M00019975
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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 (ISO/TS 20443:2017)
British Standards Institution
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Availability date: 11/05/2021
Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Message exchange<br>5 Conformance terminology and context as it <br> relates to the ISO IDMP standards and<br> corresponding technical specifications<br>6 Maintenance of IDMP data elements and IDMP identifiers<br>7 Why standardisation of identification of Medicinal <br> Products is needed<br>8 General considerations<br>9 Information for an authorised Medicinal Product<br>10 Investigational Medicinal Product Identifier (IMPID)<br>Annex A (normative) - Medicinal Product<br>Annex B (normative) - Marketing authorisation<br>Annex C (normative) - Packaged Medicinal <br> Product (including manufactured item and device)<br>Annex D (normative) - Ingredient, substance and strength<br>Annex E (normative) - Pharmaceutical product and device<br>Annex F (normative) - Clinical particulars<br>Annex G (normative) - Organisation<br>Annex H (normative) - Manufacturer/establishment<br>Annex I (normative) - Investigational Medicinal Product<br>Annex J (normative) - SPL documents<br>Annex K (informative) - Abbreviations<br>Bibliography
Describes concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.
Published | |
Document Type | Standard |
Status | Current |
Publisher | British Standards Institution |
Pages | |
ISBN | |
Committee | IST/35 |