Identification of Medicinal Products (IDMP) is a set of five ISO norms which has been developed in response to a worldwide demand for internationally harmonized specifications for medicinal products. IDMP provides the basis for the unique identification of medicinal products, it facilitates the activities of medicines regulatory agencies worldwide by jurisdiction for a variety of regulatory activities (development, registration and life cycle management of medicinal products; pharmacovigilance and risk management). IDMP is the base for the Marketing authorization of medicinal products in Europe. It requires the five ISO Norms being implemented in the Marketing Authorization Application process.
Messaging specifications are included as an integral part of the IDMP standards. They describe and protect the integrity of the interactions for the submission of regulated medicinal product information in the context of the unique product identification; they include acknowledgement of receipt including the validation of transmitted information. Health level Seven (HL7) Message Exchange are normative within the IDMP Standards.
IDMP Standards are designed to allow unambiguous identification of products across regions to improve the robustness of pharmacovigilance and regulatory activities. They can also be applied to Investigational Medicinal Products.
IDMP Standards are completed with Implementation Guides which are currently in development (2017).
The standards can be found from ISO TC 215´s deliveries
Video Identification of medicinal products
The five ISO IDMP standards
ISO 11238
Regulated information on substances
Defines substances and specified substances by their main general characteristics, and their roles in medicinal products (e.g. active, adjuvant). In addition specified substances are listed more granular with specific descriptions (e.g. including manufacturing information, grade of purity etc.).
ISO 11239
Regulated Information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
Identifies and defines concepts for each of the above. For example, in dose forms: "injection solution", "injection suspension" (or a less granular regional term linked to these)
ISO 11615
Regulated medicinal product information
Defines, characterises and uniquely identifies regulated medicinal products during their entire life cycle (development, authorisation, post-Marketing and renewal or withdrawal from the market) by describing the detailed data elements and their structural relationships
ISO 11616
Regulated pharmaceutical product information
Pharmaceutical Product Identification (PhPID) uniquely identifies a generic (pharmaceutical) representation of a medicinal product at Levels Substance(s)/Strength(s) - Strength Units /Reference Strengths per Administrable Dose Form
ISO 11240
Units of measurement
Specifies rules for the usage of units of measurement for IDMP; defines requirements for traceability to metrological standards; establishes reference code system for units; provides structure and rules for mapping between different unit vocabularies and language translations.
Maps Identification of medicinal products
See also
- European Medicines Agency
- Marketing Authorization Application
- Marketing authorization
- ISO
External links
European Medicines Agency (EMA) IDMP Landingpage
Source of article : Wikipedia
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