International scientific guideline: Octreotide acetate depot powder and solvent for suspension for injection 10mg, 20mg or 30mg product - specific bioequivalence guidance
EMA/CHMP/291571/2018 adopted by the Therapeutic Goods Administration (TGA)
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.