The aim of this revision is to improve the implementation of the regulatory framework and to adapt the text to technical progress.

After 15 years of implementation of the orphan legislation, the Commission is currently launching initiatives to improve the implementation of the regulatory framework with a view to ensure timely access to medicinal products. In this context, the Commission has decided to launch a targeted review of Commission Regulation (EC) No 847/2000 on the concept of similarity. In parallel, the Commission is also finalizing the revision of the 2003 Communication on Regulation (EC) No 141/2000 on orphan medicinal products (2003/C 178/02) which will be replaced by a notice.

In order to facilitate these revisions the Commission has released a consultation document for which it aims to collect views, relevant evidence and information from stakeholders to help it develop its thinking in this area.

Concept of ‘similar medicinal product’ in the context of the orphan legislation: adaptation to technical progress
http://ec.europa.eu/health/files/orphanmp/2016_07_pc_orphan/2016_07_consultation_paper.pdf

Proposals for change include:
• removal of the definition of active substance
• definition of similar active substance.

The second proposal for changes in the definition of similar active substance affects both chemical and biological medicinal products, as well as radiopharmaceutical medicinal products.

The consultation document has been released for a consultation period from 29 July 2016 to 4 November 2016. Contributions may be sent by e-mail to SANTE-PHARMACEUTICALS-B5@ec.europa.eu.

Related article
Biosimilars applications under review by EMA – April 2016

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