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font-weight: bold;"> <table cellpadding="6" cellspacing="3" width="175" border='0' style=" font-family:Verdana; font-size:12px; font-weight: bold;"> <div id="right_corner" align=center> &nbsp; </div> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="index.html" style="text-decoration:none; "> &nbsp;Despre Agencie </a> </td> </tr> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="organig.html" style="text-decoration:none;"> &nbsp;Organigrama </a> </td> </tr> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="persoane.html" style="text-decoration:none; "> &nbsp;Persoane de contact </a> </td> </tr> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="depart.html" style="text-decoration:none; ">&nbsp;Departamente</a></td> </tr> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="acte.html" style="text-decoration:none; "> &nbsp;Acte legislative _i &nbsp;&nbsp;&nbsp;&nbsp;normative</a> </td> </tr> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="clasificator.html" style="text-decoration:none; "> &nbsp;Clasificatorul &nbsp;&nbsp;&nbsp;&nbsp;medicamentelor</a> </td> </tr> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="buletin.html" style="text-decoration:none; "> &nbsp;Buletinul AM</a> </td> </tr> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="NMI.html" style="text-decoration:none; "> &nbsp;Nomenclatorul de &nbsp;&nbsp;&nbsp;&nbsp;medicamente</a> </td> </tr> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="http://ceacm.amed.md" target='_blank' style="text-decoration:none; "> &nbsp;Verificarea <br> &nbsp;&nbsp;&nbsp;&nbsp;autencitcii &nbsp;&nbsp;&nbsp;&nbsp;medicamentelor</a> </td> </tr> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="formular.html" style="text-decoration:none; "> &nbsp;Formulare</a> </td> </tr> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="servicii.html" style="text-decoration:none; "> &nbsp;Servicii cu plat</a> </td> </tr> <tr > <td> &nbsp;<img src=images2/arrow.gif> <a href="urgent.html" style="text-decoration:none; "> &nbsp;Informacie de urgenc</a> </td> </tr> </table> <br> </TD> <TD bgcolor='#FFFFFF' rowspan=11 valign=top style='padding: 6px;'> <table cellpadding="6" cellspacing="0" border=0 style="width: 620px; font-size: 11px; background-color: white; border: 0px solid gray; border-top: none; border-bottom: none;" > <tr> <td align=right style="font-size: 14px; color: #0000CC; "> <br> <b>Departamente </b>&nbsp;&nbsp;&nbsp;&nbsp; </td> </tr> <tr> <td colspan=2 align=left style='color: navy; font-weight: bold;'> <br>Departamentul evaluare - autorizare</td> </tr> <tr> <td colspan=2 align=center> <br> <img src="images2/sinstr.gif" align=absmiddle border=0><b> Seccia evaluare farmaceutic cu grupele de coordonare în domeniul medicamentului, industriei farmaceutice nacionale _i implementarea regulilor de bun practic de fabricacie (GMP) </b> <br><u>Atribucii: </u></td> </tr> <tr> <td><br> </td></tr> <tr> <td colspan=2 style='text-align: left; font-size: 11px;font-family: Verdana;'> <tr> <td colspan=2 style='align: justify;'> <ul> <li>Sarcina de baz a Secciei este evaluarea farmaceutic a produselor medicamentoase, de coordonare în domeniul industriei farmaceutice nacionale _i implementarea regulilor de bun practic de fabricacie (GMP). Realizând sarcina principal Seccia evaluare farmaceutic cu grupele de coordonare în domeniul medicamentului, industriei farmaceutice nacionale _i implementarea regulilor de bun practic de fabricacie (GMP) exercit