{"id":349191,"date":"2024-10-20T00:35:20","date_gmt":"2024-10-20T00:35:20","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-116152012\/"},"modified":"2024-10-26T00:14:46","modified_gmt":"2024-10-26T00:14:46","slug":"bs-en-iso-116152012","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-116152012\/","title":{"rendered":"BS EN ISO 11615:2012"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1\tScope
2\tNormative references
3\tTerms, definitions and abbreviations
3.1\tTerms and definitions <\/td>\n<\/tr>\n
22<\/td>\n3.2\tAbbreviations <\/td>\n<\/tr>\n
24<\/td>\n4\tRequirements
4.1\tConcepts required for the unique Identification of Medicinal Products <\/td>\n<\/tr>\n
27<\/td>\n5\tDescription of the information modelling principles and practices
5.1\tGeneral considerations <\/td>\n<\/tr>\n
28<\/td>\n5.2\tConceptual overview diagrams <\/td>\n<\/tr>\n
29<\/td>\n5.3\tSection high-level diagrams <\/td>\n<\/tr>\n
30<\/td>\n5.4\tDetailed description diagrams <\/td>\n<\/tr>\n
33<\/td>\n6\tIdentifying characteristics for authorized Medicinal Products
6.1\tPrimary identifiers
6.2\tMedicinal Product Identifier (MPID) <\/td>\n<\/tr>\n
34<\/td>\n6.3\tPackaged Medicinal Product Identifier (PCID) <\/td>\n<\/tr>\n
35<\/td>\n6.4\tMedicinal Product Batch Identifier (BAID_1)
6.5\tMedicinal Product Batch Identifier (BAID_2)
7\tInformation for an authorized Medicinal Product
7.1\tAuthorized Medicinal Product\u00a0\u2014 Information overview <\/td>\n<\/tr>\n
37<\/td>\n7.2\tMedicinal Product <\/td>\n<\/tr>\n
42<\/td>\n7.3\tMarketing Authorization <\/td>\n<\/tr>\n
48<\/td>\n7.4\tOrganization <\/td>\n<\/tr>\n
50<\/td>\n7.5\tManufacturer\/Establishment <\/td>\n<\/tr>\n
51<\/td>\n7.6\tPackaged Medicinal Product, including Manufactured Item and Device <\/td>\n<\/tr>\n
60<\/td>\n7.7\tIngredient, Substance and Strength <\/td>\n<\/tr>\n
64<\/td>\n7.8\tPharmaceutical Product and Device <\/td>\n<\/tr>\n
68<\/td>\n7.9\tClinical Particulars <\/td>\n<\/tr>\n
76<\/td>\n8\tIdentifying characteristics for Investigational Medicinal Products
8.1\tGeneral
8.2\tPrimary identifiers <\/td>\n<\/tr>\n
77<\/td>\n8.3\tInvestigational Medicinal Product Identifier (IMPID) <\/td>\n<\/tr>\n
78<\/td>\n8.4\tInvestigational Medicinal Product Package Identifier (IPCID)
8.5\tInvestigational Medicinal Product Batch Identifier (IBAID_1)
8.6\tInvestigational Medicinal Product Batch Identifier (IBAID_2) <\/td>\n<\/tr>\n
79<\/td>\n9\tInformation for an Investigational Medicinal Product
9.1\tConceptual overview of the information for an Investigational Medicinal Product <\/td>\n<\/tr>\n
80<\/td>\n9.2\tInvestigational Medicinal Product <\/td>\n<\/tr>\n
82<\/td>\n9.3\tClinical Trial Authorization <\/td>\n<\/tr>\n
85<\/td>\n9.4\tManufacturer\/Establishment
9.5\tInvestigational Packaged Medicinal Product <\/td>\n<\/tr>\n
86<\/td>\n9.6\tPharmaceutical Product <\/td>\n<\/tr>\n
87<\/td>\n9.7\tIngredient
9.8\tClinical particulars <\/td>\n<\/tr>\n
88<\/td>\nAnnex\u00a0A
\n(informative)<\/p>\n

Full model\u00a0\u2014 Authorized Medicinal Products conceptual level <\/td>\n<\/tr>\n

89<\/td>\nAnnex\u00a0B
\n(informative)<\/p>\n

Full model\u00a0\u2014 Authorized Medicinal Products detailed diagram <\/td>\n<\/tr>\n

90<\/td>\nAnnex\u00a0C
\n(informative)<\/p>\n

Full model\u00a0\u2014 Investigational Medicinal Products conceptual level <\/td>\n<\/tr>\n

91<\/td>\nAnnex\u00a0D
\n(informative)<\/p>\n

Full Model\u00a0\u2014 Investigational Medicinal Products detailed diagram <\/td>\n<\/tr>\n

92<\/td>\nAnnex\u00a0E
\n(informative)<\/p>\n

Worked example in tabular form <\/td>\n<\/tr>\n

101<\/td>\nAnnex\u00a0F
\n(informative)<\/p>\n

Class and attribute listing <\/td>\n<\/tr>\n

115<\/td>\nAnnex\u00a0G
\n(informative)<\/p>\n

Example implementation of Medicinal Product information <\/td>\n<\/tr>\n

123<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2012<\/td>\n128<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":349200,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[704,2641],"product_tag":[],"class_list":{"0":"post-349191","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-35-240-80","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/349191","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/349200"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=349191"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=349191"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=349191"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}