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Q&A for labelling - 8%
24.09.2021 08:57:59The requirements for labelling of Investigational medicinal products are given in European Commission guideline: The Rules Governing Medicinal Products in the European Union, Volume 4, EU Guidelines to Good Manufacturing Practice, Annex 13, Investigational Medicinal Products. This guideline is translated to the Czech and listed as VYR-32 Appendix 13.