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Definition of the concept "similar medicinal product"

Food safety, Public health

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Public consultation

ID: 1167

Lobbying Activity

4 responses

Consultation response

EuropaBio, 27 Nov 2017

General comments Regulation 141/2000 (Orphan Regulation) and the accompanying Commission Regulation EC 847/2000 have successfully stimulated research and development of orphan medicinal products. The EFPIA-EuropaBio Joint Task Force would like to emphasise the vital importance of maintaining a…

Consultation response

Vaccines Europe, 27 Nov 2017

Proposed change in Art. 1 (2.2): Amending the 1st paragraph (see attachment) The 2nd paragraph should be removed. Comments/Rationale : This vaccine example is not appropriate to illustrate similarity/non-similarity between two products containing polysaccharide substances, because it does…

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 27 Nov 2017

1. General Comments The European regulatory framework, the incentives as defined in the Orphan Medicinal Product Regulation (EC) 141/2000 and the accompanying Commission Regulation EC 847/2000 have successfully stimulated research and development of orphan medicinal products. Until 2000,…

Consultation response

Alliance for Regenerative Medicine, 27 Nov 2017

The Alliance for Regenerative Medicine (ARM) thanks the European Commission for the opportunity to provide feedback on the proposed Commission Regulation amending Regulation (EC) N° 847/2000 as regards the definition of the concept of ‘similar medicinal product’. ARM welcomes the clarification…