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1 Annex 2: Substantial Amendment Form NOTIFICATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS COMMITTEES IN THE COMMUNITY For official use: $%&'()*'+',-,./&0'*'12'3&4 5*(2.63)(*.(.%++'7&%.+'8.'/%&,-'(7,.,(.: $%&'4 $%&'()3&%*&()7*(+'62*'4 92&0(*,3%&,(.87(3,&,-'(7,.,(.: :(;7'&'.&%2&0(*,&<*'/,3&*%&,(..2;='*()&0'&*,%>4?&0,+3+(;;,&&''*'/,3&*%&,(..2;='*()&0'&*,%>4 $%&'4 To be filled in by the applicant: B0,3)(*;,3&(='23'6=(&0)(*%*'12'3&&(&0':(;7'&'.&92&0(*,&<)(*%2&0(*,3%&,(.()%substantial %;'.6;'.&%.6&(%.?&0,+3:(;;,&&'')(*,&3(7,.,(.(.%substantial%;'.6;'.&CD>'%3',.6,+%&'&0' *'>'-%.&72*7(3',.E'+&,(.9C A TYPE OF NOTIFICATION A.1 Member State in which the substantial amendment is being submitted: A.2 Notification for authorisation to the competent authority: A.3 Notification for an opinion to the ethics committee: A.4 Notification for information only 1 : A.4.1 To the competent authority A.4.2 To the Ethics committee B TRIAL IDENTIFICATION (When the amendment concerns more than one trial, repeat this form as necessary.) B.1 Does the substantial amendment concern several trials involving the same IMP? <'3.( FCGCG H)<'3*'7'%&&0,33'+&,(.%3.'+'33%*<C B.2 Eudract number: B.3 Full title of the trial4 B.4 Sponsor s protocol code number, version, and date: C IDENTIFICATION OF THE SPONSOR RESPONSIBLE FOR THE REQUEST C.1 Sponsor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

2 C.2 Legal representative 2 of the sponsor in the Community for the purpose of this trial (if different from the sponsor) :CJCG I*/%.,3%&,(.4 :CJCJ K%;'()7'*3(.&(+(.&%+&4 :CJCL 966*'334 :CJC" B'>'70(.'.2;='*4 :CJCM N%O.2;='*4 :CJCP 'Q;%,>4 D APPLICANT IDENTIFICATION, (please tick the appropriate box) D.1 Request for the competent authority $CGCG E7(.3(* $CGCJ Y'/%>*'7*'3'.&%&,-'()&0'37(.3(* $CGCL D'*3(.(*(*/%.,3%&,(.%2&0(*,3'6=<&0'37(.3(*&(;%Z'&0'%77>,+%&,(.C $CGC" :(;7>'&'='>(A4 $CGC"CG I*/%.,3%&,(.4 $CGC"CJ K%;'()7'*3(.&(+(.&%+&4 $CGC"CL 966*'334 $CGC"C" B'>'70(.'.2;='*4 $CGC"CM N%O.2;='*4 $CGC"CP?Q;%,> D.2 Request for the Ethics Committee $CJCG E7(.3(* $CJCJ Y'/%>*'7*'3'.&%&,-'()&0'37(.3(* $CJCL D'*3(.(*(*/%.,3%&,(.%2&0(*,3'6=<&0'37(.3(*&(;%Z'&0'%77>,+%&,(.C $CJC" H.-'3&,/%&(*,.+0%*/'()&0'%77>,+%&,(.,)%77>,+%=>' L 4 :(Q(*6,.%&,./,.-'3&,/%&(*R)(*;2>&,+'.&*'&*,%>T D*,.+,7%>,.-'3&,/%&(*R)(*3,./>'+'.&*'&*,%>T4 $CJCM :(;7>'&'='>(A $CJCMCG I*/%.,3%&,(.4 $CJCMCJ K%;'4 $CJCMCL 966*'334 $CJCMC" B'>'70(.'.2;='*4 $CJCMCM N%O.2;='*4 $CJCP?Q;%,>4 E SUBSTANTIAL AMENDMENT IDENTIFICATION E.1 Sponsor s substantial amendment code number, version, date for the clinical trial concerned:rt E.2 Type of substantial amendment?cjcg Amendment to information in the CT application form <'3.