Лекарствени продукти за хуманна употреба

Substances of human origin

Оценка на риска

Endocrine disruptors

Biocides

Public consultation on the revision of "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors"

  1. Български
  2. English

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 "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors" in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.

The main objective of this revision is to align the document with the Clinical Trials Regulation (EU) No 536/2014 and with the latest (scientific) insights on research with children.

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: