SFS 2009:1382 Förordning om ändring i förordningen (1993:595) om avgifter för den statliga kontrollen av läkemedel

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.ft65{font-size:14px;line-height:17px;font-family:TimesNewRoman,Bold;color:#000000;} --> <!-- p {margin: 0; padding: 0;} .ft70{font-size:14px;font-family:TimesNewRoman;color:#000000;} .ft71{font-size:16px;font-family:TimesNewRoman,Bold;color:#000000;} .ft72{font-size:14px;font-family:TimesNewRoman,Bold;color:#000000;} .ft73{font-size:14px;line-height:17px;font-family:TimesNewRoman,Bold;color:#000000;} .ft74{font-size:14px;line-height:17px;font-family:TimesNewRoman;color:#000000;} --> <!-- p {margin: 0; padding: 0;} .ft80{font-size:14px;font-family:TimesNewRoman;color:#000000;} .ft81{font-size:16px;font-family:TimesNewRoman,Bold;color:#000000;} .ft82{font-size:14px;font-family:TimesNewRoman,Bold;color:#000000;} .ft83{font-size:16px;line-height:17px;font-family:TimesNewRoman,Bold;color:#000000;} .ft84{font-size:14px;line-height:17px;font-family:TimesNewRoman;color:#000000;} --> <!-- p {margin: 0; padding: 0;} .ft90{font-size:14px;font-family:TimesNewRoman;color:#000000;} .ft91{font-size:16px;font-family:TimesNewRoman,Bold;color:#000000;} .ft92{font-size:14px;font-family:TimesNewRoman,Bold;color:#000000;} .ft93{font-size:14px;line-height:17px;font-family:TimesNewRoman,Bold;color:#000000;} .ft94{font-size:14px;line-height:17px;font-family:TimesNewRoman;color:#000000;} .ft95{font-size:16px;line-height:17px;font-family:TimesNewRoman,Bold;color:#000000;} --> <!-- p {margin: 0; padding: 0;} .ft100{font-size:14px;font-family:TimesNewRoman;color:#000000;} .ft101{font-size:16px;font-family:TimesNewRoman,Bold;color:#000000;} .ft102{font-size:14px;font-family:TimesNewRoman,Bold;color:#000000;} .ft103{font-size:14px;line-height:17px;font-family:TimesNewRoman,Bold;color:#000000;} .ft104{font-size:16px;line-height:17px;font-family:TimesNewRoman,Bold;color:#000000;} .ft105{font-size:14px;line-height:17px;font-family:TimesNewRoman;color:#000000;} --> <!-- p {margin: 0; padding: 0;} .ft110{font-size:14px;font-family:TimesNewRoman;color:#000000;} .ft111{font-size:16px;font-family:TimesNewRoman,Bold;color:#000000;} .ft112{font-size:14px;font-family:TimesNewRoman,Bold;color:#000000;} .ft113{font-size:14px;line-height:17px;font-family:TimesNewRoman;color:#000000;} .ft114{font-size:14px;line-height:17px;font-family:TimesNewRoman,Bold;color:#000000;} --> <!-- p {margin: 0; padding: 0;} .ft120{font-size:8px;font-family:TimesNewRoman;color:#000000;} --> </style> <div id="page1-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:741px;white-space:nowrap" class="ft10">1</p> <p style="position:absolute;top:197px;left:172px;white-space:nowrap" class="ft11"><b>Svensk f�rfattningssamling</b></p> <p style="position:absolute;top:309px;left:172px;white-space:nowrap" class="ft19"><b>F�rordning<br/>om �ndring i f�rordningen (1993:595) om avgifter <br/>f�r den statliga kontrollen av l�kemedel;</b></p> <p style="position:absolute;top:385px;left:172px;white-space:nowrap" class="ft10">utf�rdad den 3 december 2009.</p> <p style="position:absolute;top:420px;left:187px;white-space:nowrap" class="ft10">Regeringen f�reskriver att 6 � f�rordningen (1993:595) om avgifter f�r</p> <p style="position:absolute;top:438px;left:172px;white-space:nowrap" class="ft10">den statliga kontrollen av l�kemedel ska ha f�ljande lydelse.</p> <p style="position:absolute;top:473px;left:172px;white-space:nowrap" class="ft13"><b>6 �</b></p> <p style="position:absolute;top:471px;left:190px;white-space:nowrap" class="ft14">1</p> <p style="position:absolute;top:473px;left:209px;white-space:nowrap" class="ft10">Avgifterna betalas med f�ljande belopp.</p> <p style="position:absolute;top:1036px;left:172px;white-space:nowrap" class="ft15">1 Senaste lydelse 2006:1056.</p> <p style="position:absolute;top:512px;left:528px;white-space:nowrap" class="ft10">Avgift i kronor</p> <p style="position:absolute;top:549px;left:172px;white-space:nowrap" class="ft17"><b>L�KEMEDEL</b></p> <p style="position:absolute;top:577px;left:172px;white-space:nowrap" class="ft17"><b>Ans�kningsavgifter f�r humanl�kemedel</b></p> <p style="position:absolute;top:604px;left:172px;white-space:nowrap" class="ft13"><b>Nationella ans�kningar</b></p> <p style="position:absolute;top:626px;left:187px;white-space:nowrap" class="ft10">Komplett ans�kan, </p> <p style="position:absolute;top:646px;left:172px;white-space:nowrap" class="ft10">avgift per produkt</p> <p style="position:absolute;top:646px;left:569px;white-space:nowrap" class="ft10">374 000</p> <p style="position:absolute;top:667px;left:172px;white-space:nowrap" class="ft110">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan 77 </p> <p style="position:absolute;top:685px;left:594px;white-space:nowrap" class="ft10">000</p> <p style="position:absolute;top:705px;left:187px;white-space:nowrap" class="ft10">F�rkortad ans�kan med referens till en substans som </p> <p style="position:absolute;top:723px;left:172px;white-space:nowrap" class="ft110">inte �r eller har varit godk�nd i Sverige,<br/>avgift per produkt </p> <p style="position:absolute;top:740px;left:569px;white-space:nowrap" class="ft10">374 000</p> <p style="position:absolute;top:761px;left:172px;white-space:nowrap" class="ft110">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan 77 </p> <p style="position:absolute;top:778px;left:594px;white-space:nowrap" class="ft10">000</p> <p style="position:absolute;top:799px;left:187px;white-space:nowrap" class="ft10">�vriga f�rkortade ans�kningar, </p> <p style="position:absolute;top:816px;left:172px;white-space:nowrap" class="ft10">avgift per produkt </p> <p style="position:absolute;top:816px;left:576px;white-space:nowrap" class="ft10">77 000</p> <p style="position:absolute;top:837px;left:172px;white-space:nowrap" class="ft110">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan 44 </p> <p style="position:absolute;top:855px;left:594px;white-space:nowrap" class="ft10">000</p> <p style="position:absolute;top:875px;left:187px;white-space:nowrap" class="ft10">Radioaktivt l�kemedel,</p> <p style="position:absolute;top:893px;left:172px;white-space:nowrap" class="ft10">avgift per produkt</p> <p style="position:absolute;top:893px;left:576px;white-space:nowrap" class="ft10">77 000</p> <p style="position:absolute;top:913px;left:187px;white-space:nowrap" class="ft10">Allergen,</p> <p style="position:absolute;top:931px;left:172px;white-space:nowrap" class="ft110">avgift per grundextrakt <br/>avgift per sp�dning fr�n grundextrakt </p> <p style="position:absolute;top:931px;left:576px;white-space:nowrap" class="ft10">55 000</p> <p style="position:absolute;top:948px;left:583px;white-space:nowrap" class="ft10">5 500</p> <p style="position:absolute;top:969px;left:187px;white-space:nowrap" class="ft10">Parallellimporterat eller parallelldistribuerat l�kemedel,</p> <p style="position:absolute;top:986px;left:172px;white-space:nowrap" class="ft10">avgift per produkt och exportland </p> <p style="position:absolute;top:986px;left:576px;white-space:nowrap" class="ft10">14 300</p> <p style="position:absolute;top:292px;left:634px;white-space:nowrap" class="ft18"><b>SFS 2009:1382</b></p> <p style="position:absolute;top:318px;left:634px;white-space:nowrap" class="ft111">Utkom fr�n trycket<br/>den 11 december 2009</p> </div> <div id="page2-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:141px;white-space:nowrap" class="ft20">2</p> <p style="position:absolute;top:169px;left:142px;white-space:nowrap" class="ft21"><b>SFS 2009:1382</b></p> <p style="position:absolute;top:175px;left:633px;white-space:nowrap" class="ft20">Avgift i kronor</p> <p style="position:absolute;top:212px;left:292px;white-space:nowrap" class="ft20">Ans�kan om licens avseende lagerberedningar,</p> <p style="position:absolute;top:230px;left:277px;white-space:nowrap" class="ft23">rikslicens,<br/>avgift per produkt</p> <p style="position:absolute;top:247px;left:674px;white-space:nowrap" class="ft20">132 000</p> <p