Regulaciones Para Medicamentos de U

7/25/2019 Regulaciones Para Medicamentos de U

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Registrar Corp144 Research DriveHampton, VA 23666 USAPhone: 1!"#"!224!$1""%a&: 1!"#"!224!$1"'in(o)registrarcorp*com

http://www.registrarcorp.com/fda-drugs/api/registration.jsp?lang=es

Registrar Corp asiste a +as compa-as con e+ c.mp+imiento /e +a U*S* %DA* 0osCerti(ica/os /e Registro emiti/os por Registrar Corp con(irman .e a +a in/.stria .e.ste/ est c.mp+ien/o con e+ re.isito /e registro con +a U*S* %DA* 0a U*S* %DA noemite o reconoce Certi(ica/os /e Registro* Registrar Corp no esta a(i+ia/a con +a U*S*%oo/ an/ Dr.g A/ministration*

Regulaciones para Medicamentos de U.S. FDA

0a U*S* %DA reg.+a +os pro/.ctos /e (rmacos /estina/os a ser .ti+ia/os en e+/iagnstico, c.ra, mitigacin, tratamiento o prevencin /e en(erme/a/es 5 /estina/os aa(ectar +a estr.ct.ra o c.a+.ier (.ncin /e+ c.erpo /e +os seres h.manos o anima+es*Registrar Corp provee asistencia para Registro, Agente /e *UU*, 5 C.mp+imientoreg.+atorio para empresas /e *UU* 5 e&tran7eras en +a 8n/.stria /e %rmacos*

Registro y Listado para Nuevos Establecimientos de Medicamentos

0os propietarios . opera/ores /e to/os +os sta9+ecimientos /e e/icamentos /entro5 (.era /e sta/os Uni/os .e se /e/ican a +a (a9ricacin, preparacin, propagacin,composicin o e+a9oracin /e me/icamentos estn o9+iga/os a registrarse 5 presentar.na +ista /e to/os +os me/icamentos en /istri9.cin comercia+ a trav;s /e+ n.evoSistema +ectronico /e Registro /e Drogas 5 0ista/o /e +a U*S* %DA


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Regulaciones U.S. FDA Registro de Establecimiento deMedicamento y Requisitos de Listado

D.eos . opera/ores /e to/os +os esta9+ecimientos /e me/icamentos, no e&entos9a7o +a seccin #1$


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Revisin de Etiquetado de Medicamentos e Ingredientes

0a U*S* %DA ahora re.iere .e +as eti.etas /e me/icamentos se in/e&en .ti+ian/o0eng.a7e /e marca/o e&tensi9+e


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Registrar CorpGs Dr.g 0a9e+ing an/8ngre/ient Revie service he+pscompanies /etermine their /r.gGs +ie+5c+assi(ication an/ comp+iance ithapp+ica9+e +a9e+ing re.irements*

Registrar Corp cross re(erences 5o.r+a9e+ing against tho.san/s o( pages ithinthe Co/e o( %e/era+ Reg.+ations as e++ asthe %e/era+ Register, CDRGs 0isting o(@JC Active 8ngre/ients, R.+emaingHistor5 (or onpresciption Pro/.cts,L.i/ance Doc.ments an/ Marning 0ettersiss.e/ 95 U*S* %DA* Registrar CorpGs +a9e+revie service provi/es:

A/etai+e/ report


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https://www.registrarcorp.com/fda-drugs/otc/registration?lang=es&service=doRegList&step=1


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o(rece: Un reporte /eta++a/o


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U.S. FDA Drug Master File Requirements

Dr.g companies can s.9mit a Dr.g aster %i+e


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Deactivate a D%ith U*S* %DA

Up/ate 5o.r D% 8n(ormation ith U*S* %DA OO

"erti$icado de Registro e7pedido por Registrar "orp

mpresas registra/as con +a U*S* %DA son a men./o re.eri/as por s.s c+ientes 5provee/ores /e veri(icar s. registro U*S* %DA* Un Certi(ica/o /eRegistro e&pe/i/o porRegistrar Corp sirve como .na veri(icacin /e terceros /e s. registro U*S* %DA* Parao9tener ms in(ormacin, haga c+ic en e+ certi(ica/o /e e/icamentos .e se m.estraa +a i.ier/a*

