Просмотр кода страницы НАКАЗ МІНІСТЕРСТВА ОХОРОНИ ЗДОРОВ’Я УКРАЇНИ № 441 від 01.11.2001 р.

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<p class=rvps2><span class=rvts7>МІНІСТЕРСТВО</span><span class=rvts8> </span><span class=rvts7>ОХОРОНИ</span><span class=rvts8> </span><span class=rvts7>ЗДОРОВ</span><span class=rvts8>'</span><span class=rvts7>Я</span><span class=rvts8> </span><span class=rvts7>УКРАЇНИ</span>
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<p class=rvps2><span class=rvts7>Н</span><span class=rvts8> </span><span class=rvts7>А</span><span class=rvts8> </span><span class=rvts7>К</span><span class=rvts8> </span><span class=rvts7>А</span><span class=rvts8> </span><span class=rvts7>З</span>
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<p class=rvps2><span class=rvts7>від</span><span class=rvts8> 01.11.2001&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span class=rvts7>№</span><span class=rvts8> 441&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p>
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<p class=rvps4><span class=rvts9>Зареєстровано</span><span class=rvts6> </span><span class=rvts9>в</span><span class=rvts6> </span><span class=rvts9>Міністерстві</span>
<br><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span class=rvts9>юстиції</span><span class=rvts6> </span><span class=rvts9>України</span>
<br><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 20 </span><span class=rvts9>листопада</span><span class=rvts6> 2001 </span><span class=rvts9>р</span><span class=rvts6>.</span>
<br><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span class=rvts9>за</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> 972/6163</span>
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<p class=rvps2><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span class=rvts7>Про</span><span class=rvts8> </span><span class=rvts7>затвердження</span><span class=rvts8> </span><span class=rvts7>Порядку</span><span class=rvts8> </span><span class=rvts7>проведення</span><span class=rvts8> </span><span class=rvts7>доклінічного</span>
<br><span class=rvts8>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span class=rvts7>вивчення</span><span class=rvts8> </span><span class=rvts7>лікарських</span><span class=rvts8> </span><span class=rvts7>засобів</span><span class=rvts8>, </span><span class=rvts7>Порядку</span><span class=rvts8>&nbsp; </span><span class=rvts7>визначення</span>
<br><span class=rvts8>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span class=rvts7>установ</span><span class=rvts8>,&nbsp; </span><span class=rvts7>які</span><span class=rvts8>&nbsp;&nbsp; </span><span class=rvts7>проводять</span><span class=rvts8>&nbsp;&nbsp; </span><span class=rvts7>доклінічне</span><span class=rvts8>&nbsp; </span><span class=rvts7>вивчення</span>
<br><span class=rvts8>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span class=rvts7>лікарських</span><span class=rvts8> </span><span class=rvts7>засобів</span>
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<p class=rvps2><span class=rvts6>(</span><span class=rvts9>Із</span><span class=rvts6> </span><span class=rvts9>змінами</span><span class=rvts6>, </span><span class=rvts9>внесеними</span><span class=rvts6> </span><span class=rvts9>згідно</span><span class=rvts6> </span><span class=rvts9>з</span><span class=rvts6> </span><span class=rvts9>Наказами</span><span class=rvts6> </span><span class=rvts9>Міністерства</span>
<br><span class=rvts6>&nbsp;&nbsp;&nbsp; </span><span class=rvts9>охорони</span><span class=rvts6> </span><span class=rvts9>здоров</span><span class=rvts6>'</span><span class=rvts9>я</span>
<br><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span class=rvts9>№</span><span class=rvts6> 602 </span><span class=rvts9>від</span><span class=rvts6> 14.11.2005</span>
<br><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span class=rvts9>№</span><span class=rvts6> 66 </span><span class=rvts9>від</span><span class=rvts6> 13.02.2006 )</span></p>
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<p class=rvps3><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp; </span><span class=rvts9>Відповідно</span><span class=rvts6> </span><span class=rvts9>до</span><span class=rvts6> </span><span class=rvts9>ст</span><span class=rvts6>.&nbsp; 6 </span><span class=rvts9>Закону</span><span class=rvts6> </span><span class=rvts9>України</span><span class=rvts6>&nbsp; "</span><span class=rvts9>Про</span><span class=rvts6>&nbsp; </span><span class=rvts9>лікарські</span><span class=rvts6>&nbsp; </span><span class=rvts9>засоби</span><span class=rvts6>"</span>
<br><span class=rvts9>та</span><span class=rvts6>&nbsp; </span><span class=rvts9>з</span><span class=rvts6> </span><span class=rvts9>урахуванням</span><span class=rvts6> </span><span class=rvts9>норм</span><span class=rvts6> </span><span class=rvts9>директиви</span><span class=rvts6> </span><span class=rvts9>Ради</span><span class=rvts6> </span><span class=rvts9>ЄЕС</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> 75/318</span>
<br><span class=rvts9>від</span><span class=rvts6> 20 </span><span class=rvts9>травня</span><span class=rvts6> 1975 </span><span class=rvts9>р</span><span class=rvts6>.&nbsp; "</span><span class=rvts9>Про</span><span class=rvts6> </span><span class=rvts9>зближення</span><span class=rvts6> </span><span class=rvts9>законів</span><span class=rvts6> </span><span class=rvts9>держав</span><span class=rvts6>&nbsp; </span><span class=rvts9>ЄС</span><span class=rvts6>&nbsp; </span><span class=rvts9>відносно</span>
<br><span class=rvts9>аналітичних</span><span class=rvts6>,&nbsp;&nbsp; </span><span class=rvts9>фармако</span><span class=rvts6>-</span><span class=rvts9>токсикологічних</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>та</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>клінічних</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>норм</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>і</span>
<br><span class=rvts9>протоколів</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>випробування</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>препаратів</span><span class=rvts6>" (</span><span class=rvts9>м</span><span class=rvts6>. </span><span class=rvts9>Брюссель</span><span class=rvts6>),</span>
<br><span class=rvts9>директиви</span><span class=rvts6>&nbsp; </span><span class=rvts9>Ради</span><span class=rvts6>&nbsp; </span><span class=rvts9>ЄС</span><span class=rvts6>&nbsp; </span><span class=rvts9>№</span><span class=rvts6> 87/18 </span><span class=rvts9>від</span><span class=rvts6> 18 </span><span class=rvts9>грудня</span><span class=rvts6> 1986 </span><span class=rvts9>р</span><span class=rvts6>.&nbsp; "</span><span class=rvts9>Про</span><span class=rvts6> </span><span class=rvts9>зближення</span>
<br><span class=rvts9>законів</span><span class=rvts6>,&nbsp; </span><span class=rvts9>порядку</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>адміністративних</span><span class=rvts6> </span><span class=rvts9>положень</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6>&nbsp; </span><span class=rvts9>запровадження</span>
<br><span class=rvts9>принципів</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>належної</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>лабораторної</span><span class=rvts6>&nbsp; </span><span class=rvts9>практики</span><span class=rvts6>&nbsp; </span><span class=rvts9>та</span><span class=rvts6>&nbsp; </span><span class=rvts9>верифікації</span><span class=rvts6>&nbsp; </span><span class=rvts9>її</span>
<br><span class=rvts9>запровадження</span><span class=rvts6>&nbsp; </span><span class=rvts9>стосовно</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>випробування</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>хімічних</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>речовин</span><span class=rvts6>"&nbsp;&nbsp; (</span><span class=rvts9>м</span><span class=rvts6>.</span>
<br><span class=rvts9>Брюссель</span><span class=rvts6>),&nbsp; </span><span class=rvts9>директиви</span><span class=rvts6>&nbsp; </span><span class=rvts9>ЄС</span><span class=rvts6>&nbsp; </span><span class=rvts9>№</span><span class=rvts6>&nbsp; 88/320&nbsp; </span><span class=rvts9>від</span><span class=rvts6>&nbsp; 9&nbsp; </span><span class=rvts9>червня</span><span class=rvts6> 1988 </span><span class=rvts9>р</span><span class=rvts6>.&nbsp; "</span><span class=rvts9>Про</span>
<br><span class=rvts9>інспектування</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>і</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>перевірку</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>дотримання</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>принципів</span><span class=rvts6>&nbsp;&nbsp;&nbsp; </span><span class=rvts9>належної</span>
<br><span class=rvts9>лабораторної</span><span class=rvts6> </span><span class=rvts9>практики</span><span class=rvts6> GLP" (</span><span class=rvts9>м</span><span class=rvts6>. </span><span class=rvts9>Люксембург</span><span class=rvts6>) </span><span class=rvts7>Н</span><span class=rvts8> </span><span class=rvts7>А</span><span class=rvts8> </span><span class=rvts7>К</span><span class=rvts8> </span><span class=rvts7>А</span><span class=rvts8> </span><span class=rvts7>З</span><span class=rvts8> </span><span class=rvts7>У</span><span class=rvts8> </span><span class=rvts7>Ю</span><span class=rvts6>:</span>
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<p class=rvps3><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp; 1. </span><span class=rvts9>Затвердити</span><span class=rvts6>:</span></p>
<p class=rvps3><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp; 1.1. </span><span class=rvts9>Порядок</span><span class=rvts6>&nbsp; </span><span class=rvts9>проведення</span><span class=rvts6>&nbsp; </span><span class=rvts9>доклінічного</span><span class=rvts6>&nbsp; </span><span class=rvts9>вивчення</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>лікарських</span>
<br><span class=rvts9>засобів</span><span class=rvts6> (</span><span class=rvts9>додається</span><span class=rvts6>);</span></p>
<p class=rvps3><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp; 1.2. </span><span class=rvts9>Порядок</span><span class=rvts6> </span><span class=rvts9>визначення</span><span class=rvts6>&nbsp; </span><span class=rvts9>установ</span><span class=rvts6>,&nbsp; </span><span class=rvts9>які</span><span class=rvts6>&nbsp; </span><span class=rvts9>проводять</span><span class=rvts6>&nbsp; </span><span class=rvts9>доклінічне</span>
<br><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> (</span><span class=rvts9>додається</span><span class=rvts6>).</span></p>
<p class=rvps3><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp; 2. </span><span class=rvts9>Директору</span><span class=rvts6>&nbsp; </span><span class=rvts9>Державного</span><span class=rvts6>&nbsp; </span><span class=rvts9>фармакологічного</span><span class=rvts6> </span><span class=rvts9>центру</span><span class=rvts6> </span><span class=rvts9>МОЗ</span><span class=rvts6> </span><span class=rvts9>України</span>
<br><span class=rvts9>О</span><span class=rvts6>.</span><span class=rvts9>В</span><span class=rvts6>.</span><span class=rvts9>Стефанову</span><span class=rvts6>&nbsp; </span><span class=rvts9>забезпечити</span><span class=rvts6>&nbsp; </span><span class=rvts9>подання</span><span class=rvts6>&nbsp; </span><span class=rvts9>цього</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>наказу</span><span class=rvts6>&nbsp; </span><span class=rvts9>на</span><span class=rvts6>&nbsp;&nbsp; </span><span class=rvts9>державну</span>
<br><span class=rvts9>реєстрацію</span><span class=rvts6> </span><span class=rvts9>до</span><span class=rvts6> </span><span class=rvts9>Міністерства</span><span class=rvts6> </span><span class=rvts9>юстиції</span><span class=rvts6> </span><span class=rvts9>України</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>публікацію</span><span class=rvts6> </span><span class=rvts9>в</span><span class=rvts6> </span><span class=rvts9>засобах</span>
