{"id":2,"date":"2020-04-16T18:37:03","date_gmt":"2020-04-16T18:37:03","guid":{"rendered":"http:\/\/imifarma.com\/?page_id=2"},"modified":"2022-02-09T16:43:08","modified_gmt":"2022-02-09T14:43:08","slug":"sample-page","status":"publish","type":"page","link":"https:\/\/imi-pharma.com\/?page_id=2","title":{"rendered":"C\u00ebshtjet Rregullatore"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column width=&#8221;2\/3&#8243;][vc_column_text]<\/p>\r\n<p><strong>Departamenti i \u00e7\u00ebshtjeve rregullatore (RA)<\/strong><\/p>\r\n<p>Departamenti i \u00e7\u00ebshtjeve rregullatore (RA) i nj\u00eb kompanie farmaceutike \u00ebsht\u00eb p\u00ebrgjegj\u00ebs p\u00ebr marrjen e miratimit p\u00ebr produktet e reja farmaceutike dhe sigurimin q\u00eb mir\u00ebmbajtja t\u00eb ruhet p\u00ebr aq koh\u00eb sa kompania d\u00ebshiron ta mbaj\u00eb produktin n\u00eb treg.<\/p>\r\n<p>Specialist\u00ebt e \u00e7\u00ebshtjeve rregullatore veprojn\u00eb si nj\u00eb lidhje midis kompanive dhe autoriteteve rregullatore shtet\u00ebrore, duke siguruar q\u00eb produktet prodhohen dhe shp\u00ebrndahen n\u00eb p\u00ebrputhje me legjislacionin e duhur. Profesioni ofron mund\u00ebsi p\u00ebr udh\u00ebtime dhe pun\u00ebsim nd\u00ebrkomb\u00ebtar.<\/p>\r\n<p>Liget dhe rregulloret mbi te cilat punohet sot nga specialistet e ketij sektori jane:<\/p>\r\n<ol>\r\n<li><a href=\"https:\/\/imi-pharma.com\/wp-content\/uploads\/2022\/02\/ligj_nr_105_dt_31_7_2014_18582_12.pdf\" target=\"_blank\" rel=\"noopener\"><strong><u>Ligji p\u00ebr barnat dhe sh\u00ebrbimin farmaceutik 105\/2014 \u201cP\u00ebr barnat dhe Sh\u00ebrbimin Farmaceutik\u201d<\/u><\/strong><\/a><\/li>\r\n<li><a href=\"https:\/\/imi-pharma.com\/wp-content\/uploads\/2022\/02\/ligj_nr_89_dt_17_7_2014_18594_11.pdf\" target=\"_blank\" rel=\"noopener\"><strong><u>Ligji Nr.89\/2014 \u201cP\u00ebr Pajisjet Mjek\u00ebsore\u201d<\/u><\/strong><\/a><\/li>\r\n<li><a href=\"https:\/\/imi-pharma.com\/wp-content\/uploads\/2022\/02\/Nr.7975-date-26.7.1995.pdf\" target=\"_blank\" rel=\"noopener\"><strong><u>Ligji Nr.7975 \u201cP\u00ebr Barnat Narkotike dhe L\u00ebnd\u00ebt Psikotrope\u201d<\/u><\/strong><\/a><\/li>\r\n<li><a href=\"https:\/\/imi-pharma.com\/wp-content\/uploads\/2022\/02\/VKM-per-pajisjet-mjekesore-nr.-508-date-10.6.2015.pdf\" target=\"_blank\" rel=\"noopener\"><strong><u>Vendim nr. 508, dat\u00eb 10.6.2015 p\u00ebr miratimin e rregullit teknik \u201cP\u00ebr K\u00ebrkesat Thelb\u00ebsore, Vler\u00ebsimin e Konformitetit dhe Markimin CE t\u00eb Pajisjeve Mjek\u00ebsore t\u00eb Implantueshme Aktive<\/u><\/strong><\/a><\/li>\r\n<li><a href=\"https:\/\/imi-pharma.com\/wp-content\/uploads\/2022\/02\/Vendim-nr.-731-dt.-02.09.2015-per-vleresimin-e-CE-se-pajisjeve-mjekesore-1.pdf\" target=\"_blank\" rel=\"noopener\"><strong><u>Vendim nr. 731, dat\u00eb 2.9.2015 p\u00ebr miratimin e rregullit teknik \u201cP\u00ebr K\u00ebrkesat Thelb\u00ebsore, Vler\u00ebsimin e Konformitetit, Klasifikimin dhe Markimin CE t\u00eb Pajisjeve Mjek\u00ebsore<\/u><\/strong><\/a><\/li>\r\n<li><a href=\"https:\/\/imi-pharma.com\/wp-content\/uploads\/2022\/02\/VKM-nr.189-dt.09.03.2016-Directive-on-In-vitro-diagnostic-medical-devices-1.pdf\" target=\"_blank\" rel=\"noopener\"><strong><u>Vendim