Drug &erti$icate o$ U.S. FDA Registration

Comp+ete the (orm 9e+o to receive a Dr.g Certi(icate o( Registration iss.e/ 95Registrar Corp:

!sistencia con etencionesSin E7amen F&sico -89+E8

0as compa-as .e e&portanpro/.ctos a +os sta/os Uni/os p.e/en encontrar s.senv-os someti/os a .naK/etencin sin e&amen (-sicoKpor+a %DA /e *UU** 0ospro/.ctos s.7etos a /etencin sin e&amen (-sico son reteni/os en e+ p.erto /eentra/a, mientras .e +a %DArea+ia escr.tinios, pr.e9as5 an+isis a/iciona+es* 0osretrasos por estas /etenciones p.e/en res.+tar +argos para +as empresas /eseosas /eentregar pro/.ctos atiempo*Para o9tener a5./a con .na/etencin, simp+ementehaga c+ic en e+ Aviso/e Accin .e se m.estra a+a i.ier/a*

U.S. FDA Import Regulations

Jhe %oo/ an/ Dr.g A/ministrationGs


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comp+iant pro/.cts (rom entering the U*S* maret* Mhen /etentions occ.r, RegistrarCorp can he+p 5o. tr5 to reso+ve the/etention (avora9+5 an/ (ast*

'btainImmediate !ssistance /it, F! etentions

Registrar CorpGs team o( Reg.+ator5Specia+istsprovi/es imme/iate /etention assistance(or companies ith pro/.cts /etaine/ at the port o( entr5 95 the%DA* Simp+5 c+ic 9e+oto receive assistance ith %DA /etentions*

0earn more a9o.t %DA Detentions

8( 5o. (in/ 5o.r shipments /etaine//.e to an 8mport A+ert, there are proce/.res 95hich 5o. ma5 petition %DAto 9e remove/ (rom a Re/ 0ist or a//e/ to a Lreen 0ist*Registrar Corp provi/es assistance ith this comp+icate/ petitioning process*

0earn more a9o.t %DA 8mport A+erts

'I'LE ()%%F**D A+D DRU,S

&-A"'ER I%%F**D A+D DRU, ADMI+IS'RA'I*+

DE"AR'ME+' *F -EAL'- A+D -UMA+ SERI&ES

SU/&-A"'ER &%%DRU,S0 ,E+ERAL

PARJ 2$" RL8SJRAJ8@ @% PR@DUCRS @% DRULS AD 08SJ8L @% DRULS 8C@RC8A0 D8SJR8UJ8@

S.9part A!!Lenera+

Sec* 2$"*3 De(initions*


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prescription /r.g, an/ an5 signi(icant change in the +a9e+ or pacage insert o( an over!

the!co.nter /r.g* Changes that are not signi(icant inc+./e changes in arrangement or

printing or changes o( an e/itoria+ nat.re*


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a/vertisement is .se/ 9.t the promotiona+ content is essentia++5i/entica+, on+5 one

nee/ 9e s.9mitte/*


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4# %R 3$43, N.ne 6, 1'$, as amen/e/ at #$ %R ''#, ar* 6, 1'#B ## %R 11#"6,

ar* 2', 1''$B 66 %R #'1#6, ov* 2", 2$$1B 6' %R 4""#, A.g* 11, 2$$4T

S.9part !!&emptions

Sec* 2$"*1$ &emptions (or esta9+ishments*

Jhe (o++oing c+asses o( persons aree&empt (rom registration an/ /r.g +isting in

accor/ance ith thispart .n/er section #1$


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comp+iance ith a++ o( the re.irements o( this part* ach s.ch /istri9.tor at the time o(

s.9mitting or .p/ating /r.g +isting in(ormation as re.ire/ .n/er 2$"*3$ sha++ certi(5 to

the registere/ esta9+ishment that the s.9mission has 9een ma/e 95 provi/ing a signe/

cop5 o(%orm %DA!26#6


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processing o( a /r.g or /r.gs sha++ register the esta9+ishment ithin # /a5s a(terthe