<br><span class=rvts9>масової</span><span class=rvts6> </span><span class=rvts9>інформації</span><span class=rvts6>.</span>
<br><span class=rvts6> </span><span class=rvts10>( </span><span class=rvts11>Пункт</span><span class=rvts10>&nbsp; 3&nbsp; </span><span class=rvts11>втратив</span><span class=rvts10>&nbsp; </span><span class=rvts11>чинність</span><span class=rvts10> </span><span class=rvts11>на</span><span class=rvts10> </span><span class=rvts11>підставі</span><span class=rvts10> </span><span class=rvts11>Наказу</span><span class=rvts10> </span><span class=rvts11>Міністерства</span><span class=rvts10> </span><span class=rvts11>охорони</span><span class=rvts10> </span><span class=rvts11>здоров</span><span class=rvts10>'</span><span class=rvts11>я</span><span class=rvts10> </span><span class=rvts11>№</span><span class=rvts10> 602 </span><span class=rvts11>від</span><span class=rvts10> 14.11.2005)</span></p>
<p class=rvps3><span class=rvts10> </span><span class=rvts6>&nbsp;&nbsp;&nbsp;&nbsp; 4. </span><span class=rvts9>Контроль</span><span class=rvts6> </span><span class=rvts9>за</span><span class=rvts6> </span><span class=rvts9>виконанням</span><span class=rvts6> </span><span class=rvts9>цього</span><span class=rvts6> </span><span class=rvts9>наказу</span><span class=rvts6> </span><span class=rvts9>покласти</span><span class=rvts6> </span><span class=rvts9>на</span><span class=rvts6> </span><span class=rvts9>заступника</span>
<br><span class=rvts9>Державного</span><span class=rvts6> </span><span class=rvts9>секретаря</span><span class=rvts6> </span><span class=rvts9>А</span><span class=rvts6>.</span><span class=rvts9>П</span><span class=rvts6>.</span><span class=rvts9>Картиша</span><span class=rvts6>.</span>
<br><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts8> </span><span class=rvts7>Міністр</span><span class=rvts8>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span class=rvts7>В</span><span class=rvts8>.</span><span class=rvts7>Ф</span><span class=rvts8>.</span><span class=rvts7>Москаленко</span>
<br><span class=rvts8><br></span></p>
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<p class=rvps5><span class=rvts9>ЗАТВЕРДЖЕНО</span></p>
<p class=rvps5><span class=rvts9>наказом</span><span class=rvts6> </span><span class=rvts9>Міністерства</span><span class=rvts6> </span><span class=rvts9>охорони</span><span class=rvts6> </span><span class=rvts9>здоров</span><span class=rvts6>'</span><span class=rvts9>я</span><span class=rvts6> </span><span class=rvts9>України</span></p>
<p class=rvps5><span class=rvts9>від</span><span class=rvts6> 1 </span><span class=rvts9>листопада</span><span class=rvts6> 2001 </span><span class=rvts9>р</span><span class=rvts6>. </span><span class=rvts9>№</span><span class=rvts6> 441 </span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts9>Зареєстровано</span></p>
<p class=rvps5><span class=rvts9>в</span><span class=rvts6> </span><span class=rvts9>Міністерстві</span><span class=rvts6> </span><span class=rvts9>юстиції</span><span class=rvts6> </span><span class=rvts9>України</span></p>
<p class=rvps5><span class=rvts6>20 </span><span class=rvts9>листопада</span><span class=rvts6> 2001 </span><span class=rvts9>р</span><span class=rvts6>. </span><span class=rvts9>за</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> 972/6163 </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts7>Порядок</span></p>
<p class=rvps1><span class=rvts7>проведення</span><span class=rvts8> </span><span class=rvts7>доклінічного</span><span class=rvts8> </span><span class=rvts7>вивчення</span><span class=rvts8> </span><span class=rvts7>лікарських</span><span class=rvts8> </span><span class=rvts7>засобів</span><span class=rvts8> </span></p>
<p class=rvps1><span class=rvts8><br></span></p>
<p class=rvps1><span class=rvts8>1. </span><span class=rvts7>Загальні</span><span class=rvts8> </span><span class=rvts7>положення</span><span class=rvts8> </span></p>
<p class=rvps6><span class=rvts8><br></span></p>
<p class=rvps6><span class=rvts6>1.1. </span><span class=rvts9>Цей</span><span class=rvts6> </span><span class=rvts9>Порядок</span><span class=rvts6> </span><span class=rvts9>установлює</span><span class=rvts6> </span><span class=rvts9>основні</span><span class=rvts6> </span><span class=rvts9>вимоги</span><span class=rvts6> </span><span class=rvts9>до</span><span class=rvts6> </span><span class=rvts9>проведення</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>поширюється</span><span class=rvts6> </span><span class=rvts9>на</span><span class=rvts6> </span><span class=rvts9>всі</span><span class=rvts6> </span><span class=rvts9>види</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>1.2. </span><span class=rvts9>Доклінічне</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> (</span><span class=rvts9>дослідження</span><span class=rvts6>) </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6> </span><span class=rvts9>проводять</span><span class=rvts6> </span><span class=rvts9>підприємства</span><span class=rvts6>, </span><span class=rvts9>установи</span><span class=rvts6>, </span><span class=rvts9>організації</span><span class=rvts6>, </span><span class=rvts9>заклади</span><span class=rvts6>, </span><span class=rvts9>лабораторії</span><span class=rvts6> (</span><span class=rvts9>далі</span><span class=rvts6> - </span><span class=rvts9>Установи</span><span class=rvts6>) </span><span class=rvts9>незалежно</span><span class=rvts6> </span><span class=rvts9>від</span><span class=rvts6> </span><span class=rvts9>форми</span><span class=rvts6> </span><span class=rvts9>власності</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>відомчого</span><span class=rvts6> </span><span class=rvts9>підпорядкування</span><span class=rvts6>, </span><span class=rvts9>які</span><span class=rvts6> </span><span class=rvts9>мають</span><span class=rvts6> </span><span class=rvts9>необхідну</span><span class=rvts6> </span><span class=rvts9>матеріально</span><span class=rvts6>-</span><span class=rvts9>технічну</span><span class=rvts6> </span><span class=rvts9>базу</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>кваліфікованих</span><span class=rvts6> </span><span class=rvts9>фахівців</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>право</span><span class=rvts6> </span><span class=rvts9>на</span><span class=rvts6> </span><span class=rvts9>проведення</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6>. </span></p>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts8>2. </span><span class=rvts7>Визначення</span><span class=rvts8> </span><span class=rvts7>термінів</span><span class=rvts8> </span></p>
<p class=rvps6><span class=rvts8><br></span></p>
<p class=rvps6><span class=rvts6>2.1. </span><span class=rvts7>Доклінічне</span><span class=rvts8> </span><span class=rvts7>вивчення</span><span class=rvts8> </span><span class=rvts7>лікарського</span><span class=rvts8> </span><span class=rvts7>засобу</span><span class=rvts6> - </span><span class=rvts9>хімічні</span><span class=rvts6>, </span><span class=rvts9>фізичні</span><span class=rvts6>, </span><span class=rvts9>біологічні</span><span class=rvts6>, </span><span class=rvts9>мікробіологічні</span><span class=rvts6>, </span><span class=rvts9>фармакологічні</span><span class=rvts6>, </span><span class=rvts9>токсикологічні</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>інші</span><span class=rvts6> </span><span class=rvts9>експериментальні</span><span class=rvts6> </span><span class=rvts9>наукові</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6> </span><span class=rvts9>з</span><span class=rvts6> </span><span class=rvts9>метою</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>специфічної</span><span class=rvts6> </span><span class=rvts9>дії</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>безпечності</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>2.2. </span><span class=rvts7>Замовник</span><span class=rvts8> </span><span class=rvts7>доклінічного</span><span class=rvts8> </span><span class=rvts7>вивчення</span><span class=rvts8> </span><span class=rvts6>(</span><span class=rvts9>далі</span><span class=rvts6> - </span><span class=rvts9>Замовник</span><span class=rvts6>)</span><span class=rvts8> </span><span class=rvts6>- </span><span class=rvts9>юридична</span><span class=rvts6> </span><span class=rvts9>або</span><span class=rvts6> </span><span class=rvts9>фізична</span><span class=rvts6> </span><span class=rvts9>особа</span><span class=rvts6>, </span><span class=rvts9>незалежно</span><span class=rvts6> </span><span class=rvts9>від</span><span class=rvts6> </span><span class=rvts9>форм</span><span class=rvts6> </span><span class=rvts9>власності</span><span class=rvts6>, </span><span class=rvts9>яка</span><span class=rvts6> </span><span class=rvts9>є</span><span class=rvts6> </span><span class=rvts9>ініціатором</span><span class=rvts6> </span><span class=rvts9>початку</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>відповідає</span><span class=rvts6> </span><span class=rvts9>за</span><span class=rvts6> </span><span class=rvts9>його</span><span class=rvts6> </span><span class=rvts9>організацію</span><span class=rvts6>, </span><span class=rvts9>контроль</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6>/</span><span class=rvts9>або</span><span class=rvts6> </span><span class=rvts9>фінансування</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>2.3. </span><span class=rvts7>Виконавець</span><span class=rvts6> </span><span class=rvts7>доклінічного</span><span class=rvts8> </span><span class=rvts7>вивчення</span><span class=rvts8> </span><span class=rvts7>лікарського</span><span class=rvts8> </span><span class=rvts7>засобу</span><span class=rvts8> </span><span class=rvts6>(</span><span class=rvts9>далі</span><span class=rvts6> - </span><span class=rvts9>Виконавець</span><span class=rvts6>) - </span><span class=rvts9>установа</span><span class=rvts6> (</span><span class=rvts9>або</span><span class=rvts6> </span><span class=rvts9>декілька</span><span class=rvts6> </span><span class=rvts9>установ</span><span class=rvts6>, </span><span class=rvts9>що</span><span class=rvts6> </span><span class=rvts9>виконують</span><span class=rvts6> </span><span class=rvts9>окремі</span><span class=rvts6> </span><span class=rvts9>фази</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6>), </span><span class=rvts9>які</span><span class=rvts6> </span><span class=rvts9>мають</span><span class=rvts6> </span><span class=rvts9>повноваження</span><span class=rvts6> </span><span class=rvts9>на</span><span class=rvts6> </span><span class=rvts9>проведення</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>2.4. </span><span class=rvts7>Заявник</span><span class=rvts8> (</span><span class=rvts7>власник</span><span class=rvts8> </span><span class=rvts7>реєстраційного</span><span class=rvts8> </span><span class=rvts7>посвідчення</span><span class=rvts8>) </span><span class=rvts6>- </span><span class=rvts9>юридична</span><span class=rvts6> </span><span class=rvts9>особа</span><span class=rvts6>, </span><span class=rvts9>яка</span><span class=rvts6> </span><span class=rvts9>відповідає</span><span class=rvts6> </span><span class=rvts9>за</span><span class=rvts6> </span><span class=rvts9>виробництво</span><span class=rvts6>, </span><span class=rvts9>якість</span><span class=rvts6>, </span><span class=rvts9>безпечність</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>ефективність</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>2.5. </span><span class=rvts7>Вихідні</span><span class=rvts8> </span><span class=rvts7>дані</span><span class=rvts8> </span><span class=rvts6>- </span><span class=rvts9>всі</span><span class=rvts6> </span><span