{"id":17426,"date":"2021-09-20T17:03:28","date_gmt":"2021-09-20T17:03:28","guid":{"rendered":"https:\/\/www.tepsivo.com\/hlavni-soubor-farmakovigilancniho-systemu\/"},"modified":"2026-05-22T12:20:32","modified_gmt":"2026-05-22T12:20:32","slug":"hlavni-soubor-farmakovigilancniho-systemu","status":"publish","type":"page","link":"https:\/\/www.tepsivo.com\/cs\/hlavni-soubor-farmakovigilancniho-systemu\/","title":{"rendered":"Hlavn\u00ed soubor farmakovigilan\u010dn\u00edho syst\u00e9mu"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8220;1&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#eff1f4&#8243; custom_padding=&#8220;||21px|||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row _builder_version=&#8220;4.16&#8243; max_width=&#8220;943px&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;0px||||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;1px||||false|false&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text content_tablet=&#8220;<\/p>\n<h2 style=%22font-weight: 500;%22>Hlavn\u00ed soubor farmakovigilan\u010dn\u00edho syst\u00e9mu  <\/h2>\n<p style=%22font-weight: 400;%22>Z\u00e1kladn\u00ed dokument farmakovigilan\u010dn\u00edho syst\u00e9mu (PSMF) je kl\u00ed\u010dov\u00fd dokument vy\u017eadovan\u00fd legislativou, kter\u00fd mus\u00edte vytvo\u0159it a b\u011b\u017en\u011b udr\u017eovat, abyste mohli v p\u0159\u00edpad\u011b inspekce poskytnout p\u0159ehled o sv\u00e9m celkov\u00e9m farmakovigilan\u010dn\u00edm syst\u00e9mu.<\/p>\n<p>&#8220; content_phone=&#8220;<\/p>\n<h2 style=%22font-weight: 500;%22>Hlavn\u00ed soubor farmakovigilan\u010dn\u00edho syst\u00e9mu  <\/h2>\n<p style=%22font-weight: 400;%22>Z\u00e1kladn\u00ed dokument farmakovigilan\u010dn\u00edho syst\u00e9mu (PSMF) je kl\u00ed\u010dov\u00fd dokument vy\u017eadovan\u00fd legislativou, kter\u00fd mus\u00edte vytvo\u0159it a b\u011b\u017en\u011b udr\u017eovat, abyste mohli v p\u0159\u00edpad\u011b inspekce poskytnout p\u0159ehled o sv\u00e9m celkov\u00e9m farmakovigilan\u010dn\u00edm syst\u00e9mu.<\/p>\n<p>&#8220; content_last_edited=&#8220;on|phone&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;2em&#8220; ul_font=&#8220;||||||||&#8220; ol_font=&#8220;||||||||&#8220; header_font=&#8220;Montserrat||||||||&#8220; header_2_font=&#8220;Montserrat|700|||||||&#8220; header_2_text_color=&#8220;#312533&#8243; header_2_font_size=&#8220;36px&#8220; header_2_line_height=&#8220;1.6em&#8220; header_3_font=&#8220;Merriweather|700|||||||&#8220; header_3_text_color=&#8220;#ffc47c&#8220; header_3_font_size=&#8220;18px&#8220; header_3_line_height=&#8220;1.8em&#8220; header_4_font=&#8220;||||||||&#8220; header_5_font=&#8220;||||||||&#8220; header_6_font=&#8220;||||||||&#8220; text_orientation=&#8220;center&#8220; max_width_tablet=&#8220;&#8220; max_width_phone=&#8220;&#8220; max_width_last_edited=&#8220;on|tablet&#8220; custom_margin=&#8220;0px||||false|false&#8220; custom_margin_tablet=&#8220;0px|0px||0px|false|false&#8220; custom_margin_phone=&#8220;0px||||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;0px||||false|false&#8220; custom_padding_tablet=&#8220;|0px||0px|false|false&#8220; custom_padding_phone=&#8220;0px||||false|false&#8220; custom_padding_last_edited=&#8220;on|tablet&#8220; header_2_font_size_tablet=&#8220;&#8220; header_2_font_size_phone=&#8220;28px&#8220; header_2_font_size_last_edited=&#8220;on|phone&#8220; header_3_font_size_tablet=&#8220;&#8220; header_3_font_size_phone=&#8220;14px&#8220; header_3_font_size_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h2 style=\"font-weight: 500;\">Hlavn\u00ed soubor farmakovigilan\u010dn\u00edho syst\u00e9mu  <\/h2>\n<p style=\"font-weight: 400;\">Z\u00e1kladn\u00ed dokument farmakovigilan\u010dn\u00edho syst\u00e9mu (PSMF) je kl\u00ed\u010dov\u00fd dokument vy\u017eadovan\u00fd legislativou, kter\u00fd mus\u00edte vytvo\u0159it a b\u011b\u017en\u011b udr\u017eovat, abyste mohli v p\u0159\u00edpad\u011b inspekce poskytnout p\u0159ehled o sv\u00e9m celkov\u00e9m farmakovigilan\u010dn\u00edm syst\u00e9mu.