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 5 July 2013 to 30 September 2013.
Contributions to and results of the consultation
Below are the public responses to the above-mentioned public consultation:
Targeted stakeholders
All citizens and organisations (public and private) are welcome to contribute to this consultation.
Objective of the consultation
The unit in charge of pharmaceuticals launches a public consultation on guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another.
The consultation document
The consultation documents can be downloaded below:
- Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another (12 June 2013):
- Annex - Application form for orphan medicinal product designation (Rev. 4, 22 April 2013):
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.