Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
Period of consultation
From 16 November 2015 to 15 February 2016.
Contributions to and results of the consultation
Below are the public responses to the above-mentioned public consultation:
- Alliance for Regenerative Medicine
- Autorités Françaises
- BIA - UK BioIndustry Association
- BPI - Bundesverband der Pharmazeutischen Industrie / German Pharmaceutical Industry Association
- Dutch government
- EAHP - European Association of Hospital Pharmacists
- EFPIA - European Federation of Pharmaceutical Industries and Associations / EuropaBio Joint Task Force
- EGA - European Generic Medicines Association
- EGAN - Patients' Network for Health and Medical Research
- EHC - European Haemophilia Consortium
- EMA - European Medicines Agency
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- EURORDIS - European Organisation for Rare Diseases
- GKV-Spitzenverband
- HollandBIO / Nefarma - Netherlands Association for Innovative Pharmaceutical Companies
- Infarmed
- IPFA - International Plasma Fractionation Association
- MHRA - UK's Medicines and Healthcare products Regulatory Agency
- Quintiles
- Royal College of Physicians
- Royal College of Physicians - Faculty of Pharmaceutical Medicine
- NPPG - Neonatal and Paediatric Pharmacists Group
- REGenableMED consortium
- Regeneron Pharmaceuticals, Inc.
- Shire
- SIOP Europe - European Society for Paediatric Oncology
- Sobi
- Teva Pharmaceutical Industries Ltd.
- vfa bio
- VVD
Objective of the consultation
The European Commission is proposing to review the 2003 Communication on orphan medicinal products to streamline the regulatory framework and to adapt the Communication to technical progress. The 2003 Communication will be replaced by a notice.
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.