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Commission
Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such
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of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
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20:(Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for
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Good clinical practice for the design, conduct, recording and reporting of
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Exemption for
Hospital & Health Centres and Reconstitution
111:National implementing measures of the EU-countries
31:The directive deals with the following items:
67:Conditions of Holding a Manufacturing Licence
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82:Retention of Essential and Medical Records
61:Manufacturing or import authorisation
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18:Good Clinical Practice Directive
158:Regulation of therapeutic goods
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42:Good Clinical Practice (GCP)
79:Format of Trial Master File
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203:2005 in the European Union
183:European clinical research
193:European Union directives
168:Common Technical Document
163:European Medicines Agency
103:Text of the directive:
57:Investigator's Brochure
213:Life sciences industry
188:Pharmaceuticals policy
24:as regards conducting
22:good clinical practice
90:Inspection procedures
153:Directive 2001/83/EC
148:Directive 2001/20/EC
138:Directive 75/319/EEC
133:Directive 75/318/EEC
128:Directive 65/65/EEC1
143:Directive 93/41/EEC
74:Trial master file
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93:Final provisions
47:Ethics Committee
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37:clinical trials
26:clinical trials
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198:2005 in law
177:Categories
98:References
87:Inspectors
123:EudraLex
117:See also
106:products
72:The
45:The
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