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 15 July 2011 to 31 December 2011.
Contributions to and results of the consultation
Below are the public responses to the above-mentioned public consultation:
- Adex pharma : [English version] - [French version]
- AEFI - Comisión de Normas de Correcta Fabricación
- Aegate Salus AG
- EAMPS - Spanish Agency of Medicinal Products
- AESGP - Association Européenne des Spécialités Pharmaceutiques Grand Public
- Afi Scientifica : [1] - [2]
- Ages Austria
- Aipes
- Alliance Healthcare
- Amgros - Hospital Pharmacies in Denmark
- AOP - 0rphan Pharmaceuticals AG - Agnes Kohl
- Asso-ram - Distribuzione Primaria Farma & Salute - Associazione Operatori Commerciali e Logistici
- Association of Danish Pharmacies - Merete Kaas
- Apteekkitavaratukkukauppiaat ry – Association of Pharmaceutical Distributors (Finland)
- ASSOGENERICI – Italian Generic Medicines Association
- Bausch & Lomb
- Bristol myers squibb
- Celgene Europe Ltd / Celgene International SARL
- Conseil National de l’Ordre des Pharmaciens / French National Council of the Order of Pharmacists
- Czech Republic
- Danish Medicine Agency
- DB Schenker
- DHL Life Sciences & Healthcare - M Meakin, Vice President – Global Quality, Regulatory & Compliance
- DHL EUHQ – Vincent Koen
- EALTH - European Association for Logistics and Transportation in Healthcare
- EEA – European Express : [1] – [2] - [3]
- EFG 11 - Dr. Arno Terhechte
- EFPIA – Véronique Davoust
- EGA - European Generic medicines Association
- EIGA - European Industrial Gas Association
- EIPG - European Industrial Pharmacists Group
- EQPA - European Qualified Person Association : [1] - [2]
- European Association of Mail Order Pharmacies
- EUSP UEPS - Union européenne des Pharmacies sociales
- Farmindustria
- BMG - Federal Ministry for Health (Germany)
- Fresenius Medical Care AG (Schweiz)
- GE Healthcare
- GIRP – European Association of Pharmaceutical Full-line Wholesalers : [1] - [2] - [3]
- GKFI - Groep Kwaliteitsbewustzijn Farmaceutische Industrie (the Netherlands)
- GS1 Healthcare
- Guild of Healthcare Pharmacists
- IRC kft - Istvan Arato
- Italian ministry of health
- Kereon AG - Yves Samson
- Kocsi, Irén Dr
- kohlpharma GmbH
- LEEM - Les entreprises du medicament
- LFB Biomédicaments
- LifeConEx - David Bang and Nina Heinz
- LinkedIn Vital Logistics group
- LOGSanté – French National Federation of Pharmaceutical Depositories
- Mallet dr
- Merck Sharp & Dohme Europe Inc. - Lisette Vromans
- MHRA - Medicines and Healthcare products Regulatory Agency
- NAPW – Norwegian Association of Pharmaceutical Wholesalers
- National Committee of Pharmacists in Distribution from the General Council of Spanish Pharmacists
- Natural Medicine Company Limited
- NHS - Pharmaceutical Quality Assurance Committee
- Norwegian Medicines Agency
- PACE Bio Solutions - Jennifer Benner, Executive Director of Quality Assurance
- PGEU - Pharmaceutical Group of the European Union
- PHAGRO - Association of Pharmaceutical Full-line Wholesalers in Germany
- Pharmaceutical Quality Group of the Chartered Quality Institute
- Pharmafirst
- PHARMIG - Association of the Austrian pharmaceutical industry
- Pharmintraco - Maurizio Battistini
- PIF - Pharma Industry Finland
- PIGA - Polish Industrial Gases Association, WG-4 "Medical Gases"
- Republic of Hungary
- Sanofi Pasteur MSD (UK)
- Schulze Rico, GMP/GDP Inspector
- Shire Pharmaceuticals
- Stallergenes SA
- Stowarzyszenie Importerów Równoległych Produktów Leczniczych
- Swissmedic
- Teva Pharmaceuticals Europe B.V.
- TNT Express
- UPS Europe NV/SA
- VAPI-UPIP
- vfa.Research-Based Pharmaceutical Companies (Germany)
- York LINk : [1] - [2]
Objective of the consultation
The content of the Guidelines on Good Distribution Practice published in 1994 is no longer adequate. It needs to be reviewed to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union. Moreover, it needs to consider the new requirements for wholesale distributors and brokers established by the new Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.
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.