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ORDIN Nr

ORDIN   Nr. 858 din 17 septembrie 2003

pentru aprobarea modelului Raportului standard de evaluare a calitatii produselor medicamentoase

ACT EMIS DE: MINISTERUL SANATATII

ACT PUBLICAT IN: MONITORUL OFICIAL  NR. 708 din 10 octombrie 2003


SmartCity3


    Avand in vedere prevederile art. 10 alin. (9) 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, cu modificarile si completarile ulterioare,
    vazand Referatul de aprobare al Directiei generale farmaceutice, inspectia de farmacie si aparatura medicala nr. MB 3.350 din 3 septembrie 2003,
    in temeiul Hotararii Guvernului nr. 743/2003 privind organizarea si functionarea Ministerului Sanatatii,

    ministrul sanatatii emite urmatorul ordin:

    Art. 1
    Se aproba modelul Raportului standard de evaluare a calitatii produselor medicamentoase, potrivit anexei la prezentul ordin.
    Art. 2
    Agentia Nationala a Medicamentului, persoanele fizice si juridice interesate vor duce la indeplinire prevederile prezentului ordin.
    Art. 3
    Incepand cu data publicarii prezentului ordin toate prevederile contrare se abroga.
    Art. 4
    Prezentul ordin se va publica in Monitorul Oficial al Romaniei, Partea I.

                          Ministrul sanatatii,
                             Mircea Beuran

    ANEXA 1*)

    *) Anexa este reprodusa in facsimil.