urmtoarele funccii de baz: </li> <ol> <li> Expertiza respectrii regulilor de bun practic de fabricacie. </li> <li> Eliberarea Autorizaciilor de fabricacie pentru produsele medicamentoase fabricate de productori autohtoni. </li> <li> Expertiza fluxurilor tehnologice _i condiciilor de fabricacie a produselor medicamentoase _i produselor parafarmacetice în întreprinderile farmaceutice industriale. </li> <li> Expertiza proiectelor de regulamente tehnologice _i proceduri operacionale pentru fabricarea medicamentelor. </li> <li> Expertiza proiectelor de documente analitico-normative (Monografii farmacopeice temporare, Monografii farmacopeice, Specificacii de normare a calitcii produselor farmaceutice, Standarde nacionale _i de ramur) _i evaluarea calitcii _i conformitcii metodelor de analiz a seriilor experimentale de produse farmaceutice. </li> <li> Studii de stabilitate a substancelor _i a formelor medicamentoase. </li> <li> Elaborarea _i perfeccionarea metodelor de analiz _i criteriilor de standardizare a preparatelor medicamentoase. </li> <li> Elaborarea indicaciilor metodice necesare pentru implementarea RBPF _i controlul îndeplinirii de ctre unitcile productoare de medicamente ale acestor reguli. </li> <li> Elaborarea actelor normative pentru fabricarea medicamentelor în Republica Moldova. : </li> <li> Participarea la elaborarea proiectelor de acte legislative _i normative, ordinelor Ministerului Sntcii, materialelor metodice ce asigur calitatea _i controlul calitcii preparatelor medicamentoase fabricate în Republica Moldova. </li> <li> Organizarea seminarelor _i conferincelor _tiincifico-practice cu colaboratorii întreprinderilor productoare de medicamente _i ajutorul lor consultativ. </li> <li> Participarea la perfeccionarea speciali_tilor ce activeaz în domeniul fabricaciei de medicamente. </li> <li> Studierea proprietcilor farmaceutice ale substancelor _i compu_ilor biologic activi. </li> <li> Determinarea concentraciei substancelor medicamentoase în medii biologice. </li> <li> Investigarea farmacocineticii individuale. </li> <li> Expertiza dosarelor de bioechivalenc a preparatelor medicamentoase. </li> <li> Supravegherea studiilor de bioechivalenc. <td colspan=2 style='text-align: left; font-size: 11px;font-family: Verdana;'> <tr> <td colspan=2 style='align: justify;'> <ul> <li>Seccia evaluare farmaceutic cu grupele de coordonare în domeniul medicamentului, industriei farmaceutice nacionale _i implementarea regulilor de bun practic de fabricacie (GMP) prezint conducerii Agenciei Medicamentului darea de seam despre activitatea sa. Seccia evaluare farmaceutic cu grupele de coordonare în domeniul medicamentului, industriei farmaceutice nacionale _i implementarea regulilor de bun practic de fabricacie (GMP) activeaz în colaborare cu instituciile de profil din car _i de peste hotare. <li>Colaboratorii Seccia evaluare farmaceutic cu grupele de coordonare în domeniul medicamentului, industriei farmaceutice nacionale _i implementarea regulilor de bun practic de fabricacie (GMP) realizeaz funcciile suplimentare: <ol type='a'> <li>Organizarea _i participarea la forurile internacionale, conferince _tiincifico-practice, expozicii. <li>Activitatea în organizaciile ob_te_ti:  Asociacia Farmaci_tilor ,  Asociacia productorilor de medicamente din Republica Moldova . <li>Alte funccii ce cin de activitatea farmaceutic _i nu contravin actelor legislative _i normativelor legale. <td colspan=2 style='text-align: left; font-size: 11px;font-family: Verdana;'> <tr> <td