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The Rules Governing Medicinal Products in the European Union. Notice to Applicants V. 2B. Common Technical Document. May 2008. European Commission. Enterprise and Industry Directorate-General (, . 2. .

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Directive 2001/83/EC of the European Parliament and of the Council, of 6 November 2001 on the Community code relating to medicinal products for human use//Official Journal of the European Communities. L 311, 28.11.2001. P. 67-128 ( 2001/83/C 6 2001 , //Official Journal of the European Communities. L 311, 28.11.2001. P. 67-128).

Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Annex I: Analytical, Pharmacotoxilogical and Clinical Standards and Protocols in Respect of the Testing of Medicinal Products. Official Journal of the European Union. L 159 of 27.6.2003 ( 2003/63/C 25 2003 , 2001/83/C 6 2001 , . I: , - . Official Journal of the European Union. L 159 of 27.6.2003).

CPMP/ICH/365/96 (ICH Topic Q6B) Note for Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, September 1999 ( :

   

ICH Q5 Quality of Biotechnological Products: Stability Testing of

Biotechnological/Biological Products ( :

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