Implementation of International Organization for Standardization (ISO) identification of medicinal products (IDMP) standards

Common standards, formats and terminologies should be used in the European Union (EU) to identify and exchangepharmacovigilance and medicinal product information. This is a legally binding requirement from the EU pharmaceutical legislation for Member States, marketing-authorisation holders and the European Medicines Agency (EMA).

Since July 2012, marketing-authorisation holders of medicinal products authorised in the EU and the European Economic Area (EAA) must submit information to EMA on authorised medicines and keep this information up-to-date, in line with Article 57(2) ofRegulation (EU) 726/2004 requirements. This information must be submitted in an eXtended EudraVigilance Product Report Message (xEVPRM) format and in line with the updated reporting requirements, as stated in the legal notice and detailed guidance documents on the Guidance documents page. For more information, see Reporting requirements for authorised medicines.

Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) requires International Organization for Standardization (ISO) identification of medicinal products (IDMP) standards to be implemented in the EU for the identification and exchange of information on medicines. The ISO IDMP standards were finalised in 2012 and implementation guides are currently under development at international level. The transition to implementing the ISO IDMP standards is currently expected to be effective from July 2016.

Following the implementation of the ISO IDMP standards, the Agency will replace the data-submission format in line with the ISO IDMP standards, terminology and formats.