The Complexity of IDMP

The pioneering scheme would be based on a five-year-old package of data standards on the Identification of Medicinal Products (IDMP) drawn up by the Geneva-based International Organization for Standardization (ISO). The industry's perspective "The leading multinational pharma companies are...

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Bibliographic Details
Published in:Pharmaceutical technology Europe 2017-05, Vol.29 (5), p.6
Main Author: Milmo, Sean
Format: Article
Language:English
Subjects:
Codes
Drug dosages
Good Manufacturing Practice
Health informatics
Identification
International organizations
ISO standards
Manufacturing
Packaging
Pharmaceutical industry
Pharmaceutical sciences
Pharmacovigilance
Regulation
Regulatory agencies
Small business
Standardization
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Summary:The pioneering scheme would be based on a five-year-old package of data standards on the Identification of Medicinal Products (IDMP) drawn up by the Geneva-based International Organization for Standardization (ISO). The industry's perspective "The leading multinational pharma companies are taking IDMP seriously and are taking steps to be ready when it legally has to be implemented," said Paul Attridge, senior director R&D Europe of the Veeva Vault data management platform of San Francisco-based Veeva Systems Inc. "But a lot of mediumsized and smaller companies are holding back," he told Pharmaceutical Technology Europe. An EMA list of other applications for IDMP include batch recalls, in addition to those triggered by pharmacovigilance, inspections including those related to good manufacturing practice (GMP), drug shortages, regulatory activities such as approval of variations like process changes, e-prescriptions, and initiatives under the EU's Falsified Medicines Directive (FMD), such as the identification of individual product packs. Data management For EMA, the key application of IDMP will be the obligation for pharmaceutical companies under article 57 (6) of its amended 2004 medicines authorization legislation to submit information to the agency on authorized medicines and attributes of products such as dosage forms, country codes, package codes, and weight codes. Health informatics-Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration, and packaging (Geneva, November 2012). Health informatics-Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated pharmaceutical product...
ISSN:1753-7967