Transcription of Appendix 8 Data Requirements for New Medicine Applications
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Appendix 8 Data Requirements for New Medicine Applications
Appendix 8 Data Requirements for New Medicine Applications This document is under development. The Requirements for the data supporting a new Medicine application depend upon the category of product involved: New Higher-risk Medicine (NMA-H) New Intermediate-risk Medicine (NMA-I) New Lower-risk Medicine (NMA-L) An application for provisional consent to distribute a new Medicine Please note that a non-prescription Medicine does not automatically fall into the lower-risk Medicine category. Standard Requirements for New Medicines Medsafe s standard Requirements for the data for new medicines are as set out below. Dossiers are assessed for conformity with these Requirements . Administrative Information The proposed proprietary name for the product must be clear, unambiguous, not unacceptably similar to, or likely to be confused in any way in print, handwriting or speech with, another Medicine currently registered in New Zealand, and not misleading in any way with regard to the nature, composition, purpose, uses or effects of the product.
Appendix 8 Data Requirements for New Medicine Applications This document is under development. The requirements for the data supporting a new medicine application depend upon the category
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