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8220;2_3,1_3&#8243; 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content_phone=&#8220;<\/p>\n<h4 style=%22font-weight: 500;%22>Jak ji pro v\u00e1s m\u016f\u017eeme vyvinout<br \/>\n?  <\/h4>\n<p style=%22font-weight: 400;%22>Sestaven\u00ed PSMF nespo\u010d\u00edv\u00e1 v \u017e\u00e1dn\u00e9 velk\u00e9 magii, kouzlo je v tom, co popisuje. Pokud pot\u0159ebujete nastavit nov\u00fd farmakovigilan\u010dn\u00ed syst\u00e9m, je nejjednodu\u0161\u0161\u00ed obr\u00e1tit se na n\u00e1s. PSMF pak pro v\u00e1s bude ji\u017e p\u0159ipraven d\u00edky na\u0161\u00ed hotov\u00e9 \u0161ablon\u011b PSMF popisuj\u00edc\u00ed n\u00e1\u0161 glob\u00e1ln\u00ed komplexn\u00ed syst\u00e9m PV.    <\/p>\n<p style=%22font-weight: 400;%22>Budeme s v\u00e1mi muset spolupracovat na vypln\u011bn\u00ed n\u011bkolika pr\u00e1zdn\u00fdch m\u00edst, jako je v\u00e1\u0161 intern\u00ed syst\u00e9m kvality, organiza\u010dn\u00ed struktura, l\u00e9ka\u0159sk\u00e9 informace, dr\u017eitel\u00e9 licenc\u00ed a dal\u0161\u00ed partne\u0159i a n\u011bkolik dal\u0161\u00edch oblast\u00ed.   <\/p>\n<p>&#8220; content_last_edited=&#8220;on|phone&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;2em&#8220; header_font=&#8220;||||||||&#8220; header_4_font=&#8220;Montserrat|600|||||||&#8220; header_4_text_color=&#8220;#312533&#8243; header_4_font_size=&#8220;20px&#8220; header_4_line_height=&#8220;1.6em&#8220; text_orientation=&#8220;justified&#8220; max_width=&#8220;600px&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;||43px|0px|false|false&#8220; custom_padding=&#8220;36px|0px||0px|false|false&#8220; custom_padding_tablet=&#8220;|||0px|false|false&#8220; custom_padding_phone=&#8220;15px|||0px|false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; header_4_font_size_phone=&#8220;20px&#8220; header_4_font_size_last_edited=&#8220;off|desktop&#8220; text_orientation_tablet=&#8220;center&#8220; text_orientation_phone=&#8220;center&#8220; text_orientation_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h4 style=\"font-weight: 500;\">Jak ji pro v\u00e1s m\u016f\u017eeme vyvinout?  <\/h4>\n<p style=\"font-weight: 400;\">Sestaven\u00ed PSMF nespo\u010d\u00edv\u00e1 v \u017e\u00e1dn\u00e9 velk\u00e9 magii, kouzlo je v tom, co popisuje. Pokud pot\u0159ebujete nastavit nov\u00fd farmakovigilan\u010dn\u00ed syst\u00e9m, je nejjednodu\u0161\u0161\u00ed obr\u00e1tit se na n\u00e1s. PSMF pak pro v\u00e1s bude ji\u017e p\u0159ipraven d\u00edky na\u0161\u00ed hotov\u00e9 \u0161ablon\u011b PSMF popisuj\u00edc\u00ed n\u00e1\u0161 glob\u00e1ln\u00ed komplexn\u00ed syst\u00e9m PV.    <\/p>\n<p style=\"font-weight: 400;\">Budeme s v\u00e1mi muset spolupracovat na vypln\u011bn\u00ed n\u011bkolika pr\u00e1zdn\u00fdch m\u00edst, jako je v\u00e1\u0161 intern\u00ed syst\u00e9m kvality, organiza\u010dn\u00ed struktura, l\u00e9ka\u0159sk\u00e9 informace, dr\u017eitel\u00e9 licenc\u00ed a dal\u0161\u00ed partne\u0159i a n\u011bkolik dal\u0161\u00edch oblast\u00ed.   <\/p>\n<p>[\/et_pb_text][et_pb_button button_url=&#8220;https:\/\/www.tepsivo.com\/cs\/kontakt\/&#8220; button_text=&#8220;Kontaktujte n\u00e1s&#8220; button_alignment=&#8220;left&#8220; button_alignment_tablet=&#8220;&#8220; button_alignment_phone=&#8220;center&#8220; button_alignment_last_edited=&#8220;on|phone&#8220; module_class=&#8220;secondary-button&#8220; _builder_version=&#8220;4.16&#8243; custom_button=&#8220;on&#8220; 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custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;15px||||false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8220;3_5&#8243; _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;|||&#8220; global_colors_info=&#8220;{}&#8220; custom_padding__hover=&#8220;|||&#8220;][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;2em&#8220; header_font=&#8220;||||||||&#8220; header_4_font=&#8220;Montserrat|600|||||||&#8220; header_4_text_color=&#8220;#312533&#8243; header_4_font_size=&#8220;20px&#8220; header_4_line_height=&#8220;1.6em&#8220; text_orientation=&#8220;justified&#8220; max_width=&#8220;600px&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;|||0px|false|false&#8220; custom_padding=&#8220;66px|0px||0px|false|false&#8220; custom_padding_tablet=&#8220;|||0px|false|false&#8220; custom_padding_phone=&#8220;15px|||0px|false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; header_4_font_size_phone=&#8220;20px&#8220; header_4_font_size_last_edited=&#8220;off|desktop&#8220; text_orientation_tablet=&#8220;center&#8220; text_orientation_phone=&#8220;center&#8220; text_orientation_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h4 style=\"font-weight: 500;\">Kdy pot\u0159ebujete PSMF?<\/h4>\n<p style=\"font-weight: 400;\">Pokud pl\u00e1nujete uv\u00e9st na trh sv\u016fj prvn\u00ed l\u00e9\u010div\u00fd p\u0159\u00edpravek, m\u011bli byste m\u00edt v dob\u011b pod\u00e1n\u00ed \u017e\u00e1dosti o registraci (MAA) zaveden syst\u00e9m PV. A jak ji\u017e v\u00edte, PSMF je p\u0159ehledem tohoto syst\u00e9mu, tak\u017ee by m\u011bl b\u00fdt vypracov\u00e1n p\u0159i p\u0159edkl\u00e1d\u00e1n\u00ed MAA.   <\/p>\n<p style=\"font-weight: 400;\">Pro vlastn\u00ed \u017e\u00e1dost o MA budete pot\u0159ebovat Souhrn farmakovigilan\u010dn\u00edho syst\u00e9mu, kter\u00fd bude obsahovat \u010d\u00edslo PSMF, um\u00edst\u011bn\u00ed PSMF a podrobnosti o va\u0161\u00ed kvalifikovan\u00e9 osob\u011b pro farmakovigilanci.  <\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; custom_padding_last_edited=&#8220;on|phone&#8220; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#fafafa&#8220; custom_padding=&#8220;78px||21px|||&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;||0px||false|false&#8220; top_divider_style=&#8220;slant2&#8243; top_divider_color=&#8220;#ffffff&#8220; top_divider_height_tablet=&#8220;&#8220; top_divider_height_phone=&#8220;55px&#8220; top_divider_height_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row column_structure=&#8220;2_3,1_3&#8243; _builder_version=&#8220;4.16&#8243; width=&#8220;85%&#8220; max_width=&#8220;850px&#8220; custom_margin=&#8220;0px||||false|false&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;||0px||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;0px||0px||false|false&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;2_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_image