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Qsauri
"B"

biotechnology
Guideline or reference source
MHRA Glossary of terms
Definition
A biotechnology product is one manufactured by recombinant DNA technology, one where genetic manipulation of cells is required, or a monoclonal antibody. Applications for these products are required to be submitted through the European Centralised procedure.
Related Term
biological medicinal product
biosimilar medicinal product
 

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