Pre-clinical Biological Safety Testing on Medicinal Products Derived from Biotechnology
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چکیده
Additional Notes This note for guidance concerns the application of Part 3 of the Annex to Directive 75/318/EEC as amended with a view to the granting of a marketing authorisation for a medicinal product derived from biotechnology. It classifies products derived from biotechnology into groups and provides a summary of general methodologies pertaining to pre-clinical safety testing and minimum testing requirements for each group.
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