class=rvts9>первинні</span><span class=rvts6> </span><span class=rvts9>робочі</span><span class=rvts6> </span><span class=rvts9>записи</span><span class=rvts6>, </span><span class=rvts9>примітки</span><span class=rvts6>, </span><span class=rvts9>зареєстровані</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>задокументовані</span><span class=rvts6> </span><span class=rvts9>дані</span><span class=rvts6> </span><span class=rvts9>лабораторних</span><span class=rvts6> </span><span class=rvts9>досліджень</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>оригінальних</span><span class=rvts6> </span><span class=rvts9>візуальних</span><span class=rvts6> </span><span class=rvts9>спостережень</span><span class=rvts6>, </span><span class=rvts9>а</span><span class=rvts6> </span><span class=rvts9>також</span><span class=rvts6> </span><span class=rvts9>затверджені</span><span class=rvts6> </span><span class=rvts9>їх</span><span class=rvts6> </span><span class=rvts9>копії</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>2.6. </span><span class=rvts7>Протокол</span><span class=rvts8> </span><span class=rvts7>доклінічного</span><span class=rvts8> </span><span class=rvts7>вивчення</span><span class=rvts6> - </span><span class=rvts9>документ</span><span class=rvts6>, </span><span class=rvts9>який</span><span class=rvts6> </span><span class=rvts9>визначає</span><span class=rvts6> </span><span class=rvts9>повний</span><span class=rvts6> </span><span class=rvts9>обсяг</span><span class=rvts6> </span><span class=rvts9>доклінічних</span><span class=rvts6> </span><span class=rvts9>досліджень</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>складається</span><span class=rvts6> </span><span class=rvts9>Виконавцем</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>2.7. </span><span class=rvts7>Матеріали</span><span class=rvts8> </span><span class=rvts7>доклінічного</span><span class=rvts8> </span><span class=rvts7>вивчення</span><span class=rvts8> </span><span class=rvts7>лікарського</span><span class=rvts8> </span><span class=rvts7>засобу</span><span class=rvts6> - </span><span class=rvts9>комплект</span><span class=rvts6> </span><span class=rvts9>документів</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6>, </span><span class=rvts9>який</span><span class=rvts6> </span><span class=rvts9>включає</span><span class=rvts6> </span><span class=rvts9>звіти</span><span class=rvts6> </span><span class=rvts9>з</span><span class=rvts6> </span><span class=rvts9>хімічних</span><span class=rvts6>, </span><span class=rvts9>фізичних</span><span class=rvts6>, </span><span class=rvts9>біологічних</span><span class=rvts6>, </span><span class=rvts9>мікробіологічних</span><span class=rvts6>, </span><span class=rvts9>фармацевтичних</span><span class=rvts6>, </span><span class=rvts9>фармакологічних</span><span class=rvts6>, </span><span class=rvts9>токсикологічних</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>інших</span><span class=rvts6> </span><span class=rvts9>експериментальних</span><span class=rvts6> </span><span class=rvts9>наукових</span><span class=rvts6> </span><span class=rvts9>досліджень</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6>/</span><span class=rvts9>або</span><span class=rvts6> </span><span class=rvts9>літературних</span><span class=rvts6> </span><span class=rvts9>даних</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>складу</span><span class=rvts6>, </span><span class=rvts9>показників</span><span class=rvts6> </span><span class=rvts9>якості</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>методів</span><span class=rvts6> </span><span class=rvts9>контролю</span><span class=rvts6> </span><span class=rvts9>якості</span><span class=rvts6>, </span><span class=rvts9>властивостей</span><span class=rvts6>, </span><span class=rvts9>специфічної</span><span class=rvts6> </span><span class=rvts9>активності</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>безпечності</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6>, </span><span class=rvts9>включаючи</span><span class=rvts6> </span><span class=rvts9>протоколи</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> (</span><span class=rvts9>додатки</span><span class=rvts6> 1 - 2). </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>2.8. </span><span class=rvts8>GLP</span><span class=rvts6> - </span><span class=rvts9>правила</span><span class=rvts6> </span><span class=rvts9>належної</span><span class=rvts6> (</span><span class=rvts9>якісної</span><span class=rvts6>) </span><span class=rvts9>лабораторної</span><span class=rvts6> </span><span class=rvts9>практики</span><span class=rvts6> (Good Laboratory Practice), </span><span class=rvts9>які</span><span class=rvts6> </span><span class=rvts9>визнані</span><span class=rvts6> </span><span class=rvts9>в</span><span class=rvts6> </span><span class=rvts9>Україні</span><span class=rvts6>. </span></p>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts8>3. </span><span class=rvts7>Проведення</span><span class=rvts8> </span><span class=rvts7>доклінічного</span><span class=rvts8> </span><span class=rvts7>вивчення</span><span class=rvts8> </span><span class=rvts7>лікарського</span><span class=rvts8> </span><span class=rvts7>засобу</span><span class=rvts8> </span></p>
<p class=rvps6><span class=rvts8><br></span></p>
<p class=rvps6><span class=rvts6>3.1. </span><span class=rvts9>Доклінічне</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span><span class=rvts9>здійснюється</span><span class=rvts6> </span><span class=rvts9>на</span><span class=rvts6> </span><span class=rvts9>договірних</span><span class=rvts6> </span><span class=rvts9>засадах</span><span class=rvts6> </span><span class=rvts9>між</span><span class=rvts6> </span><span class=rvts9>Замовником</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>Виконавцем</span><span class=rvts6>. </span><span class=rvts9>При</span><span class=rvts6> </span><span class=rvts9>проведенні</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>Виконавець</span><span class=rvts6> </span><span class=rvts9>керується</span><span class=rvts6> </span><span class=rvts9>вимогами</span><span class=rvts6> GLP, </span><span class=rvts9>методичними</span><span class=rvts6> </span><span class=rvts9>рекомендаціями</span><span class=rvts6>, </span><span class=rvts9>які</span><span class=rvts6> </span><span class=rvts9>визначають</span><span class=rvts6> </span><span class=rvts9>обсяг</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>зміст</span><span class=rvts6> </span><span class=rvts9>доклінічних</span><span class=rvts6> </span><span class=rvts9>досліджень</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span><span class=rvts9>різних</span><span class=rvts6> </span><span class=rvts9>груп</span><span class=rvts6> </span><span class=rvts9>згідно</span><span class=rvts6> </span><span class=rvts9>з</span><span class=rvts6> </span><span class=rvts9>вимогами</span><span class=rvts6> </span><span class=rvts9>до</span><span class=rvts6> </span><span class=rvts9>документів</span><span class=rvts6>, </span><span class=rvts9>що</span><span class=rvts6> </span><span class=rvts9>надаються</span><span class=rvts6> </span><span class=rvts9>під</span><span class=rvts6> </span><span class=rvts9>час</span><span class=rvts6> </span><span class=rvts9>реєстрації</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6> </span><span class=rvts9>з</span><span class=rvts6> </span><span class=rvts9>урахуванням</span><span class=rvts6> </span><span class=rvts9>вимог</span><span class=rvts6>, </span><span class=rvts9>що</span><span class=rvts6> </span><span class=rvts9>застосовуються</span><span class=rvts6> </span><span class=rvts9>в</span><span class=rvts6> </span><span class=rvts9>міжнародній</span><span class=rvts6> </span><span class=rvts9>практиці</span><span class=rvts6>, </span><span class=rvts9>зокрема</span><span class=rvts6> </span><span class=rvts9>директиви</span><span class=rvts6> </span><span class=rvts9>ЄЕС</span><span class=rvts6> </span><span class=rvts9>від</span><span class=rvts6> 20.05.75 </span><span class=rvts9>№</span><span class=rvts6> 75/318 "</span><span class=rvts9>Про</span><span class=rvts6> </span><span class=rvts9>зближення</span><span class=rvts6> </span><span class=rvts9>законів</span><span class=rvts6> </span><span class=rvts9>держав</span><span class=rvts6> </span><span class=rvts9>ЄЕС</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>аналітичних</span><span class=rvts6>, </span><span class=rvts9>фармакотоксикологічних</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>клінічних</span><span class=rvts6> </span><span class=rvts9>норм</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>протоколів</span><span class=rvts6> </span><span class=rvts9>випробувань</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6>". </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>3.2. </span><span class=rvts9>Під</span><span class=rvts6> </span><span class=rvts9>час</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>Виконавець</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>Замовник</span><span class=rvts6> </span><span class=rvts9>комплектують</span><span class=rvts6> </span><span class=rvts9>документи</span><span class=rvts6> </span><span class=rvts9>згідно</span><span class=rvts6> </span><span class=rvts9>з</span><span class=rvts6> </span><span class=rvts9>Переліком</span><span class=rvts6> (</span><span class=rvts9>додаток</span><span class=rvts6> 3), </span><span class=rvts9>які</span><span class=rvts6> </span><span class=rvts9>зберігаються</span><span class=rvts6> </span><span class=rvts9>у</span><span class=rvts6> </span><span class=rvts9>Виконавця</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6>/</span><span class=rvts9>або</span><span class=rvts6> </span><span class=rvts9>Замовника</span><span class=rvts6> </span><span class=rvts9>протягом</span><span class=rvts6> 15 </span><span class=rvts9>років</span><span class=rvts6>. </span><span class=rvts9>Комплектація</span><span class=rvts6> </span><span class=rvts9>матеріалів</span><span class=rvts6> </span><span class=rvts9>здійснюється</span><span class=rvts6> </span><span class=rvts9>на</span><span class=rvts6> </span><span class=rvts9>підставі</span><span class=rvts6> </span><span class=rvts9>експериментальних</span><span class=rvts6>, </span><span class=rvts9>теоретичних</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>літературних</span><span class=rvts6> </span><span class=rvts9>даних</span><span class=rvts6> </span><span class=rvts9>відповідно</span><span class=rvts6> </span><span class=rvts9>до</span><span class=rvts6> </span><span class=rvts9>міжнародної</span><span class=rvts6> </span><span class=rvts9>практики</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>3.3. </span><span class=rvts9>За</span><span class=rvts6> </span><span class=rvts9>результатами</span><span class=rvts6> </span><span class=rvts9>проведеного</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6> </span><span class=rvts9>Виконавцем</span><span class=rvts6> </span><span class=rvts9>складається</span><span class=rvts6> </span><span class=rvts9>звіт</span><span class=rvts6>, </span><span class=rvts9>який</span><span class=rvts6> </span><span class=rvts9>затверджується</span><span class=rvts6> </span><span class=rvts9>Виконавцем</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>надається</span><span class=rvts6> </span><span class=rvts9>Замовнику</span><span class=rvts6>. </span></p>
<p class=rvps1><span class=rvts8>4. </span><span class=rvts7>Розділ</span><span class=rvts8> 4 </span><span class=rvts7>виключено</span><span class=rvts8> </span></p>
<p class=rvps5><span class=rvts8><br></span></p>
