This document provides detailed guidance on the data elements and associated business rules applicable to:
• the submission of information of authorised medicinal products for human use;
• the maintenance of authorised medicinal product data previously submitted.
to the Product Management Service (PMS) only in accordance with the International Organisation for Standardisation (ISO), Identification of Medicinal Products (IDMP).
ISO IDMP standards specify the use of standardised definitions for the identification and description of medicinal products for human use.
ISO IDMP 11615 distinguishes between Authorised Medicinal Product and Investigational Medicinal Product. Authorised Medicinal Product (AMPs) are medicinal products that have a marketing authorisation being granted by a regulatory authority…
