Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
Public consultation in preparation of the "Communication from the Commission - Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on the criteria for assessing significant studies" ("PIP Guideline").
Public consultation in preparation of the "Communication from the Commission - Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on the criteria for assessing significant studies" ("PIP Guideline").
Period of consultation
From 31 January 2007 and 30 March 2007.
Contributions to and results of the consultation
A summary of the responses is available here.
Below are the public responses to the above-mentioned public consultation:
- AIPES - Association of Imaging Producers & Equipment Suppliers
- Astellas Pharma Europe BV
- BfarM - Bundesinstitut für Arzneimittel und Medizinprodukte
- BIA - BioIndustry Association
- BPI - German Pharmaceutical Industry Association
- EFPIA - European Federation of Pharmaceutical Industries and Associations : 1 - 2
- EMEA - European Medicines Agency
- GCPA - Good Clinical Practice Alliance
- ICR - Institute of Clinical Research
- IPFA - International Plasma Fractionation Association
- MCRN - Medicines for Children Research Network
- PhRMA - Pharmaceutical Research and Manufacturers of America
- Pierre Fabre Medicament
- PRC - Paediatric Research Consultancy (Jane Lamprill)
- TEDDY network
- Voisin Consulting
- Anonymous
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.