🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN ISO 11615:2017 – TC:2020 Edition

BS EN ISO 11615:2017 – TC:2020 Edition

$280.87

Tracked Changes. Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information

Published By Publication Date Number of Pages
BSI 2020 0
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

PDF Catalog

PDF Pages PDF Title
181 undefined
189 Foreword
190 Introduction
192 1 Scope
2 Normative references
193 3 Terms, definitions and abbreviated terms
204 4 Message exchange format
205 5 Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications
6 Concepts required for the unique identification of Medicinal Products
6.1 General considerations
6.2 Authorised Medicinal Products
206 6.3 Investigational Medicinal Products
6.4 Concepts required for the unique identification of a Medicinal Product and the association with PhPID(s)
6.5 Concepts required for the unique identification of Medicinal Products and the association with the marketing authorisation number
207 6.6 Concepts required for the unique identification of Medicinal Products and the association with data carrier identifiers
208 7 Description of the information modelling principles and practices
7.1 General considerations
7.2 Conceptual overview diagrams
209 7.3 High-level diagrams
7.4 Detailed description diagrams
7.4.1 General
210 7.4.2 Relationships between classes
211 7.4.3 Attributes of classes
7.4.4 Generalised classes and patterns
7.4.5 Translation and language
8 Identifying characteristics for authorised Medicinal Products
8.1 Primary identifiers — General considerations
212 8.2 Medicinal Product Identifier (MPID)
8.2.1 General considerations
8.2.2 MPID code segments
213 8.3 Packaged Medicinal Product Identifier (PCID)
8.3.1 General considerations
214 8.3.2 Package description (PCID) code segment
8.4 Medicinal Product Batch Identifier (BAID1)
8.5 Medicinal Product Batch Identifier (BAID2)
215 9 Information for an authorised Medicinal Product
9.1 Authorised Medicinal Product — Information overview
9.1.1 General
9.1.2 Medicinal Product
9.1.3 Medicinal Product name
216 9.1.4 Header
9.1.5 Manufacturer/Establishment (organisation)
9.1.6 Marketing authorisation
9.1.7 Packaged Medicinal Product
9.1.8 Pharmaceutical product
9.1.9 Ingredient
9.1.10 Clinical particulars
9.2 Medicinal Product
9.2.1 General
217 9.2.2 Detailed description of Medicinal Product information
223 9.3 Marketing authorisation
9.3.1 General
224 9.3.2 Detailed description of marketing authorisation information
229 9.4 Organisation
9.4.1 General
9.4.2 Detailed description of organisation information
232 9.5 Manufacturer/Establishment (organisation)
9.5.1 General
9.5.2 Detailed description of manufacturer/establishment (organisation) information
233 9.6 Packaged Medicinal Product, including manufactured item and device
9.6.1 General
234 9.6.2 Detailed description of Packaged Medicinal Product information
243 9.7 Ingredient, substance and strength
9.7.1 General
9.7.2 Detailed description of ingredients, substance and strength information
246 9.8 Pharmaceutical product and device
9.8.1 General
9.8.2 Detailed description of pharmaceutical product and device information
248 9.9 Clinical particulars
9.9.1 General
249 9.9.2 Detailed description for clinical particulars information
253 10 Identifying characteristics for Investigational Medicinal Products
10.1 General
10.2 Primary identifiers
10.2.1 General considerations
254 10.3 Investigational Medicinal Product Identifier (IMPID)
10.3.1 General considerations
10.3.2 IMPID code segments
255 10.4 Investigational Medicinal Product Package Identifier (IPCID)
10.4.1 General provisions
10.4.2 Package description code segment
256 10.5 Investigational Medicinal Product Batch Identifier (BAID1)
10.6 Investigational Medicinal Product Batch Identifier (BAID2)
11 Information for an Investigational Medicinal Product
11.1 General
11.2 Conceptual overview of the information for an Investigational Medicinal Product
11.2.1 General
257 11.2.2 Investigational Medicinal Product
11.2.3 Investigational Medicinal Product name
11.2.4 Header
11.2.5 Manufacturer/Establishment (organisation)
258 11.2.6 Clinical trial authorisation
11.2.7 Investigational Packaged Medicinal Product
11.2.8 Pharmaceutical product
11.2.9 Ingredient
11.2.10 Clinical particulars
11.3 Investigational Medicinal Product
11.3.1 General
11.3.2 Detailed description of Investigational Medicinal Product information
261 11.4 Clinical trial authorisation
11.4.1 General
11.4.2 Detailed description of clinical trial authorisation information
263 11.5 Manufacturer/Establishment (organisation)
11.6 Investigational Packaged Medicinal Product
11.7 Pharmaceutical product
11.7.1 General
264 11.7.2 Pharmaceutical product
11.7.3 Dosing and route of administration
11.8 Ingredient
265 11.9 Clinical particulars
11.10 PhPID sets
11.11 Device nomenclature
11.12 Device batch identifier
11.13 Physical characteristics
11.14 Other characteristics
266 Annex A (normative) Full model — Authorised Medicinal Products detailed diagram
267 Annex B (normative) Full model — Investigational Medicinal Products detailed diagram
268 Bibliography

Related products

BS EN ISO 11615:2017 - TC
$280.87