                              RAPORT STANDARD
              de evaluare a calitatii produselor medicamentoase

 ______________________________________________________________________________
| Denumirea comerciala a produsului:                                           |
|______________________________________________________________________________|
| Forma farmaceutica, concentratia:                                            |
|______________________________________________________________________________|
| Denumirea substantei active:                                                 |
|______________________________________________________________________________|
| Producator:                                                                  |
|______________________________________________________________________________|
|I.A.      | DATE ADMINISTRATIVE                                       |punctaj|
|__________|___________________________________________________________|_______|
|        1.| Cerere de autorizare de punere pe piata                   |       |
|          |___________________________________________________________|_______|
|          | Certificatul produsului medicamentos in format OMS        |       |
|          | completat la toate rubricile si cu anexe                  |       |
|          |___________________________________________________________|_______|
|          | - numar, data:         |                                  |       |
|        2.|________________________|__________________________________|_______|
|          | - institutia emitenta: |                                  |       |
|          |________________________|__________________________________|_______|
|          | - valabilitate:        |                                  |       |
|          |________________________|__________________________________|_______|
|          |                              sau                          |       |
|__________|___________________________________________________________|_______|
|          | Certificat GMP                                            |       |
|          |___________________________________________________________|_______|
|          | - numar, data:         |                                  |       |
|          |________________________|__________________________________|_______|
|          | - institutia emitenta: |                                  |       |
|          |________________________|__________________________________|_______|
|          | - valabilitate:        |                                  |       |
|          |________________________|__________________________________|_______|
|          | Autorizatia de punere pe piata din:                       |       |
|        3.|___________________________________________________________|_______|
|          | - tara de origine:     |                                  |       |
|          |________________________|__________________________________|_______|
|          | - numar, data:         |                                  |       |
|          |________________________|__________________________________|_______|
|          | - institutia emitenta: |                                  |       |
|          |________________________|__________________________________|_______|
|          | - valabilitate         |                                  |       |
|          |________________________|__________________________________|_______|
|          | sau alte doua tari din UE*1) sau o tara membra a ICH*2):  |       |
|__________|___________________________________________________________|_______|
|          | Autorizatie de functionare (PR*3)                         |       |
|          |___________________________________________________________|_______|
|          | - numar, data:         |                                  |       |
|        4.|________________________|__________________________________|_______|
|          | - institutia emitenta: |                                  |       |
|          |________________________|__________________________________|_______|
|          | - valabilitate:        |                                  |       |
|__________|________________________|__________________________________|_______|
|I.B.1     | Rezumatul caracteristicilor produsului                    |       |
|__________|___________________________________________________________|_______|
|          | - in limba romana:                                        |       |
|          |___________________________________________________________|_______|
|          | - in engleza/franceza:                                    |       |
|__________|___________________________________________________________|_______|
|I.B.2.1   | Prospectul                                                |       |
|__________|___________________________________________________________|_______|
|          | - in limba romana:                                        |       |
|          |___________________________________________________________|_______|
|          | - in engleza/franceza:                                    |       |
|__________|___________________________________________________________|_______|
|I.B.2.2   | Propunere de ambalare si etichetare                       |       |
|__________|___________________________________________________________|_______|
|          |                                                           |       |
|__________|___________________________________________________________|_______|
|I.C.      | RAPORTUL EXPERTULUI ASUPRA DOCUMENTATIEI CHIMICO-         |       |
|          | FARMACEUTICE SI BIOLOGICE                                 |  1.00 |
|__________|___________________________________________________________|_______|
|I.C.1     | Evaluarea critica asupra:                                 |  0.70 |
|__________|___________________________________________________________|_______|
|          | - compozitiei produsului                                  |  0.05 |
|__________|___________________________________________________________|_______|
|          | - dezvoltarii farmaceutice                                |  0.05 |
|__________|___________________________________________________________|_______|
|          | - stereoizomerismului                                     |  0.05 |
|__________|___________________________________________________________|_______|
|          | - metodei de preparare                                    |  0.05 |
|__________|___________________________________________________________|_______|
|          | - validarii procesului                                    |  0.05 |
|__________|___________________________________________________________|_______|
