Medicinal products

Public consultation on the Regulation on Advanced Therapy Medicinal Products


Period of consultation

From 20 December 2012 to 31 March 2013.

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 stakeholders dealing with advanced therapy medicinal products. Comments from Small and Medium-sized Enterprises (SMEs) are particularly welcomed.

Objective of the consultation

Regulation 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC (hereafter "Advanced Therapy Regulation") requires the Commission to assess the  application of the Advanced Therapy Regulation and to produce a report.

With this public consultation, Directorate General for Health and Consumers intends to seek the view of stakeholders regarding the application of the Advanced Therapy Regulation.

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.

Additional information: