Databases and digital systems
Published:
Changes
MA Holders must comply with criterias for mandatory submission and updates of medicinal product data to EMA's Product Management Service (PMS) and Extended EudraVigilance Medicinal Product Dictionary (XEVMPD), also known as the Art. 57 database.
Background:
- PMS is part of EMA's Substance, Product, Organisation and Referential (SPOR) master data management services.
- The introduction of PMS will implement ISO IDMP standards for medicinal product information in the EU/EEA.
- PMS data will, among other things, help prevent, detect, and manage shortages of medicinal products authorised for human use. The data will also simplify the secure exchange of medicinal product information and regulatory procedures (such as enrichment of the online, electronic application form in FHIR format), as well as enable data reuse across procedures.
Actions for Marketing Authorisation Holders:
To comply with requirements related to mandatory submission and updating of medicinal product data in PMS and XEVMPD, MAHs are advised to familiarise themselves with and implement the following measures:
- For authorised medicinal products, MAHs must submit updated data to comply with Article 57 of Regulation 726/2004. Newly authorised medicinal products must be submitted as soon as possible and no later than 15 calendar days from the date of authorisation. Updates to the terms of the marketing authorisation due to variations, renewals, suspensions, transfers, deregistrations, or withdrawals must be submitted within 30 calendar days from the date the changes were approved. See relevant information on EMA's Guidance documents related to data submission for authorised medicines.
- Align data with registered terminologies for references, organisation, and substance data.
- Structure product data according to the rules in Chapter 2 of the EU Implementation Guide.
- From the end of January 2025, EMA opened for submission of structured data on pack size along with manufacturers and "manufacturing business operations" (MBOs) through Product UI.
- MAHs will be required to correct and complete PMS product data.
- Monitor EMA and eSubmission websites for updates related to requirements and implementation timelines. Information and news from EMA are available on EMA's website and via webinars held by EMA.
Relevant information:
PMS guidance documents: https://plm-portal.ema.europa.eu/Guidance/article/KA-01032/en-us
eSubmission: https://esubmission.ema.europa.eu/eaf/index.html
XEVMPD submission guide: Extended EudraVigilance medicinal product dictionary (XEVMPD) training | European Medicines Agency (EMA)
Product UI guide: https://plm-portal.ema.europa.eu/Guidance/article/KA-01048/en-us