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

    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