Medicines and Poisons (Medicines) Regulation 2021
sec.21Quality control
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sec.21 Quality control
The holder of a manufacturing licence must take all reasonable steps to ensure a medicine manufactured under the licence is fit for its intended use and free from contamination. The holder is taken to comply with subsection (1) if the holder complies with a code, guideline, standard or quality assurance scheme that is recognised for promoting best practice in the industry for the type of manufacturing authorised under the licence. (sec.21-ssec.1) The holder of a manufacturing licence must take all reasonable steps to ensure a medicine manufactured under the licence is fit for its intended use and free from contamination. (sec.21-ssec.2) The holder is taken to comply with subsection (1) if the holder complies with a code, guideline, standard or quality assurance scheme that is recognised for promoting best practice in the industry for the type of manufacturing authorised under the licence.