natgillin/translations-raw huggingface dataset:
The usual terminology to be used in describing the constituents of veterinary medicinal products means, notwithstanding the application of the other provisions of Article 12(3)(c):
Za učinkovine, ki so prisotne v obliki spojin ali derivatov, se količina izrazi s celotno maso, in če je potrebno ali ustrezno, z maso aktivnega dela ali delov molekule.
in respect of constituents which appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeia of one of the Member States, the main title at the head of the monograph in question, with reference to the pharmacopoeia concerned,
Pri zdravilih za uporabo v veterinarski medicini, ki vsebujejo učinkovino, ki je prvič predmet vloge za pridobitev dovoljenja za promet z zdravilom v kateri koli državi članici, se količina učinkovine, ki je sol ali hidrat, sistematično izrazi z maso aktivnega dela ali delov molekule.
in respect of other constituents, the international non-proprietary name (INN) recommended by the World Health Organisation (WHO), which may be accompanied by another non-proprietary name, or, failing these, the exact scientific designation; constituents not having an international non-proprietary name or an exact scientific designation shall be described by a statement of how and from what they were prepared, supplemented, where appropriate, by any other relevant details,
Pri vseh zdravilih za uporabo v veterinarski medicini, ki pozneje pridobijo dovoljenje za promet v državah članicah, se količinska sestava za isto učinkovino izrazi na enak način.
in respect of colouring matter, designation by the ‘E’ code assigned to them by Council Directive 78/25/EEC.
Farmacevtski razvoj
Quantitative particulars
Predloži se obrazložitev izbire sestave, sestavin, stične ovojnine, mogočih nadaljnjih ovojnin, zunanje ovojnine, če je ustrezno, predvidene funkcije pomožnih snovi v končnem zdravilu in proizvodnem postopku končnega proizvoda.
In order to give ‘quantitative particulars’ of all the active substances of the veterinary medicinal products, it is necessary, depending on the pharmaceutical form concerned, to specify the mass, or the number of units of biological activity, either per dosage-unit or per unit of mass or volume, of each active substance.
Obrazložitev se podpre z znanstvenimi podatki o farmacevtskem razvoju.
Units of biological activity shall be used for substances, which cannot be defined chemically.
Navede in obrazloži se presežek.
Where an International Unit of biological activity has been defined by the World Health Organisation, this shall be used.
Dokaže se, da mikrobiološke lastnosti (mikrobiološka čistost in protimikrobna aktivnost) in navodila za uporabo ustrezajo predvideni uporabi zdravila za uporabo v veterinarski medicini, kakor je opredeljeno v vlogi za pridobitev dovoljenja za promet z zdravilom.
Where no International Unit has been defined, the units of biological activity shall be expressed in such a way as to provide unambiguous information on the activity of the substances by using where applicable the European Pharmacopoeia Units.
B. OPIS NAČINA PROIZVODNJE
Whenever possible, biological activity per units of mass or volume shall be indicated.
Navedejo se ime, naslov in odgovornost vsakega proizvajalca ter vsak predlagani obrat izdelave ali objekt, vključen v proizvodnjo in preskušanje.
This information shall be supplemented:
Opis proizvodnega postopka, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu z členom 12(3)(d), se pripravi tako, da poda ustrezen strnjen pregled značilnosti uporabljenih postopkov.
in respect of single-dose preparations, by the mass or units of biological activity of each active substance in the unit container, taking into account the usable volume of the product, after reconstitution, where appropriate,
V ta namen opis vsebuje najmanj:
in respect of veterinary medicinal products to be administered by drops, by the mass or units of biological activity of each active substance contained per drop or contained in the number of drops corresponding to 1 ml or 1 g of the preparation,
navedbo različnih stopenj proizvodnje, tako da se lahko pripravi ocena, ali bi uporabljeni postopek pri izdelavi farmacevtske oblike lahko povzročil neželeno spremembo sestavin,
in respect of syrups, emulsions, granular preparations and other pharmaceutical forms to be administered in measured quantities, by the mass or units of biological activity of each active substance per measured quantity.
v primeru neprekinjene proizvodnje podrobne podatke o izvajanih varnostnih ukrepih, ki zagotavljajo homogenost končnega zdravila,
Active substances present in the form of compounds or derivatives shall be described quantitatively by their total mass, and if necessary or relevant, by the mass of the active entity or entities of the molecule.