9eginning o( the operation an/ sha++s.9mit a +ist o( ever5 /r.g in commercia+

/istri9.tion at that time* 8( the oner or operator o( the esta9+ishment has not

previo.s+5 entere/ into s.ch an operation, the oneror operator sha++ register ithin #

/a5s a(ter s.9mitting a ne /r.g app+ication, a99reviate/ ne /r.g app+ication, ne

anima+/r.g app+ication, a99reviate/ ne anima+ /r.g app+ication, re.est (or a//itionto the in/e&, me/icate/ (ee/ mi++ +icense app+ication,or a 9io+ogics +icense app+ication*

@nersor operators sha++ rene their registration in(ormation ann.a++5*

Jhe sche/.+e is as(o++os:

%irst +etter o( compan5 name Date %DA i++ mai+ (orms

A or Nan.ar5

C, D, or %e9r.ar5

%, L, orH arch

8, N, ,0* or Apri+

, @, P, , or R a5

S or J N.ne

U, V, M, F, W, or X N.+5


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Sec* 2$"*2# 8n(ormation re.ire/ in registration an/ /r.g +isting*


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statement=, the pacage insert, an/ a representative samp+ing o( an5 other +a9e+ing*


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4# %R 2#""", Apr* 1#, 1'$, as amen/e/ at ## %R 11#"", ar* 2', 1''$T

Sec* 2$"*3$ Up/ating /r.g +isting in(ormation*


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(or the registrantGs 9e+ie( that the /r.g pro/.ct is not s.97ect to section #$# or #12 o(

the act*


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prescription /r.g pro/.cts=*


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/escri9e/ in 2$"*2$, va+i/ation o( registration an/ the assignment o( a /r.g +isting

n.m9er /o not, in themse+ves, esta9+ish that the ho+/er o( the registration is +ega++5

.a+i(ie/ to /ea+ in s.ch /r.gs*

4# %R 3$43, N.ne 6, 1'$, as amen/e/ at 4 %R #4$$", ov* 3$, 1'3B #2 %R 262,

Nan* 26, 1'"B ## %R 11#"", ar* 2', 1''$B 64 %R 4$$, Nan* #, 1'''B "2 %R 6'12$,Dec* 6, 2$$"T

Sec* 2$"*3" 8nspection o( registrations an/ /r.g +istings*


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esta9+ishments*


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'I'LE ()%%F**D A+D DRU,S

&-A"'ER I%%F**D A+D DRU, ADMI+IS'RA'I*+

DE"AR'ME+' *F -EAL'- A+D -UMA+ SERI&ES

SU/&-A"'ER D%%DRU,S F*R -UMA+ USE

PARJ 314 !! APP08CAJ8@S %@R %DA APPR@VA0 J@ ARJ A M DRUL

S.9part L!!isce++aneo.s Provisions

Sec* 314*42$ Dr.g master (i+es*


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!bout Registrar "orp Me7ico

Jhe Unite/ States an/ e&ico are c+ose hen it comes to tra/e* 8n 2$13, e&ico asthe Unite/ StatesG thir/ +argest s.pp+ier o( goo/s imports, an/ ha+( o( U*S* (resh (r.itan/ vegeta9+e imports came (rom e&ico* Registrar CorpGs e&ico o((ice he+ps (oo/,/r.g, me/ica+ /evice, an/ cosmetic companies, navigate %DA reg.+ations*

Registrar Corp is a cons.+ting (irm that he+ps companies comp+5 ith U*S* %oo/ an/Dr.g A/ministration reg.+ations* %o.n/e/ in 2$$3, Registrar Corp has e&pan/e/ to 1o((ices or+/i/e an/ has assiste/ over 2$,$$$ companies meet %DA re.irements* %DAreg.+ation services are o((ere/ on a (i&e/!(ee 9asis*

P.e9+a Y22Co+* RomaDe+* C.a.htemocXip Co/e: $6"$$e&ico, D*%Phone: #2


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Regulaciones Para Medicamentos de U

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