Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe: Chapter 3

On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management service: Chapter 3 – Process for the electronic submission of medicinal products information.

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 authorization application, to the maintenance activities (e.g. variations and renewals) of the data previously submitted.

ISO IDMP standards specify the use of standardized 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 authorization holders and the European Medicines Agency (EMA) to use ISO IDMP standards for the exchange and communication of information on medicinal product.

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