colspan=2 style='align: justify;'> <ul> <li><a href='ordine/Grafic.doc' style='color: black;'> <b> Graficul de inspectare a întreprinderilor farmaceutice industriale pentru anul 2007</b> </a> <br></a> <br> <li><a href='ordine/Lista.pdf' style='color: black;'> <b> Lista documentelor necesare pentru completarea Dosarului întreprinderii </b> </a> <tr> <td colspan=2 align=justify> &nbsp; </td> </tr> <tr> <td><br><br><br> </td></tr> </table> <img src="fon5_2.gif" align=center border=0> </TD> <td valign=top > <div id="left_corner" align=center> <br><br><br> </div> <table width='190px' style='align: center;' border=0 cellpadding=0> <tr> <td style="font-size: 12px; text-align: center; "> <a href='http://ceacm.amed.md' target=_blank > <img src='Banner.gif' style='border: 0px solid green; ' alt='Verificati autenticitatea medicamentelor' > </a> <br> <br> <br> </td> </tr> <tr> <td style="font-size: 12px; text-align: center; "> <a href='cim.am.html' target=_blank > <img src='cim_t.gif' style='border: 1px solid green; ' alt='Centrul de Informatie despre Medicamente' > </a> <br> <br> </td> </tr> <tr> <td style="font-size: 12px; text-align: center; color: navy;"> <b>Noutci</b> </td> </tr> <tr> <td style="font-size: 12px; text-align: center;"> <br> <a href='studii.html' target=_blank> <img src=stud_2.gif style='border: 1px solid green;'> </a> </td> </tr> </table> </td> </TR> </TABLE> <TABLE align=center border=0 width="998" cellpadding="8" cellspacing="0" style="background-image:url('images2/fon5.bmp'); background-repeat: repeat;"> <tr> <td width=370 align=center style="font-size: 9px; font-family: Verdana; border-top: 3px solid #277797;"> <u>Adresa</u> <br> MD-2028, Republica Moldova, Chi_inu <br> str. Korolenko 2/1 <br> tel. (+373 22) 73-70-02 (anticamera) <br> <img src=images2/mail.gif align=middle> &nbsp;&nbsp; e-mail:<a href="mailto:office@amed.md" style="color: red;">office@amed.md</a><br> </td> <td valign=center align=center style="font-size: 9px; font-family: Verdana; border-top: 3px solid #277797;"> <!-- Start | SUPER.MD v2 | ID#6460 --> <SCRIPT language=JavaScript> <!--// st="<A HREF='http://super.md/' TARGET='_top'><img src='http://v1.super.md/?col=0099ff00;b=a;id=6460;v=2;je="; st+=((navigator.javaEnabled()==true)?"y":"n"); st+=";pp="+escape(document.referrer)+";cp="+escape(window.location.href); st+=";sh="+screen.height+";sw="+screen.width+";sc="+screen.colorDepth; st+="' border='0' alt='super.md'></A>"; document.write(st); //--></SCRIPT> <NOSCRIPT> <A HREF="http://super.md/" TARGET="_top"><IMG SRC="http://v1.super.md/?col=0099ff00;b=a;id=6460;v=2;je=0" alt="super.md"></A> </NOSCRIPT> <!-- End | SUPER.MD v2 | ID# --> &nbsp;&nbsp;&nbsp;&nbsp; <!-- SpyLOG --> <script src="http://tools.spylog.ru/counter2.2.js" type="text/javascript" id="spylog_code" counter="827222" ></script> <noscript> <a href="http://u8272.22.spylog.com/cnt?cid=827222&f=3&p=0" target="_blank"> <img src="http://u8272.22.spylog.com/cnt?cid=827222&p=0&f=4" alt='SpyLOG' border='0' width=88 height=31 ></a> </noscript> <!--/ SpyLOG --> </td> <td width=370 align=center style="font-size: 9px; font-family: Verdana; border-top: 3px solid #277797;"> <u>Rechizite bancare </u><br> Beneficiar: Ministerul Financelor  Trezoreria Central <br> Agencia Medicamentului <br> Codul fiscal: 1006601004002 <br> Contul trezorerial: 440100112030100 <br> Contul bancar: 3359502 <br> Banca beneficiar: Ministerul Financelor  Trezoreria Central <br> Codul bncii: TREZMD2X<br> </td> </tr> </TABLE> </body> </html>