Europe – Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe : Chapter 8

The International Organisation for Standardisation (ISO), identification of medicinal products (IDMP) standards specify the use of standardised 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 specific application of the IDMP standards for human medicinal products at the European Union and European Economic Area are described in EU IG Chapter 2 – Data elements for the electronic submission of information on medicinal products for human use. This includes information on what medicinal product information (data fields) are applicable and the associated business rules, data types and conformance governing the submission of the product information. Therefore, EU IG Chapter 2 should be considered as the main reference document while preparing a medicinal product submission of products that fall under the scope of Article 57(2) of Regulation (EC) No 726/2004, as amended by Regulation (EU) 1235/2010 and Regulation (EU) 1027/2012…