<p class=rvps6><span class=rvts10>(</span><span class=rvts11>згідно</span><span class=rvts10> </span><span class=rvts11>з</span><span class=rvts10> </span><span class=rvts11>наказом</span><span class=rvts10> </span><span class=rvts11>Міністерства</span><span class=rvts10> </span><span class=rvts11>охорони</span><span class=rvts10> </span><span class=rvts11>здоров</span><span class=rvts10>'</span><span class=rvts11>я</span><span class=rvts10> </span><span class=rvts11>України</span><span class=rvts10> </span><span class=rvts11>від</span><span class=rvts10> 13.02.2006 </span><span class=rvts11>р</span><span class=rvts10>. </span><span class=rvts11>№</span><span class=rvts10> 66)</span></p>
<div class=rvps5><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=439 valign=top>
<p class=rvps1><span class=rvts7>Директор</span><span class=rvts8> </span><span class=rvts7>Державного</span></p>
<p class=rvps1><span class=rvts7>фармакологічного</span><span class=rvts8> </span><span class=rvts7>центру</span><span class=rvts8> </span><span class=rvts7>МОЗ</span></p>
<p class=rvps1><span class=rvts7>України</span><span class=rvts8>, </span><span class=rvts7>член</span><span class=rvts8>-</span><span class=rvts7>кор</span><span class=rvts8>. </span><span class=rvts7>АМН</span><span class=rvts8> </span><span class=rvts7>України</span><span class=rvts8> </span></p>
</td>
<td colspan=2 width=216 valign=top>
<p class=rvps1><span class=rvts8><br></span></p>
<p class=rvps1><span class=rvts8><br></span></p>
<p class=rvps1><span class=rvts7>О</span><span class=rvts8>. </span><span class=rvts7>В</span><span class=rvts8>. </span><span class=rvts7>Стефанов</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td colspan=2 width=654 valign=top>
<p class=rvps7><span class=rvts7>Додаток</span><span class=rvts8> 1</span></p>
<p class=rvps7><span class=rvts9>до</span><span class=rvts6> </span><span class=rvts9>пункту</span><span class=rvts6> 2.7 </span><span class=rvts9>Порядку</span><span class=rvts6> </span><span class=rvts9>проведення</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6>  </span></p>
</td>
<td><br>
</td>
</tr>
</table>
</div>
<p><span class=rvts6><br></span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=245 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>УЗГОДЖЕНО</span><span class=rvts6> </span></p>
</td>
<td width=91 valign=top>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>  </span></p>
</td>
<td width=240 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>УЗГОДЖЕНО</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=245 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>Замовник</span><span class=rvts6> </span></p>
</td>
<td width=91 valign=top>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>  </span></p>
</td>
<td width=240 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>Виконавець</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=245 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts6>"__" _______________ 20__ </span><span class=rvts9>р</span><span class=rvts6>. </span></p>
</td>
<td width=91 valign=top>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>  </span></p>
</td>
<td width=240 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts6>"__" _______________ 20__ </span><span class=rvts9>р</span><span class=rvts6>. </span></p>
</td>
</tr>
</table>
</div>
<p><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts7>ПРОТОКОЛ</span><span class=rvts8> </span><span class=rvts7>№</span><span class=rvts8> ___</span></p>
<p class=rvps1><span class=rvts7>доклінічного</span><span class=rvts8> </span><span class=rvts7>вивчення</span><span class=rvts8> </span><span class=rvts7>нешкідливості</span><span class=rvts8> </span><span class=rvts7>лікарського</span><span class=rvts8> </span><span class=rvts7>засобу</span><span class=rvts8> </span></p>
<p class=rvps1><span class=rvts8><br></span></p>
<p class=rvps1><span class=rvts6>____________________________</span></p>
<p class=rvps1><span class=rvts6>(</span><span class=rvts9>назва</span><span class=rvts6>) </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Референтна</span><span class=rvts6> </span><span class=rvts9>речовина</span><span class=rvts6> -</span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________ </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Замовник</span><span class=rvts6> -</span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________</span></p>
<p class=rvps6><span class=rvts6>                                                                 (</span><span class=rvts9>назва</span><span class=rvts6> </span><span class=rvts9>установи</span><span class=rvts6>, </span><span class=rvts9>адреса</span><span class=rvts6>) </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Виконавець</span><span class=rvts6> -</span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________</span></p>
<p class=rvps6><span class=rvts6>                                                                  (</span><span class=rvts9>назва</span><span class=rvts6> </span><span class=rvts9>установи</span><span class=rvts6>, </span><span class=rvts9>адреса</span><span class=rvts6>) </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Відповідальний</span><span class=rvts6> </span><span class=rvts9>виконавець</span><span class=rvts6> -</span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________</span></p>
<p class=rvps6><span class=rvts6>                                                                   (</span><span class=rvts9>прізвище</span><span class=rvts6>, </span><span class=rvts9>ім</span><span class=rvts6>'</span><span class=rvts9>я</span><span class=rvts6>, </span><span class=rvts9>посада</span><span class=rvts6>) </span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6>____________________</span></p>
<p class=rvps5><span class=rvts6>(</span><span class=rvts9>особистий</span><span class=rvts6> </span><span class=rvts9>підпис</span><span class=rvts6>) </span></p>
<p class=rvps6><span class=rvts9>Термін</span><span class=rvts6> </span><span class=rvts9>виконання</span><span class=rvts6>: </span><span class=rvts9>початок</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>                                </span><span class=rvts9>закінчення</span><span class=rvts6> - </span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Зав</span><span class=rvts6>. </span><span class=rvts9>підрозділом</span><span class=rvts6> </span><span class=rvts9>доклінічних</span><span class=rvts6> </span><span class=rvts9>випробувань</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span><span class=rvts9>Виконавця</span><span class=rvts6> </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
<p><span class=rvts6> </span></p>
<p><span class=rvts9>Підпис</span><span class=rvts6>, </span><span class=rvts9>прізвище</span><span class=rvts6>, </span><span class=rvts9>ініціали</span><span class=rvts6> </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Місце</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>термін</span><span class=rvts6> </span><span class=rvts9>зберігання</span><span class=rvts6> - </span><span class=rvts9>протокол</span><span class=rvts6> </span><span class=rvts9>зберігається</span><span class=rvts6> </span><span class=rvts9>в</span><span class=rvts6> </span><span class=rvts9>архіві</span><span class=rvts6> </span><span class=rvts9>Установи</span><span class=rvts6>-</span><span class=rvts9>виконавця</span><span class=rvts6> </span><span class=rvts9>протягом</span><span class=rvts6> 15 </span><span class=rvts9>років</span><span class=rvts6> </span><span class=rvts9>з</span><span class=rvts6> </span><span class=rvts9>дати</span><span class=rvts6> </span><span class=rvts9>реєстрації</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6>. </span></p>
<p class=rvps5><span class=rvts9>Протокол</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> ____ </span></p>
<p class=rvps1><span class=rvts12><br></span></p>
<p class=rvps1><span class=rvts7>ВИКОНАВЦІ</span><span class=rvts8> </span></p>
<p class=rvps6><span class=rvts8><br></span></p>
<p class=rvps6><span class=rvts9>Відповідальний</span><span class=rvts6> </span><span class=rvts9>виконавець</span><span class=rvts6> - ___________________________________________</span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Виконавці</span><span class=rvts6>, </span><span class=rvts9>розподіл</span><span class=rvts6> </span><span class=rvts9>функцій</span><span class=rvts6>:</span><span class=rvts8>___________________________________________ </span></p>
<p class=rvps6><span class=rvts8><br></span></p>
<p class=rvps6><span class=rvts9>У</span><span class=rvts6> </span><span class=rvts9>роботі</span><span class=rvts6> </span><span class=rvts9>брали</span><span class=rvts6> </span><span class=rvts9>участь</span><span class=rvts6>: ________________________________________________</span></p>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts7>ЛАБОРАТОРНІ</span><span class=rvts8> </span><span class=rvts7>ТВАРИНИ</span><span class=rvts8> </span><span class=rvts7>ТА</span><span class=rvts8> </span><span class=rvts7>УМОВИ</span><span class=rvts8> </span><span class=rvts7>ЇХ</span><span class=rvts8> </span><span class=rvts7>УТРИМАННЯ</span><span class=rvts8> </span></p>
<p class=rvps6><span class=rvts9>Вид</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Порода</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Стать</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Маса</span><span class=rvts6> </span><span class=rvts9>тіла</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Загальна</span><span class=rvts6> </span><span class=rvts9>кількість</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Джерело</span><span class=rvts6> </span><span class=rvts9>одержання</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Дата</span><span class=rvts6> </span><span class=rvts9>одержання</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Період</span><span class=rvts6> </span><span class=rvts9>акліматизації</span><span class=rvts6> </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Індивідуальна</span><span class=rvts6> </span><span class=rvts9>ідентифікація</span><span class=rvts6> -                              (</span><span class=rvts9>СОП</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6>      ) </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Метод</span><span class=rvts6> </span><span class=rvts9>розподілу</span><span class=rvts6> </span><span class=rvts9>за</span><span class=rvts6> </span><span class=rvts9>групами</span><span class=rvts6> -                              (</span><span class=rvts9>СОП</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6>     ) </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Кількість</span><span class=rvts6> </span><span class=rvts9>тварин</span><span class=rvts6> </span><span class=rvts9>у</span><span class=rvts6> </span><span class=rvts9>клітці</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Розміри</span><span class=rvts6> </span><span class=rvts9>клітки</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Матеріал</span><span class=rvts6> </span><span class=rvts9>клітки</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Основний</span><span class=rvts6> </span><span class=rvts9>раціон</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Джерело</span><span class=rvts6> </span><span class=rvts9>води</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Температура</span><span class=rvts6> </span><span class=rvts9>повітря</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Вологість</span><span class=rvts6> </span><span class=rvts9>повітря</span><span class=rvts6> - </span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=415 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Зав</span><span class=rvts6>. </span><span class=rvts9>підрозділом</span><span class=rvts6> </span><span class=rvts9>доклінічних</span><span class=rvts6> </span><span class=rvts9>випробувань</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span><span class=rvts9>Виконавця</span><span class=rvts6> </span></p>
