dD dD

 (O0HGLFDPHQWR&RQFHSWR\GHILQLFLRQHV L E Y 2 9/ 2 00 6, d e 2 6 d e ju lio , d e g ar a n t as y u s o r a c io na l d e lo s M e d ic am e n t os y PS.


$ ,QWURGXFFLyQ\GHILQLFLRQHV D   0 H G LF D P H Q W R G H  X V R K X P D Q R 

WR G D  V X V W D Q F L D R  FR P E LQ D F Ly Q  G H  VX VWD Q F LD V T X H  VH 
'XUDQWH WRGD VX YLGD HO VHU KXPDQR KD EXVFDGR XQD H[SOLFDFLyQ D ORV IHQyPHQRV GH OD
S UH V H Q W H F R P R  S R V H H G R U D  G H  S U R S L H G D G H V  S D U D  H O
QDWXUDOH]DDVtFRPRVROXFLRQHVRUHPHGLRVDORVPDOHVRHQIHUPHGDGHVTXHSDGHFH$XQTXH
GHVGH ORV SHULRGRV KLVWyULFRV FRPR HO 3DOHROtWLFR \D VH HPSLH]DQ D FRQRFHU ODV SULPHUDV W U D W D P L H Q W R  R  S U H Y H Q F L y Q  G H H Q I H U P H G D G H V H Q  V H U H V 
SUiFWLFDVGHODPHGLFLQD\ODIDUPDFLDSODVPDGDVHQODHODERUDFLyQGHUHPHGLRVDSDUWLUGH K X P D QR V
SODQWDV\UHVWRVGHDQLPDOHVTXHVHUYtDQSDUDVDQDURFXUDUHQIHUPHGDGHVHVDSDUWLUGHO R T X H  S X H G D  X V D U V H  H Q  V H U H V K X P D Q R V R  D G P L Q L V W UD U V H 
VLJOR ;9,, FXDQGR \D VH HPSLH]D D XWLOL]DU OD SDODEUD IDUPDFLD HQ HO VHQWLGR TXH WLHQH D V H U H V K X P D Q R V F R Q  H O I L Q  G H  U H V W D X U D U  F R U UH J L U  R 
DFWXDOPHQWH \ FRPLHQ]D D GHVDUUROODUVH XQD FLHQFLD PiV FRPSOHMD FRPR VH UHIOHMD HQ ODV P R G L IL F D U O D V  I X Q F L R Q H V  I L V L R O y J L F D V
GHVFULSFLRQHVGHODSULPHUDIDUPDFRSHDGH/RQGUHV\3DUtV
H MH U F L H Q G R X Q D  D F F L y Q  I D U P D F R O y J L F D   LQ P X Q R O y J L F D  R 
P H W D E y O L F D  R  G H  H V W D E O H F H U  X Q  G L D J Q y V W LF R  P H G L F R .
Frmaco procede de la voz griega phrmakon. A
A S P IR I N A

remedio, cura, antdotoy a su vez veneno


 %/RVPHGLFDPHQWRVGHXVRKXPDQRVHSXHGHQFODVLILFDUHQ
$VtPLVPRHOPHGLFDPHQWRVHKDHODERUDGR\XWLOL]DGRDORODUJRGHODKLVWRULDGHGLIHUHQWHV 
IRUPDV$FRQWLQXDFLyQVHH[SRQHQDOJXQDVGHILQLFLRQHVRFRQFHSWRVVREUHHOPHGLFDPHQWR 0HGLFDPHQWR
WLSRVDVtFRPRRWURVWpUPLQRVGHLQWHUpVUHODFLRQDGRV 
VHFRPSRQHGHXQRXQFRQMXQWRGHSULQFLSLRVDFWLYRVLQWHJUDGRVHQXQDIRUPDIDUPDFpXWLFD
\HVWiQGHVWLQDGRVDSUHYHQLUGLDJQRVWLFDUWUDWDUDOLYLDURFXUDUHQIHUPHGDGHVRGROHQFLDV
6HGLVSHQVDQFRQRVLQUHFHWDPpGLFD


