M4E(R2) - Common technical document for the registration ...
2.5.6.4 Benefit-Risk Assessment 2.5.6.5 Appendix 2.5.7 Literature References Detailed discussion of content of the clinical overview sections 2.5.1 Product development rationale The discussion of the rationale for the development of the medicinal product should: Identify the pharmacological class of the medicinal product.
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