|          | - controlului s.a. prevazute in farmacopee                |  0.05 |
|__________|___________________________________________________________|_______|
|          | - controlului s.a. neprevazute in farmacopee              |  0.05 |
|__________|___________________________________________________________|_______|
|          | - excipientilor                                           |  0.05 |
|__________|___________________________________________________________|_______|
|          | - materialului pentru ambalajul primar                    |  0.05 |
|__________|___________________________________________________________|_______|
|          | - testelor de control pentru produsii intermediari        |  0.05 |
|__________|___________________________________________________________|_______|
|          | - testelor de control pentru produsul finit               |  0.05 |
|__________|___________________________________________________________|_______|
|          | - stabilitatii substantei active                          |  0.05 |
|__________|___________________________________________________________|_______|
|          | - stabilitatii produsului finit                           |  0.05 |
|__________|___________________________________________________________|_______|
|          | - alte informatii                                         |  0.05 |
|__________|___________________________________________________________|_______|
|          |                                                           |       |
|__________|___________________________________________________________|_______|
|I.C.2     | Partea tabulara                                           |  0.20 |
|__________|___________________________________________________________|_______|
|          |                                                           |       |
|__________|___________________________________________________________|_______|
|I.C.3     | Informatii asupra calificarii si experientei expertului   |  0.10 |
|__________|___________________________________________________________|_______|
|          |                                                           |       |
|          |___________________________________________________________|_______|
|          |    Opinia evaluatorului despre calitatea raportului expertului    |
|          |___________________________________________________________________|
|          |                                                                   |
|__________|___________________________________________________________________|
|II.       | DOCUMENTATIA CHIMICO-FARMACEUTICA SI BIOLOGICA            |  2.00 |
|__________|___________________________________________________________|_______|
|II.A      | Compozitie                                                |       |
|__________|___________________________________________________________|_______|
|II.A.1    | Compozitia produsului medicamentos                        |  0.20 |
|__________|___________________________________________________________|_______|
|          | Componenta | Cantitate | Functia in formulare |     Referinta     |
|          |            |           |                      | privind calitatea |
|          |____________|___________|______________________|___________________|
|          |____________|___________|______________________|___________________|
|          |____________|___________|______________________|___________________|
|          |____________|___________|______________________|___________________|
|          |____________|___________|______________________|___________________|
|__________|____________|___________|______________________|___________________|
|II.A.2    | Recipient                                                 |  0.20 |
|__________|___________________________________________________________|_______|
|          |                                                           |       |
|__________|___________________________________________________________|_______|
|II.A.3    | Formula folosita in studiile clinice                      |  0.10 |
|__________|___________________________________________________________|_______|
|          | - identica cu formula produsului comercial                |       |
|__________|___________________________________________________________|_______|
|          | - diferita de formula produsului comercial                |       |
|__________|___________________________________________________________|_______|
|II.A.4    | Dezvoltarea farmaceutica                                  |  1.50 |
|__________|___________________________________________________________|_______|
|          | - explicarea alegerii formulei                            |  0.20 |
|__________|___________________________________________________________|_______|
|          | - explicarea alegerii procesului de fabricatie            |  0.20 |
|__________|___________________________________________________________|_______|
|          |              | - substantei active                        |  0.20 |
|          |              |____________________________________________|_______|
|          | - comentarii | - excipientilor                            |  0.20 |
|          |   asupra:    |____________________________________________|_______|
|          |              | - produsului finit                         |  0.20 |
|          |______________|____________________________________________|_______|
|          | - eventuala utilizare a supradozarii                      |  0.05 |
|          |___________________________________________________________|_______|
|          | - explicarea | - posibilitatea sorbtiei componentelor de  |       |
|          | alegerii     | catre container                            |       |
|          | materialelor |____________________________________________|  0.20 |
|          | de ambalare  | - posibilitatea cedarii unor componente din|       |
|          |              | materialul de ambalare                     |       |
|          |______________|____________________________________________|_______|
|          | - aspecte specifice pentru alte forme dozate              |  0.25 |
|          |___________________________________________________________|_______|
|          |   Opinia evaluatorului despre modul de prezentare a dezvoltarii   |
|          |                       farmaceutice                                |
|          |___________________________________________________________________|
|          |                                                                   |
|__________|___________________________________________________________________|
|II.B      | METODA DE PREPARARE                                       |  3.00 |
|__________|___________________________________________________________|_______|