0HGLFDPHQWRHVSHFLDO
HV DTXHO PHGLFDPHQWR TXH UHTXLHUH XQ WUDWDPLHQWR HVSHFLDO D HIHFWRV GH GHPRVWUDU VX
FDOLGDGVHJXULGDG\HILFDFLD



0HGLFDPHQWRKHPRGHULYDGR
PHGLFDPHQWR D EDVH GH FRQVWLWX\HQWHV VDQJXtQHRV SUHSDUDGR LQGXVWULDOPHQWH SRU
HVWDEOHFLPLHQWRV S~EOLFRV R SULYDGRV GLFKRV PHGLFDPHQWRV FRPSUHQGHQ HQ SDUWLFXODU
DOE~PLQDIDFWRUHVGHFRDJXODFLyQHLQPXQRJOREXOLQDVGHRULJHQKXPDQR

 

M e d ic a m e n t o d e u s o h u m a n o
M e d ic a m e n t o d e u s o v e t e r i n a r io
P r i n c ip i o A c t iv o
E x c ip i e n t e :
F o r m a g a l n i c a o F o r m a F a r m a c u t ic a
M e d ic a m e n t o G e n r ic o s
P r o d u c t o S a n it a r io

7DO\FRPRVHGHVFULEHHQOD/H\GHGHMXOLRGHJDUDQWtDV\XVRUDFLRQDO
GH ORV PHGLFDPHQWRV \ SURGXFWRV VDQLWDULRV VH DEDQGRQD HO WpUPLQR HVSHFLDOLGDG
IDUPDFpXWLFD\VHLQWURGXFHODGHILQLFLyQGHPHGLFDPHQWRGHXVRKXPDQR
&
0HGLFDPHQWRLQPXQROyJLFR
HVWRGRPHGLFDPHQWRFRQVLVWHQWHHQYDFXQDVWR[LQDVVXHURV\DOpUJHQRV3XHGHQVHU

9DFXQDVLQGLYLGXDOL]DGDV
FRPRODVSUHSDUDGDVFRQDJHQWHVLQPXQL]DQWHVDFRQFHQWUDFLyQ\GLOXFLyQHVSHFLILFDHQEDVHDOD
FRUUHVSRQGLHQWHSUHVFULSFLyQSDUDXQSDFLHQWHGHWHUPLQDGR

$OpUJHQR
HV WRGR SURGXFWR GHVWLQDGR D LGHQWLILFDU R SURYRFDU XQD PRGLILFDFLyQ HVSHFtILFD \ DGTXLULGD GH OD
UHVSXHVWDLQPXQROyJLFDDXQDJHQWHDOHUJL]DQWH
 

0HGLFDPHQWRDEDVHGHSODQWDV
HV HO PHGLFDPHQWR TXH FRQWLHQH H[FOXVLYDPHQWH FRPR SULQFLSLRV DFWLYRV VXVWDQFLDV
YHJHWDOHV SUHSDUDGRV YHJHWDOHV FRPELQDFLRQHV GH pVWRV GHILQLpQGRVH VXVWDQFLD YHJHWDO \
SUHSDUDGRYHJHWDOFRPR

6XVWDQFLDV YHJHWDOHV VH GHILQHQ SRU OD SDUWH GH OD SODQWD XWLOL]DGD \ OD
GHQRPLQDFLyQ ERWiQLFD GH DFXHUGR FRQ XQ VLVWHPD ELQRPLDO TXH LQFOX\H JpQHUR
HVSHFLHYDULHGDG\DXWRUGHODSODQWD
1 & 2
dD dD

