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 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.
- Academic GMP Research Consortium
- AEMPS - Agencia Española de Medicamentos y Productos Sanitarios
- AAT - Alliance for Advanced Therapies consultation paper : [1] - [2]
- AATB - American Association of Tissue Banks
- apceth GmbH & Co. KG
- AP-HP - Assistance-Publique, Hôpitaux de Paris
- ABPI - Association of the British Pharmaceutical Industry: [1] - [2] - [3]
- AMC - ATMP Manufacturing Community
- Belgium, Superior Health Council
- BioFarmind - Netherlands Association of Biotechnological, Pharmaceutical and Life Sciences Industry
- BPI - Bundesverband der Pharmazeutischen Industrie / German Pharmaceutical Industry Association
- CELLforCURE
- Cell Therapy Catapult Limited (UK)
- Co-ACT
- Cytori Therapeutics, Inc.
- DIN Deutsches Institut für Normung e.V. / German Institute for StandardizationNAFuO - Optics and Precision Mechanics Standards Committee
- Etablissement Français du Sang
- Eucomed – Medical technology industry in Europe
- EuropaBio - European Association for Bioindustries
- EAHP - European Association of Hospital Pharmacists
- EATB - European Association of Tissue Banks
- EBE - European Biopharmaceuticals Enterprises : [1] - [2] - [3]
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- EEBA - European Eye Bank Association
- EGAN - European Genetic Alliances' Network
- EBMT - European group for Blood and Bone Marrow Transplantation
- EURORDIS - European Organisation for Rare Diseases
- ESGCT - European Society of Gene and Cell Therapy
- Farmindustria
- Federal Ministry of Health, Germany
- Fimea - Finnish Medicines Agency
- Finnish Red Cross Blood Service
- SFTCG - French Society for Cell and Gene Therapy / Société Française de Thérapie Cellulaire et Génique
- Groupe de Travail des Unités de Thérapie Cellulaire et Géniques Hospitalières
- Hannover Medical School
- Hietzing Hospital (Austria)
- IGOR - Institut für Gewebe- und Organrekonstruktion
- Innovacell Biotechnologie AG, Innsbruck
- INSERM - Institut National de la Santé et de la Recherche Médicale
- ISCT - International Society for Cellular Therapy
- Italian National Transplant Center / Centro Nazionale Trapianti
- Karolinska University Hospital Innovation Centre
- MEB - Medicines Evaluation Board (the Netherlands)
- MHRA - Medicines and Healthcare Products Regulatory Agency
- Newcastle upon Tyne Hospitals NHS Trust
- NSS - NHS National Services Scotland
- NHS Pharmaceutical Quality Assurance Committee
- Pfizer Limited
- Pirnay Jean-Paul, PhD/ Vanderkelen, Alain MS/ Verbeken Gilbert, Drs
- Radboud University Nijmegen Medical Centre, Radboud Children’s Hospital,Feitz, W.F.J. Prof.dr. Pediatric Urology
- Roslin Cells Limited
- TBF Génie Tissulaire
- BIA - UK BioIndustry Association
- UK Parkinson's Disease Society
- University Children’s Hospital Würzburg, Laboratory for Stem Cell Processing & Cellular Therapy
- University Hospital Leuven-Belgium (Dr T. Devos),University Medical Centre (UMC) St. Radboud Nijmegen (Dr H. Dolstra),UMCG Groningen (Dr A. Jorritsma-Smit),UMC Utrecht (Dr I. Slaper-Cortenbach), LUMC Leiden (Dr P. Meij)
- University of Sussex, School of Global Studies, Dr Alex Faulkner
- UZ Leuven Kindergeneeskunde/ KU Leuven (Van Gool Stefaan, M.D., Ph.D.)
- The Veneto Eye Bank Foundation (Fondazione Banca degli Occhi del Veneto Onlus)
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.