On 8 July 2022, EMA updated its Products Management Services - Implementation Guide "Implementation of International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in Europe"
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.
These provisions mandate EU member states (MSs), marketing authorisation holders (MAHs) and the European Medicines Agency (EMA) to use ISO IDMP standards for the exchange and communication of information on medicinal products.
The EU IDMP Implementation Guide (EU IG) for the submission of data on medicinal products defines the implementation requirements of the ISO IDMP standards and will be the basis for submission and exchange of medicinal product data in the EU.
SUMMARY OF CHANGES
In June 2021, the content of sections 2 and Chapter 3 of the EU Implementation Guide (IG) was amended to include information relevant to the publication of version 2.1.1 of the EU Implementation Guide (IG) documents. A portion of the information related to the publication of version 1 of the documents has been removed, while information related to versions 2.0 and 2.1 has been retained.
CLICK this LINK to know more about EU Implementation Guide.
Also to understand the recent updated Chapter 2: Data elements for the electronic submission of information on medicinal products for human use Click HERE and to understand Chapter 8 – Practical examples Click HERE
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