The chilolezo cholowaón pazida zamankhwala Ndichofunikira mwalamulo chomwe chili ndi udindo wowongolera kulowa kwa mtundu uwu wazinthu m'dziko.ís ochokera kunja, popeza ndi mtundu wazinthu zomwe ziyenera kutsata mndandanda wa malamulo otetezeka ndi miyezo yomwe imatsimikizira ubwino, ndi?, pamwamba pa zonse, chitsimikizo ogula thanzi. Choncho, Sikophweka kuitanitsa zinthu zamtunduwu..
Pamenepa, Chikalatachi ndichofunika ndipo chiyenera kuperekedwa ndi a odziwa zaumoyo, kuwunika kofananirako kukachitikaón ndi chitsimikiziroón kuti zinthuzo zimagwirizana ndi miyezo yaumoyo ndi yabwino yomwe ilián panopa mdzikoís kopita. Layisensi imawonetsetsa kuti zinthu zomwe zimachokera kunja zimapangidwira mikhalidwe yolamuliridwa komanso yomwe ilidi yothandiza pa cholinga cholengezedwa.
¿Chifukwaé Chilolezo chotengera katundu ndichofunikaón zazaumoyo?
The chilolezo cholowaón zazaumoyo Ndi chida chofunikira kwambiri chowongolera akuluakulu azaumoyo, kukhala ndi cholinga chake chachikulu kuti athe kutsimikizira kuchita bwino, chitetezo ndi khalidwe la mankhwala kufika pa país. M'malo akuluakuluíkwa abamboíses, Kulowetsa ndi kugulitsa zinthu zathanzi popanda chilolezo chofananira kungayambitse zilango zalamulo ndi zaumbanda..
Popanda chilolezochi sipadzakhalaá wotsimikiziraía de que el producto importado cumpla con las regulaciones locales, angatani kuika thanzi la ogula pachiswe. Nthawi yomweyo, imalola makampani otumiza kunja kuwonetsa kuti zinthu zawo ndi zotetezeka komanso zovomerezeka.íchachikulu, zomwe zimathandiza kupanga chidaliro chachikulu kwa ogula ndikukomera kampani yomwe ikufunsidwa.óakhoza kukhala ndi mbiri yabwinoón.
¿Ndizotheka kubweretsa mankhwala ku Spainñopanda chilolezo?
Ngati kutumizidwa kunja kwa mankhwala azachipatala kumapangidwa popanda chilolezo chofika ku Spainña, osakhalaá zotheka kuwadziwitsa mu país. Sizingathekeá kutumiza malondaíku Customs ndi, choncho, mankhwala adzakhala nazoán ayenera kuwonongedwa kapena, kulephera izo, kubwerera ku chiyambi.
Sizovomerezeka komanso sikoyenera kuitanitsa mankhwala azaumoyo ku Spain.ñpopanda chilolezo chofananira. Pamenepo, ndi Espa Agencyñfunde la Mankhwala ndi Zaumoyo (AEMPS) Ndi bungwe lomwe limayang'anira kayendetsedwe kazinthu izi, ndipo izi zimafuna kuti anthu onse amene akufuna kuitanitsa mtundu uwu wa mankhwala thanzi, ayenera kukhala ndi layisensi yochokera kunjaózogwirizana n.
Komabe, kumbukirani zimenezo esta regulationón imagwira ntchito mu zazikuluíkwa abamboíses, osati ku Spain kokhaña, kuti aí Imafuna kutsimikizira chitetezo ndi mphamvu yazaumoyo zomwe zimagulitsidwa mdziko munoís, kotero kuti ufulu ndi thanzi la ogula zitetezedwe moyenera.
Njira zogulira zinthu zathanzi
Atanena pamwamba, Tikuwunikanso njira zomwe ziyenera kutsatiridwa kuti tikwaniritse kuitanitsa.ón zazaumoyo kupita ku Spainña, zotsatirazi ndi chiyani:
- ChikalataóNambala ya wothandizira. Asanayambe kuitanitsaóNdikofunika kuti mukhale ndi chidziwitso chonseón ndi zolembaówopanga ndi/kapena nambala ya ogulitsa, Choncho, m'pofunika kulangizidwa bwino pankhaniyi kuti athe kutsatira njira zoyenera kuitanitsa mankhwala mwalamulo..
