Draft Regulation – Definition of the Concept “Similar Medicinal Product”

Commission Regulation (EC) No 847/20002 provides a definition of the concept “similar medicinal product”, which includes specific cases defining what kind of products are to be regarded as similar for the purposes of the application of Regulation (EC) No 141/2000. That definition should be updated in the light of new scientific and technical knowledge, in particular, due to major developments in the field of biological medicines, and especially advanced therapy medicinal products, and in the light of experience gained with regard to the designation and regulation of orphan medicinal products. In addition, there is a need for a clear definition of the concept ‘principal molecular structural features’, which is used within the definition of the concept ‘similar active substance’, which is in turn used within the definition of the concept ‘similar medicinal products’.
: 27 November 2017
Website: https://ec.europa.eu/

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