Новації законодавства у сфері охорони здоров я: що треба знати керівникам
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- Екатерина Вахрамеева
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1 Новації законодавства у сфері охорони здоров я: що треба знати керівникам Доповідачі: Антоніна Нижник директор ТОВ «Медконсалтинг»
2 Проект нових ліцензійних умов 3 спроба Наказ МОЗ 41Адм від «направити проекти Кабінету Міністрів України до 30 жовтня 2015 року»
3 Наказ Мінекономрозвитку і торгівлі та Державної регуляторної служби України від «Про затвердження форми та змісту ліцензії» Нова форма бланку ліцензії
4
5 Нова редакція Закону України «Про ліцензування певних видів господарської діяльності» Закон 222 від 2 березня 2015 року Набув чинності року
6 За новим Законом «Про ліцензування..» Відсутнє поняття копії ліцензії Немає адреси провадження діяльності на бланку Надсилається листповідомлення
7 п.15 ст. 13. Закону: У разі виникнення підстав для переоформлення ліцензії ліцензіат зобов'язаний протягом місяця подати до органу ліцензування заяву про переоформлення ліцензії Єдиною підставою для переоформлення ліцензії є зміна найменування юридичної особи
8 Зміна юридичної адреси не є підставою для переоформлення ліцензії Потрібно подавати відомості
9 Стаття 15 Закону: Зміни, що стосуються ліцензіата або назви виду господарської діяльності, що підлягає ліцензуванню ч.1 п.3. «у разі доповнення переліку новими документами ліцензіат повинен подати до органу ліцензування документи, якими доповнено перелік»
10 У разі зміни форми відомостей, що додаються до заяви про отримання ліцензії, ліцензіат подає органу ліцензування відомості, форму яких змінено, за новою формою.
11 п. 2 ст.15 Закону: Ліцензіат зобов'язаний повідомляти органу ліцензування про всі зміни даних, які були зазначені в його документах, що додавалися до заяви про отримання ліцензії не пізніше ніж один місяць з дня настання таких змін Лист від МОЗ
12 ст. 5 Закону: «Позапланова перевірка дотримання ліцензіатом вимог ліцензійних умов здійснюється тільки за наявності погодження Експертно-апеляційної ради»
13 Окремі новації Затверджено новий порядок утилізації лікарських засобів (Наказ МОЗ України 242 від ) Утилізація тільки через ліцензовані підприємства Подання звітів про утилізацію до Держлікслужби
14 Окремі новації Скасовано наказ МОЗ України від 21 січня 2010 року 11 «Про затвердження Порядку обігу наркотичних засобів...» Наказом МОЗ України 494 від введено нові форми журналів
15 Скасовано наказ МОЗ 24 Про затвердження протоколів надання медичної допомоги за спеціальністю «Медицина невідкладних станів» Відмінено форму надання згоди на обробку персональних даних Змінено форму 003-6/о
16 Накази МОЗ України з питань якості медичних послуг Наказ Міністерства охорони здоров я України «Про моніторинг клінічних індикаторів якості медичної допомоги» Наказ МОЗ України «Про створення та впровадження медикотехнологічних документів зі стандартизації медичної допомоги в системі Міністерства охорони здоровя України» Наказ Міністерства охорони здоров я України «Про затвердження Індикаторів якості медичної допомоги» р. 743 Наказ Міністерства охорони здоров я України «Про порядок контролю якості медичної допомоги» р. N 752 Наказ Міністерства охорони здоров я України «Про організацію клініко-експертної оцінки якості медичної допомоги»
17 Локальні клінічні протоколи п.2.7 Ліцензійних умов провадження господарської діяльності з медичної практики п Наказу МОЗ України 80 від «Про затвердження Порядку контролю за додержанням Ліцензійних умов» Відсутність розроблених та затверджених закладом охорони здоров'я локальних клінічних протоколів є підставою для анулювання ліцензії
18 тел.: +380(44) ,
19 тел.: +380(44) ,
20 Дякуємо за увагу! (067)
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