(?CJCJ Amendment to the protocol <'3.(?CJCL Amendment to other documents appended to the initial application form <'3.(?CJCLCG H)<'337'+,)<4?CJC" Amendment to other documents or information: <'3.(?CJC"CG H)<'337'+,)<4?CJCM This amendment concerns mainly urgent safety measures already implemented <'3.(?CJCP This amendment is to notify a temporary halt of the trial <'3.(?CJC[ This amendment is to request the restart of the trial <'3.( J 933&%&'6,.9*&,+>'G#()$,*'+&,-'JXXG8JX8?:C L 9++(*6,./&(.%&,(.%>>'/,3>%&,(.C MX

3 E.3 Reasons for the substantial amendment:?clcg Changes in safety or integrity of trial subjects yes no?clcj Changes in interpretation of scientific documents/value of the trial yes no?clcl Changes in quality of IMP(s) yes no?clc" Changes in conduct or management of the trial yes no?clcm Change or addition of principal investigator(s), co-ordinating investigator yes no?clcp Change of sponsor, legal representative, applicant yes no?clc[ Change/addition of site(s) yes no?clc\ Change in transfer of major trial related duties yes no?clc\cg If yes, specify:?clc# Other change yes no?clc#cg If yes, specify:?clcgx Other case yes no?clcgxcg If yes, specify E.4 Information on temporary halt of trial?c"cg Date of temporary halt R]]]]8SS8$$T?C"CJ Recruitment has been stopped <'3.(?C"CL Treatment has been stopped <'3.(?C"C" K2;='*()7%&,'.&33&,>>*'+',-,./&*'%&;'.&%&&,;'()&0'&';7(*%*<0%>&,.&0'SE+(.+'*.'6 =<&0'%;'.6;'.& RT?C"CM What is (are) the reason(s) for the temporary halt??c"cmcg E%)'&< <'3.(?C"CMCJ Y%+Z()')),+%+< <'3.(?C"CMCL I&0'* <'3.(?C"CMCLCG H)<'3&((&0'*U37'+,)<4?C"CP Briefly describe (free text)4 ^23&,),+%&,(.)(*%&';7(*%*<0%>&()&0'&*,%> B0'7*(7(3'6;%.%/';'.&()7%&,'.&3*'+',-,./&*'%&;'.&%&&,;'()&0'0%>&(free text). B0'+(.3'12'.+'3()&0'&';7(*%*<0%>&)(*&0''-%>2%&,(.()&0'*'32>&3%.6)(*(-'*%>> *,3Z='.'),&%33'33;'.&()&0',.-'3&,/%&,(.%>;'6,+,.%>7*(62+&(free text). F REASONS FOR SUBSTANTIAL AMENDMENT (one or two sentences): G BRIEF DESCRIPTION OF THE CHANGES (free text): MG

4 H CHANGE OF CLINICAL TRIAL SITE(S)/INVESTIGATOR(S) IN THE MEMBER STATE CONCERNED BY THIS AMENDMENT H.1 Type of change _CGCG Addition of a new site _CGCGCG Principal investigatorr7*(-,6'6'&%,>3='>(at _CGCGCGCG 5,-'..%;' _CGCGCGCJ S,66>'.%;'R,)%77>,+%=>'T _CGCGCGCL N%;,><.%;' _CGCGCGC" `2%>,),+%&,(.3RS$aaCCT _CGCGCGCM D*()'33,(.%>%66*'33 _CGCJ Removal of an existing site _CGCJCG Principal investigatorr7*(-,6'6'&%,>3='>(at _CGCJCGCG 5,-'..%;' _CGCJCGCJ S,66>'.%;'R,)%77>,+%=>'T _CGCJCGCL N%;,><.%;' _CGCJCGC" `2%>,),+%&,(.3RS$aaCCT _CGCJCGCM D*()'33,(.%>%66*'33 _CGCL Change of co-ordinating investigatorr7*(-,6'6'&%,>3='>(a()&0'.'a+((*6,.%&,./,.