Guideline on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products

We have adopted this International Scientific Guideline - EMA/CHMP/BWP/429241/2013

Last updated

28 August 2024

About this guideline

Overseas effective date: 1 December 2013

Categories: Biologicals | Active substance | Manufacture, characterisation and control of the active substance

TGA Annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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