SFS 2019:211 Förordning om ändring i förordningen (2017:932) om avgifter för anmälda organ för medicintekniska produkter

<div><style type="text/css"> <!-- p {margin: 0; padding: 0;} .ft10{font-size:17px;font-family:ABCDEE+TimesNewRomanPSMT;color:#000000;} .ft11{font-size:28px;font-family:ABCDEE+TimesNewRomanPS;color:#000000;} .ft12{font-size:21px;font-family:ABCDEE+TimesNewRomanPS;color:#000000;} .ft13{font-size:18px;font-family:ABCDEE+TimesNewRomanPS;color:#000000;} .ft14{font-size:17px;font-family:ABCDEE+TimesNewRomanPS;color:#000000;} .ft15{font-size:15px;font-family:ABCDEE+TimesNewRomanPSMT;color:#000000;} .ft16{font-size:14px;font-family:ABCDEE+TimesNewRomanPSMT;color:#000000;} .ft17{font-size:19px;font-family:ABCDEE+TimesNewRomanPS;color:#000000;} .ft18{font-size:19px;font-family:KKHBVU+TimesNewRomanPS;color:#000000;} .ft19{font-size:14px;font-family:FNSXDE+TimesNewRomanPSMT;color:#000000;} .ft110{font-size:17px;line-height:20px;font-family:ABCDEE+TimesNewRomanPSMT;color:#000000;} .ft111{font-size:18px;line-height:29px;font-family:ABCDEE+TimesNewRomanPS;color:#000000;} .ft112{font-size:14px;line-height:18px;font-family:ABCDEE+TimesNewRomanPSMT;color:#000000;} --> <!-- p {margin: 0; padding: 0;} .ft20{font-size:17px;font-family:ABCDEE+TimesNewRomanPSMT;color:#000000;} .ft21{font-size:16px;font-family:ABCDEE+TimesNewRomanPS;color:#000000;} .ft22{font-size:16px;font-family:NRULRO+TimesNewRomanPS;color:#000000;} .ft23{font-size:17px;font-family:ABCDEE+TimesNewRomanPS;color:#000000;} .ft24{font-size:15px;font-family:ABCDEE+TimesNewRomanPSMT;color:#000000;} .ft25{font-size:14px;font-family:ABCDEE+TimesNewRomanPSMT;color:#000000;} .ft26{font-size:17px;line-height:20px;font-family:ABCDEE+TimesNewRomanPSMT;color:#000000;} --> </style> <div id="page1-div" style="position:relative;width:892px;height:1262px;"> <img width="892" height="1262" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1129px;left:794px;white-space:nowrap" class="ft10">1 </p> <p style="position:absolute;top:155px;left:98px;white-space:nowrap" class="ft11"><b>Svensk f�rfattningssamling </b></p> <p style="position:absolute;top:222px;left:98px;white-space:nowrap" class="ft12"><b>F�rordning </b></p> <p style="position:absolute;top:245px;left:98px;white-space:nowrap" class="ft12"><b>om �ndring i f�rordningen (2017:932) om avgifter f�r </b></p> <p style="position:absolute;top:268px;left:98px;white-space:nowrap" class="ft12"><b>anm�lda organ f�r medicintekniska produkter </b></p> <p style="position:absolute;top:307px;left:98px;white-space:nowrap" class="ft10">Utf�rdad den 25 april 2019 </p> <p style="position:absolute;top:348px;left:98px;white-space:nowrap" class="ft110">Regeringen f�reskriver att det i f�rordningen (2017:932) om avgifter f�r <br/>anm�lda organ f�r medicintekniska produkter ska inf�ras fyra nya para-<br/>grafer, 7 a7 d ��, och n�rmast f�re 7 a � en ny rubrik av f�ljande lydelse. </p> <p style="position:absolute;top:450px;left:98px;white-space:nowrap" class="ft110"><b>Avgift f�r yttranden <br/>7 a �</b> F�r arbete med s�dana vetenskapliga yttranden och yttranden som <br/>anges i kapitel II avsnitt 5.2 i bilaga IX till Europaparlamentets och r�dets <br/>f�rordning (EU) 2017/745 ska en avgift betalas av det anm�lda organet. </p> <p style="position:absolute;top:560px;left:98px;white-space:nowrap" class="ft14"><b>�rende </b></p> <p style="position:absolute;top:560px;left:457px;white-space:nowrap" class="ft14"><b>Avgift kronor </b></p> <p style="position:absolute;top:589px;left:98px;white-space:nowrap" class="ft15">Ny aktiv substans </p> <p style="position:absolute;top:589px;left:457px;white-space:nowrap" class="ft15">500 000 </p> <p style="position:absolute;top:616px;left:98px;white-space:nowrap" class="ft15">K�nd aktiv substans inom nytt anv�ndningsomr�de </p> <p style="position:absolute;top:616px;left:457px;white-space:nowrap" class="ft15">250 000 </p> <p style="position:absolute;top:643px;left:98px;white-space:nowrap" class="ft15">K�nd aktiv substans inom etablerad anv�ndning </p> <p style="position:absolute;top:643px;left:457px;white-space:nowrap" class="ft15">150 000 </p> <p style="position:absolute;top:670px;left:98px;white-space:nowrap" class="ft15">�ndring st�rre </p> <p style="position:absolute;top:670px;left:461px;white-space:nowrap" class="ft15"> 50 000 </p> <p style="position:absolute;top:698px;left:98px;white-space:nowrap" class="ft15">�ndring mindre </p> <p style="position:absolute;top:698px;left:461px;white-space:nowrap" class="ft15"> 10 000 </p> <p style="position:absolute;top:742px;left:98px;white-space:nowrap" class="ft110"><b>7 