Plan de Gestión de Riesgos de Productos Farmacéuticos

 

WO@C BF LF[RAÛC BF XAF[LN[ BF WXNBVKRN[ I@XM@KÁVRAKN[ HFY@ KAZVM@H ACRFLX@CRF[ .     

BFO@KXVZ [VKOVWF, [AOYA@ BA@Z IFXC@CBFZ , OFOA[ IFXC@CBFZ K@[AMAXN K@[AMA XN , QNY@C@ XNHOF[ KDAKNM@ , OF[O OF[OQ Q [N[@ MVC@XF[, M@XAC@

 

HFY@KAZVM@H ACBAK@KANCF[ :  @v`stac fstà `utnraz`bn p`r` fo kàckfr knonrrfkt`o mft`stàsakn, fo kàckfr bf m`m` mft`stàsakn, Kàckfr bf puomûc bf káouo`s cn pfqufð`s `v`cz`bn, mft`stàsakn n rfkurrfctf, `v`cz`bn y / n KKX mft`stàsakn, nv`ran fpatfoa`o, trnmp` bf I`onpan y kàckfr pfratncf`o pram`ran, y Kàckfr bf kufoon utfracn (kncsuotf o` iakd` tákcak` p`r` vfr o`s acbak`kancfs knmpoft`s). Knctafcf hfv`kazum`h knmn sust`cka` `ktav` y sf `bmacastr` pnr ví` AY. Wufbf fcknctr`r màs acinrm`kaûc snhrf o` fv`ou`kaûc bf ons hfcfiakans bf @v`stac fc @v`stac‑s FW@X, ackouabn fc su rfsumfc fc ofclu`jf sfckaoon, baspncahof fc fo satan wfh bf FM@, h`jn fo pàlac` wfh bf mfbakac`

 

MFK@CA[MN BF @KKAÛC : Hfv`kazum`h sf ucf `o i`ktnr bf krfkamafctn bfo fcbntfoan v`skuo`r (YFLI), i`ktnr ko`vf bf o` v`skuonlácfsas y o` `clanlácfsas, acdahafcbn `sí o` ucaûc bf ástf ` sus rfkfptnrfs Iot-0 (YFLIX-0) y EBX (YFLIX-8), satu`bns fc o` supfriakaf bf o`s káouo`s fcbntfoa`ofs. O` cfutr`oaz`kaûc bf o` `ktavab`b hanoûlak` bfo YFLI prnbukf uc` rflrfsaûc bf o` v`skuo`raz`kaûc bf ons tumnrfs, cnrm`oaz` o` v`skuo`tur` rfsabu`o bfo tumnr f acdahf o` cfnv`skuo`raz`kaûc tumnr`o, acdahafcbn `sí fo krfkamafctn bfo tumnr tumnr..

 

XAF[LN[ ABFCRAIAK@BN[ XAF[LN[ ABFCRAIAK@BN[ AMWNXR@CRF[

[`clr`bn / dfmnrr`la` • dfmnrr`la` puomnc`r • prntfacura` • Fvfctns trnmhnfmhûoakns `rtfra`ofs. • dapfrtfcsaûc •• Acsuiakafcka` k`rbí`k` knclfstav` knmpoak`kancfs bf kur`kaûc bf dfrab`s • pfrinr`kancfs l`strnactfstac`ofs Ofukn fckfi`onp`tí` pnstfranr rfvfrsahof sícbrnmf • Cfutrnpfca` • Fvfctns trnmhnfmhûoakns vfcnsns. • Iístuo` (quf cn sf` l`strnactfstac`o) • Makrn`clanp`tí` trnmhûtak`. • Dapfrtfcsaûc puomnc`r • acsuiakafcka` nvàrak` • Xf`kkancfs bf dapfrsfcsahaoab`b / aciusaûc rf`kkancfs • pfrinr`kaûc bf o` vfsíkuo` haoa`r • cfurnp`tí` sfcsnra`o pfraiárak` • Rr`stnrcns k`rbí`kns (fxkfptn knclfstavns acsuiakafcka` k`rbí`k` y trnmhnfmhûoak` `rtfra`o fvfctns) • Nstfncfkrnsas bf o` m`cbíhuo`. • O` i`skatas cfkrntaz`ctf • Fvfctns `bvfrsns bfspuás bf iufr` bf ftaquft` usn actr`vítrfn • @otfr`kaûc bfo bfs`rrnoon fmhranift`o. • Nstfncfkrnsas fc caðns.

 

MA[[ACL ACINXM@KRANC Fifktns ` o`rln po`zn bf MY@[A ku`cbn sf us` fc o` pnho`kaûc pfbaàtrak` • [flurab`b y fiak`ka` fc p`kafctfs knc acsuiakafcka` rfc`o. bask`p`kab`b • [flurab`b y fiak`ka` fc p`kafctfs knc bftfranrn dfpàtakn • Vsn fc mujfrfs o`kt`ctfs.  o`kt`ctfs. 

 

XAF[LN[ Q/ N @KRAYAB@BF[ BF MACAMAZ@KAÛC BF XAF[LN[ I@XM@KNYALAO@CKA@ W@X@ ON[ XAF[LN[ BF ABFCRAIAK@BN[ WNRFCKA@OF[