/DVVXVWDQFLDVYHJHWDOHVHQJOREDQ &&RPSRVLFLyQGHORVPHGLFDPHQWRV

ODVSODQWDVSULQFLSDOPHQWHHQWHUDVIUDJPHQWDGDVRFRUWDGDV 
ODVSDUWHVGHSODQWDV &DGDPHGLFDPHQWRFRQWLHQH
DOJDV 
KRQJRV\ 0DWHULDSULPD
OtTXHQHV QR WUDWDGRV QRUPDOPHQWH HQ IRUPD VHFD SHUR WDPELpQ IUHVFRV VH FRQVLGHUD TXH HV WRGD VXVWDQFLD DFWLYD R LQDFWLYD HPSOHDGD HQ OD IDEULFDFLyQ GH XQ
PHGLFDPHQWR \D SHUPDQH]FD LQDOWHUDGD VH PRGLILTXH R GHVDSDUH]FD HQ HO WUDQVFXUVR GH
GHWHUPLQDGRV H[XGDGRV TXH QR KDQ VLGR VRPHWLGRV D XQ WUDWDPLHQWR HVSHFtILFR
GLFKRSURFHVR
WDPELpQVHFRQVLGHUDQVXVWDQFLDVYHJHWDOHV


(M6LO\EXPPDULDQXP/*DHUWQHU(OQRPEUHFRP~QHVFDUGRPDULDQR 3ULQFLSLRDFWLYR
 HVODPDWHULDFXDOTXLHUDTXHVHDVXRULJHQKXPDQRDQLPDOYHJHWDOTXtPLFRRGHRWURWLSR
3UHSDUDGRVYHJHWDOHV DODTXHVHDWULEX\HXQDDFWLYLGDGDSURSLDGDSDUDFRQVWLWXLUXQPHGLFDPHQWR
ORVTXHVHREWLHQHQVRPHWLHQGRODVVXVWDQFLDVYHJHWDOHVDWUDWDPLHQWRVFRPRH[WUDFFLyQ 
GHVWLODFLyQSUHQVDGRIUDFFLRQDPLHQWRSXULILFDFLyQFRQFHQWUDFLyQRIHUPHQWDFLyQ ([FLSLHQWH
 HV DTXHOOD PDWHULD TXH LQFOXLGD HQ ODV IRUPDV JDOpQLFDV VH DxDGH OD ORV SULQFLSLRV
6HLQFOX\HQ
DFWLYRV R D VXV DVRFLDFLRQHV SDUD VHUYLUOHV GH YHKtFXOR SRVLELOLWDU VX SUHSDUDFLyQ \
VXVWDQFLDVYHJHWDOHVWULWXUDGDVRSXOYHUL]DGDVWLQWXUDVH[WUDFWRVDFHLWHVHVHQFLDOHV]XPRV
H[SULPLGRV\H[XGDGRVWUDWDGRV HVWDELOLGDG PRGLIL FDU VXV SURSLHGDGHV RUJDQROpSWLFDV R GHWHUPLQDU ODV SURSLHGDGHV ItVLFR
 TXtPLFDVGHOPHGLFDPHQWRDVtFRPRVXELRGLVSRQLELOLGDG
(MGHODJXDFDWH3HUVHD DPHULFDQD0LOOHUVHXWLOL]DHODFHLWH$YRFDGR ROHXP REWHQLGRSRU 
H[SUHVLyQGHODSXOSDGHOIUXWR '3UHSDUDFLyQGHPHGLFDPHQWRV
 
0HGLFDPHQWRKRPHRSiWLFR )RUPDJDOpQLFDRIRUPDIDUPDFpXWLFD
HV HO REWHQLGR D SDUWLU GH VXVWDQFLDV GHQRPLQDGDV FHSDV KRPHRSiWLFDV FRQ DUUHJOR D XQ 'LVSRVLFLyQ TXH DGRSWDQ ORV SULQFLSLRV DFWLYRV \ H[FLSLHQWHV SDUD FRQVWLWXLU XQ
SURFHGLPLHQWR GH IDEULFDFLyQ KRPHRSiWLFR GHVFULWR HQ OD )DUPDFRSHD (XURSHD HQ OD 5HDO PHGLFDPHQWR
)DUPDFRSHD (VSDxRODRHQVX GHIHFWR HQ XQDIDUPDFRSHD XWLOL]DGD GHIRUPDRILFLDO HQ XQ 6HGHILQHSRUODFRPELQDFLyQGHODIRUPDHQODTXHHOSURGXFWRIDUPDFpXWLFR
SDtV GH OD 8QLyQ (XURSHD 8Q PHGLFDPHQWR KRPHRSiWLFR SRGUi FRQWHQHU YDULRV SULQFLSLRV
HV SUHVHQWDGR SRU HO IDEULFDQWH \ OD IRUPD HQ OD TXH HV DGPLQLVWUDGD DO
DFWLYRV

