The Genomic Complex
Manufacturing Standards for Innovative Therapy Medicines Derived from Biological Material for Human Use
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The term "ATMs" is understood to refer to both advanced therapy medicinal products that have been granted a marketing authorization and advanced therapy medicinal products that are the subject of clinical trials or are used as a reference in a clinical trial (investigational advanced therapy medicinal product). This guide specifies the GMP requirements that must govern the manufacture of ATMPs that have been granted a marketing authorization and ATMPs used in a clinical trial context. This guide does not apply to medicinal products other than ATMPs. However, the detailed guidelines referred to...
The term "ATMs" is understood to refer to both advanced therapy medicinal products that have been granted a marketing authorization and advanced therapy medicinal products that are the subject of clinical trials or are used as a reference in a clinical trial (investigational advanced therapy medicinal product). This guide specifies the GMP requirements that must govern the manufacture of ATMPs that have been granted a marketing authorization and ATMPs used in a clinical trial context. This guide does not apply to medicinal products other than ATMPs. However, the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/c4 and Article 63(1) of Regulation (EU) No 536/2014 do not apply to ATMPs unless specifically referred to in these guidelines. If specific provisions only concern advanced therapy medicinal products that have been granted a marketing authorization, the term used is "authorized ATMPs".
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