Public consultation on the revision of Annex 15: Qualification and Validation
Period of consultation
From 6 February 2014 to 31 May 2014.
Contributions to and results of the consultation
Below are the public responses to the above-mentioned public consultation:
- AESGP - Association of the European Self-Medication Industry
- Allergy Therapeutics
- APIC - Active Pharmaceutical Ingredients Committee
- AQPA - Austrian Qualified Person Association
- BCGA - British Comressed Gas Association
- Dr. V. K. Bhalla
- Cleaning Validation Technologies
- Comes compliance services, Ravensburg (Germany)
- EALTH - European Association for Logistics and Transportation in Healthcare
- ECA Fondation
- EEA - Euroean Express Association
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EGA - European Generic Medicines Association
- EIPG - European Industrial Pharmacists Group
- GE Healthcare Life Sciences
- German Expert Group 10 "Qualification/Validation"
- Gilead Sciences Ltd.
- Dr. Aidan Harrington
- IFAH - Europe-Animal Health Industry
- ISPE - International Society for Pharmaceutical Engineering
- LEEM - Les Entreprises du Médicament
- Ministry of Health (Lithuania)
- Mallet, Jean-Denis - Docteur en pharmacie, ancien inspecteur
- Norgine Limited
- Orion Corporation
- PDA - Parenteral Drug Association
- Pharma Systems International Ltd. (UK)
- PHARMIG - Association of the Austrian pharmaceutical industry
- PM Group
- Recipharm Stockholm AB
- Sanyuan, Luo
- Soares, João
- Swissmedic - Swiss Agency for Therapeutic Products
- UPIP-VAPI - Vereniging der Apothekers van de Pharmaceutische Industrie/Union des Pharmaciens de l'Industrie Pharmaceutique
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.