APPLICATION FORM FOR RENEWAL OF A MARKETING AUTHORISATION
HUMAN VETERINARY NATIONAL AUTHORISATION IN MRP/DCP MRP/DCP procedure nu!er " # $$/$/$$$$/$$$/$$/$$ EU AUTHORISATION NATIONAL AUTHORISATION ONLY Reference Member State: AT BE BG ! " #E #$ EE E% ES &' &R (R () 'E 'S 'T %' %T %) %* MT +% +, -% -T R, SE S' S$ )$
oncerne. Member States: AT BE BG ! " #E #$ EE E% ES &' &R (R () 'E 'S 'T %' %T %) %* MT +% +, -% -T R, SE S' S$ )$ +,+E 's t/e 0ro.uct currently mar1ete.2 !es +o 'f yes3 in 4/ic/ Member States 2 2 AT BE BG ! " #E #$ EE E% ES &' &R (R () 'E 'S 'T %' %T %) %* MT +% +, -% -T R, SE S' S$ )$ 5'nvente.6+ame: Active substance5s6: -/armacot/era0eutic classification 5Grou0 7 AT co.e6: -/armaceutical form5s6 an. stren8t/5s6 3 : Route5s6 of a.ministration 3 : Tar8et s0ecies 3 : MA number5s6 3 : +ame an. a..ress of MA /ol.er:
+ame an. a..ress of ontact 9 :
Tele0/one number: &a: number: E;mail: A00licant<s reference: #ate of first aut/orisation in Reference Member State=E): #ate of e:0iry of current aut/orisation in Reference Member State=E): #ate of first aut/orisation in t/e oncerne. Member State to 4/ic/ t/is a00lication is ma.e: #ate of e:0iry of current aut/orisation in t/e oncerne. Member State: -ro0ose. ommon Rene4al #ate: 1 (uman Me.icinal -ro.ucts: +umber to be com0lete. by t/e Mar1etin8 Aut/orisation (ol.er3 reflectin8 t/e correct se>uential MR-=#- +umber accor.in8 to *olume 2A3 /a0ter 23 ?@ +umberin8 System for t/e -roce.ures for Mutual Reco8nition an. #ecentralise. -roce.ure as 0ublis/e. on t/e Aebsite of t/e Euro0ean ommission 5/tt0:==ec@euro0a@eu=/ealt/=.ocuments=eu.rale:=vol;2=in.e:Ben@/tm 6 *eterinary Me.icinal -ro.ucts: Rene4al number to be issue. by t/e Reference Member State before submission of t/e a00lication accor.in8 to t/e corres0on.in8 M#5v6 Best -ractice Gui.e 5/tt0:==444@/ma@eu6 2 &or centrally aut/orise. 0ro.ucts a list of E) Member States = +or4ay = 'celan. 4/ere t/e 0ro.uct is on t/e mar1et s/oul. be 0rovi.e. in a se0arate a00en.i: 3 &or centrally aut/orise. 0ro.ucts t/is information3 inclu.in8 0ac1a8in8 an. 0ac1 siCe5s63 s/oul. be 0rovi.e. in tabular format in a se0arate a00en.i: 5cf@ Anne: A to (M-=*M- ,0inion6 9 As s0ecifie. in section 2@9@3 in -art 1A@ 'f .ifferent3 attac/ letter of aut/orisation -a8e 1 Revision July 2013 APPROVED MANUFACTURERS Aut/orise. manufacturer5s6 5or im0orter6 res0onsible for !%&c' re(e%)e in t/e EEA 5in accor.ance 4it/ Articles 90 an. D1 of #irective 2001=E3=E3 as amen.e.3 or Articles 99 an. DD of #irective 2001=E2=E 5as s/o4n in t/e 0ac1a8e leaflet an. 4/ere a00licable in t/e labellin8 or Anne: '' of t/e #ecision6 om0any +ame: A..ress: ountry: Tele0/one: Telefa:: E;mail: Further manufacturers responsible for batch release can be detailed in the text field below, in the same format as shown above.
For !(ood produc&) %nd *%cc+ne)# State laboratory or laboratory .esi8nate. for official !%&c' re(e%)e3 as accor.ance 4it/ Articles 1115163 1133 119 516;526 an. 11D of #irective 2001=E3=E as amen.e.@ +ame: A..ress: ountry: Tele0/one: Telefa:: E;mail: Further manufacturers responsible for batch release can be detailed in the text field below, in the same format as shown above.
