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Revision July 2013

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
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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.

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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

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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
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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@
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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@
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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
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