src=&#8220;https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/11\/world-map-with-almost-transparent-background.png&#8220; title_text=&#8220;world-map-with-almost-transparent-background&#8220; align_tablet=&#8220;&#8220; align_phone=&#8220;center&#8220; align_last_edited=&#8220;on|phone&#8220; disabled_on=&#8220;off|on|on&#8220; _builder_version=&#8220;4.16&#8243; max_height_tablet=&#8220;&#8220; max_height_phone=&#8220;193px&#8220; max_height_last_edited=&#8220;on|phone&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;||5px||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;95px||||false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;5px||0px||false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;2em&#8220; header_font=&#8220;||||||||&#8220; header_4_font=&#8220;Montserrat|600|||||||&#8220; header_4_text_color=&#8220;#312533&#8243; header_4_font_size=&#8220;20px&#8220; header_4_line_height=&#8220;1.6em&#8220; text_orientation=&#8220;justified&#8220; max_width=&#8220;600px&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;|||0px|false|false&#8220; custom_padding=&#8220;36px|0px||0px|false|false&#8220; custom_padding_tablet=&#8220;|||0px|false|false&#8220; custom_padding_phone=&#8220;15px|||0px|false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; header_4_font_size_phone=&#8220;20px&#8220; header_4_font_size_last_edited=&#8220;off|desktop&#8220; text_orientation_tablet=&#8220;center&#8220; text_orientation_phone=&#8220;center&#8220; text_orientation_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h4 style=\"font-weight: 500;\">Kde ho pot\u0159ebujete?<\/h4>\n<p style=\"font-weight: 400;\">P\u0159edev\u0161\u00edm je PSMF po\u017eadavkem evropsk\u00fdch z\u00e1konod\u00e1rc\u016f, tak\u017ee pokud jste p\u0159\u00edtomni alespo\u0148 na jednom evropsk\u00e9m trhu, mus\u00edte v\u00e9st z\u00e1kladn\u00ed dokumentaci farmakovigila\u010dn\u00edho syst\u00e9mu.<\/p>\n<p style=\"font-weight: 400;\">Krom\u011b toho m\u016f\u017ee b\u00fdt nutn\u00e9 udr\u017eovat m\u00edstn\u00ed PSMF v n\u011bkolika zem\u00edch, nap\u0159\u00edklad ve Francii, Sa\u00fadsk\u00e9 Ar\u00e1bii nebo nov\u011b ve Spojen\u00e9m kr\u00e1lovstv\u00ed a dal\u0161\u00edch zem\u00edch po cel\u00e9m sv\u011bt\u011b.<\/p>\n<p style=\"font-weight:400;\">Britsk\u00e1 PSMF je po brexitu nov\u00fdm po\u017eadavkem a sou\u010d\u00e1st\u00ed na\u0161\u00ed glob\u00e1ln\u00ed slu\u017eby. Pod\u00edvejte se, <a style=\"color: #b5302f; font-weight: 500;\" href=\"https:\/\/www.tepsivo.com\/pharmacovigilance-services\/brexit-pharmacovigilance-in-the-uk\/\">co pro v\u00e1s m\u016f\u017eeme ud\u011blat ve Spojen\u00e9m kr\u00e1lovstv\u00ed a<\/a> jak se orientovat v po\u017eadavc\u00edch MHRA na farmakovigilanci. <\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_image src=&#8220;https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/11\/world-map-with-almost-transparent-background.png&#8220; title_text=&#8220;world-map-with-almost-transparent-background&#8220; disabled_on=&#8220;on|off|off&#8220; _builder_version=&#8220;4.16&#8243; max_height_tablet=&#8220;&#8220; max_height_phone=&#8220;193px&#8220; max_height_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;95px||||false|false&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#fafafa&#8220; custom_margin=&#8220;0px||||false|false&#8220; custom_margin_tablet=&#8220;0px||||false|false&#8220; custom_margin_phone=&#8220;0px||||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;36px||2px||false|false&#8220; top_divider_color=&#8220;#ffffff&#8220; top_divider_height=&#8220;89px&#8220; top_divider_flip=&#8220;horizontal&#8220; bottom_divider_color=&#8220;#ffffff&#8220; bottom_divider_height=&#8220;53px&#8220; bottom_divider_flip=&#8220;horizontal&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row