Site5s6 in EEA or in countries 4/ere an MRA or ot/er E) arran8ements a00ly3 4/ere !%&c' con&ro(/&e)&+n, ta1es 0lace3 as re>uire. by Article D1 of #irective 2001=E3=E as amen.e. or Article DD of #irective 2001=E2=E3 if .ifferent from above: om0any +ame: A..ress: ountry: Tele0/one: Telefa:: E;mail: Further sites can be detailed in the text field below, in the same format as shown above.
Manufacturer5s6 of t/e ed+c+n%( produc& an. site5s6 of manufacture 5inclu.in8 .iluent an. solvent manufacturin8 sites6: om0any +ame: A..ress: ountry: Tele0/one: Telefa:: E;mail: Brief .escri0tion of functions 0erforme. by manufacturer of .osa8e form=assembler3 etc: Further manufacturers can be detailed in the text field below, in the same format as shown above.
-a8e 2 Revision July 2013 Manufacturer5s6 of t/e %c&+*e )u!)&%nce-). Note: All manufacturing sites involved in the manufacturing process of each source of active substance should be listed. Broker or supplier details alone are not sufficient om0any +ame: A..ress: ountry: Tele0/one: Telefa:: E;mail: Further active substance manufacturers can be detailed in the text field below, in the same format as shown above.
/UALITATIVE AND /UANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE SU0STANCE-S. AND THE E1CIPIENT-S. (For centrall authorised products the composition should be provided separatel in tabular format as part of the !ualit "xpert #tatement.$ A note should be given as to which %uantit the composition refers (e.g. & capsule$. 'ist the active substance(s$ separatel from the excipients +ame of active substanceF5s6
Guantity
)nit
Mono8ra0/ stan.ar.
+ame of e:ci0ientF5s6
Guantity
)nit
Mono8ra0/ stan.ar.
F(nl one name should be given, in the following order of priorit: )NN, *h. "ur., National *harmacopoeia, common name, scientific name. +he active substance should be declared b its recommended )NN, accompanied b its salt or hdrate form if relevant. #etails of any overa8es s/oul. no& be inclu.e. in t/e formulation but state. belo4: ; active substance5s6 ; e:ci0ient5s6 ()f revised product information (#m*,, 'abelling and-or *ackage 'eaflet$ is proposed to take account of issues raised b the expert, specif the precise present and proposed wording, underlining or highlighting the changed words. Alternativel, such listing ma be provided as a separate document attached to the application form6@ PRESENT PRODUCT INFORMATION TE1T PROPOSED PRODUCT INFORMATION TE1T
-a8e 3 Revision July 2013 DOCUMENTS APPENDED TO THIS APPLICATION Note: )n case of a human authorisation, delete the complete list of veterinar documents. )n case of a veterinar authorisation, delete the complete list of human documents. FOR HUMAN MEDICINAL PRODUCTS ONLY Module 1: 1@0 over %etter 1@1 om0re/ensive table of content 5not a00licable for centrally aut/orise. me.icinal 0ro.ucts6 1@2 Rene4al A00lication &orm 4it/ t/e follo4in8 anne:es: A list of all aut/orise. 0ro.uct 0resentations for 4/ic/ rene4al is sou8/t in tabular format #etails on contact 0ersons: H Gualifie. 0erson in t/e EEA for -/armacovi8ilance H ontact 0erson in t/e EEA 4it/ overall res0onsibility for 0ro.uct .efects an. recalls H ontact 0erson for scientific service in t/e EEA in c/ar8e of information about t/e me.icinal 0ro.uct %ist of E) Member States = +or4ay = 'celan. 4/ere t/e 0ro.uct is on t/e mar1et an. in.icatin8 for eac/ country 4/ic/ 0resentations are mar1ete. an. t/e launc/ .ate /ronolo8ical list of all 0ost;aut/orisation submissions since 8rant of t/e Mar1etin8 aut/orisation or last rene4al: a list of all a00rove. or 0en.in8 Ty0e 'A='B an. Ty0e '' variations3 E:tensions3 Art I1536 +otifications3 )SR an. -S)R3 8ivin8 t/e 0roce.ure number 54/ere a00licable63 .ate of submission3 .ate of a00roval 5if a00rove.6 an. brief .escri0tion of t/e c/an8e@ /ronolo8ical list of con.itions an. S0ecific ,bli8ations 5for centrally aut/orise. 