SDFLHQWH

(MHPSORFiSVXODFRPSULPLGRJHOVXSRVLWRULR
0HGLFDPHQWRJHQpULFR

PHGLFDPHQWRTXHWLHQHODPLVPDFRPSRVLFLyQFXDOLWDWLYD\FXDQWLWDWLYDHQSULQFLSLRVDFWLYRV
\ODPLVPDIRUPDIDUPDFpXWLFD\FX\DELRHTXLYDOHQFLDFRQHOPHGLFDPHQWRGHUHIHUHQFLD
1RPEUHGHOPHGLFDPHQWR
KDVLGRGHPRVWUDGDSRUHVWXGLRVDGHFXDGRVGHELRGLVSRQLELOLGDG LGHQWLILFD DO PHGLFDPHQWR \ FRQVWD GH OD GHQRPLQDFLyQ GHO PHGLFDPHQWR GRVLV \
 IRUPD IDUPDFpXWLFD \ FXDQGR SURFHGD OD PHQFLyQ GH ORV GHVWLQDWDULRV ODFWDQWHV
 QLxRVRDGXOWRV
 (MHPSOR)HEUHFWDOPJVXSRVLWRULRV,QIDQWLO



0HGLFDPHQWRSXEOLFLWDULR 'HQRPLQDFLyQFRP~Q
VRQDTXHOORVPHGLFDPHQWRVTXHSXHGHQVHUREMHWRGHSXEOLFLGDGGHVWLQDGDDOS~EOLFR\TXH HVOD'HQRPLQDFLyQ2ILFLDO(VSDxROD'2(DWULEXLGDDFDGDSULQFLSLRDFWLYRSRUOD
GHEHQFXPSOLUWRGRVORVUHTXLVLWRVTXHVHUHODFLRQDQDFRQWLQXDFLyQ

$JHQFLD(VSDxRODGH0HGLFDPHQWRV\3URGXFWRV6DQLWDULRV(QVXGHIHFWRVHXWLOL]D
D4XHQRVHILQDQFLHQFRQIRQGRVS~EOLFRV OD 'HQRPLQDFLyQ &RP~Q ,QWHUQDFLRQDO '&, UHFRPHQGDGD SRU OD 2UJDQL]DFLyQ
E 4XH SRU VX FRPSRVLFLyQ \ REMHWLYR HVWpQ GHVWLQDGRV \ FRQFHELGRV SDUD VX 0XQGLDO GH OD 6DOXG \ HQ HO FDVR GH QR H[LVWLU QL '2( QL '&, VH XWLOL]D OD
XWLOL]DFLyQVLQODLQWHUYHQFLyQGHXQPpGLFRTXHUHDOLFHHOGLDJQyVWLFRSUHVFULSFLyQ GHQRPLQDFLyQFRP~QXVXDO
RVHJXLPLHQWRGHOWUDWDPLHQWR (V HO QRPEUH GH OD VXVWDQFLD R SULQFLSLR DFWLYR UHVSRQVDEOH GHO HIHFWR
F4XHQRFRQWHQJDQHQVXFRPSRVLFLyQVXVWDQFLDVSVLFRWUySLFDVQLHVWXSHIDFLHQWHV WHUDSpXWLFRGHOPHGLFDPHQWR
 6HSXHGHGHFLUTXHHVHOQRPEUH FLHQWtILFRGHOPHGLFDPHQWRPLHQWUDVTXH
0HGLFDPHQWRKXpUIDQR
OD PDUFD HV XQ QRPEUH FRPHUFLDO $SDUHFH VLHPSUH HQ HO HQYDVH \ HQ HO
VRQ DTXHOORV SURGXFWRV GHVWLQDGRV DO GLDJQyVWLFR D OD SUHYHQFLyQ R HO WUDWDPLHQWR GH ODV
(QIHUPHGDGHV 5DUDV LQFOXLGDV ODV GH RULJHQ JHQpWLFR VRQ DTXHOODV HQIHUPHGDGHV FRQ
SURVSHFWRGHEDMRGHOQRPEUHFRPHUFLDO
SHOLJUR GH PXHUWH R GH LQYDOLGH] FUyQLFD TXH WLHQHQ XQD IUHFXHQFLD SUHYDOHQFLD EDMD (MHPSOR'2(SDUDFHWDPRO
PHQRU GH  FDVRV SRU FDGD  KDELWDQWHV HQ OD &RPXQLGDG VHJ~Q OD GHILQLFLyQ GH OD 
8QLyQ(XURSHD 'RVLVGHOPHGLFDPHQWR
 HVHOFRQWHQLGRGHSULQFLSLRDFWLYRH[SUHVDGRHQFDQWLGDGSRUXQLGDGGHWRPDSRU
 XQLGDGGHYROXPHQRGHSHVRHQIXQFLyQGHODSUHVHQWDFLyQ
& 3 & 4
dD