-'3&,/%&(*t _CGCLCG 5,-'..%;' _CGCLCJ S,66>'.%;' _CGCLCL N%;,><.%;' _CGCLC" `2%>,),+%&,(.RS$aaaCT _CGCLCM D*()'33,(.%>%66*'33 _CGCLCP H.6,+%&'&0'.%;'()&0'7*'-,(23+(Q(*6,.%&,./,.-'3&,/%&(*4 _CGC" Change of principal investigator at an existing siter7*(-,6'6'&%,>3='>(a()&0'.'a7*,.+,7%>,.-'3&,/%&(*t _CGC"CG 5,-'..%;' _CGC"CJ S,66>'.%;' _CGC"CL N%;,><.%;' _CGC"C" `2%>,),+%&,(.3RS$aaCCT _CGC"CM D*()'33,(.%>%66*'33 _CGC"CP H.6,+%&'&0'.%;'()&0'7*'-,(237*,.+,7%>,.-'3&,/%&(*4 I CHANGE OF INSTRUCTIONS TO CA FOR FEEDBACK TO SPONSOR I.1 Change of contact for feedback on application* I.2 :0%./'&(*'12'3&&(*'+',-'%.CO;>+(7<():B96%&% <'3.( HCJCG $(<(2A%.&%CO;>),>'+(7<()&0':B9)(*;6%&%3%-'6(.?26*%:Bb <'3.( HCJCGCG H)<'37*(-,6'&0''Q;%,>%66*'33R'3T&(A0,+0,&30(2>6='3'.&R27&(M%66*'33'3T4 HCJCJ $(<(2A%.&&(*'+',-'&0,3-,%7%33A(*67*(&'+&'6>,.ZR3T " b <'3.( H)<(2%.3A'*.(&(12'3&,(.HCJCJ&0'CO;>),>'A,>>='&*%.3;,&&'6=<>'333'+2*''Q;%,>>,.ZR3T HCJCL $(<(2A%.&&(3&(7;'33%/'3&(%.';%,>)(*A0,+0&0'<A'*'7*'-,(23><*'12'3&'6b <'3.( HCJCLCG H)<'37*(-,6'&0''Q;%,>%66*'33R'3T&(A0,+0)''6=%+Z30(2>6.(>(./'*='3'.&4 (*This will only come into effect from the time at which the request is processed in EudraCT). " B0,3*'12,*'3%?26*%Y,.Z%++(2.&CRE''AAAC'26*%+&C';'%C'2C,.&)(*6'&%,>3T MJ

5 J LIST OF THE DOCUMENTS APPENDED TO THE NOTIFICATION FORM Please submit only relevant documents and/or when applicable make clear references to the ones already submitted. Make clear references to any changes of separate pages and submit old and new texts. Tick the appropriate box(es). J.1 Covering letter stating the type of amendment and the reason(s) J.2 Summary of the proposed amendment J.3 List of modified documents (identity, version, date) J.4 If applicable, pages with previous and new wording J.5 Supportive information J.6 Revised.xml file and copy of initial application form with amended data highlighted J.7 Comments on any novel aspect of the amendment if any : K SIGNATURE OF THE APPLICANT IN THE MEMBER STATE K.1 H0'*'=<+(.),*;&0%&8+(.),*;(.='0%>)()&0'37(.3(*&0%&R6'>'&'A0,+0,3.(&%77>,+%=>'T B0'%=(-',.)(*;%&,(./,-'.(.&0,3*'12'3&,3+(**'+&c B0'&*,%>A,>>='+(.62+&'6%++(*6,./&(&0'7*(&(+(>U.%&,(.%>*'/2>%&,(.%.6&0'7*,.+,7>'3() /((6+>,.,+%>7*%+&,+'c%.6 H&,3*'%3(.%=>')(*&0'7*(7(3'6%;'.6;'.&&(='2.6'*&%Z'.C K.2 APPLICANT OF THE REQUEST FOR THE COMPETENT AUTHORITYR%33&%&'6,.3'+&,(.:CGT4 dcjcg E,/.%&2*' M 4 dcjcj D*,.&.%;'4 dcjcl $%&'4 K.3 APPLICANT OF THE REQUEST FOR THE ETHICS COMMITTEE (%33&%&'6,.3'+&,(.:CJT4 dclcg E,/.%&2*' P 4 dclcj D*,.&.%;'4 dclcl $%&'4 M I.%.%77>,+%&,(.&(&0':(;7'&'.&92&0(*,&<(.><U&0'%77>,+%.&&(&0':(;7'&'.&92&0(*,&<.''63&(3,/.C P I.%.%77>,+%&,(.&(&0'?&0,+3:(;;,&&''(.><U&0'%77>,+%.&&(&0'?&0,+3:(;;,&&''.''63&(3,/.C ML