</td>
<td width=240 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
<p><span class=rvts6> </span><span class=rvts9>Підпис</span><span class=rvts6>, </span><span class=rvts9>прізвище</span><span class=rvts6>, </span><span class=rvts9>ініціали</span><span class=rvts6> </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps5><span class=rvts9>Протокол</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> ______ </span></p>
<p class=rvps1><span class=rvts12><br></span></p>
<p class=rvps1><span class=rvts7>ДОЗИ</span><span class=rvts8> </span><span class=rvts7>ТА</span><span class=rvts8> </span><span class=rvts7>УМОВИ</span><span class=rvts8> </span><span class=rvts7>ВВЕДЕННЯ</span><span class=rvts8> </span><span class=rvts7>РЕЧОВИНИ</span><span class=rvts8> </span></p>
<p class=rvps6><span class=rvts8>_________________________________________________________________</span></p>
<p class=rvps6><span class=rvts8>_________________________________________________________________</span></p>
<p class=rvps6><span class=rvts8>_________________________________________________________________ </span></p>
<p class=rvps1><span class=rvts13><br></span></p>
<p class=rvps1><span class=rvts9>ПЛАН</span><span class=rvts6> </span><span class=rvts9>ЕКСПЕРИМЕНТУ</span><span class=rvts6> </span></p>
<p class=rvps1><span class=rvts12><br></span></p>
<div><table border=1 style="border-width : 0px" cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td rowspan=2 width=243 valign=top style="border-width : 1px; border-color: #000000;">
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>Експериментальна</span><span class=rvts6> </span><span class=rvts9>група</span><span class=rvts6> </span></p>
</td>
<td rowspan=2 width=75 valign=top style="border-width : 1px; border-color: #000000;">
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>Доза</span><span class=rvts6>, </span><span class=rvts9>мг</span><span class=rvts6>/</span><span class=rvts9>кг</span><span class=rvts6> </span></p>
</td>
<td colspan=2 width=259 valign=top style="border-width : 1px; border-color: #000000;">
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>Номери</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=144 valign=top style="border-width : 1px; border-color: #000000;">
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>Самців</span><span class=rvts6> </span></p>
</td>
<td width=115 valign=top style="border-width : 1px; border-color: #000000;">
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>Самок</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=243 valign=top style="border-width : 1px; border-color: #000000;">
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>1. </span></p>
</td>
<td width=75 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=144 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=115 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
</tr>
<tr valign=top>
<td width=243 valign=top style="border-width : 1px; border-color: #000000;">
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>2. </span></p>
</td>
<td width=75 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=144 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=115 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
</tr>
<tr valign=top>
<td width=243 valign=top style="border-width : 1px; border-color: #000000;">
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>3. </span></p>
</td>
<td width=75 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=144 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=115 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
</tr>
<tr valign=top>
<td width=243 valign=top style="border-width : 1px; border-color: #000000;">
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>4. </span></p>
</td>
<td width=75 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=144 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=115 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
</tr>
<tr valign=top>
<td width=243 valign=top style="border-width : 1px; border-color: #000000;">
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>5. </span></p>
</td>
<td width=75 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=144 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=115 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
</tr>
<tr valign=top>
<td width=243 valign=top style="border-width : 1px; border-color: #000000;">
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>6. (</span><span class=rvts9>контроль</span><span class=rvts6>) </span></p>
</td>
<td width=75 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=144 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
<td width=115 valign=top style="border-width : 1px; border-color: #000000;">
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Обґрунтування</span><span class=rvts6> </span><span class=rvts9>доз</span></p>
<p class=rvps6><span class=rvts8>___________________________________________</span></p>
<p class=rvps6><span class=rvts8>___________________________________________ </span></p>
<p class=rvps1><span class=rvts8><br></span></p>
<p class=rvps1><span class=rvts9>УМОВИ</span><span class=rvts6> </span><span class=rvts9>ЕКСПЕРИМЕНТУ</span><span class=rvts6> </span></p>
<p class=rvps6><span class=rvts12><br></span></p>
<p class=rvps6><span class=rvts9>Частота</span><span class=rvts6> </span><span class=rvts9>введень</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Шлях</span><span class=rvts6> </span><span class=rvts9>введення</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Спосіб</span><span class=rvts6> </span><span class=rvts9>введення</span><span class=rvts6> - _______________________________ (</span><span class=rvts9>СОП</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> _______) </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Підготовка</span><span class=rvts6> </span><span class=rvts9>препарату</span><span class=rvts6> </span><span class=rvts9>для</span><span class=rvts6> </span><span class=rvts9>введення</span><span class=rvts6> -_</span><span class=rvts8>_________________________________</span></p>
<p class=rvps6><span class=rvts6>__________________________________________________________________ </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Режим</span><span class=rvts6> </span><span class=rvts9>дозування</span><span class=rvts6>____________________________________________________ </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Носій</span><span class=rvts6> (</span><span class=rvts9>розчинник</span><span class=rvts6>)____________________________________________________ </span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=415 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Зав</span><span class=rvts6>. </span><span class=rvts9>підрозділом</span><span class=rvts6> </span><span class=rvts9>доклінічних</span><span class=rvts6> </span><span class=rvts9>випробувань</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span><span class=rvts9>Виконавця</span><span class=rvts6> </span></p>
</td>
<td width=240 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
<p><span class=rvts6> </span><span class=rvts9>Підпис</span><span class=rvts6>, </span><span class=rvts9>прізвище</span><span class=rvts6>, </span><span class=rvts9>ініціали</span><span class=rvts6> </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps5><span class=rvts9>Протокол</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> ______ </span></p>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>ІНТЕГРАЛЬНІ</span><span class=rvts6> </span><span class=rvts9>ПОКАЗНИКИ</span><span class=rvts6> </span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Параметри</span><span class=rvts6>  </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Терміни</span><span class=rvts6> </span><span class=rvts9>спостереження</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Виживання</span><span class=rvts6>  </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Щоденно</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Маса</span><span class=rvts6> </span><span class=rvts9>тіла</span><span class=rvts6> (</span><span class=rvts9>СОП</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> _____) </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>1, 3, 7, 14-</span><span class=rvts9>й</span><span class=rvts6> </span><span class=rvts9>дні</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Споживання</span><span class=rvts6> </span><span class=rvts9>їжі</span><span class=rvts6> (</span><span class=rvts9>СОП</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> _____) </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>7-</span><span class=rvts9>й</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> 14-</span><span class=rvts9>й</span><span class=rvts6> </span><span class=rvts9>дні</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Клінічні</span><span class=rvts6> </span><span class=rvts9>спостереження</span><span class=rvts6> (</span><span class=rvts9>СОП</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> _____) </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Щоденно</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Інші</span><span class=rvts6> </span><span class=rvts9>показники</span><span class=rvts6> </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>У</span><span class=rvts6> </span><span class=rvts9>разі</span><span class=rvts6> </span><span class=rvts9>потреби</span><span class=rvts6> </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps1><span class=rvts12><br></span></p>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>ПАТОМОРФОЛОГІЧНІ</span><span class=rvts6> </span><span class=rvts9>ДОСЛІДЖЕННЯ</span><span class=rvts6> </span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Метод</span><span class=rvts6> </span><span class=rvts9>евтаназії</span><span class=rvts6> (</span><span class=rvts9>СОП</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> _____) </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>14-</span><span class=rvts9>й</span><span class=rvts6> </span><span class=rvts9>день</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Макроскопічні</span><span class=rvts6> </span><span class=rvts9>спостереження</span><span class=rvts6> </span><span class=rvts9>розтину</span><span class=rvts6> (</span><span class=rvts9>СОП</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> _____) </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>14-</span><span class=rvts9>й</span><span class=rvts6> </span><span class=rvts9>день</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Коефіцієнти</span><span class=rvts6> </span><span class=rvts9>маси</span><span class=rvts6> </span><span class=rvts9>внутрішніх</span><span class=rvts6> </span><span class=rvts9>органів</span><span class=rvts6> (</span><span class=rvts9>СОП</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> ____) </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>14-</span><span class=rvts9>й</span><span class=rvts6> </span><span class=rvts9>день</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Спеціальні</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6> </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>У</span><span class=rvts6> </span><span class=rvts9>разі</span><span class=rvts6> </span><span class=rvts9>потреби</span><span class=rvts6> </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps1><span class=rvts12><br></span></p>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>СТАТИСТИЧНА</span><span class=rvts6> </span><span class=rvts9>ОБРОБКА</span><span class=rvts6> </span><span class=rvts9>ДАНИХ</span><span class=rvts6> </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Параметри</span><span class=rvts6> </span><span class=rvts9>токсичності</span></p>