style="position:absolute;top:268px;left:292px;white-space:nowrap" class="ft20">Duplikatans�kan,</p> <p style="position:absolute;top:286px;left:277px;white-space:nowrap" class="ft20">avgift per produkt, l�kemedelsform eller styrka</p> <p style="position:absolute;top:286px;left:681px;white-space:nowrap" class="ft20">22 000</p> <p style="position:absolute;top:306px;left:292px;white-space:nowrap" class="ft20">Ans�kan om godk�nnande i s�dana fall d�r produkten </p> <p style="position:absolute;top:324px;left:277px;white-space:nowrap" class="ft20">den 1 april 2006 var godk�nd som naturl�kemedel</p> <p style="position:absolute;top:324px;left:681px;white-space:nowrap" class="ft20">15 400</p> <p style="position:absolute;top:368px;left:277px;white-space:nowrap" class="ft24"><b>Ans�kningar d�r Sverige agerar ber�rd medlemsstat i <br/>den �msesidiga eller den decentraliserade proceduren</b></p> <p style="position:absolute;top:408px;left:292px;white-space:nowrap" class="ft20">Komplett ans�kan,</p> <p style="position:absolute;top:425px;left:277px;white-space:nowrap" class="ft20">avgift per produkt</p> <p style="position:absolute;top:425px;left:674px;white-space:nowrap" class="ft20">220 000</p> <p style="position:absolute;top:446px;left:277px;white-space:nowrap" class="ft23">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan</p> <p style="position:absolute;top:464px;left:681px;white-space:nowrap" class="ft20">44 000</p> <p style="position:absolute;top:484px;left:292px;white-space:nowrap" class="ft20">F�rkortad ans�kan med referens till en substans som </p> <p style="position:absolute;top:502px;left:277px;white-space:nowrap" class="ft23">inte �r eller har varit godk�nd i Sverige,<br/>avgift per produkt<br/>avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan </p> <p style="position:absolute;top:519px;left:674px;white-space:nowrap" class="ft20">220 000</p> <p style="position:absolute;top:555px;left:681px;white-space:nowrap" class="ft20">44 000</p> <p style="position:absolute;top:575px;left:292px;white-space:nowrap" class="ft20">�vriga f�rkortade ans�kningar,</p> <p style="position:absolute;top:593px;left:277px;white-space:nowrap" class="ft20">avgift per produkt</p> <p style="position:absolute;top:593px;left:681px;white-space:nowrap" class="ft20">77 000</p> <p style="position:absolute;top:613px;left:277px;white-space:nowrap" class="ft23">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan 44 </p> <p style="position:absolute;top:631px;left:699px;white-space:nowrap" class="ft20">000</p> <p style="position:absolute;top:651px;left:292px;white-space:nowrap" class="ft20">Duplikatans�kan,</p> <p style="position:absolute;top:669px;left:277px;white-space:nowrap" class="ft20">avgift per produkt, l�kemedelsform eller styrka</p> <p style="position:absolute;top:669px;left:681px;white-space:nowrap" class="ft20">22 000</p> <p style="position:absolute;top:713px;left:277px;white-space:nowrap" class="ft24"><b>F�rnyat godk�nnande efter fem �r (decentraliserat, <br/>�msesidigt och nationellt)</b></p> <p style="position:absolute;top:753px;left:292px;white-space:nowrap" class="ft20">F�rnyat godk�nnande per produkt, inkluderande alla </p> <p style="position:absolute;top:771px;left:277px;white-space:nowrap" class="ft20">styrkor av samma l�kemedelsform i samma ans�kan</p> <p style="position:absolute;top:771px;left:681px;white-space:nowrap" class="ft20">16 500</p> <p style="position:absolute;top:815px;left:277px;white-space:nowrap" class="ft24"><b>Tillkommande avgifter f�r ett befintligt nationellt <br/>godk�nt humanl�kemedel</b></p> <p style="position:absolute;top:855px;left:292px;white-space:nowrap" class="ft20">Ny l�kemedelsform eller styrka, </p> <p style="position:absolute;top:872px;left:277px;white-space:nowrap" class="ft23">avgift per produkt<br/>avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan </p> <p style="position:absolute;top:872px;left:681px;white-space:nowrap" class="ft20">77 000</p> <p style="position:absolute;top:908px;left:681px;white-space:nowrap" class="ft20">44 000</p> <p style="position:absolute;top:928px;left:292px;white-space:nowrap" class="ft20">Ny dosering utanf�r dosintervall (avser per dos) </p> <p style="position:absolute;top:928px;left:681px;white-space:nowrap" class="ft20">77 000</p> <p style="position:absolute;top:948px;left:292px;white-space:nowrap" class="ft20">Ny indikation inkluderande eventuell dos- och styrke-</p> <p style="position:absolute;top:966px;left:277px;white-space:nowrap" class="ft20">�ndring 77 </p> <p style="position:absolute;top:966px;left:699px;white-space:nowrap" class="ft20">000</p> <p style="position:absolute;top:987px;left:292px;white-space:nowrap" class="ft20">St�rre �ndrings�rende som inte �r en typ 1-�ndring och </p> <p style="position:absolute;top:1004px;left:277px;white-space:nowrap" class="ft23">som inte kr�ver en ny ans�kan exklusive indikations- och <br/>dos�ndring 8 </p> <p style="position:absolute;top:1022px;left:699px;white-space:nowrap" class="ft20">250</p> </div> <div id="page3-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:745px;white-space:nowrap" class="ft30">3</p> <p style="position:absolute;top:167px;left:637px;white-space:nowrap" class="ft31"><b>SFS 2009:1382</b></p> <p style="position:absolute;top:175px;left:528px;white-space:nowrap" class="ft30">Avgift i kronor</p> <p style="position:absolute;top:212px;left:187px;white-space:nowrap" class="ft30">Ans�kan om �ndring av receptstatus</p> <p style="position:absolute;top:212px;left:576px;white-space:nowrap" class="ft30">77 000</p> <p style="position:absolute;top:233px;left:187px;white-space:nowrap" class="ft30">Ans�kan om �ndring av receptstatus d�r substansen</p> <p style="position:absolute;top:250px;left:172px;white-space:nowrap" class="ft33">redan varit f�rem�l f�r samma �ndring och d�r produkt-<br/>resum� och bipacksedel �r i allt v�sentligt lika</p> <p style="position:absolute;top:268px;left:576px;white-space:nowrap" class="ft30">11 000</p> <p style="position:absolute;top:288px;left:187px;white-space:nowrap" class="ft30">F�rl�ngd skyddsperiod f�r ny indikation</p> <p style="position:absolute;top:288px;left:576px;white-space:nowrap" class="ft30">22 000</p> <p style="position:absolute;top:309px;left:187px;white-space:nowrap" class="ft30">F�rl�ngd skyddsperiod f�r ny indikation f�r en v�leta-</p> <p style="position:absolute;top:326px;left:172px;white-space:nowrap" class="ft30">blerad substans </p> <p style="position:absolute;top:326px;left:576px;white-space:nowrap" class="ft30">22 000</p> <p style="position:absolute;top:371px;left:172px;white-space:nowrap" class="ft34"><b>Sverige agerar referensland i den �msesidiga <br/>proceduren</b></p> <p style="position:absolute;top:411px;left:187px;white-space:nowrap" class="ft30">Komplett ans�kan,</p> <p style="position:absolute;top:428px;left:172px;white-space:nowrap" class="ft30">avgift per produkt</p> <p style="position:absolute;top:428px;left:569px;white-space:nowrap" class="ft30">220 000</p> <p style="position:absolute;top:449px;left:187px;white-space:nowrap" class="ft30">F�rkortad ans�kan,</p> <p style="position:absolute;top:466px;left:172px;white-space:nowrap" class="ft30">avgift per produkt </p> <p style="position:absolute;top:466px;left:569px;white-space:nowrap" class="ft30">110 000</p> <p style="position:absolute;top:487px;left:187px;white-space:nowrap" class="ft30">Duplikatans�kan,</p> <p style="position:absolute;top:504px;left:172px;white-space:nowrap" class="ft30">avgift per produkt</p> <p style="position:absolute;top:504px;left:576px;white-space:nowrap" class="ft30">22 000</p> <p style="position:absolute;top:525px;left:187px;white-space:nowrap" class="ft30">Ans�kan d�r Sverige agerar referensland i den �msesidi-</p> <p style="position:absolute;top:542px;left:172px;white-space:nowrap" class="ft33">ga proceduren och produkten redan blivit godk�nd i annat <br/>land genom �msesidigt godk�nnande, komplett ans�kan,<br/>avgift per produkt </p> <p style="position:absolute;top:578px;left:569px;white-space:nowrap" class="ft30">132 