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  • The nature of any cellular system(s) used for production, and, if relevant, the use of recombinant DNA technology, including the use of the expression ‘produced in XXX cells by recombinant DNA technology’, should be mentioned in the SPC, in a pattern as set by the following examples: ‘produced in human diploid (MRC-5) cells’ ‘produced in Escherichia coli cells by recombinant DNA technology’ ‘produced in chick-embryo cells’ ‘derived from human plasma donors’ Herbal medicinal products The quantitative declaration should be in accordance with the Note for Guidance on Quality of Herbal Medicinal Products. (cs)
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