<p class=rvps6><span class=rvts8>___________________________________________</span></p>
<p class=rvps6><span class=rvts8>___________________________________________</span></p>
<p class=rvps6><span class=rvts8>___________________________________________  </span></p>
<p class=rvps6><span class=rvts8><br></span></p>
<p class=rvps6><span class=rvts9>Маса</span><span class=rvts6> </span><span class=rvts9>тіла</span><span class=rvts6> _______________________________________________________</span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Маса</span><span class=rvts6> </span><span class=rvts9>внутрішніх</span><span class=rvts6> </span><span class=rvts9>органів</span><span class=rvts6> ___________________________________________</span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Процедура</span><span class=rvts6> </span><span class=rvts9>випадкової</span><span class=rvts6> </span><span class=rvts9>вибірки</span><span class=rvts6> _____________________________________</span></p>
<p class=rvps6><span class=rvts6>________________________________________________________________ </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td colspan=2 width=415 valign=top>
<p><span class=rvts9>Зав</span><span class=rvts6>. </span><span class=rvts9>підрозділом</span><span class=rvts6> </span><span class=rvts9>доклінічних</span><span class=rvts6> </span><span class=rvts9>випробувань</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span><span class=rvts9>Виконавця</span><span class=rvts6> </span></p>
</td>
<td width=240 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span><span class=rvts9>Підпис</span><span class=rvts6>, </span><span class=rvts9>прізвище</span><span class=rvts6>, </span><span class=rvts9>ініціали</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td><br>
</td>
<td colspan=2 width=300 valign=top>
<p class=rvps5><span class=rvts7>Додаток</span><span class=rvts8> 2</span></p>
<p class=rvps5><span class=rvts9>до</span><span class=rvts6> </span><span class=rvts9>пункту</span><span class=rvts6> 2.7 </span><span class=rvts9>Порядку</span><span class=rvts6> </span><span class=rvts9>проведення</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span></p>
</td>
</tr>
</table>
</div>
<p><span class=rvts6><br></span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=245 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts7>УЗГОДЖЕНО</span><span class=rvts6> </span></p>
</td>
<td width=91 valign=top>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts8> </span><span class=rvts6> </span></p>
</td>
<td width=240 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts7>УЗГОДЖЕНО</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=245 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>Замовник</span><span class=rvts6> </span></p>
</td>
<td width=91 valign=top>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>  </span></p>
</td>
<td width=240 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>Виконавець</span><span class=rvts6> </span></p>
</td>
</tr>
<tr valign=top>
<td width=245 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts6>"__" _______________ 20__ </span><span class=rvts9>р</span><span class=rvts6>. </span></p>
</td>
<td width=91 valign=top>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>  </span></p>
</td>
<td width=240 valign=top>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts6>"__" _______________ 20__ </span><span class=rvts9>р</span><span class=rvts6>. </span></p>
</td>
</tr>
</table>
</div>
<p><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts7>ПРОТОКОЛ</span><span class=rvts8> </span><span class=rvts7>№</span><span class=rvts8> _____</span></p>
<p class=rvps1><span class=rvts7>доклінічного</span><span class=rvts8> </span><span class=rvts7>вивчення</span><span class=rvts8> </span><span class=rvts7>специфічної</span><span class=rvts8> </span><span class=rvts7>активності</span><span class=rvts8> </span><span class=rvts7>лікарського</span><span class=rvts8> </span><span class=rvts7>засобу</span><span class=rvts8> </span></p>
<p class=rvps1><span class=rvts8><br></span></p>
<p class=rvps1><span class=rvts6>____________________________</span></p>
<p class=rvps1><span class=rvts6>(</span><span class=rvts9>назва</span><span class=rvts6>) </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Референтна</span><span class=rvts6> </span><span class=rvts9>речовина</span><span class=rvts6> </span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________ </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Замовник</span><span class=rvts6> </span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________</span></p>
<p class=rvps6><span class=rvts6>                                                                   (</span><span class=rvts9>назва</span><span class=rvts6> </span><span class=rvts9>установи</span><span class=rvts6>, </span><span class=rvts9>адреса</span><span class=rvts6>) </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Виконавець</span><span class=rvts6>: </span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________</span></p>
<p class=rvps6><span class=rvts6>                                                                   (</span><span class=rvts9>назва</span><span class=rvts6> </span><span class=rvts9>установи</span><span class=rvts6>, </span><span class=rvts9>адреса</span><span class=rvts6>)</span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________ </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Відповідальний</span><span class=rvts6> </span><span class=rvts9>виконавець</span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________</span></p>
<p class=rvps6><span class=rvts6>                                                                    (</span><span class=rvts9>прізвище</span><span class=rvts6>, </span><span class=rvts9>ім</span><span class=rvts6>'</span><span class=rvts9>я</span><span class=rvts6>, </span><span class=rvts9>посада</span><span class=rvts6>)</span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________ </span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6>____________________</span></p>
<p class=rvps5><span class=rvts6>(</span><span class=rvts9>особистий</span><span class=rvts6> </span><span class=rvts9>підпис</span><span class=rvts6>) </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Термін</span><span class=rvts6> </span><span class=rvts9>виконання</span><span class=rvts6>: </span><span class=rvts9>початок</span><span class=rvts6> - </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>                                 </span><span class=rvts9>закінчення</span><span class=rvts6> </span><span class=rvts9>–</span><span class=rvts6> </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=415 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Зав</span><span class=rvts6>. </span><span class=rvts9>підрозділом</span><span class=rvts6> </span><span class=rvts9>доклінічних</span><span class=rvts6> </span><span class=rvts9>випробувань</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span><span class=rvts9>Виконавця</span><span class=rvts6> </span></p>
</td>
<td width=240 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
<p><span class=rvts6> </span><span class=rvts9>Підпис</span><span class=rvts6>, </span><span class=rvts9>прізвище</span><span class=rvts6>, </span><span class=rvts9>ініціали</span><span class=rvts6> </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps5><span class=rvts9>Протокол</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> ______ </span></p>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts9>Інформація</span><span class=rvts6> </span><span class=rvts9>про</span><span class=rvts6> </span><span class=rvts9>учасників</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>випробування</span><span class=rvts6> </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Місце</span><span class=rvts6> </span><span class=rvts9>проведення</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6>,</span></p>
<p class=rvps6><span class=rvts9>адреса</span><span class=rvts6>, </span><span class=rvts9>телефон</span><span class=rvts6>, </span><span class=rvts9>факс</span><span class=rvts6>, </span><span class=rvts9>електронна</span><span class=rvts6> </span><span class=rvts9>пошта</span><span class=rvts6> _____________________________</span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________</span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________ </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Відповідальний</span><span class=rvts6> </span><span class=rvts9>Виконавець</span><span class=rvts6> ________________________________________ </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts9>Замовник</span><span class=rvts6>,</span></p>
<p class=rvps6><span class=rvts9>адреса</span><span class=rvts6>, </span><span class=rvts9>телефон</span><span class=rvts6>, </span><span class=rvts9>факс</span><span class=rvts6>, </span><span class=rvts9>електронна</span><span class=rvts6> </span><span class=rvts9>пошта</span><span class=rvts6> _____________________________</span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________</span></p>
<p class=rvps6><span class=rvts6>_________________________________________________________________ </span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Зав</span><span class=rvts6>. </span><span class=rvts9>підрозділом</span><span class=rvts6> </span><span class=rvts9>доклінічних</span><span class=rvts6> </span><span class=rvts9>випробувань</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span><span class=rvts9>Виконавця</span><span class=rvts6> </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6>  </span></p>
<p><span class=rvts6> </span></p>
<p><span class=rvts9>Підпис</span><span class=rvts6>, </span><span class=rvts9>прізвище</span><span class=rvts6>, </span><span class=rvts9>ініціали</span><span class=rvts6> </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>  </span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts9>Протокол</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> ______ </span></p>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts7>Загальна</span><span class=rvts8> </span><span class=rvts7>інформація</span><span class=rvts8> </span><span class=rvts7>про</span><span class=rvts8> </span><span class=rvts7>дослідження</span><span class=rvts8> </span></p>
<p class=rvps6><span class=rvts8><br></span></p>
<p class=rvps6><span class=rvts6>1. </span><span class=rvts9>Назва</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>2. </span><span class=rvts9>Методика</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6>, </span><span class=rvts9>використані</span><span class=rvts6> </span><span class=rvts9>апаратура</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>реактиви</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>3. </span><span class=rvts9>Вид</span><span class=rvts6> </span><span class=rvts9>тварин</span><span class=rvts6>, </span><span class=rvts9>що</span><span class=rvts6> </span><span class=rvts9>використовувались</span><span class=rvts6> </span><span class=rvts9>у</span><span class=rvts6> </span><span class=rvts9>дослідженні</span><span class=rvts6>, </span><span class=rvts9>їх</span><span class=rvts6> </span><span class=rvts9>кількість</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>4. </span><span class=rvts9>Вид</span><span class=rvts6> </span><span class=rvts9>наркозу</span><span class=rvts6>, </span><span class=rvts9>шляхи</span><span class=rvts6> </span><span class=rvts9>введення</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6>, </span><span class=rvts9>дози</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>5. </span><span class=rvts9>Спосіб</span><span class=rvts6> </span><span class=rvts9>гуманного</span><span class=rvts6> </span><span class=rvts9>умертвіння</span><span class=rvts6> </span><span class=rvts9>тварин</span><span class=rvts6> </span><span class=rvts9>після</span><span class=rvts6> </span><span class=rvts9>проведення</span><span class=rvts6> </span><span class=rvts9>досліджень</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>6. </span><span class=rvts9>Детальний</span><span class=rvts6> </span><span class=rvts9>план</span><span class=rvts6> </span><span class=rvts9>проведення</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6> </span><span class=rvts9>із</span><span class=rvts6> </span><span class=rvts9>вказівкою</span><span class=rvts6> </span><span class=rvts9>тривалості</span><span class=rvts6> </span><span class=rvts9>етапів</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>термінів</span><span class=rvts6>. </span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Зав</span><span class=rvts6>. </span><span class=rvts9>підрозділом</span><span class=rvts6> </span><span class=rvts9>доклінічних</span><span class=rvts6> </span></p>