dejansko proizvodno formulo s podrobnimi podatki o količini vseh uporabljenih snovi, količini pomožnih snovi ali s približnimi navedki, če tako zahteva farmacevtska oblika; navedejo se vse snovi, ki se v postopku proizvodnje zdravila lahko izgubijo; navedejo in utemeljijo se vsi presežki,
For veterinary medicinal products containing an active substance which is the subject of an application for marketing authorisation in any Member State for the first time, the quantitative statement of an active substance which is a salt or hydrate shall be systematically expressed in terms of the mass of the active entity or entities in the molecule.
navedbo stopenj proizvodnje, pri katerih se opravi vzorčenje za kontrolne preskuse med izdelavo, in uporabljenih omejitev, kadar drugi podatki v dokumentih, ki spremljajo vlogo, kažejo, da so ti preskusi potrebni za nadzor kakovosti končnega proizvoda,
All subsequently authorised veterinary medicinal products in the Member States shall have their quantitative composition stated in the same way for the same active substance.
eksperimentalne študije, ki potrjujejo proizvodni postopek, in po potrebi shemo postopka potrditve za serije obsega proizvodnje,
Development pharmaceutics
pri sterilnih zdravilih, kadar se uporabljajo standardne sterilizacijske razmere, ki niso navedene v farmakopeji, podrobne podatke o uporabljenih postopkih sterilizacije in/ali postopkih asepse.
An explanation shall be provided with regard to the choice of composition, constituents, immediate packaging, possible further packaging, outer packaging if relevant, the intended function of the excipients in the finished product and the method of manufacture of the finished product.
C. KONTROLA VHODNIH SNOVI
This explanation shall be supported by scientific data on development pharmaceutics.
Splošne zahteve
The overage, with justification thereof, shall be stated.
V tem odstavku so „vhodne snovi“ vse sestavine zdravila za uporabo v veterinarski medicini in po potrebi sestavine njegovega vsebnika, vključno s sistemom zapiranja, kakor je navedeno v točki 1 oddelka A zgoraj.
The microbiological characteristics (microbiological purity and antimicrobial activity) and usage instructions shall be proven to be appropriate for the intended use of the veterinary medicinal product as specified in the marketing authorisation application dossier.
V vlogi se navedejo specifikacije in informacije o preskusih, ki se izvajajo za nadzor kakovosti vseh serij vhodnih snovi.
B. DESCRIPTION OF THE MANUFACTURING METHOD
Rutinski preskusi, ki se izvajajo za vsako serijo vhodnih snovi, morajo biti taki, kot so bili navedeni v vlogi za pridobitev dovoljenja za promet z zdravilom.
The name, address and responsibility of each manufacturer and each proposed production site or facility involved in manufacturing and testing shall be indicated.
Če se uporabljajo še preskusi, ki niso navedeni v farmakopeji, se predložijo dokazi, da vhodne snovi izpolnjujejo zahteve glede kakovosti iz te farmakopeje.
The description of the manufacturing method accompanying the application for marketing authorisation pursuant to Article 12(3)(d), shall be drafted in such a way as to give an adequate synopsis of the nature of the operations employed.
Kadar Evropska direkcija za kakovost zdravil in zdravstva za vhodno snov, učinkovino ali pomožno snov že izda certifikat o ustreznosti, je ta certifikat sklic na ustrezno monografijo Evropske farmakopeje.
For this purpose it shall include at least:
Kadar se uporabi sklic na certifikat o ustreznosti, proizvajalec pisno zagotovi predlagatelju, da se proizvodni postopek ni spremenil od izdaje certifikata o ustreznosti s strani Evropske direkcije za kakovost zdravil in zdravstva.
mention of the various stages of manufacture, so that an assessment can be made of whether the processes employed in producing the pharmaceutical form might have produced an adverse change in the constituents,
Za vhodne snovi se predloži certifikat o analizi, da se potrdi izpolnjevanje opredeljenih specifikacij.
in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity of the finished product,
Učinkovine
the actual manufacturing formula, with the quantitative particulars of all the substances used, the quantities of excipients, however, being given in approximate terms insofar as the pharmaceutical form makes this necessary; mention shall be made of any substances that may disappear in the course of manufacture; any overage shall be indicated and justified,
Navedejo se ime, naslov in odgovornost vsakega proizvajalca in vsak predlagani obrat izdelave ali objekt, vključen v proizvodnjo in preskušanje.
