PD CEN ISO/TS 20443:2018
Current
The latest, up-to-date edition.
Health informatics. Identification of medicinal products. Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information
Hardcopy , PDF
English
05-24-2018
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Message exchange
5 Conformance terminology and context as it
relates to the ISO IDMP standards and
corresponding technical specifications
6 Maintenance of IDMP data elements and IDMP identifiers
7 Why standardisation of identification of Medicinal
Products is needed
8 General considerations
9 Information for an authorised Medicinal Product
10 Investigational Medicinal Product Identifier (IMPID)
Annex A (normative) - Medicinal Product
Annex B (normative) - Marketing authorisation
Annex C (normative) - Packaged Medicinal
Product (including manufactured item and device)
Annex D (normative) - Ingredient, substance and strength
Annex E (normative) - Pharmaceutical product and device
Annex F (normative) - Clinical particulars
Annex G (normative) - Organisation
Annex H (normative) - Manufacturer/establishment
Annex I (normative) - Investigational Medicinal Product
Annex J (normative) - SPL documents
Annex K (informative) - Abbreviations
Bibliography
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.