|II.B.1    | Formula de fabricatie (inclusiv detalii despre marimea    |  0.30 |
|          | seriei)                                                   |       |
|__________|___________________________________________________________|_______|
|          |                                                                   |
|__________|___________________________________________________________________|
|II.B.2    | Procesul de fabricatie                                    |  1.70 |
|__________|___________________________________________________________|_______|
|          | - metoda de fabricatie                                    |  1.00 |
|          |___________________________________________________________|_______|
|          | - lista echipamentelor                                    |  0.10 |
|          |___________________________________________________________|_______|
|          | - control interfazic                                      |  0.50 |
|          |___________________________________________________________|_______|
|          | - schema de fabricatie                                    |  0.10 |
|__________|___________________________________________________________|_______|
|II.B.3    | Validarea procesului tehnologic                           |  1.00 |
|__________|___________________________________________________________|_______|
|          | - validare retrospectiva (minimum 10 serii)               |       |
|          |___________________________________________________________|_______|
|          |                              sau                          |       |
|          |___________________________________________________________|_______|
|          | - validare prospectiva (minimum 3 serii)                  |       |
|          |___________________________________________________________|_______|
|          |         Opinia evaluatorului despre metoda de preparare           |
|          |___________________________________________________________________|
|          |                                                                   |
|__________|___________________________________________________________________|
|II.C      | CONTROLUL MATERIILOR PRIME                                |  4.00 |
|__________|___________________________________________________________|_______|
|II.C.1    | Substanta/substantele activa/active                       |  2.00 |
|__________|___________________________________________________________|_______|
|          | - producatorul substantei active                          |  0.10 |
|__________|___________________________________________________________|_______|
|II.C.1.1  | Specificatii si teste de rutina                           |  0.50 |
|__________|___________________________________________________________|_______|
|II.C.1.1.1| Substanta activa descrisa in farmacopee                   |  0.40 |
|__________|___________________________________________________________|_______|
|          | - existenta certificatului de conformitate cu FE*4)       |  0.70 |
|          |___________________________________________________________|_______|
|          | - prezentarea parametrilor suplimentari, daca este cazul  |  0.20 |
|__________|___________________________________________________________|_______|
|          |                               sau                         |       |
|__________|___________________________________________________________|_______|
|II.C.1.1.2| Substanta activa nedescrisa in farmacopee si substanta    |       |
|si        | activa descrisa in farmacopee dar fara certificat de      |       |
|II.C.1.2  | conformitate cu FE*4)                                     |       |
|__________|___________________________________________________________|_______|
|          | Existenta DMF*5)-ului sau date stiintifice                |  1.30 |
|          |___________________________________________________________|_______|
|          | - nomenclatura                                            |  0.05 |
|          |___________________________________________________________|_______|
|          | - descriere                                               |  0.05 |
|          |___________________________________________________________|_______|
|          | - fabricatie                                              |  0.20 |
|          |___________________________________________________________|_______|
|          | - controlul de calitate in timpul fabricatiei             |  0.20 |
|          |___________________________________________________________|_______|
|          | - dezvoltarea chimica                                     |  0.20 |
|          |___________________________________________________________|_______|
|          | - impuritati                                              |  0.20 |
|          |___________________________________________________________|_______|
|          | - validarea metodelor de analiza                          |  0.20 |
|          |___________________________________________________________|_______|
|          | - studii de stabilitate                                   |  0.20 |
|          |___________________________________________________________|_______|
|          | - serii analizate                                         |  0.00 |
|          |___________________________________________________________|_______|
|          | - discutarea diferentelor, daca exista, intre nivelele    |  0.00 |
|          | de impuritati din seriile utilizate in studiile           |       |
|          | pre-clinice, clinice si seriile de productie              |       |
|__________|___________________________________________________________|_______|
|          | Buletine de analiza                                       |  0.10 |
|__________|___________________________________________________________|_______|
|II.C.2    | Excipienti                                                |  1.00 |
|__________|___________________________________________________________|_______|
|          | - mentionarea producatorilor                              |  0.00 |
|__________|___________________________________________________________|_______|
|II.C.2.1  | Specificatii si teste de rutina                           |       |
|__________|___________________________________________________________|_______|
|          | - excipienti descrisi in farmacopee                       |  0.70 |
|          |___________________________________________________________|_______|
|          |                              sau                          |       |
|          |___________________________________________________________|_______|
|          | - excipienti nedescrisi| - caracteristici fizice          |  0.05 |