0ro.ucts6 submitte. since 8rant of mar1etin8 aut/orisation or last rene4al in.icatin8 sco0e3 status3 .ate of submission an. .ate 4/en issue /as been resolve. 54/ere a00licable6 Revise. list of all remainin8 con.itions an. any S0ecific ,bli8ations 5for centrally aut/orise. 0ro.ucts6 54/ere a00licable6 A statement3 or 4/en available3 a certificate of GM- com0liance3 not more t/an t/ree years ol.3 for t/e manufacturer5s6 of t/e me.icinal 0ro.uct liste. in t/e a00lication issue. by an EEA com0etent aut/ority or MRA 0artner aut/ority@ A reference to t/e Eu.raGM- .atabase 4ill suffice3 once t/is is available &or manufacturin8 sites of t/e me.icinal 0ro.uct not locate. in t/e EEA or in t/e territory of an MRA 0artner3 a list of t/e most recent GM- ins0ections carrie. out by ot/er aut/orities in.icatin8 t/e .ate3 ins0ection team an. outcome -a8e 9 Revision July 2013 A .eclaration by t/e Gualifie. -erson 5G-6 of eac/ of t/e manufacturin8 aut/orisation /ol.ers 5i@e@ locate. in t/e EEA6 liste. in t/e a00lication form 4/ere t/e active substance5s6 is use. as a startin8 material3 t/at t/e active substance5s6 is manufacture. in accor.ance 4it/ t/e 8ui.elines on 8oo. manufacturin8 0ractice for startin8 materials as a.o0te. by t/e E) D A/ere .ifferent3 a .eclaration by t/e Gualifie. -erson 5G-6 of t/e manufacturin8 aut/orisation /ol.er5s6 liste. in t/e a00lication form as res0onsible for batc/ release3 t/at t/e active substance5s6 is manufacture. in accor.ance 4it/ t/e 8ui.elines on 8oo. manufacturin8 0ractice for startin8 materials as a.o0te. by t/e E) 1@3@1 Sm-3 %abellin8 an. -ac1a8e %eaflet 1@3@3 S0ecimen 5for centrally aut/orise. 0ro.ucts only6 1@9 'nformation about t/e e:0ert 1@9@1 Guality 5incl@ Si8nature 7 *6 1@9@2 +on;clinical 5incl@ Si8nature 7 *6 J 4/ere a00licable 1@9@3 linical 5incl@ Si8nature 7 *6 1@E@1 Summary of -/armacovi8ilance System 54/ere a00licable6 1@E@2 Ris1 Mana8ement -lan 54/ere a00licable6 Module 2 2@3 A..en.um to Guality ,verall Summary 2@9 A..en.um to +on;clinical ,vervie4 J54/ere a00licable6 2@D A..en.um to linical ,vervie4 D +ote: A/ere more t/an one Gualifie. -erson 5G-6 is involve.3 a sin8le .eclaration by one of t/e G-s that the active substance(s) used as a starting material are manufactured in accordance with the guidelines on good manufacturing practice for starting materials as adopted by the EU, may be submitte. 0rovi.e. t/at: T/e .eclaration ma1es it clear t/at it is si8ne. on be/alf of all t/e involve. G-s@ T/e arran8ements are un.er0inne. by a tec/nical a8reement as .escribe. in /a0ter ? of t/e GM- Gui.e an. t/e G- 0rovi.in8 t/e .eclaration is t/e one i.entifie. in t/e a8reement as ta1in8 s0ecific res0onsibility for t/e GM- com0liance of t/e active substance manufacturer5s6@ -a8e D Revision July 2013 FOR VETERINARY MEDICINAL PRODUCTS ONLY 1@0 over %etter 1@1 om0re/ensive table of content 2 Rene4al A00lication &orm 4it/ t/e follo4in8 anne:es: 2@1 %ist of all aut/orise. 0ro.uct 0resentations for 4/ic/ rene4al is sou8/t in tabular format 2@2 #etails on contact 0ersons: H Gualifie. 0erson in t/e EEA for -/armacovi8ilance an. t/e G- for -/armacovi8ilance in t/e MS3 if .ifferent H ontact 0erson in t/e EEA 4it/ overall res0onsibility for 0ro.uct .efects an. recalls H ontact 0erson at t/e a..ress of t/e Mar1etin8 Aut/orisation (ol.er 5if .ifferent from t/e a..ress of t/e contact 0erson .urin8 t/e 0roce.ure6 2@3 %ist of E) Member States = +or4ay = 'celan. 4/ere t/e 0ro.uct is on t/e mar1et an. in.icatin8 for eac/ country 4/ic/ 0resentations are mar1ete. an. t/e launc/ .ate 2@9 /ronolo8ical list of all 0ost aut/orisation submissions 5variations3 e:tensions etc@63 con.itions an.3 any S0ecific ,bli8ations 5for centrally aut/orise. 