ORDIN   Nr. 95 din  6 februarie 2003

pentru aprobarea Hotararii Consiliului Stiintific al Agentiei Nationale a Medicamentului nr. 7 din 17 ianuarie 2003 referitoare la modificarea incadrarii unor preparate farmaceutice in categoria Separanda sau Venena, din Farmacopeea Romana, editia a X-a

ACT EMIS DE: MINISTERUL SANATATII SI FAMILIEI

ACT PUBLICAT IN: MONITORUL OFICIAL  NR. 149 din  7 martie 2003

    Avand in vedere prevederile alin. (9) al art. 10 din Ordonanta Guvernului nr. 125/1998 privind infiintarea, organizarea si functionarea Agentiei Nationale a Medicamentului, aprobata cu modificari si completari prin Legea nr. 594/2002,
    vazand Referatul de aprobare nr. DB 964 din 5 februarie 2003 al Directiei generale farmaceutice,
    in temeiul Hotararii Guvernului nr. 22/2001 privind organizarea si functionarea Ministerului Sanatatii si Familiei, cu modificarile si completarile ulterioare,

    ministrul sanatatii si familiei emite urmatorul ordin:

    Art. 1
    Se aproba Hotararea Consiliului Stiintific al Agentiei Nationale a Medicamentului nr. 7 din 17 ianuarie 2003 referitoare la modificarea incadrarii unor preparate farmaceutice in categoria Separanda sau Venena, din Farmacopeea Romana, editia a X-a, prevazuta in anexa care face parte integranta din prezentul ordin.
    Art. 2
    Directiile din cadrul Ministerului Sanatatii si Familiei, ministerele cu retea sanitara proprie, agentii economici si toate unitatile care desfasoara activitati in scop medical cu substantele si produsele prevazute in anexa la prezentul ordin vor duce la indeplinire prevederile prezentului ordin.
    Art. 3
    Prezentul ordin se va publica in Monitorul Oficial al Romaniei, Partea I.

                        Ministrul sanatatii si familiei,
                                 Daniela Bartos

    ANEXA 1

                               HOTARAREA Nr. 7
                             din 17 ianuarie 2003
referitoare la modificarea incadrarii unor preparate farmaceutice in categoria Separanda sau Venena, din Farmacopeea Romana, editia a X-a

    Consiliul Stiintific al Agentiei Nationale a Medicamentului, constituit in baza ordinelor ministrului sanatatii si familiei nr. 30/2002 si nr. 995/2002, intrunit la convocarea presedintelui Agentiei Nationale a Medicamentului in sedinta ordinara din data de 17 ianuarie 2003,
    in conformitate cu art. 10 din Ordonanta Guvernului nr. 125/1998 privind infiintarea, organizarea si functionarea Agentiei Nationale a Medicamentului, aprobata cu modificari si completari prin Legea nr. 594/2002,

    adopta urmatoarea hotarare:

    Art. 1
    Se aproba eliminarea termenilor Separanda si Venena privind conditiile de conservare prevazute in monografiile preparatelor farmaceutice din Farmacopeea Romana, editia a X-a, inscrise in anexa nr. I*).
    Art. 2
    Se aproba modificarea tabelelor Separanda si Venena din Farmacopeea Romana, editia a X-a, conform anexelor nr. II*) si III*), in concordanta cu prevederile art. 1.
------------
    *) Tabelele Separanda si Venena, modificate prin prezenta hotarare, precum si precizarea conditiilor de conservare la monografiile din anexa nr. I vor fi publicate in Suplimentul 2003 al Farmacopeei Romane, editia a X-a.

    Art. 3
    Prezenta hotarare se va aproba prin ordin al ministrului sanatatii si familiei si va fi publicata in Monitorul Oficial al Romaniei, Partea I.

                  Presedintele Consiliului Stiintific al
                   Agentiei Nationale a Medicamentului,
                       acad. prof. dr. Victor Voicu

    ANEXA 1 *1)
    la hotarare

    *1) Anexa nr. I este reprodusa in facsimil.

    Se elimina termenul Separanda de la conditiile de conservare din urmatoarele monografii de preparate farmaceutice din FRX:

