization, and Referential) services is performed by the EMA.

2. XEVMPD Data Mappings and Initial Data Migration. Similar to the SIAMED II process, this involves mapping XEVMPD data with other SPOR services and conducting the initial migration of CAPs and non-CAPs. The business rules provided by the EMA to the MAHs include:

• Only the latest version of non-nullified records is migrated to PMS.
• The authorization status should not be “Not Valid – Superseded by Marketing Authorization Transfer” or “Not Valid – Superseded by Marketing Authorization Renewal/Variation” for successful migration.
• Records must include certain mandatory fields like Authorized Pharmaceutical Form, Legal Basis, and Medicinal Product Type to be migrated successfully.

3. Match and Merge of CAP Products. To ensure the smooth operation of this process, typos, legacy terms, and splittable terms should be taken into consideration when checking data in XEVMPD by selecting the correct term or updating XEVMPD to use an approved standard term. It is also critically important to ensure that the MAH (LOC ID) in SIAMED II and XEVMPD are the same. Notably, only EU records from XEVMPD will be considered for matching.

EMA’s recommendations to applicants

To avoid incorrect data migration which could result in delays of eAF application submission and impact CAP procedures such as parallel distribution, inspections, etc., EMA recommends the following steps that should be followed before the Q2 of 2024:

1. Familiarize with the EU IDMP Implementation Guides.

2. Check the XEVMPD data to avoid Data Quality issues:

• Authorisation Status – check it not only for valid but also for withdrawn records. Transferred records shall have the status “non valid – superseded by MA transfer”.
• Legal basis – cannot be null/empty.
• Product full name – check that product full name is consistent (no spaces, typos etc.) across similar/grouped EV codes.
• Authorisation number – for CP ensure it should align with Annex A.
• EU number – for CAPs should be the same as the Authorisation number.
• MRP/CP number – for CP ensure it aligns with Annex A and for BE products is consistent across frouped EV codes.
• Authorised Dose Form – Check mapping across EV and RMS.
• Administrable Dose Form – refers to the dose from administered to the patient (might not be the same as the authorised dose form).
• Active substance – check mapping to SMS, If SVG flag = 0 select another substance for the product.
• Strength – shall be consistent among EV codes to be grouped.
• MAH – check mapping to OMS (LOC ID). If missing/wrong, open a request in Service Now to correct the mappings.
• Packages – ensure all packages for CAPs are entered separately (one EV code per package), even if they were withdrawn or surrendered.
• Grouping – for records grouped by name, check that EV codes belonging to the same medicinal product have the same name and active substance and strength. For records grouped by MA number, check that EV codes belonging to the same medicinal product has the same MA number and same active substance and strength.

3. Use the export tool to extract full list of EV codes in Excel or CSV to see full information.

4. Ensure any Data Quality findings are permanently solved:

• EMA will contact QPPVs requesting the update of XEVMPD to solve data quality issues. MAHs must ensure that QPPV/company email is monitored and that data is corrected in XEVMPD system. It must be ensured that emails from [email protected] are not sent to spam folder.
• MAHs shall review the 3rd Ack after EMA performs validations and if needed, update their systems. If they don’t agree with the change, a ticked should be raised to system Service Now.
• For records where “Product vailidity” is “Not Assessed“, the reason should be reviewed why it was not assessed. It might be a duplicate of another record or there is missing information/documentation.

5. Support web-based eAF:

• XEVMPD can also have products not in scope of Art. 57 such as herbal or homeopathic products.
• If needed in a variation form, MAHs can submit these products to XEVMPD following instructions in chapter II in XEVMPD.
• If needed, pack sizes for medicinal products where the MA number is assigned at medicinal product level can be submitted as well. Package description in XEVMPD should be populated correctly.
• Pending MRPs and DCPs will be submitted to XEVMPD when eAF allows NAPs variations.

Summary

In conclusion, with the Q2 of 2024 deadline approaching for the implementation of ISO IDMP standards, it’s crucial for MAHs to prepare for the upcoming changes. Adhering to EMA’s recommendations will not only ensure compliance but also streamline the data migration process, avoiding potential delays and impacts on product management and distribution.

At Insuvia, we understand the complexities of XEVMPD and ISO IDMP standards like no other. Our team of experts is ready to guide you through every step of the data migration process, ensuring that your product information management meets EMA’s expectations with ease. Whether you’re navigating the initial data migration, struggling with data quality issues, or looking for strategic advice on managing your product data, Insuvia is here to help.

Don’t let the ISO IDMP implementation process overwhelm you. Contact Insuvia today, and let us simplify your journey towards compliance and operational excellence. Our expertise is your peace of mind. Take the next step towards seamless data migration and compliance. Reach out to Insuvia now.