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 1 June 2010 to 30 September 2010.
Contributions to and results of the consultation
Below are the public responses to the above-mentioned public consultation:
- Afssaps - Agence française de sécurité sanitaire des produits de santé
- AESGP - Association of the European Self-Medication Industry
- BfArM - Federal Institute for Drugs and Medical Devices
- Cancer Research UK
- EANM - European Association of Nuclear Medicine
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EQAC - European Quality Assurance Confederation
- EUCROF - European CRO Federation
- EuropaBio - The European Association for Bioindustries
- Hoffmann-La-Roche, Basel
- Les Laboratoires Servier
- Novo Nordisk A/S
Objective of the consultation
This draft guidance aims at clarifying the dossier-requirements for so-called non-investigational medicinal products. It is herewith submitted for public consultation.
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.