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S.R. CWA 15914-1:2009

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

CRITERIA, METHODOLOGY AND PROCEDURES FOR CREATING AN E-CODIFICATION CONCERNING SUBSTANCES USED IN PHARMACEUTICAL COMPOUNDING
Available format(s)

Hardcopy , PDF

Withdrawn date

05-13-2021

Language(s)

English

Published date

01-01-2009

Preview

Foreword
1 Scope
2 Normative References
3 Definitions and abbreviations
  3.1 Definitions
  3.2 Abbreviations
4 The source of data
  4.1 Supplier of substances
  4.2 Pharmacopoeia
  4.3 Reference books and reviews
  4.4 Scientific committee
  4.5 Maintenance
5 The Criteria of E-codification
  5.1 Criteria of identicalness
  5.2 Criteria of therapeutic similarity
  5.3 Criteria of pharmacological properties
6 The structure of the database
  6.1 The E-codification
       6.1.1 The first key
       6.1.2 The second key
       6.1.3 The third key
  6.2 Data structure of the basic pharmaceutical information
       on the substance
       6.2.1 Preferred Name
       6.2.2 Notes
       6.2.3 CAS number
       6.2.4 Group
       6.2.5 Density
       6.2.6 Melting point
       6.2.7 Doping code
       6.2.8 Substance and Supplier evaluation
       6.2.9 Molecurar weight
  6.3 Substance record
  6.4 Data structure of the Synonyms
       6.4.1 Synonyms first key
       6.4.2 Synonyms
       6.4.3 Reference country code
       6.4.4 Reference source
       6.4.5 Language
  6.5 Synonyms record
  6.6 Data structure of the essential pharmacological
       information on the substance
       6.6.1 Dose first key
       6.6.2 ATC code
       6.6.3 DDD
       6.6.4 Average daily dose
       6.6.5 Maximum daily dose
       6.6.6 Minimum daily dose
       6.6.7 Unit of measurement
       6.6.8 Route of administration code/Application type
       6.6.9 Route of administration description/Application
              type description
       6.6.10 Patient target
       6.6.11 Source of information
       6.6.12 Note
       6.6.13 MedDRA code
       6.6.14 MedDRA description
  6.7 Dose record
  6.8 Data structure of the national information
       6.8.1 National information first key
       6.8.2 National notes
       6.8.3 Reference country code
       6.8.4 Country name
       6.8.5 Language
       6.8.6 Any field needs for specific national information
  6.9 National information record
  6.10 Data structure of the Supplier record
       6.10.1 Supplier first key
       6.10.2 Company
       6.10.3 Reference country code
       6.10.4 Country name
       6.10.5 Address of the registered office
       6.10.6 Postal code of the registered office
       6.10.7 City of the registered office
       6.10.8 Province of the registered office
       6.10.9 Address of operative seat
       6.10.10 Postal code of the operative seat
       6.10.11 City of operative seat
       6.10.12 Province of operative seat
       6.10.13 Tax number
       6.10.14 Telephone number for orders
       6.10.15 Fax number for orders
       6.10.16 E-mail address for orders
       6.10.17 Sales officer's name
       6.10.18 Sales officer's telephone number
       6.10.19 Sales officer's e-mail
       6.10.20 Telephone number
       6.10.21 Fax number
  6.11 Supplier record
  6.12 Chart of data structure
Annex A: Part of plants
Annex B: Production processes and general treatments for herbal
         preparations
Annex C: Solvents for herbal, animal and mineral preparations
Annex D: Physical form for substances with herbal and animal origin
Annex E: Part of the animal

Describes the technical requirements for creating the record structure and E-codification of the various substances supplied by commercial suppliers and used by the pharmacist in the pharmacy for preparing "Magistral Formula" and "Formula Officinalis" as defined by the European Directive 2001/83, Article 3, Paragraph 1 and 2.

DocumentType
Standard
Pages
36
PublisherName
National Standards Authority of Ireland
Status
Withdrawn

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