Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Structured Product Labeling standard: A tool for IDMP implementation and electronic package leaflet creation?

Dr. Stefanie Blättermann (Abschlußjahr: 2016)

Summary
Language: English
Identification of Medicinal Products (IDMP) is a general term for five global standards which were developed by the International Organization for Standardization defining terminology, formats and standards for unique and global identification of medicinal products. As a result, consistent and simplified documentation, coding and exchange of information on medicinal products between marketing authorization holders and regulatory authorities will be enabled. In the European Union (EU), stakeholders are obliged to make use of these defined formats and standards for data submission to the European Medicines Agency from July 2016, following a phased implementation process.
For submission of ISO IDMP data, the Structured Product Labeling (SPL) standard from Health Level 7 was determined as data submission format. The SPL standard is an Extensible Markup Language standard which is used for submission of structured product information to the Food and Drug Administration in the United States (US) since 2005.
In the present thesis, an introduction of the SPL standard is given. Also, the ISO 11615 standard defining the Medicinal Product is introduced with focus on its specifications on the content, structures and relationships of data element classes. An approach is performed to bring together the IDMP exchange format SPL and the IDMP data by presenting the Clinical Particulars class of the Medicinal Product in the SPL document structure reflecting the relationships specified by ISO 11615.
As the SPL standard is a well-established data exchange format for submission of product information between regulatory stakeholders and healthcare institutions in the US, the question is raised whether the SPL standard might not also be used for creation and exchange of electronical product information in the EU. In this context, an evaluation is performed on the status quo situation whether demand exists to also make use of the SPL standard for creation of electronic product information in the EU.
Pages: 41
Annexes: pages: 4