000</p> <p style="position:absolute;top:598px;left:187px;white-space:nowrap" class="ft30">Ans�kan d�r Sverige agerar referensland i den �msesidi-</p> <p style="position:absolute;top:616px;left:172px;white-space:nowrap" class="ft33">ga proceduren och produkten redan blivit godk�nd i annat <br/>land genom �msesidigt godk�nnande, f�rkortad ans�kan,<br/>avgift per produkt</p> <p style="position:absolute;top:651px;left:576px;white-space:nowrap" class="ft30">66 000</p> <p style="position:absolute;top:672px;left:187px;white-space:nowrap" class="ft30">Ans�kan d�r Sverige agerar referensland i den �msesidi-</p> <p style="position:absolute;top:689px;left:172px;white-space:nowrap" class="ft33">ga proceduren och produkten redan blivit godk�nd i annat <br/>land genom �msesidigt godk�nnande, duplikatans�kan,<br/>avgift per produkt</p> <p style="position:absolute;top:725px;left:576px;white-space:nowrap" class="ft30">13 200</p> <p style="position:absolute;top:745px;left:187px;white-space:nowrap" class="ft30">�ndring typ 2, exklusive indikations�ndring</p> <p style="position:absolute;top:745px;left:576px;white-space:nowrap" class="ft30">16 500</p> <p style="position:absolute;top:766px;left:187px;white-space:nowrap" class="ft30">�ndring typ 2, inklusive indikations- och dos�ndring </p> <p style="position:absolute;top:766px;left:569px;white-space:nowrap" class="ft30">110 000</p> <p style="position:absolute;top:810px;left:172px;white-space:nowrap" class="ft34"><b>Sverige agerar referensland i den decentraliserade <br/>proceduren</b></p> <p style="position:absolute;top:850px;left:187px;white-space:nowrap" class="ft30">Komplett ans�kan,</p> <p style="position:absolute;top:867px;left:172px;white-space:nowrap" class="ft30">avgift per produkt</p> <p style="position:absolute;top:867px;left:569px;white-space:nowrap" class="ft30">594 000</p> <p style="position:absolute;top:888px;left:172px;white-space:nowrap" class="ft33">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan 77 </p> <p style="position:absolute;top:905px;left:594px;white-space:nowrap" class="ft30">000</p> <p style="position:absolute;top:926px;left:187px;white-space:nowrap" class="ft30">F�rkortad ans�kan med referens till en substans som </p> <p style="position:absolute;top:943px;left:172px;white-space:nowrap" class="ft33">inte har varit godk�nd i Sverige,<br/>avgift per produkt</p> <p style="position:absolute;top:961px;left:569px;white-space:nowrap" class="ft30">594 000</p> <p style="position:absolute;top:982px;left:172px;white-space:nowrap" class="ft33">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan</p> <p style="position:absolute;top:999px;left:576px;white-space:nowrap" class="ft30">77 000</p> </div> <div id="page4-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:141px;white-space:nowrap" class="ft40">4</p> <p style="position:absolute;top:169px;left:142px;white-space:nowrap" class="ft41"><b>SFS 2009:1382</b></p> <p style="position:absolute;top:175px;left:633px;white-space:nowrap" class="ft40">Avgift i kronor</p> <p style="position:absolute;top:212px;left:292px;white-space:nowrap" class="ft40">�vriga f�rkortade ans�kningar, </p> <p style="position:absolute;top:230px;left:277px;white-space:nowrap" class="ft40">avgift per produkt</p> <p style="position:absolute;top:230px;left:674px;white-space:nowrap" class="ft40">187 000</p> <p style="position:absolute;top:250px;left:277px;white-space:nowrap" class="ft43">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan 44 </p> <p style="position:absolute;top:268px;left:699px;white-space:nowrap" class="ft40">000</p> <p style="position:absolute;top:288px;left:292px;white-space:nowrap" class="ft40">Duplikatans�kan,</p> <p style="position:absolute;top:306px;left:277px;white-space:nowrap" class="ft43">avgift per produkt<br/>avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan</p> <p style="position:absolute;top:306px;left:681px;white-space:nowrap" class="ft40">44 000</p> <p style="position:absolute;top:341px;left:681px;white-space:nowrap" class="ft40">22 000</p> <p style="position:absolute;top:362px;left:292px;white-space:nowrap" class="ft40">�ndring typ 2, exklusive indikations�ndring</p> <p style="position:absolute;top:362px;left:681px;white-space:nowrap" class="ft40">16 500</p> <p style="position:absolute;top:382px;left:292px;white-space:nowrap" class="ft40">�ndring typ 2, inklusive indikations- och dos�ndring </p> <p style="position:absolute;top:382px;left:673px;white-space:nowrap" class="ft40">110 000</p> <p style="position:absolute;top:427px;left:277px;white-space:nowrap" class="ft44"><b>Sverige agerar ber�rd medlemsstat i den �msesidiga <br/>eller den decentraliserade proceduren</b></p> <p style="position:absolute;top:466px;left:292px;white-space:nowrap" class="ft40">�ndring typ 2</p> <p style="position:absolute;top:466px;left:688px;white-space:nowrap" class="ft40">5 500</p> <p style="position:absolute;top:487px;left:292px;white-space:nowrap" class="ft40">Ny form eller styrka</p> <p style="position:absolute;top:487px;left:681px;white-space:nowrap" class="ft40">44 000</p> <p style="position:absolute;top:507px;left:292px;white-space:nowrap" class="ft40">�ndring typ 2, indikations- och dos�ndring</p> <p style="position:absolute;top:507px;left:681px;white-space:nowrap" class="ft40">44 000</p> <p style="position:absolute;top:552px;left:277px;white-space:nowrap" class="ft42"><b>�rsavgifter f�r humanl�kemedel</b></p> <p style="position:absolute;top:574px;left:292px;white-space:nowrap" class="ft40">L�kemedel med komplett ans�kan, godk�nt i </p> <p style="position:absolute;top:573px;left:554px;white-space:nowrap" class="ft40">mindre �n </p> <p style="position:absolute;top:591px;left:277px;white-space:nowrap" class="ft40">fem �r </p> <p style="position:absolute;top:591px;left:681px;white-space:nowrap" class="ft40">83 600</p> <p style="position:absolute;top:612px;left:292px;white-space:nowrap" class="ft40">L�kemedel med f�rkortad ans�kan och komplett ans�-</p> <p style="position:absolute;top:629px;left:277px;white-space:nowrap" class="ft40">kan godk�nt i mer �n fem �r samt lagerberedningar</p> <p style="position:absolute;top:629px;left:681px;white-space:nowrap" class="ft40">41 800</p> <p style="position:absolute;top:650px;left:277px;white-space:nowrap" class="ft43">avgift per ytterligare l�kemedelsform eller styrka (inte f�r <br/>lagerberedning)</p> <p style="position:absolute;top:668px;left:681px;white-space:nowrap" class="ft40">17 600</p> <p style="position:absolute;top:688px;left:292px;white-space:nowrap" class="ft40">L�kemedel med duplikatans�kan som godk�nts under �r </p> <p style="position:absolute;top:706px;left:277px;white-space:nowrap" class="ft43">2000 eller senare, <br/>avgift per l�kemedelsform eller styrka</p> <p style="position:absolute;top:723px;left:681px;white-space:nowrap" class="ft40">17 600</p> <p style="position:absolute;top:744px;left:292px;white-space:nowrap" class="ft40">�rsavgift f�r parallellimporterade l�kemedel ska betalas </p> <p style="position:absolute;top:761px;left:277px;white-space:nowrap" class="ft40">med en tredjedel av de ovan angivna beloppen</p> <p style="position:absolute;top:782px;left:292px;white-space:nowrap" class="ft40">Allergen,</p> <p style="position:absolute;top:799px;left:277px;white-space:nowrap" class="ft43">avgift per produkt<br/>avgift per sp�dning fr�n grundextrakt </p> <p style="position:absolute;top:799px;left:688px;white-space:nowrap" class="ft43">8 800<br/>1 100</p> <p style="position:absolute;top:838px;left:292px;white-space:nowrap" class="ft40">Radiofarmaka,</p> <p style="position:absolute;top:855px;left:277px;white-space:nowrap" class="ft40">avgift per form eller styrka</p> <p style="position:absolute;top:855px;left:688px;white-space:nowrap" class="ft40">8 800</p> <p style="position:absolute;top:900px;left:277px;white-space:nowrap" class="ft41"><b>Ans�kningsavgifter f�r veterin�rl�kemedel</b></p> <p style="position:absolute;top:927px;left:277px;white-space:nowrap" class="ft42"><b>Nationella ans�kningar</b></p> <p