Public consultation on draft guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use

Public health community

Period of consultation

From 6 February 2013 to 30 April 2013.

Contributions to and results of the consultation

Gedeon Richter Plc., Merck KGaA, Teva Pharmaceutical Industries Ltd. and UCB Pharma SA requested that their response not be published.

Below are the public responses to the above-mentioned public consultation:

• AESGP - Association Européenne des Spécialités Pharmaceutiques Grand Public
• APIC - Active Pharmaceutical Ingredients Committee
• CHEMO
• DEUTSCHE POST DHL
• EFPIA - European Federation of Pharmaceutical Industries
• EISAI Manufacturing Limited
• FECC - European Association of Chemical Distributors
• FRESENIUS-Kabi Deutschland GMBH
• GIRP - European Association of Pharmaceutical Full-line Wholesalers
• Glenmark Pharmaceuticals
• ISPE - International Society for Pharmaceutical Engineering
• LEEM - Les entreprises du médicaments
• LifeConEx
• MAGYOS
• PDA - Parenteral Drug Association
• PHARMIG - Association of the Austrian pharmaceutical industries
• POLISH HERBAL Committee
• QUEMACO - Chemical Marketing Company
• RANBAXY Lab
• SCIENCE PHARMA
• SGAE - Secrétariat Général des Affaires Etrangères (France)
• The Finnish Pharmacists Society
• VDC - Drug and Chemical Association
• White Wave - Pharmaceutical Consultancy Company
• Yusen Logistics Ltd. (UK)

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:

• Good Distribution Practice
• Good Distribution Practice - Major developments