Product Management Services – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe

On 30 June 2021 the EMA published the guidance on ISO implementation for the IDMP in Europe.

The ISO IDMP standards specify the use of standardized definitions for the identification and description of medicinal products for human use. The purpose of these standards is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, by providing a common product ’language’ for stakeholders to use in their interactions.

The use of ISO IDMP standards is required in accordance with Articles 25 and 26 of Commission Implementing Regulation (EU) No 520/2012. These provisions mandate member states (MSs), marketing authorization holders (MAHs) and the European Medicines Agency (EMA) to use ISO IDMP standards for the exchange and communication of information on medicinal products.

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