style="position:absolute;top:949px;left:292px;white-space:nowrap" class="ft40">Komplett ans�kan,</p> <p style="position:absolute;top:966px;left:277px;white-space:nowrap" class="ft40">avgift per produkt</p> <p style="position:absolute;top:966px;left:674px;white-space:nowrap" class="ft40">187 000</p> <p style="position:absolute;top:987px;left:277px;white-space:nowrap" class="ft43">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan 38 </p> <p style="position:absolute;top:1005px;left:699px;white-space:nowrap" class="ft40">500</p> </div> <div id="page5-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:745px;white-space:nowrap" class="ft50">5</p> <p style="position:absolute;top:167px;left:637px;white-space:nowrap" class="ft51"><b>SFS 2009:1382</b></p> <p style="position:absolute;top:175px;left:528px;white-space:nowrap" class="ft50">Avgift i kronor</p> <p style="position:absolute;top:212px;left:187px;white-space:nowrap" class="ft50">F�rkortad ans�kan med referens till en substans som </p> <p style="position:absolute;top:230px;left:172px;white-space:nowrap" class="ft53">inte �r eller har varit godk�nd i Sverige,<br/>avgift per produkt</p> <p style="position:absolute;top:248px;left:569px;white-space:nowrap" class="ft50">187 000</p> <p style="position:absolute;top:268px;left:172px;white-space:nowrap" class="ft53">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan</p> <p style="position:absolute;top:286px;left:576px;white-space:nowrap" class="ft50">38 500</p> <p style="position:absolute;top:306px;left:187px;white-space:nowrap" class="ft50">�vriga f�rkortade ans�kningar,</p> <p style="position:absolute;top:324px;left:172px;white-space:nowrap" class="ft50">avgift per produkt</p> <p style="position:absolute;top:324px;left:576px;white-space:nowrap" class="ft50">38 500</p> <p style="position:absolute;top:344px;left:172px;white-space:nowrap" class="ft53">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan</p> <p style="position:absolute;top:362px;left:576px;white-space:nowrap" class="ft50">22 000</p> <p style="position:absolute;top:382px;left:187px;white-space:nowrap" class="ft50">Parallellimporterat eller parallelldistribuerat l�kemedel,</p> <p style="position:absolute;top:400px;left:172px;white-space:nowrap" class="ft50">avgift per produkt och exportland </p> <p style="position:absolute;top:400px;left:576px;white-space:nowrap" class="ft50">14 300</p> <p style="position:absolute;top:420px;left:187px;white-space:nowrap" class="ft50">Ans�kan om licens avseende lagerberedningar, riksli-</p> <p style="position:absolute;top:438px;left:172px;white-space:nowrap" class="ft53">cens,<br/>avgift per produkt </p> <p style="position:absolute;top:456px;left:576px;white-space:nowrap" class="ft50">77 000</p> <p style="position:absolute;top:476px;left:187px;white-space:nowrap" class="ft50">Ans�kan om karenstids- och gr�nsv�rdesbest�mning</p> <p style="position:absolute;top:476px;left:583px;white-space:nowrap" class="ft50">5 500</p> <p style="position:absolute;top:497px;left:187px;white-space:nowrap" class="ft50">Duplikatans�kan,</p> <p style="position:absolute;top:514px;left:172px;white-space:nowrap" class="ft50">avgift per produkt, l�kemedelsform eller styrka </p> <p style="position:absolute;top:514px;left:576px;white-space:nowrap" class="ft50">22 000</p> <p style="position:absolute;top:559px;left:172px;white-space:nowrap" class="ft54"><b>Ans�kningar d�r Sverige agerar ber�rd medlemsstat i <br/>den �msesidiga proceduren eller den decentraliserade <br/>proceduren</b></p> <p style="position:absolute;top:616px;left:187px;white-space:nowrap" class="ft50">Komplett ans�kan,</p> <p style="position:absolute;top:634px;left:172px;white-space:nowrap" class="ft50">avgift per produkt</p> <p style="position:absolute;top:634px;left:569px;white-space:nowrap" class="ft50">110 000</p> <p style="position:absolute;top:654px;left:172px;white-space:nowrap" class="ft53">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan</p> <p style="position:absolute;top:672px;left:576px;white-space:nowrap" class="ft50">22 000</p> <p style="position:absolute;top:692px;left:187px;white-space:nowrap" class="ft50">F�rkortad ans�kan med referens till en substans som </p> <p style="position:absolute;top:710px;left:172px;white-space:nowrap" class="ft53">inte �r eller har varit godk�nd i Sverige,<br/>avgift per produkt </p> <p style="position:absolute;top:727px;left:569px;white-space:nowrap" class="ft50">110 000</p> <p style="position:absolute;top:748px;left:172px;white-space:nowrap" class="ft53">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan</p> <p style="position:absolute;top:766px;left:576px;white-space:nowrap" class="ft50">22 000</p> <p style="position:absolute;top:786px;left:187px;white-space:nowrap" class="ft50">�vriga f�rkortade ans�kningar, </p> <p style="position:absolute;top:804px;left:172px;white-space:nowrap" class="ft50">avgift per produkt</p> <p style="position:absolute;top:804px;left:576px;white-space:nowrap" class="ft50">38 500</p> <p style="position:absolute;top:824px;left:172px;white-space:nowrap" class="ft53">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan</p> <p style="position:absolute;top:842px;left:576px;white-space:nowrap" class="ft50">22 000</p> <p style="position:absolute;top:862px;left:187px;white-space:nowrap" class="ft50">Duplikatans�kan,</p> <p style="position:absolute;top:880px;left:172px;white-space:nowrap" class="ft50">avgift per produkt, l�kemedelsform eller styrka </p> <p style="position:absolute;top:880px;left:576px;white-space:nowrap" class="ft50">22 000</p> <p style="position:absolute;top:924px;left:172px;white-space:nowrap" class="ft54"><b>F�rnyat godk�nnande efter fem �r (decentraliserat, <br/>�msesidigt och nationellt)</b></p> <p style="position:absolute;top:964px;left:187px;white-space:nowrap" class="ft50">F�rnyat godk�nnande,</p> <p style="position:absolute;top:982px;left:172px;white-space:nowrap" class="ft50">avgift per produkt</p> <p style="position:absolute;top:982px;left:576px;white-space:nowrap" class="ft50">11 000</p> </div> <div id="page6-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:141px;white-space:nowrap" class="ft60">6</p> <p style="position:absolute;top:169px;left:142px;white-space:nowrap" class="ft61"><b>SFS 2009:1382</b></p> <p style="position:absolute;top:175px;left:633px;white-space:nowrap" class="ft60">Avgift i kronor</p> <p style="position:absolute;top:212px;left:277px;white-space:nowrap" class="ft63"><b>Tillkommande avgifter f�r ett befintligt nationellt <br/>godk�nt veterin�rl�kemedel</b></p> <p style="position:absolute;top:253px;left:292px;white-space:nowrap" class="ft60">Ny l�kemedelsform eller styrka,</p> <p style="position:absolute;top:271px;left:277px;white-space:nowrap" class="ft60">avgift per produkt</p> <p style="position:absolute;top:271px;left:681px;white-space:nowrap" class="ft60">38 500</p> <p style="position:absolute;top:292px;left:277px;white-space:nowrap" class="ft64">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan</p> <p style="position:absolute;top:309px;left:681px;white-space:nowrap" class="ft60">22 000</p> <p style="position:absolute;top:330px;left:292px;white-space:nowrap" class="ft60">Ny dosering utanf�r dosintervall,</p> <p style="position:absolute;top:347px;left:277px;white-space:nowrap" class="ft60">avgift per dos</p> <p style="position:absolute;top:347px;left:681px;white-space:nowrap" class="ft60">38 500</p> <p style="position:absolute;top:368px;left:292px;white-space:nowrap" class="ft60">Ny indikation inkluderande eventuell dos- och styrke-</p> <p style="position:absolute;top:385px;left:277px;white-space:nowrap" class="ft60">�ndring 38 </p> <p style="position:absolute;top:385px;left:699px;white-space:nowrap" class="ft60">500</p> <p style="position:absolute;top:406px;left:292px;white-space:nowrap" class="ft60">Ans�kan om �ndring av receptstatus </p> <p style="position:absolute;top:406px;left:681px;white-space:nowrap" class="ft60">38 500</p> <p style="position:absolute;top:426px;left:292px;white-space:nowrap" class="ft60">Ans�kan