Regulacion Bolivia

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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9;

9> =/

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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

Documents

Regulacion Bolivia