<p><span class=rvts9>випробувань</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span></p>
<p><span class=rvts9>Виконавця</span><span class=rvts6> </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6> </span></p>
<p><span class=rvts6> </span></p>
<p><span class=rvts6> </span></p>
<p><span class=rvts9>Підпис</span><span class=rvts6>, </span><span class=rvts9>прізвище</span><span class=rvts6>, </span><span class=rvts9>ініціали</span><span class=rvts6> </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>  </span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts6><br></span></p>
<p class=rvps5><span class=rvts9>Протокол</span><span class=rvts6> </span><span class=rvts9>№</span><span class=rvts6> ______ </span></p>
<p class=rvps1><span class=rvts7>Зміст</span><span class=rvts8> </span></p>
<p class=rvps1><span class=rvts8><br></span></p>
<p class=rvps6><span class=rvts8><br></span></p>
<p class=rvps6><span class=rvts6>1. </span><span class=rvts9>Мета</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>2. </span><span class=rvts9>Завдання</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>3. </span><span class=rvts9>Речовина</span><span class=rvts6>, </span><span class=rvts9>що</span><span class=rvts6> </span><span class=rvts9>вивчається</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>4. </span><span class=rvts9>Контрольна</span><span class=rvts6> </span><span class=rvts9>речовина</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>5. </span><span class=rvts9>Обґрунтування</span><span class=rvts6> </span><span class=rvts9>обраної</span><span class=rvts6> </span><span class=rvts9>схеми</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>6. </span><span class=rvts9>Характеристика</span><span class=rvts6> </span><span class=rvts9>піддослідних</span><span class=rvts6> </span><span class=rvts9>тварин</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>7. </span><span class=rvts9>Матеріали</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>7.1. </span><span class=rvts9>Опис</span><span class=rvts6> </span><span class=rvts9>препарату</span><span class=rvts6>, </span><span class=rvts9>що</span><span class=rvts6> </span><span class=rvts9>вивчається</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>7.2. </span><span class=rvts9>Упаковка</span><span class=rvts6>, </span><span class=rvts9>маркування</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>7.3. </span><span class=rvts9>Збереження</span><span class=rvts6> </span><span class=rvts9>препарату</span><span class=rvts6>, </span><span class=rvts9>що</span><span class=rvts6> </span><span class=rvts9>вивчається</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>7.4. </span><span class=rvts9>Умови</span><span class=rvts6> </span><span class=rvts9>передачі</span><span class=rvts6>, </span><span class=rvts9>обліку</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>повернення</span><span class=rvts6> </span><span class=rvts9>препарату</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>8. </span><span class=rvts9>Структура</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>8.1. </span><span class=rvts9>Загальний</span><span class=rvts6> </span><span class=rvts9>план</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>8.2. </span><span class=rvts9>Критерії</span><span class=rvts6> </span><span class=rvts9>включення</span><span class=rvts6>, </span><span class=rvts9>виключення</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>вибування</span><span class=rvts6> </span><span class=rvts9>тварин</span><span class=rvts6> </span><span class=rvts9>із</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>9. </span><span class=rvts9>Схема</span><span class=rvts6> </span><span class=rvts9>застосування</span><span class=rvts6> </span><span class=rvts9>препарату</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>9.1. </span><span class=rvts9>Спосіб</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>шляхи</span><span class=rvts6> </span><span class=rvts9>введення</span><span class=rvts6> </span><span class=rvts9>препарату</span><span class=rvts6>, </span><span class=rvts9>який</span><span class=rvts6> </span><span class=rvts9>вивчається</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>9.2. </span><span class=rvts9>Спосіб</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>шляхи</span><span class=rvts6> </span><span class=rvts9>введення</span><span class=rvts6> </span><span class=rvts9>референтного</span><span class=rvts6> </span><span class=rvts9>препарату</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>10. </span><span class=rvts9>Методи</span><span class=rvts6>, </span><span class=rvts9>які</span><span class=rvts6> </span><span class=rvts9>використовуються</span><span class=rvts6> </span><span class=rvts9>при</span><span class=rvts6> </span><span class=rvts9>проведенні</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>11. </span><span class=rvts9>Оцінка</span><span class=rvts6> </span><span class=rvts9>ефективності</span><span class=rvts6> </span><span class=rvts9>препарату</span><span class=rvts6>, </span><span class=rvts9>який</span><span class=rvts6> </span><span class=rvts9>вивчається</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>12. </span><span class=rvts9>Етичні</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>правові</span><span class=rvts6> </span><span class=rvts9>норми</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>13. </span><span class=rvts9>Використання</span><span class=rvts6> </span><span class=rvts9>одержаної</span><span class=rvts6> </span><span class=rvts9>інформації</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>право</span><span class=rvts6> </span><span class=rvts9>на</span><span class=rvts6> </span><span class=rvts9>публікацію</span><span class=rvts6> </span><span class=rvts9>результатів</span><span class=rvts6> </span><span class=rvts9>проведених</span><span class=rvts6> </span><span class=rvts9>досліджень</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>14. </span><span class=rvts9>Поправки</span><span class=rvts6> </span><span class=rvts9>до</span><span class=rvts6> </span><span class=rvts9>протоколу</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>специфічної</span><span class=rvts6> </span><span class=rvts9>активності</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6> (</span><span class=rvts9>повинні</span><span class=rvts6> </span><span class=rvts9>бути</span><span class=rvts6> </span><span class=rvts9>узгоджені</span><span class=rvts6> </span><span class=rvts9>із</span><span class=rvts6> </span><span class=rvts9>сектором</span><span class=rvts6> </span><span class=rvts9>доклінічних</span><span class=rvts6> </span><span class=rvts9>випробувань</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span><span class=rvts9>ДФЦ</span><span class=rvts6> </span><span class=rvts9>МОЗ</span><span class=rvts6> </span><span class=rvts9>України</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>Замовником</span><span class=rvts6>). </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>15. </span><span class=rvts9>Обробка</span><span class=rvts6> </span><span class=rvts9>результатів</span><span class=rvts6> </span><span class=rvts9>дослідження</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>16. </span><span class=rvts9>Складання</span><span class=rvts6> </span><span class=rvts9>звіту</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>17. </span><span class=rvts9>Використана</span><span class=rvts6> </span><span class=rvts9>література</span><span class=rvts6>. </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts9>Зав</span><span class=rvts6>. </span><span class=rvts9>підрозділом</span><span class=rvts6> </span><span class=rvts9>доклінічних</span><span class=rvts6> </span></p>
<p><span class=rvts9>випробувань</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span></p>
<p><span class=rvts9>Виконавця</span><span class=rvts6> </span></p>
</td>
<td width=288 valign=top>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6> </span></p>
<p><span class=rvts6> </span></p>
<p><span class=rvts6> </span></p>
<p><span class=rvts9>Підпис</span><span class=rvts6>, </span><span class=rvts9>прізвище</span><span class=rvts6>, </span><span class=rvts9>ініціали</span><span class=rvts6> </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps6><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<p><span class=rvts6><br></span></p>
<div><table border=0 cellpadding=0 cellspacing=-1 style="border-color: #000000; border-collapse: collapse;">
<tr valign=top>
<td width=312 valign=top>
<p class=rvps5><span class=rvts6> </span><span class=rvts7>Додаток</span><span class=rvts8> 3</span></p>
<p class=rvps5><span class=rvts9>до</span><span class=rvts6> </span><span class=rvts9>пункту</span><span class=rvts6> 3.2 </span><span class=rvts9>Порядку</span><span class=rvts6> </span><span class=rvts9>проведення</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6> </span></p>
</td>
</tr>
</table>
</div>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts7>Перелік</span><span class=rvts8> </span><span class=rvts7>документів</span><span class=rvts8> </span><span class=rvts7>доклінічного</span><span class=rvts8> </span><span class=rvts7>вивчення</span><span class=rvts8> </span><span class=rvts7>лікарського</span><span class=rvts8> </span><span class=rvts7>засобу</span><span class=rvts8>, </span><span class=rvts7>які</span><span class=rvts8> </span><span class=rvts7>повинні</span><span class=rvts8> </span><span class=rvts7>зберігатися</span><span class=rvts8> </span><span class=rvts7>Виконавцем</span><span class=rvts8> </span><span class=rvts7>та</span><span class=rvts8> </span><span class=rvts7>Замовником</span><span class=rvts8> </span></p>
<p class=rvps6><span class=rvts8><br></span></p>
