Section F: How will my product be classified under the biologicals framework? to prior to completing this section. If unsure, please provide your interpretation with justification in the request to us. Question (Guidance) Decision Comments/ Justification F1 Is your product mentioned Yes Your product will be – as class 1 in Schedule 16 of regulated as a 1’ biological ‘Class the ? No Proceed to Question F2 – F2 Could your product be Yes Contact us at – appropriate to be ? No Proceed to Question F3 – F3 Is your product mentioned Yes Your product will be – as a specific class of regulated as that class of biologicals in Schedule 16 biological (class 4 biological) of the (currently only class No Proceed to Question F4 – 4 biologicals)? F4 Is your product ? Yes Proceed to Question F5 – No Your product will be – regulated as a 3’ biological ‘class F5 Is the ? Yes Your product will be – regulated as a 2 biological ‘class No Your product will be – regulated as a 3’ biological. ‘class F6 Your understanding of the classification of your biological
Section F: How will my product be classified under the biologicals framework? to prior to completing this section. If unsure, please provide your interpretation with justification in the request to us. Question (Guidance) Decision Comments/ Justification F1 Is your product mentioned as class 1 in Schedule 16 of the ? Yes – Your product will be regulated as a ‘Class 1’ biological No – Proceed to Question F2 F2 Could your product be appropriate to be ? Yes – Contact us at No – Proceed to Question F3 F3 Is your product mentioned as a specific class of biologicals in Schedule 16 of the (currently only class 4 biologicals)? Yes – Your product will be regulated as that class of biological (class 4 biological) No – Proceed to Question F4 F4 Is your product ? Yes – Proceed to Question F5 No – Your product will be regulated as a ‘class 3’ biological F5 Is the ? Yes – Your product will be regulated as a ‘class 2 biological No – Your product will be regulated as a ‘class 3’ biological. F6 Your understanding of the classification of your biological
request-advice-biologicals.docx