b �</b> F�r arbete med ett s�dant vetenskapligt yttrande som anges i kapitel <br/>II avsnitt 5.3.1 i bilaga IX till Europaparlamentets och r�dets f�rordning <br/>(EU) 2017/745 ska en avgift betalas av det anm�lda organet. </p> <p style="position:absolute;top:822px;left:98px;white-space:nowrap" class="ft14"><b>�rende </b></p> <p style="position:absolute;top:822px;left:457px;white-space:nowrap" class="ft14"><b>Avgift kronor </b></p> <p style="position:absolute;top:851px;left:98px;white-space:nowrap" class="ft15">Ny ans�kan </p> <p style="position:absolute;top:851px;left:457px;white-space:nowrap" class="ft15">200 000 </p> <p style="position:absolute;top:878px;left:98px;white-space:nowrap" class="ft15">�ndring st�rre </p> <p style="position:absolute;top:878px;left:461px;white-space:nowrap" class="ft15"> 50 000 </p> <p style="position:absolute;top:905px;left:98px;white-space:nowrap" class="ft15">�ndring mindre </p> <p style="position:absolute;top:905px;left:461px;white-space:nowrap" class="ft15"> 10 000 </p> <p style="position:absolute;top:950px;left:98px;white-space:nowrap" class="ft110"><b>7 c �</b> F�r arbete med ett s�dant vetenskapligt yttrande som anges i kapitel <br/>II avsnitt 5.4 i bilaga IX till Europaparlamentets och r�dets f�rordning (EU) <br/>2017/745 ska en avgift betalas av det anm�lda organet. </p> <p style="position:absolute;top:1030px;left:98px;white-space:nowrap" class="ft14"><b>�rende </b></p> <p style="position:absolute;top:1030px;left:457px;white-space:nowrap" class="ft14"><b>Avgift kronor </b></p> <p style="position:absolute;top:1059px;left:98px;white-space:nowrap" class="ft15">Ny ans�kan </p> <p style="position:absolute;top:1059px;left:457px;white-space:nowrap" class="ft15">200 000 </p> <p style="position:absolute;top:1086px;left:98px;white-space:nowrap" class="ft15">�ndring st�rre </p> <p style="position:absolute;top:1086px;left:461px;white-space:nowrap" class="ft15"> 50 000 </p> <p style="position:absolute;top:1113px;left:98px;white-space:nowrap" class="ft15">�ndring mindre </p> <p style="position:absolute;top:1113px;left:461px;white-space:nowrap" class="ft15"> 10 000 </p> <p style="position:absolute;top:224px;left:649px;white-space:nowrap" class="ft17"><b>SFS</b></p> <p style="position:absolute;top:221px;left:683px;white-space:nowrap" class="ft18"><b> 2019:211 </b></p> <p style="position:absolute;top:247px;left:649px;white-space:nowrap" class="ft112">Publicerad <br/>den</p> <p style="position:absolute;top:263px;left:671px;white-space:nowrap" class="ft19"> 2 maj 2019 </p> </div> <div id="page2-div" style="position:relative;width:892px;height:1262px;"> <img width="892" height="1262" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1129px;left:794px;white-space:nowrap" class="ft20">2 </p> <p style="position:absolute;top:52px;left:676px;white-space:nowrap" class="ft21"><b>SFS</b></p> <p style="position:absolute;top:49px;left:705px;white-space:nowrap" class="ft22"><b> 2019:211 </b></p> <p style="position:absolute;top:51px;left:98px;white-space:nowrap" class="ft26"><b>7 d �</b> F�r arbete med ett s�dant yttrande som anges i kapitel II avsnitt 5.2 <br/>i bilaga IX till Europaparlamentets och r�dets f�rordning (EU) 2017/746 ska <br/>en avgift betalas av det anm�lda organet. </p> <p style="position:absolute;top:132px;left:98px;white-space:nowrap" class="ft23"><b>�rende </b></p> <p style="position:absolute;top:132px;left:457px;white-space:nowrap" class="ft23"><b>Avgift kronor </b></p> <p style="position:absolute;top:161px;left:98px;white-space:nowrap" class="ft24">Ny ans�kan </p> <p style="position:absolute;top:161px;left:457px;white-space:nowrap" class="ft24">60 000 </p> <p style="position:absolute;top:188px;left:98px;white-space:nowrap" class="ft24">�ndring st�rre </p> <p style="position:absolute;top:188px;left:457px;white-space:nowrap" class="ft24">30 000 </p> <p style="position:absolute;top:215px;left:98px;white-space:nowrap" class="ft24">�ndring mindre </p> <p style="position:absolute;top:215px;left:457px;white-space:nowrap" class="ft24">10 000 </p> <p style="position:absolute;top:261px;left:115px;white-space:nowrap" class="ft20">Denna f�rordning tr�der i kraft den 1 juni 2019. </p> <p style="position:absolute;top:301px;left:98px;white-space:nowrap" class="ft20">P� regeringens v�gnar </p> <p style="position:absolute;top:342px;left:98px;white-space:nowrap" class="ft20">ANNA EKSTR�M </p> <p style="position:absolute;top:363px;left:385px;white-space:nowrap" class="ft26">Lars Hedengran <br/>(Socialdepartementet) </p> </div> </div> ;