6Requirements in relation to permissible ingredients being contained in medicine

6 Requirements in relation to permissible ingredients being contained in medicine

For an ingredient mentioned in column 2 of an item in the table in Schedule 1, the following requirements are specified for the purposes of paragraph 26BB(1)(b) of the Act: (a) the ingredient must only be used in a medicine for a purpose specified in relation to the ingredient in column 3 of that item; and (b) subject to section 6A, the ingredient must comply with the requirements specified in relation to the ingredient in column 4 of that item; and (c) if the ingredient is derived from animal originthe safety of the ingredient must have been assessed against, and comply with, the principles and requirements in the European Pharmacopoeia general monograph 1483 Products with risk of transmitting agents of animal spongiform encephalopathies, including General Text 5.2.8: Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products.