IDMP Identification Medicinal Products Standards | Revised 2017

Update 26.10.2017

ISO/TC 215 Health informatics

A series of standards called IDMP (Identification of Medicinal Products) is under revision and will bring a host of benefits to patients and the healthcare community. Implementing these standards should simplify the exchange of information between stakeholders and enhance the interoperability of systems in the medical field.

IDMP standards and technical specifications, comprising ISO 11616, ISO 11615, ISO/DIS 11238, ISO/TS 20451, ISO/TS 20443 and ISO/TS 19844, support the activities of medicines agencies worldwide. These cover a variety of regulatory activities related to the development, registration and life-cycle management of medicinal products, as well as pharmacovigilance and risk management.

To meet the primary objectives of the regulation of medicines and pharmacovigilance, the reliable exchange of medicinal product information in a robust and consistent manner is essential. IDMP standards fully support this and that is why a revision of the standards was deemed opportune.

ISO IDMP standards cover the following aspects to describe a medicinal product: 

- Medicinal product name
- Ingredient substances
- Pharmaceutical product (route of administration, strength)
- Marketing authorization
- Clinical particulars
- Packaging
- Manufacturing

Standards:

ISO 11615:2017
Health informatics
Identification of medicinal products
Data elements and structures for the unique identification and exchange of regulated medicinal product information

ISO 11616:2017
Health informatics
Identification of medicinal products
Data elements and structures for unique identification and exchange of regulated pharmaceutical product information

ISO/DIS 11238 [Under development]
Health informatics
Identification of medicinal products
Data elements and structures for the unique identification and exchange of regulated information on substances

ISO/TS 20451:2017
Health informatics
Identification of medicinal products
Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

ISO/TS 20443:2017
Health informatics
Identification of medicinal products
Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information

ISO/TS 19844:2016
Health informatics
Identification of medicinal products
Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances[/box-note]

Fonte: ISO