Nr. 189, dat\u00eb 9.3.2016 p\u00ebr miratimin e rregullit teknik \u201cP\u00ebr K\u00ebrkesat Thelb\u00ebsore, Markimin CE dhe Vler\u00ebsimin e Konformitetit t\u00eb Pajisjeve Mjek\u00ebsore Diagnostikuese in Vitro<\/u><\/strong><\/a><\/li>\r\n<li><a href=\"https:\/\/imi-pharma.com\/wp-content\/uploads\/2022\/02\/urdheri-360-1.pdf\" target=\"_blank\" rel=\"noopener\"><strong><u>Urdh\u00ebr nr. 360 dat\u00eb 22.08.2016 \u201cMbi Procedurat dhe Rregullat e Regjistimin e Pajisjeve Mjekesore Ndryshimet dhe Anulimin e Regjistrimit te Tyre, Dokumentacionin e Nevojshem dhe Kostot Perkatese<\/u><\/strong><\/a><\/li>\r\n<li><a href=\"https:\/\/imi-pharma.com\/wp-content\/uploads\/2022\/02\/Formulari-1-1.pdf\" target=\"_blank\" rel=\"noopener\"><strong><u>Formulari I Regjistrimit Te Pajisje Mjekesore<\/u><\/strong><\/a><\/li>\r\n<li><a href=\"https:\/\/imi-pharma.com\/wp-content\/uploads\/2022\/02\/Urdher-Pajisjet-734-1.pdf\" target=\"_blank\" rel=\"noopener\"><strong><u>Urdh\u00ebr nr. 734 dat\u00eb 18.10.2019 per disa ndryshime ne urdhein nr. 360 dat\u00eb 22.08.2016 \u201cMbi Procedurat dhe Rregullat e Regjistimin e Pajisjeve Mjekesore Ndryshimet dhe Anulimin e Regjistrimit te Tyre, Dokumentacionin e Nevojshem dhe Kostot Perkatese\u201d<\/u><\/strong><\/a><\/li>\r\n<\/ol>\r\n<p>Per t&#8217;u perditesuar per te rejat me te fundit ne fushen rregulatore perdorim faqen zyrtare te Agencise Kometare te Barnave dhe Pajisjeve Mjekesore:<\/p>\r\n<p><a href=\"http:\/\/akbpm.gov.al\"><strong><u>akbpm.gov.al<\/u><\/strong><\/a><\/p>\r\n<p>\u00a0<\/p>\r\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/3&#8243;][media animation=&#8221;none&#8221; image=&#8221;902&#8243;][\/vc_column][\/vc_row]<\/p><\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column width=&#8221;2\/3&#8243;][vc_column_text] Departamenti i \u00e7\u00ebshtjeve rregullatore (RA) Departamenti i \u00e7\u00ebshtjeve rregullatore (RA) i nj\u00eb kompanie farmaceutike \u00ebsht\u00eb p\u00ebrgjegj\u00ebs p\u00ebr marrjen e miratimit p\u00ebr produktet e reja farmaceutike dhe sigurimin q\u00eb mir\u00ebmbajtja t\u00eb ruhet p\u00ebr aq koh\u00eb sa kompania d\u00ebshiron ta mbaj\u00eb produktin n\u00eb treg. Specialist\u00ebt e \u00e7\u00ebshtjeve rregullatore veprojn\u00eb si nj\u00eb lidhje midis kompanive dhe [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"","meta":{"footnotes":""},"class_list":["post-2","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/imi-pharma.com\/index.php?rest_route=\/wp\/v2\/pages\/2","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/imi-pharma.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/imi-pharma.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/imi-pharma.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/imi-pharma.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2"}],"version-history":[{"count":13,"href":"https:\/\/imi-pharma.com\/index.php?rest_route=\/wp\/v2\/pages\/2\/revisions"}],"predecessor-version":[{"id":901,"href":"https:\/\/imi-pharma.com\/index.php?rest_route=\/wp\/v2\/pages\/2\/revisions\/901"}],"wp:attachment":[{"href":"https:\/\/imi-pharma.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}