custom_padding_last_edited=&#8220;on|phone&#8220; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#ffffff&#8220; max_width=&#8220;876px&#8220; custom_padding=&#8220;30px||3px||false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;&#8220; border_radii=&#8220;off|10px|10px||&#8220; box_shadow_style=&#8220;preset1&#8243; box_shadow_color=&#8220;rgba(0,0,0,0.1)&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; header_4_font=&#8220;Montserrat|600|||||||&#8220; header_4_text_color=&#8220;#312533&#8243; header_4_font_size=&#8220;20px&#8220; header_4_line_height=&#8220;1.4em&#8220; max_width=&#8220;100%&#8220; custom_padding=&#8220;|15px||15px|false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;|29px||29px|false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h4 style=\"font-weight: 500; text-align: center;\">A jak se ujist\u00edme, \u017ee je to aktu\u00e1ln\u00ed?  <\/h4>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8220;1_2,1_2&#8243; use_custom_gutter=&#8220;on&#8220; gutter_width=&#8220;1&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#ffffff&#8220; max_width=&#8220;876px&#8220; custom_padding=&#8220;1px||12px||false|false&#8220; border_radii=&#8220;off||||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;1_2&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_image src=&#8220;https:\/\/tepsivo.com\/wp-content\/uploads\/2021\/03\/tepsivo-automated-pv-solution-screenshot.png&#8220; title_text=&#8220;tepsivo-automated-pv-solution-screenshot&#8220; _builder_version=&#8220;4.16&#8243; max_width=&#8220;89%&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;-13px||||false|false&#8220; custom_padding=&#8220;0px||||false|false&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8220;1_2&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;0px|0px||0px|false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;17px|55px|12px||false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;5px|29px||29px|false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"text-align: justify;\">V syst\u00e9mu Tepsivo PV<span class=\"NormalTextRun SCXW69252997 BCX0\">se<\/span> QPPV EU jednodu\u0161e <\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">p\u0159ihl\u00e1s\u00ed<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> <\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">do<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> na\u0161\u00ed vlastn\u00ed<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> platformy<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> <\/span><span class=\"NormalTextRun SpellingErrorV2 SCXW69252997 BCX0\">Tepsivo<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> a v\u0161e vid\u00ed sami,<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> p\u0159i\u010dem\u017e mohou p\u0159\u00edmo komentovat <\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">jakoukoli<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> \u010dinnost <\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">podle sv\u00e9ho uv\u00e1\u017een\u00ed.