Abstract
Ïã¸ÛÁùºÏ²Ê¿ª½± 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.
Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of Ïã¸ÛÁùºÏ²Ê¿ª½± 11615:2017.
General information
-
Status: PublishedPublication date: 2017-10Stage: International Standard to be revised [90.92]
-
Edition: 2Number of pages: 79
-
Technical Committee :Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 215ICS :35.240.80
- RSS updates
Amendments
Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.
Amendment 1
Edition 2022
Life cycle
-
Previously
WithdrawnÏã¸ÛÁùºÏ²Ê¿ª½± 11615:2012
-
Now
PublishedÏã¸ÛÁùºÏ²Ê¿ª½± 11615:2017
A standard is reviewed every 5 years
Stage: 90.92 (To be revised)-
00
Preliminary
-
10
Proposal
-
20
Preparatory
-
30
Committee
-
40
Enquiry
-
50
Approval
-
60
Publication
-
90
Review
-
95
Withdrawal
Amendments
Provide additional content; available for purchase; not included in the text of the existing standard.PublishedÏã¸ÛÁùºÏ²Ê¿ª½± 11615:2017/Amd 1:2022
-
00
-
Will be replaced by
Under developmentÏã¸ÛÁùºÏ²Ê¿ª½±/AWI 11615
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)