XEVMPD and IDMP Compliance
Pharmacovigilance
Since July 2012, MAHs in the EU are responsible for submitting and maintaining information on all EU-approved medicinal products and development substances of EU-based clinical trials to the XEVMPD (Article 57) database.
In parallel, the upcoming implementation of the Identification of Medicinal Products (IDMP) standards will introduce a new data-driven framework for medicinal product information management across the EU.
PVpharm provides expert support to ensure compliance with XEVMPD (Article 57) and upcoming IDMP requirements, helping you maintain accurate product data and stay inspection ready.
Our services include:
- XEVMPD Data Entry and Maintenance: Submission of initial and updated product data to the EMA’s XEVMPD database, including validation and consistency checks.
- Data Quality Review and Gap Analysis: Verification of existing product data against EMA requirements, identification of gaps, and implementation of corrective actions.
- IDMP Readiness Support: Strategic planning and data mapping services to prepare your organisation for phased IDMP implementation (based on ISO IDMP standards and SPOR framework).
- Controlled Vocabularies and Standards Alignment: Ensuring that all submitted data aligns with EMA’s referentials and terminologies (e.g., RMS, OMS, SMS, and PMS).
- Training and Process Integration: Training for internal teams and integration of XEVMPD/IDMP compliance into regulatory workflows and quality systems.
