Europe – Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe : Chapter 3

This chapter provides guidance on the process governing the electronic submission of human medicinal products in the European Economic Area (EEA), in accordance with ISO IDMP standards i.e. using the FHIR message from PMS.
This guidance covers the entire process from the initial submission of the marketing authorisation application, to the maintenance activities (e.g. variations and renewals) of the data previously submitted.
ISO IDMP standards specify the use of standardised definitions and structures for the identification and description of medicinal products for human use. The use of ISO IDMP is required in accordance with Articles 25 and 26 of Commission Implementing Regulation (EU) No 520/2012. These provisions mandate Member States, marketing authorisation holders and the European Medicines Agency (EMA) to use ISO IDMP standards for the exchange and communication of information on medicinal product…