    CAPSULAE CYCLOPHOSFAMIDI
    CAPSULAE RETINOLI ACETATIS
    COMPRESSI ACIDII NICOTINICI
    COMPRESSI DIGITALIS
    COMPRESSI ETHINYLESTRADIOLI COMPRESSI
    HYDROXYPROGESTERONI ACETAS
    COMPRESSI ISONIASIDI
    COMPRESSI METAMIZOLI NATRICI
    COMPRESSI METHYLTESTOSTERONI
    COMPRESSI PHENYTOINI
    COMPRESSl TAMOXIFENI CITRATIS
    COMPRESSI OBDUCTI AMITRIPTTYLINI HYDROCHLORIDI
    COMPRESSl OBDUCTI NORTRIPTYLINI HYDROCHLORIDI
    INJECTABILE AMITRIPTTYLINI HYDROCHLORIDI
    INJECTABILE COFFEINI ET NATTRII BENZOATIS
    INJECTABILE GLYCERYLI TRINITRATIS
    INJECTABILE HYDROXYPROGESTERONI CAPROATIS
    INJECTABILE LIDOCAINI HYDROCHLORIDI
    INJECTABILE PAPAVERINI HYDROCHLORIDI
    INJECTABILE PROCAINI HYDROCLORIDI
    INJECTABILE PROCAINI HYDROCLORIDI
    SIRUPUS BELLADONNAE
    SOLUTIO IODI SPIRITUOSA
    SOLUTIO PHENYLHYDRARGYRI BORATIS 0,2%
    ==================================================
    Se elimina termenul Venena de la conditiile de conservare din urmatoarele monografii de preparate farmaceutice din FRX:

    COMPRESSI DIGOXINI
    COMPRESSI COLCHICINI
    COMPRESSl OBDUCTI LANATOSIDI C
    INJECTABILE DESLANOSIDI
    INJECTABILE DIGOXINI
    INJECTABILE METHYLERGOMETRINI HYDROGENOMALEATIS
    SOLUTIO DIGITOXINI 0,1%
    SOLUTIO DIGOXINI 0,05%
    SOLUTIO EPINEPHRINI 0,1%
    SOLUTIO IODI SPIRITUOSA
    SOLUTIO METHYLERGOMETRINI HYDROGENII MALEATIS

    ANEXA 2*)
    la hotarare

    *) Anexa nr. II este reprodusa in facsimil.

                                  SEPARANDA
 ____________________________________________________________________________
|      Substante active                    | Substante active si preparatele |
|                                          | farmaceutice care le contin     |
|__________________________________________|_________________________________|
| Acetazolamidum                           | Cyclobarbitalum                 |
| Acidum aceticum                          | Cyclobarbitalum calcicum        |
| Acidum hydrochloricum                    | Diazepamum                      |
| Acidum iopanoicum                        | Glutethimidum                   |
| Acidum lacticum                          | Imipramini hydrochloridum       |
| Acidum nicotinicum                       | Levomepromazini hydrogenomaleas |
| Acidum phosphoricum                      | Lithii carbonas                 |
| Aconiti tuber                            | Maprotilini hydrochloridum      |
| Aminoglutethimidum                       | Meprobamatum                    |
| Aminophyllinum                           | Nitrazepamum                    |
| Amitriptylini hydrochloridum             | Phenobarbitalum                 |
| Amobarbitalum natricum                   | Phenobarbitalum natricum        |
| Argenti nitras                           |                                 |
| Barbitalum                               |                                 |
| Barbitalum natricum                      |                                 |
| Belladonnae folium                       |                                 |
| Benzocainum                              |                                 |
| Bromisovalum                             |                                 |
| Butylscopolammonii bromidum              |                                 |
| Chinidini sulfas                         |                                 |
| Chinini hydrochloridum                   |                                 |
| Chinini sulfas                           |                                 |
| Chlordiazepoxidum                        |                                 |
| Chloropyramini hydrochloridum            |                                 |
| Clomipramini hydrochloridum              |                                 |
| Coffeinum                                |                                 |
| Coffeinum et acidum citricum             |                                 |
| Coffeinum et natrii benzoas              |                                 |
| Colecalciferolum                         |                                 |
| Cortisoni acetas                         |                                 |
| Cyclophosphamidum                        |                                 |
| Dequalinii chloridum                     |                                 |
| Desoxycortoni acetas                     |                                 |
| Dexamethasonum                           |                                 |
| Digitalis purpureae folium               |                                 |
| Digitalis purpureae pulvis titratus      |                                 |
| Dihydralazini sulfas                     |                                 |
| Disulfiramum                             |                                 |
| Ephedrini hydrochloridum                 |                                 |
| 4'-Epidoxorubicini hydrochloridum        |                                 |
| Ergocalciferolum                         |                                 |
| Ethacridini lactas                       |                                 |
| Ethinylestradiolum                       |                                 |
| Ethionamidum                             |                                 |
| Extractum Belladonnae siccum             |                                 |
| Furosemidum                              |                                 |
| Glyceryli trinitratis solutio concentrata|                                 |
| Guanethidini sulfas                      |                                 |
| Hydrargyri oxydum flavum                 |                                 |
| Hydrochlorothiazidum                     |                                 |
| Hydrocortisoni acetas                    |                                 |
| Hydrocortisoni hemisuccinas              |                                 |
| Hydrocortisonum                          |                                 |
| Hydroxyprogesteroni acetas               |                                 |
| Hydroxyprogesteroni caproas              |                                 |
| Indometacinum                            |                                 |
| Iodum                                    |                                 |
| Ipecacuanhae radix                       |                                 |
| Isoniazidum                              |                                 |
| Isoprenalini hydrochloridum              |                                 |
| Lidocaini hydrochloridum                 |                                 |
| Mepacrini hydrochloridum                 |                                 |
| Metamizolum natricum                     |                                 |
| Methotrexatum                            |                                 |
| Methyltestosteronum                      |                                 |
| Naphazolini hydrochloridum               |                                 |
| Natrii fluoridum                         |                                 |
| Natrii iodidum                           |                                 |
| Natrii nitris                            |                                 |
| Nifedipinum                              |                                 |
| Nitrofurantoinum                         |                                 |
| Northptylini hydrochloridum              |                                 |
| Noscapini hydrochloridum                 |                                 |
| Papaverini hydrochloridum                |                                 |
| Paracetamolum                            |                                 |
| Pentaerithrityli tetranitras dilutum     |                                 |
| Phenylhydrargyri boras                   |                                 |
| Phenytoinum                              |                                 |
| Podophylli resina                        |                                 |
| Prednisoloni acetas                      |                                 |
| Prednisolonum                            |                                 |
| Prednisoni acetas                        |                                 |
| Prednisonum                              |                                 |
| Primidonum                               |                                 |
| Procaini hydrochloridum                  |                                 |
| Prochlorperazini hydrogenomaleas         |                                 |
| Progesteronum                            |                                 |
| Promethazini hydrogenomaleas             |                                 |
| Propranololi hydrochloridum              |                                 |
| Pyrazinamidum                            |                                 |
| Resorcinolum                             |                                 |
| Retinoli acetatis solutio oleosa         |                                 |
| Solutio hydrogenii peroxydi concentrata  |                                 |
| Sparteini sulfas                         |                                 |
| Tamoxifeni citras                        |                                 |
| Testosteroni phenylpropionas             |                                 |
| Testosteroni propionas                   |                                 |
| Theobrominum                             |                                 |
| Theophyllinum                            |                                 |
| Tinctura Aconiti                         |                                 |
| Tinctura Belladonnae                     |                                 |
| Tolbutamidum                             |                                 |
| Triamcinoloni acetonidum                 |                                 |
| Trifluoperazini dihydrochloridum         |                                 |
| Trihexyphenidyli hydrochloridum          |                                 |
| Trimethoprimum                           |                                 |
| Xantinoli nicotinas                      |                                 |
| Zinci chloridum                          |                                 |
| Zinci sulfas                             |                                 |
|__________________________________________|_________________________________|