- Zofunikira téakatswiri opanga. Musanayambe ndi kuitanitsaókukhalaá Ndikofunikira kusanthula kuti wopanga akugwirizana ndi European Regulations yomwe ikugwira ntchito.ón muzochitika zilizonse, kotero kuti makampani omwe sapanga m'njira yotetezeka aletsedwe.
- Kuphunzira za malamulo. Ndikofunikira kuchita lipoti téwosuliza momwe adawunikidwaúndi mankhwala omwe akufunsidwaón ndipo chilichonse chikuwonekera pokhudzana ndi kuvomerezedwa kwakeón, adamás kudziwa ngati ingatumizidwe ku Spain kapena ayiña. Chifukwa cha lipoti ili kukhalaá zotheka kudziwa chiyanié Zogulitsa sizingatsimikizidwe kapena kugulitsidwa ku Unión ku Ulaya.
- Chilolezo cha olowetsa kunja. Monga tanena kale, m'pofunika kukonza chilolezo ndi Espa Agencyñfunde la Mankhwala ndi Zaumoyo (AEMPS) ku kuí kuti apitirize kuitanitsaón, zomwe zidzakhalireá kutsatira zofunikira zosiyanasiyana zomwe bungwe likufuna, kupereka zolemba zonseón témalipoti okhazikika komanso oyenerera kuti pasakhale vuto potumiza katundu.ón amtundu uwu za zinthu ku Spainña.
- Njira yolowera kunjaón. Kamodzi layisensi yapezeka,á Ndikofunikira kukhazikitsa njira zomwe akuluakulu aboma ndi mabungwe amafunikira kuti apereke kuwala kobiriwira pakulowetsa.ón ya chipangizo chachipatala. Pakuti izi zidzakhalaá kupanga zolemba zosiyanasiyana kuti apereke monga kusankhaóchiwerengero cha ogulitsa, zowongolera, kuyenderaón, kutsatira, kusunga kapena kusonkhanitsa zonena, mwa ena.
- Chizindikiro cha CE chazinthu. Monga momwe zimafunira ndi malamulo apano, Zolemba zonse ziyenera kukonzedwaón témawonekedwe owoneka bwino omwe amafunidwa ndi malamulo aku Europe komanso mayeso ofananirako azinthu ayenera kukonzedwa kuti musangalale ndi chizindikiro cha CE..
Kachiwiri, kumbukirani zimenezo Ogulitsa kunja atha kungoyambitsa msika wa Unión ku Ulaya, mankhwala ogwirizana ndi European Medical Device Regulations. Además, Onse ogulitsa kunja ali ndi udindo wowonetsetsa kuti malondawo ali ndi msika wa CE komanso kuti adapangidwa malinga ndi zomwe alengeza.ón Kugwirizana kwazinthu za EU; wopangayo adziwike moyenerera ndikusankha nthumwi yovomerezeka; Zogulitsazo ziyenera kulembedwa motsatira Health Products Regulation ndikutsaganañado wa malangizo ntchito zofunika ntchito yake otetezeka. Kwa inu, wopanga adzateroá adapatsa chinthucho chizindikiritso único.
Ngati wogulitsa kunja akuwona kapena ali ndi chifukwa choganiza kuti chinthucho sichitsatira zofunikira za European Regulation, sindingatheá zikhazikitseni pamsika mpaka zitabweretsedwa kuti zigwirizane, ndi kudziwitsaá kwa wopanga ndi woyimira wovomerezeka wa izi.
kuphatikiza apo, pamene wogulitsa akuganiza kuti katunduyo zimabweretsa chiopsezo chachikulu kapenaá zachinyengo, wachifundoá kudziwitsa akuluakulu oyenerera a boma membala momwe imakhazikitsidwa.