|          | in farmacopee          |__________________________________|_______|
|          |                        | - teste de identificare          |  0.15 |
|          |                        |__________________________________|_______|
|          |                        | - teste de puritate cu limite    |  0.15 |
|          |                        | pentru impuritati definite       |       |
|          |                        |__________________________________|_______|
|          |                        | - teste fizice                   |  0.15 |
|          |                        |__________________________________|_______|
|          |                        | - teste chimice                  |  0.15 |
|          |                        |__________________________________|_______|
|          |                        | - alte teste                     |  0.05 |
|__________|________________________|__________________________________|_______|
|II.C.2.2  | Date stiintifice - pentru excipienti folositi pentru      |  0.20 |
|          | prima data la fabricatia produselor medicamentoase        |       |
|__________|___________________________________________________________|_______|
|          |                                                           |       |
|__________|___________________________________________________________|_______|
|          | Buletine de analiza                                       |  0.10 |
|__________|___________________________________________________________|_______|
|II.C.3    | Materiale de ambalare (ambalaj primar)                    |  1.00 |
|__________|___________________________________________________________|_______|
|          | - declararea producatorului*6)                            |  0.10 |
|__________|___________________________________________________________|_______|
|II.C.3.1  | Specificatii si teste de rutina                           |  0.50 |
|__________|___________________________________________________________|_______|
|          | - tip material                                            |  0.10 |
|          |___________________________________________________________|_______|
|          | - elementele containerului (denumire, descriere,          |  0.10 |
|          | dimensiuni)                                               |       |
|          |___________________________________________________________|_______|
|          | - schita containerului                                    |  0.15 |
|          |___________________________________________________________|_______|
|          | - specificatii de calitate si proceduri de testare        |  0.15 |
|__________|___________________________________________________________|_______|
|II.C.3.2  | Date stiintifice                                          |  0.30 |
|__________|___________________________________________________________|_______|
|          | - certificat de conformitate pentru materialul de         |  0.15 |
|          | executie a containerului sau alte tipuri de documente     |       |
|          |___________________________________________________________|_______|
|          | - compozitia materialului*6) (cu eventuali aditivi)       |  0.15 |
|__________|___________________________________________________________|_______|
|          | Buletine de analiza                                       |  0.10 |
|__________|___________________________________________________________|_______|
|          |     Opinia evaluatorului asupra controlului materiilor prime      |
|          |___________________________________________________________________|
|          |                                                                   |
|__________|___________________________________________________________________|
|II.D      | CONTROLUL PRODUSILOR INTERMEDIARI (daca este cazul)       |  0.20 |
|__________|___________________________________________________________|_______|
|          |                                                           |       |
|          |                                                           |       |
|          |                                                           |       |
|          |                                                           |       |
|          |                                                           |       |
|          |                                                           |       |
|__________|___________________________________________________________|_______|
|II.E      | CONTROLUL PRODUSULUI FINIT                                |  5.00 |
|__________|___________________________________________________________|_______|
|II.E.1    | Specificatii si teste de rutina pentru produsul finit     |       |
|__________|___________________________________________________________|_______|
|II.E.1.1  | Specificatiile produsului si testele la eliberare         |  2.25 |
|__________|___________________________________________________________|_______|
|          | a) Parametri de| - forma farmaceutica                     |  0.40 |
|          | calitate       |__________________________________________|_______|
|          | referitori la: | - compozitia| - substanta activa         |  0.25 |
|          |                | chimica     | (I*7), D*8))               |       |
|          |                |             |____________________________|       |
|          |                |             | - excipienti| - conservant |       |
|          |                |             |             | (I*7), D^8)) |       |
|          |                |             |             |______________|       |
|          |                |             |             | - edulcorant |       |
|          |                |             |             | (I*7))       |       |
|          |                |             |             |______________|       |
|          |                |             |             | - colorant   |       |
|          |                |             |             | (I*7))       |       |
|          |                |             |             |______________|       |
|          |                |             |             | - alti       |       |
|          |                |             |             | excipienti   |       |
|          |                |             |             | (I*7))       |       |
|          |                |_____________|_____________|______________|_______|
|          |                | - puritate chimica        | - produsi    |  0.50 |
|          |                |                           | inruditi     |       |
|          |                |                           |______________|       |
|          |                |                           | - produsi de |       |
|          |                |                           | degradare    |       |