om �ndring av receptstatus d�r substansen re-</p> <p style="position:absolute;top:444px;left:277px;white-space:nowrap" class="ft64">dan varit f�rem�l f�r samma �ndring och d�r produktresu-<br/>m� och bipacksedel �r i allt v�sentligt lika</p> <p style="position:absolute;top:462px;left:681px;white-space:nowrap" class="ft60">11 000</p> <p style="position:absolute;top:482px;left:292px;white-space:nowrap" class="ft60">St�rre �ndrings�rende som inte �r en typ 1-�ndring och </p> <p style="position:absolute;top:500px;left:277px;white-space:nowrap" class="ft64">som inte kr�ver en ny ans�kan exklusive indikations- och <br/>dos�ndring 8 </p> <p style="position:absolute;top:517px;left:699px;white-space:nowrap" class="ft60">250</p> <p style="position:absolute;top:538px;left:292px;white-space:nowrap" class="ft60">F�rl�ngd skyddsperiod f�r nytt djurslag </p> <p style="position:absolute;top:538px;left:681px;white-space:nowrap" class="ft60">22 000</p> <p style="position:absolute;top:582px;left:277px;white-space:nowrap" class="ft65"><b>Sverige agerar referensland i den �msesidiga <br/>proceduren</b></p> <p style="position:absolute;top:622px;left:292px;white-space:nowrap" class="ft60">Komplett ans�kan,</p> <p style="position:absolute;top:640px;left:277px;white-space:nowrap" class="ft60">avgift per produkt</p> <p style="position:absolute;top:640px;left:674px;white-space:nowrap" class="ft60">110 000</p> <p style="position:absolute;top:660px;left:292px;white-space:nowrap" class="ft60">F�rkortad ans�kan,</p> <p style="position:absolute;top:678px;left:277px;white-space:nowrap" class="ft60">avgift per produkt</p> <p style="position:absolute;top:678px;left:681px;white-space:nowrap" class="ft60">55 000</p> <p style="position:absolute;top:698px;left:292px;white-space:nowrap" class="ft60">Duplikatans�kan,</p> <p style="position:absolute;top:716px;left:277px;white-space:nowrap" class="ft60">avgift per produkt</p> <p style="position:absolute;top:716px;left:681px;white-space:nowrap" class="ft60">22 000</p> <p style="position:absolute;top:736px;left:292px;white-space:nowrap" class="ft60">Ans�kan d�r Sverige agerar referensland i den �msesidi-</p> <p style="position:absolute;top:754px;left:277px;white-space:nowrap" class="ft64">ga proceduren och produkten redan blivit godk�nd i annat <br/>land genom �msesidigt godk�nnande, komplett ans�kan,<br/>avgift per produkt </p> <p style="position:absolute;top:789px;left:681px;white-space:nowrap" class="ft60">66 000</p> <p style="position:absolute;top:810px;left:292px;white-space:nowrap" class="ft60">Ans�kan d�r Sverige agerar referensland i den �msesidi-</p> <p style="position:absolute;top:827px;left:277px;white-space:nowrap" class="ft64">ga proceduren och produkten redan blivit godk�nd i annat <br/>land genom �msesidigt godk�nnande, f�rkortad ans�kan,<br/>avgift per produkt</p> <p style="position:absolute;top:863px;left:681px;white-space:nowrap" class="ft60">33 000</p> <p style="position:absolute;top:883px;left:292px;white-space:nowrap" class="ft60">Ans�kan d�r Sverige agerar referensland i den �msesidi-</p> <p style="position:absolute;top:901px;left:277px;white-space:nowrap" class="ft64">ga proceduren och produkten redan blivit godk�nd i annat <br/>land genom �msesidigt godk�nnande, duplikatans�kan,<br/>avgift per produkt</p> <p style="position:absolute;top:936px;left:681px;white-space:nowrap" class="ft60">13 200</p> <p style="position:absolute;top:956px;left:292px;white-space:nowrap" class="ft60">�ndring typ 2, exklusive indikations�ndring </p> <p style="position:absolute;top:956px;left:681px;white-space:nowrap" class="ft60">16 500</p> <p style="position:absolute;top:977px;left:292px;white-space:nowrap" class="ft60">�ndring typ 2, indikations- och dos�ndring </p> <p style="position:absolute;top:977px;left:681px;white-space:nowrap" class="ft60">55 000</p> </div> <div id="page7-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:745px;white-space:nowrap" class="ft70">7</p> <p style="position:absolute;top:167px;left:637px;white-space:nowrap" class="ft71"><b>SFS 2009:1382</b></p> <p style="position:absolute;top:175px;left:528px;white-space:nowrap" class="ft70">Avgift i kronor</p> <p style="position:absolute;top:212px;left:172px;white-space:nowrap" class="ft73"><b>Sverige agerar referensland i den decentraliserade <br/>proceduren</b></p> <p style="position:absolute;top:252px;left:187px;white-space:nowrap" class="ft70">Komplett ans�kan,</p> <p style="position:absolute;top:270px;left:172px;white-space:nowrap" class="ft70">avgift per produkt </p> <p style="position:absolute;top:270px;left:569px;white-space:nowrap" class="ft70">297 000</p> <p style="position:absolute;top:290px;left:172px;white-space:nowrap" class="ft74">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan</p> <p style="position:absolute;top:308px;left:576px;white-space:nowrap" class="ft70">38 500</p> <p style="position:absolute;top:328px;left:187px;white-space:nowrap" class="ft70">F�rkortad ans�kan med referens till en substans som </p> <p style="position:absolute;top:346px;left:172px;white-space:nowrap" class="ft74">inte varit godk�nd i Sverige,<br/>avgift per produkt</p> <p style="position:absolute;top:363px;left:569px;white-space:nowrap" class="ft70">297 000</p> <p style="position:absolute;top:384px;left:172px;white-space:nowrap" class="ft74">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan 38 </p> <p style="position:absolute;top:401px;left:594px;white-space:nowrap" class="ft70">500</p> <p style="position:absolute;top:422px;left:187px;white-space:nowrap" class="ft70">�vriga f�rkortade ans�kningar,</p> <p style="position:absolute;top:440px;left:172px;white-space:nowrap" class="ft70">avgift per produkt</p> <p style="position:absolute;top:440px;left:576px;white-space:nowrap" class="ft70">93 500</p> <p style="position:absolute;top:460px;left:172px;white-space:nowrap" class="ft74">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan 22 </p> <p style="position:absolute;top:478px;left:594px;white-space:nowrap" class="ft70">000</p> <p style="position:absolute;top:498px;left:187px;white-space:nowrap" class="ft70">Duplikatans�kan,</p> <p style="position:absolute;top:516px;left:172px;white-space:nowrap" class="ft70">avgift per produkt</p> <p style="position:absolute;top:516px;left:576px;white-space:nowrap" class="ft70">22 000</p> <p style="position:absolute;top:536px;left:172px;white-space:nowrap" class="ft74">avgift f�r ytterligare l�kemedelsform eller styrka i samma <br/>ans�kan</p> <p style="position:absolute;top:554px;left:576px;white-space:nowrap" class="ft70">22 000</p> <p style="position:absolute;top:574px;left:187px;white-space:nowrap" class="ft70">�ndring typ 2, exklusive indikations�ndring </p> <p style="position:absolute;top:574px;left:576px;white-space:nowrap" class="ft70">16 500</p> <p style="position:absolute;top:595px;left:187px;white-space:nowrap" class="ft70">�ndring typ 2, indikations- och dos�ndring </p> <p style="position:absolute;top:595px;left:576px;white-space:nowrap" class="ft70">55 000</p> <p style="position:absolute;top:639px;left:172px;white-space:nowrap" class="ft73"><b>Sverige agerar ber�rd medlemsstat i den �msesidiga <br/>eller den decentraliserade proceduren</b></p> <p style="position:absolute;top:677px;left:187px;white-space:nowrap" class="ft70">�ndring typ 2</p> <p style="position:absolute;top:677px;left:583px;white-space:nowrap" class="ft70">5 500</p> <p style="position:absolute;top:698px;left:187px;white-space:nowrap" class="ft70">Ny form eller styrka</p> <p style="position:absolute;top:698px;left:576px;white-space:nowrap" class="ft70">22 000</p> <p style="position:absolute;top:718px;left:187px;white-space:nowrap" class="ft70">�ndring typ 2, indikations- och dos�ndring</p> <p style="position:absolute;top:718px;left:576px;white-space:nowrap" class="ft70">22 000</p> <p style="position:absolute;top:763px;left:172px;white-space:nowrap" class="ft72"><b>�rsavgifter f�r veterin�rl�kemedel</b></p> <p style="position:absolute;top:785px;left:187px;white-space:nowrap" class="ft70">L�kemedel