Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
This document was previously called "Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs)".
Period of consultation
From 1 June 2016 to 31 August 2016.
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:
- ACRO - Association of Clinical Research Organizations
- AESGP - Association of the European Self-Medication Industry
- AKDA - German Association of Hospital Pharmacists (Germany)
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- ANSM (France)
- ArisGlobal
- Cancer Research UK / British Heart Foundation
- EAHP - European Association of Hospital Pharmacists
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EORTC - European Organisation for Research and Treatment of Cancer
- EUCROF - European CRO Federation
- EuropaBio - European Association for Bioindustries
- Genethon
- Gilead Sciences International Ltd.
- Hammersmith Medicines Research
- HRA - Health Research Authority (UK)
- IPFA - International Plasma Fractionation Association
- KKS-Network - Network of Coordinating Centers for Clinical Trials (Germany)
- MPA - Medical Products Agency (Sweden)
- Nextrasearch di Gasparetto Adolfo & C.
- NPCTAG - National Pharmacy Clinical Trials Advisory Group
- Teva Pharmaceutical Industries Ltd.
Targeted stakeholders
All citizens and organisations are welcome to contribute to this consultation.
Objective of the consultation
With this public consultation the Directorate General for Health and Food Safety, DG SANTE, intends to seek the views of stakeholders - and other interested parties - on the revision of the document "Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)" in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.
The main objective of this revision is to align it with the Clinical Trials Regulation and with the latest (scientific) insights.
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.