<p class=rvps6><span class=rvts8>- </span><span class=rvts9>протокол</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>поправки</span><span class=rvts6> </span><span class=rvts9>до</span><span class=rvts6> </span><span class=rvts9>нього</span><span class=rvts6> (</span><span class=rvts9>якщо</span><span class=rvts6> </span><span class=rvts9>такі</span><span class=rvts6> </span><span class=rvts9>є</span><span class=rvts6>); </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>- </span><span class=rvts9>договір</span><span class=rvts6> </span><span class=rvts9>між</span><span class=rvts6> </span><span class=rvts9>Замовником</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>Виконавцем</span><span class=rvts6>; </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>- </span><span class=rvts9>зразок</span><span class=rvts6> </span><span class=rvts9>упаковки</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6>, </span><span class=rvts9>що</span><span class=rvts6> </span><span class=rvts9>вивчається</span><span class=rvts6>; </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>- </span><span class=rvts9>сертифікати</span><span class=rvts6> </span><span class=rvts9>аналізу</span><span class=rvts6> </span><span class=rvts9>якості</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6>; </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>- </span><span class=rvts9>акти</span><span class=rvts6> </span><span class=rvts9>про</span><span class=rvts6> </span><span class=rvts9>перевірки</span><span class=rvts6> </span><span class=rvts9>проведення</span><span class=rvts6> </span><span class=rvts9>доклінічного</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6> </span><span class=rvts9>Замовником</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>ДФЦ</span><span class=rvts6> </span><span class=rvts9>МОЗ</span><span class=rvts6> </span><span class=rvts9>України</span><span class=rvts6> (</span><span class=rvts9>якщо</span><span class=rvts6> </span><span class=rvts9>такі</span><span class=rvts6> </span><span class=rvts9>перевірки</span><span class=rvts6> </span><span class=rvts9>проводилися</span><span class=rvts6>); </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>- </span><span class=rvts9>первинна</span><span class=rvts6> </span><span class=rvts9>документація</span><span class=rvts6> (</span><span class=rvts9>індивідуальні</span><span class=rvts6> </span><span class=rvts9>протоколи</span><span class=rvts6> </span><span class=rvts9>дослідів</span><span class=rvts6>, </span><span class=rvts9>роздрук</span><span class=rvts6> </span><span class=rvts9>приладів</span><span class=rvts6>, </span><span class=rvts9>фотографічні</span><span class=rvts6> </span><span class=rvts9>негативи</span><span class=rvts6> </span><span class=rvts9>тощо</span><span class=rvts6>); </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>- </span><span class=rvts9>звіти</span><span class=rvts6> </span><span class=rvts9>про</span><span class=rvts6> </span><span class=rvts9>доклінічне</span><span class=rvts6> </span><span class=rvts9>вивчення</span><span class=rvts6>, </span><span class=rvts9>підписані</span><span class=rvts6> </span><span class=rvts9>Виконавцем</span><span class=rvts6>, </span><span class=rvts9>які</span><span class=rvts6> </span><span class=rvts9>містять</span><span class=rvts6>: </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<ul style="text-indent: 8px; margin-left: 48px; list-style-position: outside;">
<li class=rvps8 style="{ margin-left: 0 }"><span class=rvts9>обґрунтування</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>кількісного</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>якісного</span><span class=rvts6> </span><span class=rvts9>складу</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6>, </span><span class=rvts9>вибору</span><span class=rvts6> </span><span class=rvts9>композиції</span><span class=rvts6>, </span><span class=rvts9>складових</span><span class=rvts6> </span><span class=rvts9>речовин</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>пояснення</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>допоміжних</span><span class=rvts6> </span><span class=rvts9>речовин</span><span class=rvts6>; </span></li>
</ul>
<p class=rvps6><span class=rvts6><br></span></p>
<ul style="text-indent: 8px; margin-left: 48px; list-style-position: outside;">
<li class=rvps8 style="{ margin-left: 0 }"><span class=rvts9>у</span><span class=rvts6> </span><span class=rvts9>випадку</span><span class=rvts6> </span><span class=rvts9>відтвореного</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6> - </span><span class=rvts9>дані</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>ідентичності</span><span class=rvts6> </span><span class=rvts9>складу</span><span class=rvts6> </span><span class=rvts9>лікарського</span><span class=rvts6> </span><span class=rvts9>засобу</span><span class=rvts6> </span><span class=rvts9>відносно</span><span class=rvts6> </span><span class=rvts9>препарату</span><span class=rvts6> </span><span class=rvts9>порівняння</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>обґрунтування</span><span class=rvts6> </span><span class=rvts9>змін</span><span class=rvts6> </span><span class=rvts9>складу</span><span class=rvts6> </span><span class=rvts9>допоміжних</span><span class=rvts6> </span><span class=rvts9>речовин</span><span class=rvts6>, </span><span class=rvts9>якщо</span><span class=rvts6> </span><span class=rvts9>такі</span><span class=rvts6> </span><span class=rvts9>зміни</span><span class=rvts6> </span><span class=rvts9>були</span><span class=rvts6>; </span></li>
</ul>
<p class=rvps6><span class=rvts6><br></span></p>
<ul style="text-indent: 8px; margin-left: 48px; list-style-position: outside;">
<li class=rvps8 style="{ margin-left: 0 }"><span class=rvts9>фізико</span><span class=rvts6>-</span><span class=rvts9>хімічні</span><span class=rvts6> </span><span class=rvts9>властивості</span><span class=rvts6>, </span><span class=rvts9>які</span><span class=rvts6> </span><span class=rvts9>впливають</span><span class=rvts6> </span><span class=rvts9>на</span><span class=rvts6> </span><span class=rvts9>біодоступність</span><span class=rvts6>: </span></li>
</ul>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>• </span><span class=rvts9>кристалічну</span><span class=rvts6> </span><span class=rvts9>форму</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>коефіцієнт</span><span class=rvts6> </span><span class=rvts9>розчинності</span><span class=rvts6> </span><span class=rvts9>або</span><span class=rvts6> </span><span class=rvts9>інші</span><span class=rvts6> </span><span class=rvts9>дані</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>розчинності</span><span class=rvts6> </span><span class=rvts9>діючих</span><span class=rvts6> </span><span class=rvts9>речовин</span><span class=rvts6>; </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>• </span><span class=rvts9>рекомендований</span><span class=rvts6> </span><span class=rvts9>розмір</span><span class=rvts6> </span><span class=rvts9>кристалів</span><span class=rvts6> (</span><span class=rvts9>частинок</span><span class=rvts6>) </span><span class=rvts9>діючих</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>допоміжних</span><span class=rvts6> </span><span class=rvts9>речовин</span><span class=rvts6>; </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>• </span><span class=rvts9>стан</span><span class=rvts6> </span><span class=rvts9>сольватації</span><span class=rvts6>; </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6>• </span><span class=rvts9>коефіцієнт</span><span class=rvts6> </span><span class=rvts9>розподілення</span><span class=rvts6> </span><span class=rvts9>олія</span><span class=rvts6>/</span><span class=rvts9>вода</span><span class=rvts6> (</span><span class=rvts9>для</span><span class=rvts6> </span><span class=rvts9>препаратів</span><span class=rvts6>, </span><span class=rvts9>які</span><span class=rvts6> </span><span class=rvts9>використовуються</span><span class=rvts6> </span><span class=rvts9>в</span><span class=rvts6> </span><span class=rvts9>формі</span><span class=rvts6> </span><span class=rvts9>розчину</span><span class=rvts6>, </span><span class=rvts9>наводяться</span><span class=rvts6> </span><span class=rvts9>дані</span><span class=rvts6> </span><span class=rvts9>лише</span><span class=rvts6> </span><span class=rvts9>за</span><span class=rvts6> </span><span class=rvts9>цим</span><span class=rvts6> </span><span class=rvts9>пунктом</span><span class=rvts6>). </span></p>
<p class=rvps6><span class=rvts6><br></span></p>
<ul style="text-indent: 8px; margin-left: 48px; list-style-position: outside;">
<li class=rvps8 style="{ margin-left: 0 }"><span class=rvts9>для</span><span class=rvts6> </span><span class=rvts9>твердих</span><span class=rvts6> </span><span class=rvts9>форм</span><span class=rvts6> </span><span class=rvts9>наводяться</span><span class=rvts6> </span><span class=rvts9>дані</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>вивільнення</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>розчинності</span><span class=rvts6> </span><span class=rvts9>активних</span><span class=rvts6> </span><span class=rvts9>інгредієнтів</span><span class=rvts6>, </span><span class=rvts9>отриманих</span><span class=rvts6> i</span><span class=rvts9>№</span><span class=rvts6> vitro </span><span class=rvts9>при</span><span class=rvts6> </span><span class=rvts9>моделюванні</span><span class=rvts6> </span><span class=rvts9>середовища</span><span class=rvts6> </span><span class=rvts9>шлунка</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>кишок</span><span class=rvts6>. </span><span class=rvts9>У</span><span class=rvts6> </span><span class=rvts9>разі</span><span class=rvts6> </span><span class=rvts9>необхідності</span><span class=rvts6> </span><span class=rvts9>такі</span><span class=rvts6> </span><span class=rvts9>дані</span><span class=rvts6> </span><span class=rvts9>наводяться</span><span class=rvts6> </span><span class=rvts9>і</span><span class=rvts6> </span><span class=rvts9>для</span><span class=rvts6> </span><span class=rvts9>інших</span><span class=rvts6> </span><span class=rvts9>форм</span><span class=rvts6>, </span><span class=rvts9>крім</span><span class=rvts6> </span><span class=rvts9>розчинів</span><span class=rvts6>, </span><span class=rvts9>у</span><span class=rvts6> </span><span class=rvts9>першу</span><span class=rvts6> </span><span class=rvts9>чергу</span><span class=rvts6> </span><span class=rvts9>це</span><span class=rvts6> </span><span class=rvts9>стосується</span><span class=rvts6> </span><span class=rvts9>відтворених</span><span class=rvts6> </span><span class=rvts9>лікарських</span><span class=rvts6> </span><span class=rvts9>засобів</span><span class=rvts6>, </span><span class=rvts9>для</span><span class=rvts6> </span><span class=rvts9>яких</span><span class=rvts6> </span><span class=rvts9>наводяться</span><span class=rvts6> </span><span class=rvts9>ці</span><span class=rvts6> </span><span class=rvts9>дані</span><span class=rvts6> </span><span class=rvts9>в</span><span class=rvts6> </span><span class=rvts9>порівнянні</span><span class=rvts6> </span><span class=rvts9>з</span><span class=rvts6> </span><span class=rvts9>даними</span><span class=rvts6> </span><span class=rvts9>для</span><span class=rvts6> </span><span class=rvts9>зразка</span><span class=rvts6> </span><span class=rvts9>препарату</span><span class=rvts6>, </span><span class=rvts9>який</span><span class=rvts6> </span><span class=rvts9>відтворюється</span><span class=rvts6>; </span></li>
</ul>
<p class=rvps6><span class=rvts6><br></span></p>
<ul style="text-indent: 8px; margin-left: 48px; list-style-position: outside;">
<li class=rvps8 style="{ margin-left: 0 }"><span class=rvts9>обґрунтування</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>показників</span><span class=rvts6> </span><span class=rvts9>якості</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>методів</span><span class=rvts6> </span><span class=rvts9>контролю</span><span class=rvts6>, </span><span class=rvts9>дані</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>стабільності</span><span class=rvts6>; </span></li>
</ul>
<p class=rvps6><span class=rvts6><br></span></p>
<ul style="text-indent: 8px; margin-left: 48px; list-style-position: outside;">
<li class=rvps8 style="{ margin-left: 0 }"><span class=rvts9>дані</span><span class=rvts6> </span><span class=rvts9>щодо</span><span class=rvts6> </span><span class=rvts9>фармакокінетики</span><span class=rvts6> </span><span class=rvts9>та</span><span class=rvts6> </span><span class=rvts9>фармакодинаміки</span><span class=rvts6>. </span></li>
</ul>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts6>____________ </span></p>
<p class=rvps1><span class=rvts6><br></span></p>
<p class=rvps1><span class=rvts6> </span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps3><span class=rvts6><br></span></p>
<p class=rvps6><span class=rvts6><br></span></p>
[[Категория:Законодательство]]