    ANEXA 3 *1)
    la hotarare

    *1) Anexa nr. III este reprodusa in facsimil.

                                VENENA
 _________________________________________________________________________
|                                   | Substante stupefiante si preparatele|
|    Substante puternic active      | farmaceutice care le contin         |
|___________________________________|_____________________________________|
| Acenocoumarolum                   | Cocaini hydrochloridum              |
| Amfetamini sulfas*)              | Codeini hydrochloridum*)            |
| Atropini sulfas                   | Codeini phosphas*)                  |
| Bromocriptini mesylas             | Codeinum*)                          |
| Clonidinum                        | Ethylmorphini hydrochloridum*)      |
| Colchicinum                       | Hydromorphoni hydrochloridum        |
| Deslanosidum                      | Methadoni hydrochloridum            |
| Digitoxinum                       | Morphini hydrochloridum             |
| Digoxinum                         | Opium                               |
| Dihydroergotamini mesylas         | Opium pulveratum                    |
| Epinephrinum                      | Pethidini hydrochloridum            |
| Ergometrini hydrogenomaleas       | Pulvis Opii et Ipecacuanhae         |
| Ergotamini tartras                | Tinctura anticholerina*)            |
| Histamini dihydrochloridum        | Tinctura Opii                       |
| Lanatosidum C                     |                                     |
| Methylergometrini hydrogenomaleas |                                     |
| Neostigmini bromidum              |                                     |
| Norepinephrini hydrogenotartras   |                                     |
| Physostigmini salicylas           |                                     |
| Pilocarpini hydrochloridum        |                                     |
| Pilocarpini nitras                |                                     |
| Reserpinum                        |                                     |
| Scopolamini hydrobromidum         |                                     |
|___________________________________|_____________________________________|
    *) Preparatele farmaceutice care contin aceste substante se pastreaza la Separanda, cu exceptia celor care se elibereaza fara prescriptie medicala (OTC) si a preparatelor magistrale, care se pastreaza in conditii normale.
    *) Preparatele farmaceutice care contin aceasta substanta se pastreaza la
Venena.