medicines regulatory authority
- Guideline or reference source
- ISO11615 IDMP Data elements and structures for the unique identification and exchange of regulated medicinal product information
- Definition
- institutional body that, according to the legal system under which it has been established, is responsible for the granting of marketing authorization for Medicinal Products NOTE In certain jurisdictions, the role of the institutional body which according to the legal system grants the marketing authorization of Medicinal Products may be complemented by an additional institutional body responsible for the evaluation and supervision of Medicinal Products. For example, in the EU the European Commission is the institutional body that grants the marketing authorization of Medicinal Products and the European Medicines Agency is the body responsible for the evaluation and supervision of Medicinal Products.
- Use
- regulatory authority
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