med komplett ans�kan, godk�nd i mindre �n </p> <p style="position:absolute;top:802px;left:172px;white-space:nowrap" class="ft70">fem �r </p> <p style="position:absolute;top:802px;left:576px;white-space:nowrap" class="ft70">27 500</p> <p style="position:absolute;top:823px;left:187px;white-space:nowrap" class="ft70">L�kemedel med f�rkortad ans�kan och komplett ans�-</p> <p style="position:absolute;top:840px;left:172px;white-space:nowrap" class="ft70">kan �ldre �n fem �r samt lagerberedningar </p> <p style="position:absolute;top:823px;left:576px;white-space:nowrap" class="ft70">13 750</p> <p style="position:absolute;top:861px;left:172px;white-space:nowrap" class="ft74">avgift per ytterligare l�kemedelsform eller styrka (inte f�r <br/>lagerberedning) 13 </p> <p style="position:absolute;top:878px;left:594px;white-space:nowrap" class="ft70">200</p> <p style="position:absolute;top:899px;left:187px;white-space:nowrap" class="ft70">L�kemedel med duplikatans�kan som godk�ndes under </p> <p style="position:absolute;top:917px;left:172px;white-space:nowrap" class="ft70">�r 2000 eller senare,</p> <p style="position:absolute;top:937px;left:172px;white-space:nowrap" class="ft70">avgift per l�kemedelsform eller styrka</p> <p style="position:absolute;top:937px;left:576px;white-space:nowrap" class="ft70">13 200</p> <p style="position:absolute;top:957px;left:187px;white-space:nowrap" class="ft70">�rsavgift f�r parallellimporterade l�kemedel ska betalas </p> <p style="position:absolute;top:975px;left:172px;white-space:nowrap" class="ft70">med en tredjedel av de angivna beloppen</p> </div> <div id="page8-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:141px;white-space:nowrap" class="ft80">8</p> <p style="position:absolute;top:169px;left:142px;white-space:nowrap" class="ft81"><b>SFS 2009:1382</b></p> <p style="position:absolute;top:175px;left:633px;white-space:nowrap" class="ft80">Avgift i kronor</p> <p style="position:absolute;top:212px;left:277px;white-space:nowrap" class="ft83"><b>�vriga �rsavgifter f�r human- och <br/>veterin�rl�kemedel</b></p> <p style="position:absolute;top:257px;left:277px;white-space:nowrap" class="ft82"><b>Tillverkning av l�kemedel</b></p> <p style="position:absolute;top:279px;left:292px;white-space:nowrap" class="ft80">Grundavgift h�gst tre l�kemedelsformer</p> <p style="position:absolute;top:279px;left:681px;white-space:nowrap" class="ft80">41 250</p> <p style="position:absolute;top:300px;left:292px;white-space:nowrap" class="ft80">Till�gg f�r fler �n tre l�kemedelsformer </p> <p style="position:absolute;top:300px;left:681px;white-space:nowrap" class="ft80">13 750</p> <p style="position:absolute;top:320px;left:292px;white-space:nowrap" class="ft80">Till�gg f�r parenterala l�kemedel </p> <p style="position:absolute;top:320px;left:681px;white-space:nowrap" class="ft80">27 500</p> <p style="position:absolute;top:340px;left:292px;white-space:nowrap" class="ft80">�rsavgift f�r begr�nsad tillsynsinsats</p> <p style="position:absolute;top:340px;left:681px;white-space:nowrap" class="ft80">20 625</p> <p style="position:absolute;top:361px;left:292px;white-space:nowrap" class="ft80">�rsavgift f�r tillverkning av medicinska gaser </p> <p style="position:absolute;top:361px;left:681px;white-space:nowrap" class="ft80">14 025</p> <p style="position:absolute;top:405px;left:277px;white-space:nowrap" class="ft83"><b>�vriga ans�kningsavgifter f�r human- och <br/>veterin�rl�kemedel</b></p> <p style="position:absolute;top:447px;left:292px;white-space:nowrap" class="ft80">Ans�kan om tillst�nd att utf�ra klinisk pr�vning</p> <p style="position:absolute;top:467px;left:277px;white-space:nowrap" class="ft80">ett pr�vningsst�lle</p> <p style="position:absolute;top:467px;left:681px;white-space:nowrap" class="ft80">33 000</p> <p style="position:absolute;top:487px;left:277px;white-space:nowrap" class="ft80">avgift per tillkommande pr�vningsst�lle</p> <p style="position:absolute;top:487px;left:688px;white-space:nowrap" class="ft80">1 100</p> <p style="position:absolute;top:508px;left:292px;white-space:nowrap" class="ft80">Ans�kan om licens </p> <p style="position:absolute;top:508px;left:699px;white-space:nowrap" class="ft80">165</p> <p style="position:absolute;top:528px;left:292px;white-space:nowrap" class="ft80">�ndring av innehavare av marknadsf�ringstillst�nd</p> <p style="position:absolute;top:528px;left:688px;white-space:nowrap" class="ft80">2 750</p> <p style="position:absolute;top:549px;left:292px;white-space:nowrap" class="ft80">Ans�kan om tillst�nd att tillverka l�kemedel </p> <p style="position:absolute;top:549px;left:674px;white-space:nowrap" class="ft80">110 000</p> <p style="position:absolute;top:569px;left:292px;white-space:nowrap" class="ft80">Ans�kan om tillst�nd att tillverka medicinska gaser </p> <p style="position:absolute;top:569px;left:681px;white-space:nowrap" class="ft80">55 000</p> <p style="position:absolute;top:590px;left:292px;white-space:nowrap" class="ft80">Vetenskaplig r�dgivning</p> <p style="position:absolute;top:590px;left:681px;white-space:nowrap" class="ft80">22 000</p> <p style="position:absolute;top:634px;left:277px;white-space:nowrap" class="ft82"><b>Laboratorier med GLP-reglerad verksamhet</b></p> <p style="position:absolute;top:656px;left:292px;white-space:nowrap" class="ft80">�rsavgift f�r s�kerhetsstudier</p> <p style="position:absolute;top:656px;left:681px;white-space:nowrap" class="ft80">55 000</p> <p style="position:absolute;top:677px;left:292px;white-space:nowrap" class="ft80">�rsavgift f�r analysverksamhet</p> <p style="position:absolute;top:677px;left:681px;white-space:nowrap" class="ft80">13 750</p> <p style="position:absolute;top:721px;left:277px;white-space:nowrap" class="ft81"><b>L�KEMEDELSN�RA PRODUKTER</b></p> <p style="position:absolute;top:748px;left:277px;white-space:nowrap" class="ft81"><b>Ans�kningsavgifter f�r naturl�kemedel</b></p> <p style="position:absolute;top:776px;left:277px;white-space:nowrap" class="ft82"><b>Nationella ans�kningar</b></p> <p style="position:absolute;top:797px;left:292px;white-space:nowrap" class="ft80">Bibliografisk ans�kan,</p> <p style="position:absolute;top:815px;left:277px;white-space:nowrap" class="ft80">avgift per produkt </p> <p style="position:absolute;top:815px;left:681px;white-space:nowrap" class="ft80">49 500</p> <p style="position:absolute;top:836px;left:292px;white-space:nowrap" class="ft80">F�rnyat godk�nnande,</p> <p style="position:absolute;top:853px;left:277px;white-space:nowrap" class="ft80">avgift per produkt</p> <p style="position:absolute;top:853px;left:681px;white-space:nowrap" class="ft80">11 000</p> <p style="position:absolute;top:874px;left:292px;white-space:nowrap" class="ft80">St�rre �ndrings�rende som inte �r en typ 1-�ndring och </p> <p style="position:absolute;top:891px;left:277px;white-space:nowrap" class="ft84">som inte kr�ver en ny ans�kan, exklusive indikations-<br/>�ndring och dos </p> <p style="position:absolute;top:909px;left:688px;white-space:nowrap" class="ft80">6 875</p> <p style="position:absolute;top:929px;left:292px;white-space:nowrap" class="ft80">Ny indikation inkluderande eventuell dos- och styrke-</p> <p style="position:absolute;top:947px;left:277px;white-space:nowrap" class="ft80">�ndring 11 </p> <p style="position:absolute;top:947px;left:699px;white-space:nowrap" class="ft80">000</p> <p style="position:absolute;top:968px;left:292px;white-space:nowrap" class="ft80">Ny dosering utanf�r redan godk�nt dosintervall,</p> <p style="position:absolute;top:985px;left:277px;white-space:nowrap" class="ft80">avgift per dos </p> <p style="position:absolute;top:1003px;left:292px;white-space:nowrap" class="ft80">�ndring av innehavare av marknadstillst�nd </p> <p style="position:absolute;top:985px;left:681px;white-space:nowrap" class="ft80">11 000</p> <p style="position:absolute;top:1003px;left:688px;white-space:nowrap" class="ft80">2 475</p> </div> <div id="page9-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:745px;white-space:nowrap" class="ft90">9</p> <p