regulacion bolivia
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7/25/2019 Regulacion Bolivia
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Bolivia
Regulations &Requirements
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Agenda Structure: Unidad de Medicamentos y Tecnologas en Salud
(UNIM!" A##lica$le Regulations %egal classication o' medicinal #roducts Bolivia Regulatory %andsca#e Su$mission rocess To#ics Requirements: )ase I (Aval" To#ics Requirements: )ase II (Registration" or Rene*al +uestions,Ans*ers Bolivia
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Structure : UNIM! (Resol- Min- N. //0"
Ministerio de Salud
1iceministerio deSalud y romoci2n
!irecci2n 3eneralde Servicios de
Salud
UNIM!
4rea de Suministroy Uso Racional
4rea de valuaci2ny Registro
4rea de 1igilanciay 5ontrol
5omisi2n6armacol2gica
5omisi2nNacional del
Sistema Nacionalde
6armacovigilancia
IN%ASA
57N5AM8T
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%egal classication o' medicinal#roducts
Generics Drugs
Brand Name Drugs
Domeo#at)ic !rugs lantsE animal and mineral source- S#ecialE $iologicE $loodE dietaryE dental and radio #)armaceuticals
#roducts Vaccines and biologics
5osmetics Medical !evices Reagents 'or diagnostic and clinical la$oratory
No mutual recognition agreements 'or drugs registration #rocess *it)eFternal agencies-
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Bolivia Regulatorylandsca#e (I"
Regulation:
3overnmental riorities : %o* #rices,National )armaceutical Industry-
MarGeting Aut)oriHation Dolder is t)e manu'acturer ($ulG"-
Resolutions can $e used $y dierent com#anies (%oA"-
No s#ecic regulation 'or $io similar #roducts are availa$le-
Im#ortation must $e a##roved $y BoD 'or eac) $atc)-
)armacology 5ommitte : 5linical,No 5linical valuation
Re'erences 5ountries: US and MA
Dossier
a#er dossier is required- 5linical,No clinical in'ormation can $e acce#ta$le in 5!-
5T! 'ormat is acce#ta$le- No translation required
Several local 'orms is required-
Quality Control Activities:
Bolivia )as AD7 recognition 'or %ocal %a$ testing IN%ASA
%ocal Testing Activities
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Bolivia Regulatorynviroment (II"
New Products
? Ste#s 'orN5,Biological,1accines
9J )ase: A1A% (Sa'ety andeKcacy"
?J )ase: +uality , 5 ,3M ,Sam#les
A##roval Timelines: 9?mont)s
A'ter a##roval a %ocal testingmust $e #er'ormed (BoD
sc)edule #rior rene*al"
Su$mission: T*o arts >co#ies
Sam#les
anu!acturing sitec"anges #PN$%
Ne* Sanitary Registration
Requirements: +ualitydossier , 5 , 3M,Sam#les
A##roval Timelines: ;mont)s
Su$mission: T*o arts , T*o5o#ies
Sam#les
Renewals
Must $e su$mitted ; mont)s
#rior eF#iration until 9mont) o' license eF#ired
A##roval Timelines: /mont)s
Results o' local testing must$e included
Su$mission: T*o arts , T*o
5o#ies
Sam#les
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Bolivia Regulatory%andsca#e (III"
Post Approval C"anges:
T)e 'ollo*ing #rocess can $e c)ange *it)in t)e same license: S)el' li'e eFtension ++6M'g ++ 5om#osition 5)ange %N 5)anges acGaging Site 5)ange < Secondary #acGaging acGaging 5om#onent 5)ange Additional resentation
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Su$mission rocess (I"%i'ecycle,
Regional3ro*t)
S7S Regulatory:
(%a aH< Bolivia"
%egal Re#resentative
(Santa 5ruH Bolivia"
BoD Bolivia
(%a aH"
Su$missionRece#tion
9 day
Build!ossier
!is#atc)
Signature
57!ocuments
Signature
?
days
!ossier#ermanece en
Santa 5ruH #or @das9 day
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Su$mission rocess (II"
)ase I : ?/mont)s )ase II : 9? mont)s
Renewal :&'( mont"s
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To#ics Requirements: )aseI (Aval" 57 !ocuments
%ocal 6orm NJ 0 %ocal 6orm NJ 9
No 5M5 !ocuments 5linicalStudies No clinica Studies
Ancilliary !ocument A##roval 5ountry o' 7rigin Lorld*ide Registration Status Re'erences
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o# cs equ rements: aseII (Registration" or Rene*al
(I" Su$mission consist in t*o #arts
art I : 6or UNIM! valuation art II: 6or 57N5AM8T
57 !ocuments: %ocal 6orm NJ @ %ocal 6orm NJ 0 %ocal 5ertications
5 6rom manu'acturing source country m$assy %egaliHation F#iration date: ? years-
%oA : F#iration date: 9 year
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o# cs equ rements: aseII (Registration" or Rene*al
(II" 5M5 !ocuments
++6 :
Must #resent in detail t)e drug su$stances (salts and t)eir corres#onding$ases"E eFci#ientsE s*eetenersE colorantsE #reservativesE avoring agentsEetc- T)e 'unction o' eac) com#onent must $e s#ecied-
5oA :
S#ecication must $e aligned to re'erence #)armaco#eia-
Re'erence #rocedureE eF#iration date and manu'acturing date is required-
Regulation detail mandatory tests 'or eac) dosage 'orm-
T)ree consecutive $atc)es
Sta$ility:
I' t)e sta$ility data is not signed $y t)e res#onsi$leE a cover letter isrequired-
Time#oints: E =E ;E E 9?E 9>E ?/E =;E />E ;
=-?-R ! 5old 5)ain Trans#ort +ualication (L)en a##lica$le"
%etter signed $y quality res#onsi$le to descri$e t)e eF#iration date 'ormat-
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To#ics Requirements:Sam#les
%a$els and %eaet Sam#les )ysical Sam#le is required-
T*o sam#les are required (art 9 andart ?" Art*orG MocG is also su$mitted-
roduct Sam#le N5 : Must $e la$eled using t)e
art*orGs a##roved in t)e country o'
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+uestions and Ans*ers
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