a statement of the stages of manufacture at which sampling is carried out for in-process control tests and the limits applied, where other data in the documents supporting the application show such tests to be necessary for the quality control of the finished product,
Za dobro opredeljeno učinkovino lahko proizvajalec učinkovine ali predlagatelj uredi, da proizvajalec učinkovine v ločenem dokumentu predloži naslednje informacije neposredno pristojnemu organu kot glavno datoteko o učinkovini:
experimental studies validating the manufacturing process and where appropriate a process validation scheme for production scale batches,
podroben opis proizvodnega postopka;
for sterile products, where non-pharmacopoeial standard sterilisation conditions are used, details of the sterilisation processes and/or aseptic procedures used.
opis nadzora kakovosti med proizvodnjo;
C. CONTROL OF STARTING MATERIALS
opis postopka potrditve.
General requirements
V tem primeru proizvajalec zagotovi predlagatelju vse potrebne podatke, ki bi mu lahko bili potrebni pri prevzemanju odgovornosti za zdravilo za uporabo v veterinarski medicini.
For the purposes of this paragraph, ‘starting materials’ shall mean all the constituents of the veterinary medicinal product and, if necessary, of its container including its closure, as referred to in Section A, point 1, above.
Proizvajalec predlagatelju pisno potrdi, da zagotavlja konsistentnost med serijami ter da ne bo spreminjal proizvodnega postopka ali specifikacij brez obvestila predlagatelju.
The dossier shall include the specifications and information on the tests to be conducted for quality control of all batches of starting materials.
Dokumenti in podrobni podatki, ki podpirajo vlogo za takšno spremembo, se predložijo pristojnim organom; dokumenti in podrobni podatki se zagotovijo predlagatelju, kadar zadevajo njegovo vlogo pri glavni datoteki o učinkovini.
The routine tests carried out on each batch of starting materials must be as stated in the application for marketing authorisation.
Kadar ni na voljo certifikat o ustreznosti učinkovine, se predložijo informacije o načinu proizvodnje, nadzoru kakovosti, nečistočah ter dokazi o molekularni strukturi.
If tests other than those mentioned in a pharmacopoeia are used, this shall be justified by providing proof that the starting materials meet the quality requirements of that pharmacopoeia.
Informacije o proizvodnem postopku vključujejo opis proizvodnega postopka učinkovine, ki je zaveza predlagatelja za proizvodnjo učinkovine.
Where a Certificate of Suitability has been issued by the European Directorate for the Quality of Medicines and HealthCare for a starting material, active substance or excipient, this Certificate constitutes the reference to the relevant monograph of the European Pharmacopoeia.
Navede se seznam vseh snovi, potrebnih za proizvodnjo učinkovine ali učinkovin, ter opredeli, na kateri stopnji postopka se posamezne snovi uporabljajo.
Where a Certificate of Suitability is referred to, the manufacturer shall give an assurance in writing to the applicant that the manufacturing process has not been modified since the granting of the certificate of suitability by the European Directorate for the Quality of Medicines and HealthCare.
Predložijo se informacije o kakovosti in kontroli teh snovi.
Certificates of Analysis shall be presented for the starting materials in order to demonstrate compliance with the defined specification.
Navedejo se informacije, ki dokazujejo, da snovi izpolnjujejo standarde, ustrezne za predvideno uporabo.
Active substances
Informacije o nadzoru kakovosti vključujejo preskuse (vključno s preskusi sprejemljivosti), izvedene pri vsaki pomembni stopnji, informacije o kakovosti in kontroli vmesnih stopenj ter študije postopka potrditve in/ali ocenjevanja, kakor je primerno.
The name, address, and responsibility of each manufacturer and each proposed production site or facility involved in manufacturing and testing of an active substance shall be indicated.
Po potrebi vključujejo tudi podatke o potrditvi analitskih metod, ki se uporabljajo za učinkovino.
For a well-defined active substance, the active substance manufacturer or the applicant may arrange for the following information to be supplied in a separate document directly to the competent authorities by the manufacturer of the active substance as an Active Substance Master File:
V informacijah o nečistočah se navedejo predvidene nečistoče ter ravni in narava ugotovljenih nečistoč.
a detailed description of the manufacturing process;
Kadar je primerno, se navedejo tudi informacije o varnosti teh nečistoč.
a description of the quality control during manufacture;
Za biotehnološka zdravila za uporabo v veterinarski medicini se pri podatkih o molekularni strukturi navedejo shematična zaporedja aminokislin in relativna molekulska masa.
a description of the process validation.