|          |                |___________________________|______________|_______|
|          |                | - siguranta produsului    | - sterilitate|  0.30 |
|          |                |                           |______________|       |
|          |                |                           | - contaminare|       |
|          |                |                           | microbiana   |       |
|          |                |                           |______________|       |
|          |                |                           | - endotoxine |       |
|          |                |                           | bacteriene   |       |
|          |                |                           |______________|       |
|          |                |                           | - impuritati |       |
|          |                |                           | pirogene     |       |
|          |                |                           |______________|       |
|          |                |                           | - toleranta  |       |
|          |                |                           | locala       |       |
|          |________________|___________________________|______________|_______|
|          | b) Limite de   | - conform prevederilor farmacopeelor     |  0.30 |
|          | admisibilitate |__________________________________________|       |
|          |                | - conform unor prevederi speciale        |       |
|__________|________________|__________________________________________|_______|
|          | c) Metodologie de control                                 |  1.45 |
|__________|___________________________________________________________|_______|
|          | - principiul metodei                                      |  0.60 |
|          |___________________________________________________________|_______|
|          | - formula de calcul                                       |  0.40 |
|          |___________________________________________________________|_______|
|          | - echipamentul folosit                                    |  0.15 |
|          |___________________________________________________________|_______|
|          | - spectru anexat                                          |  0.10 |
|          |___________________________________________________________|_______|
|          | - cromatograma de referinta anexata                       |  0.20 |
|__________|___________________________________________________________|_______|
|          | d) Validare analitica                                     |  1.00 |
|__________|___________________________________________________________|_______|
|          |                | - protocol experimental                  |  0.30 |
|          |                |__________________________________________|_______|
|          |                | - rezultate                              |  0.30 |
|          |                |__________________________________________|_______|
|          |                | - spectre, cromatograme de referinta     |  0.10 |
|          |                |__________________________________________|_______|
|          |                | - interpretarea rezultatelor             |  0.30 |
|__________|________________|__________________________________________|_______|
|          | Buletine de analiza                                       |  0.15 |
|__________|___________________________________________________________|_______|
|          | Analiza seriilor                                          |  0.15 |
|          |___________________________________________________________|_______|
|          |   Opinia evaluatorului referitoare la controlul produsului finit  |
|          |___________________________________________________________________|
|          |                                                                   |
|__________|___________________________________________________________________|
|II.F      | TESTAREA STABILITATII                                     |  4.80 |
|__________|___________________________________________________________|_______|
|II.F.1    | Testarea stabilitatii substantei active                   |  1.50 |
|__________|___________________________________________________________|_______|
|          | - producatorul substantei active                          |  0.05 |
|__________|___________________________________________________________|_______|
|          | - locul de productie                                      |  0.05 |
|__________|___________________________________________________________|_______|
|          | - varianta/variantele de sinteza                          |  0.05 |
|__________|___________________________________________________________|_______|
|          | - seriile      | - numar                                  |  0.05 |
|          | testate        |__________________________________________|_______|
|          |                | - tip (industrial, pilot, experimental)  |  0.05 |
|          |                |__________________________________________|_______|
|          |                | - ambalaj                                |  0.05 |
|          |________________|__________________________________________|_______|
|          | - metodologia  | - in conditii de stres                   |  0.10 |
|          | de testare     |__________________________________________|_______|
|          |                | - in conditii accelerate                 |  0.15 |
|          |                |__________________________________________|_______|
|          |                | - pe termen lung                         |  0.15 |
|          |                |__________________________________________|_______|
|          |                | - testarea fotostabilitatii              |  0.10 |
|          |________________|__________________________________________|_______|
|          | - specificatia |                                          |  0.10 |
|          | de calitate    |                                          |       |
|          |________________|__________________________________________|_______|
|          | - procedurile  | - tipul de metoda                        |  0.15 |
|          | analitice de   |__________________________________________|_______|
|          | testare        | - validarea                              |  0.15 |
|          |________________|__________________________________________|_______|
|          | - rezultatele  |                                          |  0.10 |
|          | testelor       |                                          |       |
|          |________________|__________________________________________|_______|
|          | - concluziile  | - conditiile de depozitare pentru        |  0.05 |
