About this initiative
COMMISSION REGULATION (EU) …/… amending Regulation (EC) No 847/2000 as regards the definition of the concept 'similar medicinal product'
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ISCT (United States)
ISCT appreciates the opportunity to submit comments on the EC DG Health and Food Safety’s draft regulation amending Regulation (EC) No 847/2000 regarding the definition of the concept 'similar medicinal product'. ISCT acknowledges the difficulty of defining the concept of similar medicinal product for ATMPs and considers the proposal reasonable. Nevertheless, we would also like to express our concern related to the ambiguity of the concepts ...
We fully endorse the suggestion made regarding the modification of Art 1 (3.2) of the Draft Regulation on the definition of the concept 'similar medicinal product' to read as follows: Gene therapy medicinal products: Two gene therapy medicinal products shall not be considered similar when there are differences in the therapeutic sequence, viral vector, transfer system, regulatory sequences or approaches for the delivery of the product to...
EFPIA-EuropaBio Joint Task Force on Orphan Medicinal Products and Rare Diseases (Belgium)
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 favourable regulatory environment to continue to see progress in treating rare diseases. In order to have a consistent and transparent process, further...
Alliance for Regenerative Medicine (Belgium)
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 to the recommendations for Advanced Therapy Medicinal Products (ATMPs) which now more clearly differentiate the requirements by types of products, i.e....
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, research for therapies treating rare diseases was scarce due to the complexities of research and the limited commercial attractiveness linked to the small...
Vaccines Europe (Belgium)
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 not take into consideration the chemical and biological complexity of conjugated vaccine antigens. Similarity in the context of vaccines cannot be defined...