SPOR Management (IDMP)
The identification of medicinal products consists in a series of standards that were created by the International Organization for Standardization (ISO) to provide standardized medicinal products identification to improve drug safety. Implementation is starting with EMA and FDA should follow very soon.
Learn more about ISO standards.
IDMP is worldwide standard that will require to provide nearly twice more data pre and post marketing than European Article 57 (xEVMPD).
Those data come from different functions (PV, Regulatory, Clinical, Supply Chain, Industrial Affairs…), managed in several and heterogeneous sources (databases, documents, spreadsheets, etc.…).
Its implementation requires a clear strategy, based on cross-functional approach and impacting multiple information management systems.
Timelines are aggressive and iterated implementation asked by the agency requires agility.
IDMP compliance : From challenges to business opportunities
Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
Marketing-authorisation holders (MAHs) of medicines authorised in the European Union (EU) and European Economic Area (EEA) must submit information on these medicines to the European Medicines Agency (EMA) and must keep this information up-to-date.
This is a legally binding requirement from the EU pharmaceutical legislation (Article 57(2) of Regulation 726/2004). More detail here
Identification of Medicinal Products (IDMP)
The International Organisation for Standardisation (ISO), Identification of Medicinal Products (IDMP) standards specify the use of standardised definitions for the identification and description of medicinal products for human use.
- ISO IDMP comprises five separate standards. More detail here
- IDMP Implementation (by region and by phase). More detail here
Our service Offer
Teelia provides an XEVMPD and IDMP consulting and data management services to help organizations prepare for implementation. The following are our XEVMPD and IDMP Services