style="position:absolute;top:167px;left:637px;white-space:nowrap" class="ft91"><b>SFS 2009:1382</b></p> <p style="position:absolute;top:175px;left:528px;white-space:nowrap" class="ft90">Avgift i kronor</p> <p style="position:absolute;top:212px;left:172px;white-space:nowrap" class="ft91"><b>Ans�kningsavgifter f�r vissa utv�rtes l�kemedel</b></p> <p style="position:absolute;top:240px;left:172px;white-space:nowrap" class="ft93"><b>Nationella ans�kningar och ans�kningar d�r Sverige <br/>agerar referensland eller ber�rd medlemsstat i den <br/>�msesidiga proceduren eller ber�rd medlemsstat i den <br/>decentraliserade proceduren</b></p> <p style="position:absolute;top:314px;left:187px;white-space:nowrap" class="ft90">Bibliografisk ans�kan,</p> <p style="position:absolute;top:332px;left:172px;white-space:nowrap" class="ft90">avgift per produkt</p> <p style="position:absolute;top:332px;left:576px;white-space:nowrap" class="ft90">49 500</p> <p style="position:absolute;top:353px;left:187px;white-space:nowrap" class="ft90">F�rnyat godk�nnande,</p> <p style="position:absolute;top:370px;left:172px;white-space:nowrap" class="ft90">avgift per produkt</p> <p style="position:absolute;top:370px;left:576px;white-space:nowrap" class="ft90">11 000</p> <p style="position:absolute;top:391px;left:187px;white-space:nowrap" class="ft90">St�rre �ndrings�rende som inte �r en typ 1-�ndring och </p> <p style="position:absolute;top:408px;left:172px;white-space:nowrap" class="ft94">som inte kr�ver en ny ans�kan, exklusive indikations�nd-<br/>ring och dos</p> <p style="position:absolute;top:426px;left:583px;white-space:nowrap" class="ft90">6 875</p> <p style="position:absolute;top:446px;left:187px;white-space:nowrap" class="ft90">Ny indikation inkluderande eventuell dos- och styrke-</p> <p style="position:absolute;top:464px;left:172px;white-space:nowrap" class="ft90">�ndring</p> <p style="position:absolute;top:482px;left:187px;white-space:nowrap" class="ft90">Ny dosering utanf�r redan godk�nt dosintervall,</p> <p style="position:absolute;top:499px;left:172px;white-space:nowrap" class="ft90">avgift per dos</p> <p style="position:absolute;top:464px;left:576px;white-space:nowrap" class="ft90">11 000</p> <p style="position:absolute;top:499px;left:576px;white-space:nowrap" class="ft90">11 000</p> <p style="position:absolute;top:520px;left:187px;white-space:nowrap" class="ft90">�ndring av innehavare av marknadsf�ringstillst�nd 2 </p> <p style="position:absolute;top:520px;left:594px;white-space:nowrap" class="ft90">475</p> <p style="position:absolute;top:564px;left:172px;white-space:nowrap" class="ft93"><b>Ans�kningar d�r Sverige agerar referensland i den <br/>decentraliserade proceduren </b></p> <p style="position:absolute;top:582px;left:569px;white-space:nowrap" class="ft90">110 000</p> <p style="position:absolute;top:623px;left:172px;white-space:nowrap" class="ft95"><b>Ans�kningsavgifter f�r traditionella <br/>v�xtbaserade l�kemedel</b></p> <p style="position:absolute;top:668px;left:172px;white-space:nowrap" class="ft93"><b>Nationella ans�kningar och ans�kningar d�r Sverige <br/>agerar referensland eller ber�rd medlemsstat i den <br/>�msesidiga proceduren eller ber�rd medlemsstat i den <br/>decentraliserade </b></p> <p style="position:absolute;top:721px;left:278px;white-space:nowrap" class="ft92"><b>proceduren</b></p> <p style="position:absolute;top:743px;left:187px;white-space:nowrap" class="ft90">Ny ans�kan,</p> <p style="position:absolute;top:761px;left:172px;white-space:nowrap" class="ft90">avgift per produkt </p> <p style="position:absolute;top:761px;left:576px;white-space:nowrap" class="ft90">66 000</p> <p style="position:absolute;top:781px;left:187px;white-space:nowrap" class="ft90">Ans�kan med produkt upptagen p� f�rteckning uppr�t-</p> <p style="position:absolute;top:799px;left:172px;white-space:nowrap" class="ft90">tad av Europeiska gemenskapernas kommission </p> <p style="position:absolute;top:799px;left:576px;white-space:nowrap" class="ft90">44 000</p> <p style="position:absolute;top:819px;left:187px;white-space:nowrap" class="ft90">Ans�kan om registrering i s�dana fall d�r produkten den </p> <p style="position:absolute;top:837px;left:172px;white-space:nowrap" class="ft90">1 april 2006 var godk�nd som naturl�kemedel </p> <p style="position:absolute;top:837px;left:576px;white-space:nowrap" class="ft90">15 400</p> <p style="position:absolute;top:857px;left:187px;white-space:nowrap" class="ft90">F�rnyad registrering,</p> <p style="position:absolute;top:875px;left:172px;white-space:nowrap" class="ft90">avgift per produkt</p> <p style="position:absolute;top:875px;left:576px;white-space:nowrap" class="ft90">15 400</p> <p style="position:absolute;top:896px;left:187px;white-space:nowrap" class="ft90">St�rre �ndrings�rende som inte �r en typ 1-�ndring och </p> <p style="position:absolute;top:913px;left:172px;white-space:nowrap" class="ft94">som inte kr�ver en ny ans�kan, exklusive indikations�nd-<br/>ring och dos </p> <p style="position:absolute;top:931px;left:576px;white-space:nowrap" class="ft90">11 000</p> <p style="position:absolute;top:951px;left:187px;white-space:nowrap" class="ft90">Ny indikation inkluderande eventuell dos- och styrke-</p> <p style="position:absolute;top:969px;left:172px;white-space:nowrap" class="ft90">�ndring</p> <p style="position:absolute;top:969px;left:576px;white-space:nowrap" class="ft90">22 000</p> <p style="position:absolute;top:989px;left:187px;white-space:nowrap" class="ft90">Ny dosering utanf�r redan godk�nt dosintervall,</p> <p style="position:absolute;top:1007px;left:172px;white-space:nowrap" class="ft90">avgift per dos</p> <p style="position:absolute;top:1007px;left:576px;white-space:nowrap" class="ft90">22 000</p> <p style="position:absolute;top:1028px;left:187px;white-space:nowrap" class="ft90">�ndring av registreringsinnehavare </p> <p style="position:absolute;top:1028px;left:583px;white-space:nowrap" class="ft90">2 750</p> </div> <div id="page10-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:141px;white-space:nowrap" class="ft100">10</p> <p style="position:absolute;top:169px;left:142px;white-space:nowrap" class="ft101"><b>SFS 2009:1382</b></p> <p style="position:absolute;top:175px;left:633px;white-space:nowrap" class="ft100">Avgift i kronor</p> <p style="position:absolute;top:212px;left:277px;white-space:nowrap" class="ft103"><b>Ans�kningar d�r Sverige agerar referensland i den <br/>decentraliserade proceduren </b></p> <p style="position:absolute;top:230px;left:674px;white-space:nowrap" class="ft100">110 000</p> <p style="position:absolute;top:276px;left:277px;white-space:nowrap" class="ft104"><b>�vriga ans�kningsavgifter f�r naturl�kemedel, <br/>traditionella v�xtbaserade l�kemedel och vissa <br/>utv�rtes l�kemedel</b></p> <p style="position:absolute;top:335px;left:292px;white-space:nowrap" class="ft100">Parallellimporterat l�kemedel per produkt och land </p> <p style="position:absolute;top:335px;left:681px;white-space:nowrap" class="ft100">11 000</p> <p style="position:absolute;top:355px;left:292px;white-space:nowrap" class="ft100">Ans�kan om tillst�nd att utf�ra klinisk pr�vning vid ett </p> <p style="position:absolute;top:373px;left:277px;white-space:nowrap" class="ft100">pr�vningsst�lle</p> <p style="position:absolute;top:373px;left:681px;white-space:nowrap" class="ft100">30 250</p> <p style="position:absolute;top:393px;left:277px;white-space:nowrap" class="ft100">avgift per tillkommande pr�vningsst�lle</p> <p style="position:absolute;top:393px;left:688px;white-space:nowrap" class="ft100">1 100</p> <p style="position:absolute;top:414px;left:292px;white-space:nowrap" class="ft100">Ans�kan om tillst�nd att tillverka naturl�kemedel, tradi-</p> <p style="position:absolute;top:431px;left:277px;white-space:nowrap" class="ft105">tionella v�xtbaserade l�kemedel eller vissa utv�rtes l�ke-<br/>medel 55 </p> <p style="position:absolute;top:449px;left:699px;white-space:nowrap" class="ft100">000</p> <p style="position:absolute;top:493px;left:277px;white-space:nowrap" class="ft101"><b>�rsavgift