|          | producatorului | perioada de valabilitate                 |       |
|          |                |__________________________________________|_______|
|          |                | - termen de valabilitate si/sau termen de|  0.05 |
|          |                | retestare propus                         |       |
|          |________________|__________________________________________|_______|
|          | - studii de stabilitate in curs de desfasurare            |  0.10 |
|__________|___________________________________________________________|_______|
|          |                                                           |       |
|__________|___________________________________________________________|_______|
|II.F.2    | TESTAREA STABILITATII PRODUSULUI FINIT                    |  3.30 |
|__________|___________________________________________________________|_______|
|          | - seriile testate      | - numar                          |  0.05 |
|          |                        |__________________________________|_______|
|          |                        | - tip (industrial, pilot,        |  0.10 |
|          |                        | experimental)                    |       |
|          |                        |__________________________________|_______|
|          |                        | - ambalaj                        |  0.05 |
|          |                        |__________________________________|_______|
|          |                        | - loc de productie pentru        |  0.05 |
|          |                        | produsul finit                   |       |
|          |                        |__________________________________|_______|
|          |                        | - declararea producatorului      |  0.10 |
|          |                        | substantei active, a calitatii   |       |
|          |                        | acesteia si, dupa caz, a         |       |
|          |                        | variantei de sinteza             |       |
|          |________________________|__________________________________|_______|
|          | - metodologia de       | - in conditii accelerate         |  0.25 |
|          | testare                |__________________________________|_______|
|          |                        | - pe termen lung                 |  0.40 |
|          |                        |__________________________________|_______|
|          |                        | - testarea fotostabilitatii      |  0.10 |
|          |________________________|__________________________________|_______|
|          | - procedurile analitice| - descriere                      |  0.35 |
|          | de testare             |__________________________________|_______|
|          |                        | - validare                       |  0.40 |
|          |________________________|__________________________________|_______|
|          | - rezultatele testelor, cromatograme si/sau spectre       |  0.40 |
|          | justificative                                             |       |
|          |___________________________________________________________|_______|
|          | - concluziile          | - specificatia de calitate pentru|  0.50 |
|          | producatorului         | perioada de valabilitate propusa |       |
|          |                        |__________________________________|_______|
|          |                        | - conditiile de depozitare pentru|  0.10 |
|          |                        | perioada de valabilitate         |       |
|          |                        |__________________________________|_______|
|          |                        | - termen de valabilitate propus  |  0.10 |
|          |________________________|__________________________________|_______|
|          | - studii de stabilitate in curs de desfasurare            |  0.20 |
|          |___________________________________________________________|_______|
|          | - studii de stabilitate pentru solutia reconstituita      |       |
|          | si/sau diluata (daca este cazul)                          |       |
|          |___________________________________________________________|_______|
|          | - metodologie de testare                                  |  0.10 |
|          |___________________________________________________________|_______|
|          | - concluziile          | - termen de valabilitate propus  |  0.05 |
|          | producatorului         |__________________________________|       |
|          |                        | - conditiile de depozitare pentru|       |
|          |                        | perioada de valabilitate         |       |
|          |________________________|__________________________________|_______|
|          |                              sau                                  |
|          |___________________________________________________________________|
|          | - studii de stabilitate dupa prima deschidere (daca este  |       |
|          | cazul)                                                    |       |
|          |___________________________________________________________|_______|
|          | - metodologie de testare                                  |  0.10 |
|          |___________________________________________________________|_______|
|          | - concluziile          | - termen de valabilitate propus  |  0.05 |
|          | producatorului         |__________________________________|       |
|          |                        | - conditiile de depozitare pentru|       |
|          |                        | perioada de valabilitate         |       |
|          |________________________|__________________________________|_______|
|          |     Opinia evaluatorului in legatura cu testarea stabilitatii     |
|          |___________________________________________________________________|
|          |                                                                   |
|__________|___________________________________________________________________|
|            CONCLUZIE PRIVIND CONTINUTUL DOCUMENTATIEI DEPUSE                 |
|______________________________________________________________________________|
|          |                                                                   |
|          |                                                                   |
|          |                                                                   |
|          |                                                                   |
|          |                                                                   |
|          |                                                                   |
|          |                                                                   |
|__________|___________________________________________________________________|

