Period of consultation
From 28 August 2015 to 24 November 2015.
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
- ADKA - German Association of Hospital Pharmacists
- AEFI - Spanish Association of Pharmacists in Industry
- AEMPS - Spanish Agency of Medicines and Medical Devices
- AESGP - Association of the European Self-Medication Industry
- AFI - Italian Association of Industrial Pharmacists
- BAH - Bundesverband der Arzneimittel-Hersteller e. V.
- Baxalta
- Dutch Health Care Inspectorate
- efpia - European Federation of Pharmaceutical Industries and Associations
- EIPG - European Industrial Pharmacists Group
- European Qualified Person Association, IMP Working Group
- EuropaBio - European Association for Bio-Industries
- Leem - Les Entreprises du médicament (France)
- Medicines & Healthcare products Regulatory Agency (UK)
- MPA - Medical Products Agency (Sweden)
- PHARMIG - Association of the Austrian pharmaceutical industry
- REGenableMED consortium (UK)
- SciencePharma - Polish consultancy company
- Scientific Archivists Group Ltd (UK)
- Shire HGT AB (Sweden)
- TEVA Pharmaceutical Industries Ltd.
- Anonymous 1
- Anonymous 2
- Anonymous 3
- Anonymous 4
Objective of the consultation
Article 63(1) requires the European Commission to:
- adopt delegated acts to specify the principles and guidelines on good manufacturing practice and detailed arrangement for inspection for ensuring the quality of investigational medicinal products; and
- adopt and publish detailed guidelines in line with those principles of good manufacturing practice for investigational medicinal products.
Two public consultations are carried out to seek the views of stakeholders on and inform the development of such delegated acts and guidelines.
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.