Public consultation on the concept of "similar medicinal product" in the context of the orphan legislation
Period of consultation
From 29 July 2016 to 04 November 2016.
Contributions to and results of the consultation
A summary of the responses is available here.
Please note that two contributors requested their responses not to be made public and one contributor requested his / hers response to be published anonymously.
Below are the public responses to the above-mentioned public consultation:
- ARM - Alliance for Regenerative Medicine
- BIA - UK Bioindustry Association
- Dutch government
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EHC - European Haemophilia Consortium
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- EURORDIS - Rare Diseases Europe
- Medicines & Healthcare product Regulatory Agency (UK)
- Medicines for Europe
- PGEU - Pharmaceutical Group of European Union
- Royal College of Physicians
- TLV - The Dental and Pharmaceutical Benefits Agency (Sweden)
All citizens and organisations (public and private) are welcome to contribute to this consultation.
Objective of the consultation
The European Commission is proposing to review the concept of "similar medicinal products" in the context of the orphan legislation. The aim is to improve the implementation of the regulatory framework and to adapt the text to technical progress.
The consultation document
The consultation document can be downloaded here.
Protection of personal data
The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.
Specific privacy statement
Please consult the Privacy Statement to be downloaded here.