    NOTA:
    1. Punctaj maxim: 20 puncte
    2. Punctaj minim pentru aprobarea autorizatiei de punere pe piata: 19 puncte
    3. Punctaj pentru solicitare de completari: 12.0 - 18.9 puncte
    4. Punctaj pentru respingerea autorizatiei de punere pe piata: <12 puncte
    5. In situatia in care un capitol sau subcapitol nu se aplica se puncteaza cu punctajul maxim.
------------
    *1) UE = Uniunea Europeana
    *2) ICH = International Conference on Harmonization (Conferinta Internationala pentru Armonizare)
    *3) PR = produse romanesti
    *4) FE = Farmacopeea Europeana
    *5) DMF = Drug Master File
    *6) obligatorie numai pentru ambalaje din plastic pentru preparate oftalmice si injectabile
    *7) I = identificare
    *8) D= dozare



SmartCity5

COMENTARII la Ordinul 858/2003

Momentan nu exista niciun comentariu la Ordinul 858 din 2003
Comentarii la alte acte
ANONIM a comentat Decretul 276 1997
    I Almost Lost All My Fonte To Divorce Get Help With WRAITH HACKERS RECOVERY Did you know that there are professional private investigators who can help you obtain information on your spouse, including texts/calls and erased messages if he/she attempts to act smart and deletes them? This can aid you with your divorce process, which the lawyer will require. Contact Wraith Hacker Recovery. They can follow their location using live GPS, monitor text messages, WhatsApp, and Snapchat, recover deleted conversations, and handle any issues. All of this is done with no traces. They will show you how they will hack and allow you access to SPY on their phone. https://wraithhackers.com/ https://t.me/wraithhacks Whatsapp number: +1 (667) 349-1550 Write to wraithhacks@protonmail.com
ANONIM a comentat Rectificare 158 2015
    ASSISTANCE IN HELPING RECOVERY LOST CRYPTO FUNDS Hire WRAITH HACKERS RECOVERY I’d like to share my experience after falling victim to a cryptocurrency scam and losing $11,500 amount of money. I had invested in what I believed was a legitimate platform, but everything changed when I attempted to withdraw my funds and encountered unexpected problems. During this difficult situation, I came across Wraith Hackers Recovery and decided to reach out for assistance. I’m grateful that I did. Their team was professional, knowledgeable, and supportive throughout the process, taking the time to explain the steps involved and guide me through the recovery efforts. With their assistance, I was able to recover $9,978 of the funds I had lost. htt ps:// wraithhackers. com/ htt ps:// t.me / wraithhacks Whatsapp number: +1 (667) 349-1550 Write to wraithhacks @ protonmail. com
ANONIM a comentat Ordin 335 2021
    Legitimate Crypto Recovery Companies 2026 Hire WRAITH HACKERS RECOVERY At Wraith Hackers Recovery, the team is committed to providing professional cryptocurrency recovery support through advanced technology, expertise, and transparent communication. They aim to keep up with developments in the field while helping clients understand their available options. If you’ve lost cryptocurrency through a scam or fraud, you can contact Wraith Hackers Recovery to learn more about their services, recovery process, and requirements. https://wraithhackers.com/ https://t.me/wraithhacks Whatsapp number: +1 (667) 349-1550 Write to wraithhacks@protonmail.com.
ANONIM a comentat Ordin 38 2002
    HIRE A LICENSED CRYPTO RECOVERY EXPERT Hire WRAITH HACKERS RECOVERY I’m sharing my personal experience of how I sought help after becoming a victim of a cryptocurrency scam. I had invested a significant amount of money through what I believed was a legitimate platform, but everything changed when I attempted to withdraw my funds and encountered difficulties. Unsure of what to do next, I began looking for assistance and came across Wraith Hackers Recovery. I decided to contact them to learn more about my options, and I’m grateful that I did. Throughout the process, I received guidance and support that helped me better understand the steps involved in attempting to recover my lost funds. With their assistance, I was able to recover a substantial portion of the money I had lost. The experience was extremely stressful, but having support throughout the process made a significant difference for me. https://wraithhackers.com/ https://t.me/wraithhacks Whatsapp number: +1 (667) 349-1550 Write to wraithhacks@protonmail.com.
ANONIM a comentat Ordin 1287 2007
    usually don’t comment on these threads but this one hit close. Short version: hired the dark web ethical hacking and cybersecurity firm CyberH4cks. com paid about $55k USD, never used a single file in court, still worth it. Longer version: my ex was telling everyone (including the kids) that I cheated, that she was the victim, etc. Meanwhile I had suspicions but nothing concrete. What made the military grade hackers at CyberH4cks different from local PIs was that they weren’t limited to Instagram screenshots and parking-lot photos. A lot of modern infidelity leaves digital exhaust in places most people never look encrypted comms, burner accounts, stuff that lives off the regular web. we eventually opened a case with them on telegram with cellphone number +1 551 414 8634 (@cyberh4cks) They explained (in plain English) that some of that intelligence only exists in dark-web forums and data brokers you access via Tor / onion routing. Again they did that part, not me. I never even asked for the raw material. Didn’t want it. All that mattered was that my ex found out an independent forensic team had already pieced together the timeline. After that? Completely different person. Cooperative. Reasonable. Quiet. The kids stopped hearing nonsense. Divorce wrapped fast. That’s what I paid for.
ANONIM a comentat Decretul 360 2017
    How Marv Web Can Assist in Cryptocurrency Recovery The recovery of cryptocurrencies has been revolutionized by MARV Web. They are incredibly quick and effective, making sure that every procedure goes without a hitch. Their customer support is always accessible and friendly, and their service is unmatched in terms of dependability. I've never felt more confident or comfortable about my ability to properly recover my cryptocurrency holdings. Because of their exceptional quickness, dependability, and effectiveness in bitcoin recovery, MARV Web stands out in the industry and is highly recommended! They can be reached at: Email address: marv.web@mail.com WhatsApp;+601126730582 Web;https://marvweb9.wixsite.com/marv-web-crypto-expe
ANONIM a comentat Legea 266 2001
    How Marv Web Can Assist in Cryptocurrency Recovery The recovery of cryptocurrencies has been revolutionized by MARV Web. They are incredibly quick and effective, making sure that every procedure goes without a hitch. Their customer support is always accessible and friendly, and their service is unmatched in terms of dependability. I've never felt more confident or comfortable about my ability to properly recover my cryptocurrency holdings. Because of their exceptional quickness, dependability, and effectiveness in bitcoin recovery, MARV Web stands out in the industry and is highly recommended! They can be reached at: Email address: marv.web@mail.com WhatsApp;+601126730582 Web;https://marvweb9.wixsite.com/marv-web-crypto-expe
ANONIM a comentat Decizia 220 2018
    Buongiorno E-mail: giovannidinatale1954@­gmail.­com Offerte individuali in denaro da 2.000 a 5.200.000, con un tasso di interesse è rimborsabile del 3% in un periodo compreso tra 2 e 30 anni. Condizioni ragionevoli se la mia offerta ti interessa contattami di più rapidamente per discutere le modalità e documenti da fornire. giovannidinatale1954@­gmail.­com
ANONIM a comentat Decizia 220 2018
    Buongiorno E-mail: giovannidinatale1954@­gmail.­com Offerte individuali in denaro da 2.000 a 5.200.000, con un tasso di interesse è rimborsabile del 3% in un periodo compreso tra 2 e 30 anni. Condizioni ragionevoli se la mia offerta ti interessa contattami di più rapidamente per discutere le modalità e documenti da fornire. giovannidinatale1954@­gmail.­com
ANONIM a comentat Decretul 358 1948
    What type of loan do you need? Personal loan Car loan Refinancing Mortgage Business capital (start or expand your business) Have you lost hope and think that there is no way out, but your financial problems are still not gone? Do not hesitate to contact us for possible business cooperation. Contact us (WhatsApp) number +918131851434 contact email id : sumitihomelend@gmail.com Mr. Damian Sumiti
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