0ro.ucts6 submitte. since 8rant of mar1etin8 aut/orisation or last rene4al in.icatin8 sco0e3 status3 .ate of submission an. .ate 4/en issue /as been resolve. 2@D Revise. list of all remainin8 con.itions an.3 any S0ecific ,bli8ations 5for centrally aut/orise. 0ro.ucts6 54/ere a00licable6 2@I -roof of 0ayment of fee3 4/ere relevant 2@? A statement3 or 4/en available3 a certificate of GM- com0liance3 not more t/an t/ree years ol.3 for t/e manufacturer5s6 of t/e me.icinal 0ro.uct liste. in t/e a00lication issue. by an EEA com0etent aut/ority or MRA 0artner aut/ority@ 2@E 'n a..ition3 for manufacturin8 sites of t/e me.icinal 0ro.uct not locate. in t/e EEA or in t/e territory of an MRA 0artner3 a list of t/e most recent GM- ins0ections carrie. out by ot/er aut/orities in.icatin8 t/e .ate3 ins0ection team an. outcome@ 2@K A .eclaration by t/e Gualifie. -erson 5G-6 of eac/ of t/e manufacturin8 aut/orisation /ol.ers 5i@e@ locate. in t/e EEA6 liste. in t/e a00lication form 4/ere t/e active substance5s6 is use. as a startin8 material3 t/at t/e active substance5s6 is manufacture. in accor.ance 4it/ t/e 8ui.elines on 8oo. manufacturin8 0ractice for startin8 materials as a.o0te. by t/e E) I 2@10 A/ere .ifferent3 a .eclaration by t/e Gualifie. -erson 5G-6 of t/e manufacturin8 aut/orisation /ol.er5s6 liste. in t/e a00lication form as res0onsible for batc/ release3 t/at t/e active substance5s6 is manufacture. in accor.ance 4it/ t/e 8ui.elines on 8oo. manufacturin8 0ractice for startin8 materials as a.o0te. by t/e E) I 3 S-3 %abellin8 an. -ac1a8e %eaflet I +ote: A/ere more t/an one Gualifie. -erson 5G-6 is involve.3 a sin8le .eclaration by one of t/e G-s that the active substance(s) used as a starting material are manufactured in accordance with the guidelines on good manufacturing practice for starting materials as adopted by the EU, may be submitte. 0rovi.e. t/at: T/e .eclaration ma1es it clear t/at it is si8ne. on be/alf of all t/e involve. G-s@ T/e arran8ements are un.er0inne. by a tec/nical a8reement as .escribe. in /a0ter ? of t/e GM- Gui.e an. t/e G- 0rovi.in8 t/e .eclaration is t/e one i.entifie. in t/e a8reement as ta1in8 s0ecific res0onsibility for t/e GM- com0liance of t/e active substance manufacturer5s6@ -a8e I Revision July 2013 9 Guality e:0ert statement 5incl@ Si8nature 7 *63 inclu.in8: 9@1 urrently aut/orise. s0ecifications for t/e active substance an. t/e finis/e. 0ro.uct 9@2 Gualitative an. >uantitative com0osition in terms of t/e active substance5s6 an. t/e e:ci0ient5s6 D linical e:0ert statement 5incl@ Si8nature 7 *6 I Safety e:0ert statement 5incl@ Si8nature 7 *6 ? -erio.ic Safety )0.ate Re0ort an. Summary Bri.8in8 Re0ort if a00licable E #eclaration of current TSE status ' /ereby ma1e a00lication for t/e above Mar1etin8 Aut/orisation to be rene4e.@ ' .eclare t/at t/e >uality of t/e 0ro.uct3 in res0ect of t/e met/o.s of 0re0aration an. control3 /as been re8ularly u0.ate. by variation 0roce.ure to ta1e account of tec/nical an. scientific 0ro8ress in accor.ance 4it/ Article 23 of #irective 2001=E3=E or Article 2? 516 of #irective 2001=E2=E or Article 1I or Article 91516 of Re8ulation 5E6 +o ?2I=2009@ T/e 0ro.uct conforms 4it/ current (M-=*M- >uality 8ui.elines 4/ere relevant@ ' confirm t/at no c/an8es /ave been ma.e to t/e 0ro.uct 0articulars ot/er t/an t/ose a00rove. by t/e om0etent Aut/ority@ &ees 0ai. or 4ill be 0ai.3 if a00licable Amount=urrency: M%+n S+,n%&or2$$$$$$$$$$$$$$$$$$$$$$$$$$ Status 5Job title6BBBBBBBBBBBBBBBBBBBBBB -rint nameBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB #ate Second S+,n%&or2$$$$$$$$$$$$$$$$$$$$$$$$ (where appropriate$ Status 5Job title6BBBBBBBBBBBBBBBBBBBBBB -rint nameBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB #ate -a8e ?