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Clco 15032019 39 Doc.Pdf 2019 . № Е Н Е Н , а а юа « а аю- » ( 009/2011) 1. 3: ) ; ) : «- – , - (, .);»; ) : « – , , – , - . , - , (), ; 2 – , () ( ) ;»; ) : « - – - , , , ;». 2. 5: ) 2.11 : «2.11. ;»; ) 3 : « () - : ; , ; ; ; ; ; ; ; 3 (, , ); ; ; ; 100- .»; ) 4.2 : «4.2. - , : 1) - , () 20 % , ; 2) , ; 3) , -, ; 4) , ; 5) ; 6) ; 7) ; 8) ; 9) ; 10) 100- ; 11) , , , 4 , ( ) 0,1 – 6,0 %; 12) (, . .), 10,0.»; ) 7.2: : «– , , , , , . , , , , , . . ;»; «» « »; « »; ) 9.1 : « , () , 5 ( 11). , (: «/InРrОНТОnts …»).»; ) 9.2: : «– (, () , () ). . 5 (ml) 5 (Р), ;»; : «– : « …» (); « …» (); « …» () « …» (, ); « …» « …» (); « …» « …» (); « … , » (, ). « …» «…». « », « », « » . « …», 6 , . , (, , , . .), : «… ()». (. .) , (.. ..). . «-», «.», «/» . - , . «… (, )», , «… (, , )», ;»; : « () : ; ; ( ); ( ); ( , ) ( ); 7 .»; ) 9.3: : « (INCI) , «» «» , (: «/InРrОНТОnts …»).»; : « . , .»; : «, , 9.2 . , , , : , ( ) ( ) , ; (, ) () ; () ( ); ( 9.2 ); 8 , - . , (, , . .). ( 11).»; ) 9.4 : «9.4. 9.2 , . , , .»; ) 9.5 « » «, () ( ), , (), (ml, L) (Р, ФР)». 3. 51 : «а 51. аю- а аа 1. . 2. () , , () , , 9 ». 4. 6: ) 4: : « - , 13.»; ; ) 5: : «– , , - , , 2 – 5 , ;»; : « () , , ;»; : «– 7 5 ( 10 ) ( ) GMP ( 3, 4), ; – () - (GMP) ( 6), ;»; : « - , 13 .»; ; ) 6 : «6. - – . – : , ; ; 11 , – ; (), , – , ; () – , () ( 4); , 5 , , . . , 5 . ( ) – () . 12 – ( , 5 , ) 5 .»; ) 7 : « - , , (). 8 « » , 25 2012 . № 293, : « , …» ( ). - () : () ; - , ( ), () , () ( 13 , ()). ; - , () , () , () ( ) . ; () Э АЭ. - . , , , , - . , , : ( ) , , - , , 2 – 5 , ; ( ) , - , ; 14 (), , , 3 – 6 5 , (); , ; ( ) .». 5. 9: ) «» « ()»; ) «» « ()». 6. 1 – 6 : 15 « 1 « - » ( 009/2011) ЕЕЧЕНЬ , а аю аю- E ( - CAS - ( - (INCI)/ , В (INN) (Chemical (EINECS – Abstract Service European Registry)) Inventory of Existing Commercial Chemical Substances)) 1 2 3 4 5 1 N-5--2- N-(5-Chlorobenzoxazol-2-yl)acetamide 35783-57-4 - 2 2-А (2-Acetoxyethyl)trimethylammonium 51-84-3 200-128-9 () hydroxide (acetylcholine) and its salts 3 (INN) Deanol aceglumate (INN) 3342-61-8 222-085-5 16 E ( - CAS - ( - (INCI)/ , В (INN) (Chemical (EINECS – Abstract Service European Registry)) Inventory of Existing Commercial Chemical Substances)) 1 2 3 4 5 4 (INN) Spironolactone (INN) 52-01-7 200-133-6 5 [4-(4--3-)-3,5-- [4-(4-Hydroxy-3-iodophenoxy)-3,5- 51-24-1 200-086-1 Ж ( (INN) diiodophenyl] acetic acid (Tiratricol(INN)) А) and its salts 6 (INN) Methotrexate (INN) 59-05-2 200-413-8 7 А (INN) Aminocaproic acid (INN) and its salts 60-32-2 200-469-3 8 (INN), , Cinchophen (INN), its salts, derivatives 132-60-5 205-067-1 and salts of these derivatives 9 (INN) Thyropropic acid (INN) and its salts 51-26-3 - 10 Trichloroacetic acid 76-03-9 200-927-2 11 А , Aconitum napellus L. (leaves, roots and 84603-50-9 283-252-6 galenical mixtures) 12 А ( А Aconitine (principal alkaloid of Aconitum 302-27-2 206-121-7 ) napellus L.) and its salts 13 А ( ) Adonis vernalis L.
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