<\/span><\/p>\n<p>[\/et_pb_text][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;|55px|||false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;|29px||29px|false|false&#8220; custom_padding_last_edited=&#8220;on|desktop&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"text-align: justify;\"><span class=\"NormalTextRun SCXW23593537 BCX0\">Z\u00e1konn\u00fd po\u017eadavek na p\u0159\u00edstup k PSMF a dohled nad v\u0161emi \u00fakoly v oblasti fotovoltaiky je <\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">zaru\u010den <\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">po celou dobu<\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">. Des\u00edtky u\u0161et\u0159en\u00fdch hodin administrativy ka\u017ed\u00fd m\u011bs\u00edc a \u0161\u0165astn\u011bj\u0161\u00ed EU QPPV.<\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">, efektivn\u011bj\u0161\u00ed a soust\u0159ed\u011bn\u011bj\u0161\u00ed na to, co by m\u011blo b\u00fdt d\u016fle\u017eit\u00e9 a k \u010demu jsou vy\u0161koleni.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row use_custom_gutter=&#8220;on&#8220; gutter_width=&#8220;2&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#ffffff&#8220; max_width=&#8220;876px&#8220; custom_margin=&#8220;-33px||||false|false&#8220; custom_padding=&#8220;1px||29px||false|false&#8220; border_radii=&#8220;off|||10px|10px&#8220; box_shadow_style=&#8220;preset1&#8243; box_shadow_vertical=&#8220;16px&#8220; box_shadow_blur=&#8220;14px&#8220; box_shadow_color=&#8220;rgba(0,0,0,0.1)&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text content_tablet=&#8220;&#8220; content_phone=&#8220;<\/p>\n<p style=%22font-weight: 400;%22>\nP\u0159e\u010dt\u011bte si v\u00edce o na\u0161em<a style=%22color: #b5302f; font-weight: 500;%22 href=%22https:\/\/www.tepsivo.com\/pharmacovigilance-services\/global-pharmacovigilance-system\/%22>glob\u00e1ln\u00edm komplexn\u00edm farmakovigilan\u010dn\u00edm syst\u00e9mu<br \/>\n<\/a> a o tom, jak jej \u0159\u00edd\u00edme prost\u0159ednictv\u00edm na\u0161\u00ed jedine\u010dn\u00e9 <a style=%22color: #b5302f; font-weight: 500;%22 href=%22https:\/\/www.tepsivo.com\/pharmacovigilance-software\/tepsivo-platform\/%22>platformy Tepsivo<\/a>.<\/p>\n<p>&#8220; content_last_edited=&#8220;on|phone&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;1.6em&#8220; ul_font=&#8220;||||||||&#8220; ol_font=&#8220;||||||||&#8220; header_font=&#8220;||||||||&#8220; header_2_font=&#8220;Merriweather|700|||||||&#8220; header_2_font_size=&#8220;36px&#8220; header_2_line_height=&#8220;1.6em&#8220; header_3_font=&#8220;Merriweather|700|||||||&#8220; header_3_text_color=&#8220;#ffc47c&#8220; header_3_font_size=&#8220;18px&#8220; header_3_line_height=&#8220;1.8em&#8220; header_4_font=&#8220;||||||||&#8220; header_5_font=&#8220;||||||||&#8220; header_6_font=&#8220;||||||||&#8220; text_orientation=&#8220;center&#8220; max_width=&#8220;80%&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;1px|||||&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;45px||||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; header_2_font_size_tablet=&#8220;&#8220; header_2_font_size_phone=&#8220;20px&#8220; header_2_font_size_last_edited=&#8220;on|phone&#8220; header_3_font_size_tablet=&#8220;&#8220; header_3_font_size_phone=&#8220;14px&#8220; header_3_font_size_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"font-weight: 400;\">P\u0159e\u010dt\u011bte si v\u00edce o na\u0161em <a style=\"color: #b5302f; font-weight: 500;\" href=\"https:\/\/www.tepsivo.com\/pharmacovigilance-services\/global-pharmacovigilance-system\/\">glob\u00e1ln\u00edm komplexn\u00edm farmakovigilan\u010dn\u00edm syst\u00e9mu<\/a><br \/>\na o tom, jak jej \u0159\u00edd\u00edme prost\u0159ednictv\u00edm na\u0161\u00ed jedine\u010dn\u00e9 <a style=\"color: #b5302f; font-weight: 500;\" href=\"https:\/\/www.tepsivo.com\/pharmacovigilance-software\/tepsivo-platform\/\">platformy Tepsivo<\/a>.