manufacturing authorization
- Guideline or reference source
- ISO11615 IDMP Data elements and structures for the unique identification and exchange of regulated medicinal product information
- Definition
- manufacture of the Medicinal Products within a jurisdiction subject to the holding of an authorization NOTE Such authorization may be required for both total and partial manufacture and for the various processes of dividing up, packaging or presentation. However, such authorization may not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorized in a jurisdiction to carry out such processes.
- Related Term
- distribution authorization
- good manufacturing practice
- manufacturing authorization date
- marketing authorization holder
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