Home » EMA Establishes Standards for Producing Unique Identifiers for Drugs
EMA Establishes Standards for Producing Unique Identifiers for Drugs
Drugmakers selling into the EU will have two years to begin complying with a new set of ISO global standards that will create a unique identifier for drugs.
The five ISO IDMP standards define the data elements and structures for the unique identification of and exchange of regulated information on:
- Substances (ISO 11238);
- Pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239);
- Units of measurement (ISO 11240);
- Regulated pharma product information (ISO 11616); and
- Regulated medicinal product information (ISO 11615).
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