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; custom_padding_last_edited=&#8220;on|desktop&#8220; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#fafafa&#8220; use_background_color_gradient=&#8220;on&#8220; background_color_gradient_stops=&#8220;#fafafa 0%|#ffffff 100%&#8220; background_color_gradient_start=&#8220;#fafafa&#8220; background_color_gradient_end=&#8220;#ffffff&#8220; custom_margin=&#8220;0px||||false|false&#8220; custom_margin_tablet=&#8220;0px||||false|false&#8220; custom_margin_phone=&#8220;0px||||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;2px||39px||false|false&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;&#8220; top_divider_color=&#8220;#ffffff&#8220; top_divider_height=&#8220;89px&#8220; top_divider_flip=&#8220;horizontal&#8220; bottom_divider_color=&#8220;#ffffff&#8220; bottom_divider_height=&#8220;53px&#8220; bottom_divider_flip=&#8220;horizontal&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row use_custom_gutter=&#8220;on&#8220; gutter_width=&#8220;2&#8243; _builder_version=&#8220;4.16&#8243; background_enable_color=&#8220;off&#8220; width_tablet=&#8220;&#8220; width_phone=&#8220;100%&#8220; width_last_edited=&#8220;on|phone&#8220; max_width=&#8220;876px&#8220; custom_margin=&#8220;53px||||false|false&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;40px||21px||false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;1px||1px||false|false&#8220; border_radii=&#8220;off||||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text content_last_edited=&#8220;off|desktop&#8220; _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;1.6em&#8220; ul_font=&#8220;||||||||&#8220; ol_font=&#8220;||||||||&#8220; header_font=&#8220;||||||||&#8220; header_2_font=&#8220;Merriweather|700|||||||&#8220; header_2_font_size=&#8220;36px&#8220; header_2_line_height=&#8220;1.6em&#8220; header_3_font=&#8220;Merriweather|700|||||||&#8220; header_3_text_color=&#8220;#ffc47c&#8220; header_3_font_size=&#8220;18px&#8220; header_3_line_height=&#8220;1.8em&#8220; header_4_font=&#8220;||||||||&#8220; header_5_font=&#8220;||||||||&#8220; header_6_font=&#8220;||||||||&#8220; text_orientation=&#8220;center&#8220; max_width=&#8220;80%&#8220; module_alignment=&#8220;center&#8220; custom_margin=&#8220;1px|||||&#8220; custom_margin_tablet=&#8220;&#8220; custom_margin_phone=&#8220;|0px||0px|false|false&#8220; custom_margin_last_edited=&#8220;on|phone&#8220; custom_padding=&#8220;|0px||0px|false|false&#8220; header_2_font_size_tablet=&#8220;&#8220; header_2_font_size_phone=&#8220;20px&#8220; header_2_font_size_last_edited=&#8220;on|phone&#8220; header_3_font_size_tablet=&#8220;&#8220; header_3_font_size_phone=&#8220;14px&#8220; header_3_font_size_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"font-weight: 400;\">Obra\u0165te se na n\u00e1s a my v\u00e1m p\u0159edvedeme, jak pou\u017e\u00edvat na\u0161i \u0161ablonu PSMF, p\u0159esn\u011b podle po\u017eadovan\u00fdch pokyn\u016f PSMF. M\u016f\u017eeme za\u010d\u00edt se vzorem PSMF a pokra\u010dovat d\u00e1le. <\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#0c9cd1&#8243; use_background_color_gradient=&#8220;on&#8220; background_color_gradient_stops=&#8220;#F4F5F7 0%|#F4F5F7 100%&#8220; background_color_gradient_start=&#8220;#F4F5F7&#8243; background_color_gradient_end=&#8220;#F4F5F7&#8243; custom_margin=&#8220;-1px||||false|false&#8220; custom_padding=&#8220;0px||21px||false|false&#8220; top_divider_style=&#8220;slant2&#8243; top_divider_color=&#8220;#ffffff&#8220; top_divider_height=&#8220;75px&#8220; top_divider_flip=&#8220;horizontal&#8220; top_divider_height_tablet=&#8220;&#8220; top_divider_height_phone=&#8220;55px&#8220; top_divider_height_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;92px|||||&#8220; 