(2WURVSURGXFWRVTXHQRVRQPHGLFDPHQWRV

 3URGXFWRGHKLJLHQHSHUVRQDOVRQDTXHOODVVXVWDQFLDVRSUHSDUDGRVTXH
VLQ WHQHU OD FRQVLGHUDFLyQ OHJDO GH PHGLFDPHQWRV SURGXFWRV VDQLWDULRV FRVPpWLFRV R
ELRFLGDVHVWiQGHVWLQDGRVDVHUDSOLFDGRVVREUHODSLHOGLHQWHVPXFRVDVGHOFXHUSRKXPDQR
FRQILQDOLGDGGHKLJLHQHRGHHVWpWLFDRSDUDQHXWUDOL]DURHOLPLQDUHFWRSDUiVLWRV
 3URGXFWR FRVPpWLFR VRQ ODV VXVWDQFLDV R SUHSDUDGRV GHVWLQDGRV D VHU SXHVWRV HQ
FRQWDFWRFRQODVGLYHUVDVSDUWHVVXSHUILFLDOHVGHOFXHUSRKXPDQRHSLGHUPLVVLVWHPDSLORVR
\FDSLODUXxDVODELRV\yUJDQRVJHQLWDOHVH[WHUQRVFRQORVGLHQWHV\ODVPXFRVDVEXFDOHV
FRQHOILQH[FOXVLYRRSULQFLSDOGHOLPSLDUORVSHUIXPDUORVPRGLILFDUVXDVSHFWR\RFRUUHJLU
ORVRORUHVFRUSRUDOHV\RSURWHJHUORVRPDQWHQHUORVHQEXHQHVWDGR



O3URGXFWRVDQLWDULR
&XDOTXLHULQVWUXPHQWRGLVSRVLWLYRHTXLSRPDWHULDOXRWUR
DUWLFXORXWLOL]DGRVRORRHQFRPELQDFLyQLQFOXLGRVORVSURJUDPDV
LQIRUPiWLFRVTXHLQWHUYHQJDQHQVXEXHQIXQFLRQDPLHQWR
GHVWLQDGRSRUHOIDEULFDQWHDVHUXWLOL]DGRHQVHUHVKXPDQRVFRQ
ILQHVGH
 'LDJQyVWLFRSUHYHQFLyQFRQWUROWUDWDPLHQWRRDOLYLRGHXQDHQIHUPHGDG
 'LDJQRVWLFRFRQWUROWUDWDPLHQWRDOLYLRRFRPSHQVDFLyQGHXQDOHVLyQRGHXQD
GHILFLHQFLD
 ,QYHVWLJDFLyQVXVWLWXFLyQRPRGLILFDFLyQGHODDQDWRPtDRGHXQSURFHVR
ILVLROyJLFR
 5HJXODFLyQGHODFRQFHSFLyQ

y que no ejerza la accin principal que se desee obtener en el

interior o en la superficie del cuerpo humano por medios
farmacolgicos, inmunolgicos ni metablicos, pero a cuya funcin
puedan contribuir tales medios.

& 5