Responses to the concept paper submitted for public consultation concerning the Delegated act on the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use

Responses to the Public Consultation on Delegated act on the principles and guidelines of good manufacturing practice for active substances (one respondent - TEVA - requested its response not to be published):

• Agencia Española de Medicamentos y Productos Sanitarios(159 KB)
• AESGP - Association of the European Self-Medication Industry(131 KB)
• APIC - Active Pharmaceutical Ingedients Committee (CEFIC)(101 KB)  2nd document(199 KB)
• AssICC - Associazione Italiana Commercio Chimico(162 KB)
• Bayerisches Staatsministerium für Umwelt und Gesundheit(84 KB)
• Bayer(14 KB)
• Bogin, the Netherlands(107 KB)
• BPTF - Bulk Pharmaceuticals Task Force (U.S.A.)(2 MB)
• Brial Allergen(8 KB)
• Bundesministerium für Gesundheit (Germany)(19 KB)
• China State Food and Drug Administration(42 KB)
• Czech Republic(188 KB)
• DSM Nutritional Products Ltd. (Switzerland)(46 KB)
• EDQM - European Directorate for the Quality of Medicines & Healthcare(429 KB)
• EFCG - European Fine Chemicals Group (CEFIC)(73 KB)2nd document(199 KB)
• EFPIA - European Federation of Pharmaceutical Industries and Associations(39 KB)2nd document(129 KB)
• EGA - European Generic medicines Association(32 KB)
• EGS - European Glaucoma Society(250 KB)
• EIGA - European Industrial Gases Association(50 KB)  2nd document(15 KB)
• EIPG/GPIE - The European Industrial Pharmacists Group (114 KB)
• EUCOPE - European Confederation of Pharmaceutical Entrepreneurs(192 KB)
• France(25 KB)
• IPFA - International Plasma Fractionation Association(44 KB)
• Italy - Agenzia Italiana del Farmaco(36 KB)
• Netherlands - Ministry of Health, Welfare and Sport(65 KB)
• NVC Netherlands Packaging Centre(50 KB)
• PDA Europe gGmbH (Parenteral Drug Association)(223 KB)
• PHARMIG - Association of the Austrian pharmaceutical industry(80 KB)