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Public Health
ConsultationClosed

Public consultation on the revision of the "Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)"

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:

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.

Additional information:

Respond to the consultation

The response period for this consultation has ended. Thank you for your input.