f�r naturl�kemedel</b></p> <p style="position:absolute;top:517px;left:292px;white-space:nowrap" class="ft100">Per produkt som godk�nts f�r f�rs�ljning </p> <p style="position:absolute;top:517px;left:681px;white-space:nowrap" class="ft100">16 500</p> <p style="position:absolute;top:537px;left:292px;white-space:nowrap" class="ft100">Per produkt f�r vilka meddelats tillst�nd till f�rs�ljning </p> <p style="position:absolute;top:555px;left:277px;white-space:nowrap" class="ft105">enligt 5 � andra stycket l�kemedelslagen (1992:859) i dess <br/>lydelse f�re den 1 april 1994</p> <p style="position:absolute;top:573px;left:681px;white-space:nowrap" class="ft100">12 485</p> <p style="position:absolute;top:593px;left:292px;white-space:nowrap" class="ft100">Grundavgift tillverkare av naturl�kemedel </p> <p style="position:absolute;top:593px;left:681px;white-space:nowrap" class="ft100">27 500</p> <p style="position:absolute;top:614px;left:292px;white-space:nowrap" class="ft100">Begr�nsad tillsynsinsats</p> <p style="position:absolute;top:614px;left:681px;white-space:nowrap" class="ft100">13 750</p> <p style="position:absolute;top:658px;left:277px;white-space:nowrap" class="ft101"><b>�rsavgift f�r vissa utv�rtes l�kemedel</b></p> <p style="position:absolute;top:682px;left:292px;white-space:nowrap" class="ft100">Per produkt som godk�nts f�r f�rs�ljning</p> <p style="position:absolute;top:682px;left:681px;white-space:nowrap" class="ft100">16 500</p> <p style="position:absolute;top:702px;left:292px;white-space:nowrap" class="ft100">Per produkt f�r vilka meddelats tillst�nd till f�rs�ljning </p> <p style="position:absolute;top:720px;left:277px;white-space:nowrap" class="ft105">enligt 5 � andra stycket l�kemedelslagen (1992:859) i dess <br/>lydelse f�re den 1 april 1994</p> <p style="position:absolute;top:737px;left:681px;white-space:nowrap" class="ft100">12 485</p> <p style="position:absolute;top:758px;left:292px;white-space:nowrap" class="ft100">Grundavgift tillverkare vissa utv�rtes l�kemedel</p> <p style="position:absolute;top:758px;left:681px;white-space:nowrap" class="ft100">27 500</p> <p style="position:absolute;top:778px;left:292px;white-space:nowrap" class="ft100">Begr�nsad tillsynsinsats </p> <p style="position:absolute;top:778px;left:681px;white-space:nowrap" class="ft100">13 750</p> <p style="position:absolute;top:823px;left:277px;white-space:nowrap" class="ft104"><b>�rsavgift f�r traditionella v�xtbaserade <br/>l�kemedel</b></p> <p style="position:absolute;top:864px;left:292px;white-space:nowrap" class="ft100">Per produkt som registrerats </p> <p style="position:absolute;top:864px;left:681px;white-space:nowrap" class="ft100">44 000</p> <p style="position:absolute;top:884px;left:292px;white-space:nowrap" class="ft100">Grundavgift f�r tillverkning av traditionella v�xtbasera-</p> <p style="position:absolute;top:902px;left:277px;white-space:nowrap" class="ft100">de l�kemedel </p> <p style="position:absolute;top:902px;left:681px;white-space:nowrap" class="ft100">33 000</p> <p style="position:absolute;top:922px;left:292px;white-space:nowrap" class="ft100">Begr�nsad tillsynsinsats f�r tillverkning av traditionella </p> <p style="position:absolute;top:940px;left:277px;white-space:nowrap" class="ft100">v�xtbaserade l�kemedel</p> <p style="position:absolute;top:940px;left:681px;white-space:nowrap" class="ft100">16 500</p> </div> <div id="page11-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:738px;white-space:nowrap" class="ft110">11</p> <p style="position:absolute;top:167px;left:637px;white-space:nowrap" class="ft111"><b>SFS 2009:1382</b></p> <p style="position:absolute;top:755px;left:187px;white-space:nowrap" class="ft110"> Denna f�rordning tr�der i kraft den 1 januari 2010.</p> <p style="position:absolute;top:791px;left:172px;white-space:nowrap" class="ft110">P� regeringens v�gnar</p> <p style="position:absolute;top:826px;left:172px;white-space:nowrap" class="ft110">G�RAN H�GGLUND</p> <p style="position:absolute;top:843px;left:403px;white-space:nowrap" class="ft113">Lars Hedengran<br/>(Socialdepartementet)</p> <p style="position:absolute;top:175px;left:528px;white-space:nowrap" class="ft110">Avgift i kronor</p> <p style="position:absolute;top:212px;left:172px;white-space:nowrap" class="ft111"><b>Ans�kningsavgifter f�r homeopatiska l�kemedel</b></p> <p style="position:absolute;top:240px;left:172px;white-space:nowrap" class="ft114"><b>Registrering av medel som avses i 2 � tredje och fj�rde <br/>styckena l�kemedelslagen (1992:859)</b></p> <p style="position:absolute;top:279px;left:187px;white-space:nowrap" class="ft110">Nationella ans�kningar avseende enkelmedel i en sp�d-</p> <p style="position:absolute;top:297px;left:172px;white-space:nowrap" class="ft113">ningsserie, <br/>avgift per produkt eller per produktgrupp</p> <p style="position:absolute;top:314px;left:583px;white-space:nowrap" class="ft110">2 475</p> <p style="position:absolute;top:335px;left:187px;white-space:nowrap" class="ft110">Ans�kningar d�r Sverige agerar referensland eller be-</p> <p style="position:absolute;top:353px;left:172px;white-space:nowrap" class="ft113">r�rd medlemsstat i den �msesidiga proceduren eller ber�rd <br/>medlemsstat i den decentraliserade proceduren avseende <br/>enkelmedel i en sp�dningsserie,<br/>avgift per produkt eller per produktgrupp</p> <p style="position:absolute;top:406px;left:576px;white-space:nowrap" class="ft110">11 000</p> <p style="position:absolute;top:426px;left:187px;white-space:nowrap" class="ft110">Ans�kan d�r Sverige agerar referensland i den decentra-</p> <p style="position:absolute;top:444px;left:172px;white-space:nowrap" class="ft113">liserade proceduren avseende enkelmedel i en sp�dnings-<br/>serie,<br/>avgift per produkt eller per produktgrupp</p> <p style="position:absolute;top:479px;left:576px;white-space:nowrap" class="ft110">16 500</p> <p style="position:absolute;top:499px;left:187px;white-space:nowrap" class="ft110">F�rnyelse av registrering,</p> <p style="position:absolute;top:517px;left:172px;white-space:nowrap" class="ft110">avgift per produktgrupp</p> <p style="position:absolute;top:517px;left:583px;white-space:nowrap" class="ft110">5 500</p> <p style="position:absolute;top:537px;left:187px;white-space:nowrap" class="ft110">�ndring av registreringsinnehavare och/eller ombud,</p> <p style="position:absolute;top:555px;left:172px;white-space:nowrap" class="ft110">avgift per f�retag</p> <p style="position:absolute;top:555px;left:583px;white-space:nowrap" class="ft110">1 650</p> <p style="position:absolute;top:576px;left:187px;white-space:nowrap" class="ft110">Ans�kan om tillst�nd att tillverka homeopatika</p> <p style="position:absolute;top:576px;left:576px;white-space:nowrap" class="ft110">27 500</p> <p style="position:absolute;top:620px;left:172px;white-space:nowrap" class="ft112"><b>�rsavgifter f�r homeopatiska l�kemedel</b></p> <p style="position:absolute;top:642px;left:187px;white-space:nowrap" class="ft110">Per produkt eller per produktgrupp (avseende enkel-</p> <p style="position:absolute;top:660px;left:172px;white-space:nowrap" class="ft110">medel i en sp�dningsserie) </p> <p style="position:absolute;top:660px;left:594px;white-space:nowrap" class="ft110">250</p> <p style="position:absolute;top:680px;left:187px;white-space:nowrap" class="ft110">Grundavgift f�r tillverkning av homeopatika</p> <p style="position:absolute;top:680px;left:576px;white-space:nowrap" class="ft110">27 500</p> <p style="position:absolute;top:700px;left:187px;white-space:nowrap" class="ft110">Begr�nsad tillsynsinsats f�r tillverkning av homeopatika </p> <p style="position:absolute;top:700px;left:576px;white-space:nowrap" class="ft110">13 750</p> </div> <div id="page12-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1059px;left:539px;white-space:nowrap" class="ft120">Thomson Reuters Professional AB, tel. 08-587 671 00</p> <p style="position:absolute;top:1069px;left:609px;white-space:nowrap" class="ft120">Edita V�stra Aros, V�ster�s 2009</p> </div> </div> ;