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header_2_font_size_phone=&#8220;28px&#8220; header_2_font_size_last_edited=&#8220;on|phone&#8220; header_3_font_size_tablet=&#8220;&#8220; header_3_font_size_phone=&#8220;14px&#8220; header_3_font_size_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h2 style=\"font-weight: 500;\">Poj\u010fme si popov\u00eddat<\/h2>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8220;4.16&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_line_height=&#8220;2em&#8220; header_line_height=&#8220;1.5em&#8220; text_orientation=&#8220;center&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"font-weight: 400;\">A\u0165 u\u017e jsou tv\u00e9 pot\u0159eby jak\u00e9koli, t\u011b\u0161\u00edme se na kontakt s tebou.<br \/>\nNev\u00e1hej n\u00e1m napsat zpr\u00e1vu a my se ti hned ozveme.<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=&#8220;https:\/\/www.tepsivo.com\/cs\/zarezervujte-si-bezplatnou-15minutovou-konzultaci\/&#8220; button_text=&#8220;Zarezervujte si 15minutovou konzultaci ZDARMA&#8220; button_alignment=&#8220;center&#8220; module_class=&#8220;primary-button&#8220; _builder_version=&#8220;4.16&#8243; custom_button=&#8220;on&#8220; button_text_size=&#8220;16px&#8220; button_text_color=&#8220;#b5302f&#8220; button_bg_color=&#8220;#ffffff&#8220; button_border_width=&#8220;2px&#8220; button_border_color=&#8220;#ffffff&#8220; button_border_radius=&#8220;19px&#8220; button_font=&#8220;Montserrat||||||||&#8220; button_use_icon=&#8220;off&#8220; custom_margin=&#8220;|10px||0px|false|false&#8220; custom_padding=&#8220;9px|30px|9px|30px|true|false&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_button][et_pb_button button_url=&#8220;https:\/\/www.tepsivo.com\/cs\/kontakt\/&#8220; button_text=&#8220;Napi\u0161te zpr\u00e1vu&#8220; button_alignment=&#8220;center&#8220; module_class=&#8220;secondary-button&#8220; _builder_version=&#8220;4.16&#8243; custom_button=&#8220;on&#8220; button_text_size=&#8220;16px&#8220; button_text_color=&#8220;#ffffff&#8220; button_bg_color=&#8220;#b5302f&#8220; 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_builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text _builder_version=&#8220;4.27.4&#8243; text_font=&#8220;Montserrat||||||||&#8220; text_orientation=&#8220;center&#8220; hover_enabled=&#8220;0&#8243; global_colors_info=&#8220;{}&#8220; sticky_enabled=&#8220;0&#8243;]<\/p>\n<p style=\"font-weight: 400;\">Tepsivo Oy | <span>Haartmaninkatu 4, Building 14, 00290, Helsinki, Finsko<\/span> | DI\u010c FI31367614 | <a style=\"color: #7f7f7f;\" href=\"mailto:contact@tepsivo.com\">contact@tepsivo.com <\/a>| +358 402 204 698 | <a style=\"color: #7f7f7f;\" href=\"https:\/\/www.tepsivo.com\/privacy-policy\/\"><u>Z\u00e1sady ochrany osobn\u00edch \u00fadaj\u016f<\/u><\/a><\/p>\n<p>\n<script type=\"text\/javascript\">\n  var leady_track_key=\"zFCZE4xPhPJ6iw4D\";\n  (function(){\n    var l=document.createElement(\"script\");l.type=\"text\/javascript\";l.async=true;\n    l.src='https:\/\/t.leady.com\/'+leady_track_key+\"\/L.js\";\n    var s=document.getElementsByTagName(\"script\")[0];s.parentNode.insertBefore(l,s);\n  })();\n<\/script>\n<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Hlavn&iacute; 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