Učinkovine, navedene v farmakopejah
In this case, the manufacturer shall however provide the applicant with all the data which may be necessary for the latter to take responsibility for the veterinary medicinal product.
Splošne in specifične monografije Evropske farmakopeje se uporabljajo za vse učinkovine, ki so v njej objavljene.
The manufacturer shall confirm in writing to the applicant that he shall ensure batch to batch consistency and not modify the manufacturing process or specifications without informing the applicant.
Za sestavine, ki izpolnjujejo zahteve Evropske farmakopeje ali farmakopeje ene od držav članic, se šteje, da v zadostni meri izpolnjujejo pogoje iz člena 12(3)(i).
Documents and particulars supporting the application for such a change shall be supplied to the competent authorities those documents and particulars shall also be supplied to the applicant where they concern the applicant’s part of the Active Substance Master File.
V tem primeru se lahko opis analitskih metod in postopkov nadomesti s pravilnim sklicem na ustrezno farmakopejo v vsakem ustreznem oddelku.
Additionally, information on the method of manufacture, on quality control and on impurities as well as evidence of the molecular structure shall be provided where a Certificate of Suitability for the active substance is not available:
Kadar je specifikacija iz monografije Evropske farmakopeje ali nacionalne farmakopeje države članice nezadostna za zagotovitev kakovosti snovi, lahko pristojni organi od predlagatelja zahtevajo ustreznejše specifikacije, vključno z omejitvami specifičnih nečistoč, določenimi s potrjenimi postopki preskušanja.
Information on the manufacturing process shall include a description of the active substance manufacturing process that represents the applicant’s commitment for the manufacture of the active substance.
Pristojni organi obvestijo organe, pristojne za to farmakopejo.
All materials needed in order to manufacture the active substance(s) shall be listed, identifying where each material is used in the process.
Imetnik dovoljenja za promet z zdravilom organom te farmakopeje predloži podatke o domnevnih pomanjkljivostih ter o dodatnih uporabljenih specifikacijah.
Information on the quality and control of those materials shall be provided.
Kadar je učinkovina opisana v farmakopeji države članice, ne pa v monografiji Evropske farmakopeje, se uporablja farmakopeja države članice.
Information demonstrating that materials meet standards which are appropriate for their intended use shall be provided.
Kadar učinkovina ni opisana niti v Evropski farmakopeji niti v farmakopeji države članice, se lahko sprejme skladnost z monografijo farmakopeje tretje države, če se dokaže njena ustreznost; v teh primerih predlagatelj predloži kopijo monografije ter po potrebi njen prevod.
Information on quality control shall contain tests (including acceptance criteria) carried out at every critical step, information on the quality and control of intermediates and process validation and/or evaluation studies as appropriate.
Predložijo se podatki, ki dokazujejo, da je monografija ustrezna za kontrolo učinkovine.
It shall also contain validation data for the analytical methods applied to the active substance, where appropriate.
Učinkovine, ki niso navedene v farmakopejah
Information on impurities shall indicate predictable impurities together with the levels and nature of observed impurities.
Sestavine, ki niso navedene v farmakopeji, se opišejo v obliki monografije po naslednjih poglavjih:
It shall also contain information on the safety of these impurities where relevant.
ime sestavine, ki izpolnjuje zahteve iz točke 2 oddelka A, se lahko nadomesti z blagovnimi ali znanstvenimi sopomenkami;
For biotechnological veterinary medicinal products, evidence of molecular structure shall include the schematic amino acid sequence and relative molecular mass.
opredelitev snovi, opisane v podobni obliki, kot jo uporablja Evropska farmakopeja, spremljajo vse potrebne obrazložitve, še posebno glede molekulske strukture.
Active substances listed in pharmacopoeias
Kadar se snovi lahko opišejo le z načinom proizvodnje, je opis dovolj podroben, da se lahko opredelijo konstantna sestava in konstantni učinki snovi;
The general and specific monographs of the European Pharmacopoeia shall be applicable to all active substances appearing in it.
metode identifikacije se lahko opišejo v obliki celotnih tehnik, ki se uporabljajo za izdelavo snovi, ter v obliki preskusov, ki jih je treba izvajati rutinsko;
Constituents fulfilling the requirements of the European Pharmacopoeia or the pharmacopoeia of one of the Member States shall be deemed to comply sufficiently with Article 12(3)(i).
