Data on medicines (ISO IDMP standards): post-authorisation

All holders of marketing authorisations for medicines in the European Union (EU) and the European Economic Area (EEA) must submit information to the European Medicines Agency (EMA) on authorised medicines and keep this information up-to-date.

In this section

• Data submission on authorised medicines (Article 57)
• Public data from Article 57 database
• Reporting requirements for marketing-authorisation holders
• Registration
• Extended EudraVigilance medicinal product dictionary (XEVMPD) training

In other sections

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

• Data on medicines (ISO IDMP standards): overview
• Substance, product, organisation and referential (SPOR) master data