Data on medicines (ISO IDMP standards): marketing authorisation

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP).

EMA is implementing the standards in a phased programme based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) master data.

Marketing authorisation holders should consider the regulatory information in the sections below:

• Data on medicines (ISO IDMP standards)
• Substance, product, organisation and referential (SPOR) master data
• Data submission on authorised medicines (Article 57)