preskusi čistosti se opišejo za vsako posamezno predvideno nečistočo, zlasti za tiste, ki imajo lahko škodljiv učinek, in po potrebi tiste, ki bi v kombinaciji snovi, na katere se vloga nanaša, lahko imele neželen učinek na stabilnost zdravila ali bi popačile analitske rezultate;
In this case the description of the analytical methods and procedures shall be replaced in each relevant section by an appropriate reference to the pharmacopoeia in question.
preskusi in omejitve kontrolnih parametrov, pomembnih za končno zdravilo, kot sta velikost delca in sterilnost, se opišejo in po potrebi se potrdijo tudi metode;
In cases where a specification contained in a monograph of the European Pharmacopoeia or in the national pharmacopoeia of a Member State is insufficient to ensure the quality of the substance, the competent authorities may request more appropriate specifications from the applicant, including limits for specific impurities with validated test procedures.
pri kompleksnih snoveh rastlinskega ali živalskega izvora je treba razlikovati med primeri, kjer je zaradi farmakoloških učinkov potrebna kemijska, fizikalna ali biološka kontrola glavnih sestavin, in primeri, kjer snovi vsebujejo eno ali več skupin učinkovin s podobnim delovanjem, za katere se lahko sprejme enotna metoda določanja vsebnosti.
The competent authorities shall inform the authorities responsible for the pharmacopoeia in question.
Navedeni podatki dokažejo, da so predlagani postopki preskušanja zadostni za nadzor kakovosti učinkovine iz opredeljenega vira.
The marketing authorisation holder shall provide the authorities of that pharmacopoeia with the details of the alleged insufficiency and the additional specifications applied.
Fizikalno-kemijske lastnosti, ki lahko vplivajo na biološko dostopnost
In the absence of a European Pharmacopoeia monograph for an active substance, and where the active substance is described in the pharmacopoeia of a Member State, that monograph may be applied.
Kot del splošnega opisa učinkovin, če je od njih odvisna biološka uporabnost zdravila za uporabo v veterinarski medicini, se predložijo naslednji podatki o učinkovinah, ne glede na to, ali so opisane v farmakopejah ali ne:
In cases where an active substance is described neither in the European Pharmacopoeia nor in the pharmacopoeia of a Member State, compliance with the monograph of a third country pharmacopoeia may be accepted if its suitability is demonstrated; in such cases, the applicant shall submit a copy of the monograph accompanied by a translation where appropriate.
kristalinična oblika in koeficient raztapljanja,
Data to demonstrate the ability of the monograph to adequately control the quality of the active substance shall be presented.
velikost delcev, po potrebi po upraševanju,
Active substances not in a pharmacopoeia
stopnja vsebnosti vlage,
Constituents which are not given in any pharmacopoeia shall be described in the form of a monograph under the following headings:
porazdelitveni koeficient olje/voda,
the name of the constituent, meeting the requirements of Section A point 2, shall be supplemented by any trade or scientific synonyms;
vrednosti pK/pH.
the definition of the substance, set down in a form similar to that used in the European Pharmacopoeia, shall be accompanied by any necessary explanatory evidence, especially concerning the molecular structure.
Prve tri alinee se ne uporabljajo pri snoveh, ki se uporabljajo samo v raztopinah.
Where substances can only be described by their manufacturing method, the description shall be sufficiently detailed to characterise a substance which is constant both on its composition and in its effects;
Pomožne snovi
methods of identification may be described in the form of complete techniques as used for production of the substance, and in the form of tests which ought to be carried out as a routine matter;
Splošne in specifične monografije Evropske farmakopeje se uporabljajo za vse snovi, ki so v njej objavljene.
purity tests shall be described in relation to each individual predictable impurity, especially those which may have a harmful effect, and, if necessary, those which, having regard to the combination of substances to which the application refers, might adversely affect the stability of the medicinal product or distort analytical results;
Pomožne snovi izpolnjujejo zahteve ustrezne monografije Evropske farmakopeje.
tests and limits to control parameters relevant to the finished product, such as particle size and sterility shall be described and methods shall be validated where relevant;
Kadar monografija ne obstaja, se lahko uporabi sklic na farmakopejo države članice.
with regard to complex substances of plant or animal origin, a distinction must be made between the case where multiple pharmacological effects render chemical, physical or biological control of the principal components necessary, and the case of substances containing one or more groups of principles having similar activity, in respect of which an overall method of assay may be accepted.
Kadar sklic na monografijo ne obstaja, se lahko uporabi sklic na farmakopejo tretje države.