ICH S9 Yes No If Yes, please indicate if the trial covers several indications/pathologies and if all are S9 : Quality section Active substance (Section S of IMPD) Generalities # Questions Yes No If yes, specify 1 Has the active substance a monograph ? If yes, specify: Ph. Eur. a Pharmacopoeia of an EU MS USP/JP 2 How the suitability of the monograph has Indicate the relevant pages of the IMPD been shown with regard to the (S.2.2): implemented process? 3 Has the Active substance a valid CEP* If yes: CEP No.: Holder: special tests/limits, re-test period, TSE information, if relevant, should be indicated: 4 Is the active substance of an authorised If yes, indicate the authorised drug product : drug product in the EU from the same manufacturer using the same process? 5 Is the active substance described in an If yes, ASMF number : ASMF* already submitted to ANSM and accepted in support of a given drug product? 6 None of the above (full S Section) * Biologicals are not concerned with Manufacture (S.2) Control of Materials (S.2.3) # Questions Yes No 1 Is there any material of animal or human If yes, fill viral safety section. origin used in the process? Characterisation (S.3) Impurities (S.3.2)
ICH S9 Yes No If Yes, please indicate if the trial covers several indications/pathologies and if all are S9 : Quality section Active substance (Section S of IMPD) Generalities # Questions Yes No If yes, specify 1 Has the active substance a monograph ? If yes, specify: Ph. Eur. a Pharmacopoeia of an EU MS USP/JP 2 How the suitability of the monograph has been shown with regard to the implemented process? Indicate the relevant pages of the IMPD (S.2.2): 3 Has the Active substance a valid CEP* If yes: CEP No.: Holder: special tests/limits, re-test period, TSE information, if relevant, should be indicated: 4 Is the active substance of an authorised drug product in the EU from the same manufacturer using the same process? If yes, indicate the authorised drug product : 5 Is the active substance described in an ASMF* already submitted to ANSM and accepted in support of a given drug product? If yes, ASMF number : 6 None of the above (full S Section) * Biologicals are not concerned with Manufacture (S.2) Control of Materials (S.2.3) # Questions Yes No 1 Is there any material of animal or human origin used in the process? If yes, fill viral safety section. Characterisation (S.3) Impurities (S.3.2)