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Identification of medicinal products

Index Identification of medicinal products

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. [1]

10 relations: Europe, European Medicines Agency, Health Level 7, International Organization for Standardization, ISO/TC 215, Jurisdiction, Marketing authorization, Marketing Authorization Application, Pharmacovigilance, Traceability.

Europe

Europe is a continent located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere.

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European Medicines Agency

The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products.

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Health Level 7

Health Level-7 or HL7 refers to a set of international standards for transfer of clinical and administrative data between software applications used by various healthcare providers.

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International Organization for Standardization

The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards organizations.

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ISO/TC 215

The ISO/TC 215 is the International Organization for Standardization's (ISO) Technical Committee (TC) on health informatics.

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Jurisdiction

Jurisdiction (from the Latin ius, iuris meaning "law" and dicere meaning "to speak") is the practical authority granted to a legal body to administer justice within a defined field of responsibility, e.g., Michigan tax law.

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Marketing authorization

Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval, etc.), finalized by granting of a document also called marketing authorization (MA) (equivalent: product license).

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Marketing Authorization Application

Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking permission to bring a newly developed medicinal product (for example, a new medicine) to the market.

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Pharmacovigilance

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

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Traceability

Traceability is the capability to trace something.

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IDMP.

References

[1] https://en.wikipedia.org/wiki/Identification_of_medicinal_products

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