What is an IDMP and its application in Pharmacovigilance?

In response to the demand for internationally harmonized detail of medicinal products, the IDMP which comprises of a set of five ISO norms provides the basis of identifying medicinal products. IDMP standard readily facilitates ICSR (Individual Case Safety Report) submission to regulatory agencies.

The message specification in IDMP protects the integrity of medicinal product information when submitting cases to the regulatory agency. HL-7 transmissions are within the IDMP standards Health Level 7- is an international standard for facilitating data exchange between the safety/ clinical database and the regulatory agency.

The five ISO norms comprise of

ISO 11238 pertains to general characteristics of regulated medicinal products specifying where the product is an active pharmaceutical ingredient or an adjuvant. ISO 11238 also describes the grade of product used (purity, manufacturing information etc.…)

ISO 11239 pertains to regulated information on packaging, dosage form, route of administration etc.

ISO 11615 pertains to marketing authorization status of the medicinal product.

ISO 11616 pertains to reference units and strengths of the medicinal product.

ISO 11240 pertains to units of measurement and traceability of identification of medicinal products (IDMP).

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