natgillin/translations-raw huggingface dataset:
Information on the container-closure system for the active substance shall be given.
Predložijo se informacije o sistemu zapiranja vsebnika za zdravilno učinkovino.
The level of information required shall be determined by the physical state (liquid, solid) of the active substance.
Fizikalno stanje (tekoče, trdno) zdravilne učinkovine določa raven zahtevanih informacij.
Information on the container-closure system for the finished product shall be given.
Predložijo se informacije o sistemu zapiranja vsebnika za končno zdravilo.
The level of information required shall be determined by the route of administration of the veterinary medicinal product and the physical state (liquid, solid) of the dosage form.
Način dajanja zdravila za uporabo v veterinarski medicini in fizikalno stanje (tekoče, trdno) oblike odmerka določata raven zahtevanih informacij.
Packaging materials shall comply with the requirements of the appropriate European Pharmacopoeia monograph.
Ovojnine izpolnjujejo zahteve iz ustrezne monografije Evropske farmakopeje.
In the absence of such a monograph reference may be made to the Pharmacopoeia of a third country.
Kadar takšen sklic na monografijo ne obstaja, se lahko uporabi sklic na farmakopejo tretje države.
In the absence of a pharmacopoeial monograph, a specification shall be proposed and justified for the packaging material.
Kadar ne obstaja monografija farmakopeje, se za ovojnine predlaga in utemelji specifikacija.
Scientific data on the choice and suitability of the packaging material shall be presented.
Predložijo se znanstveni podatki o izbiri in ustreznosti ovojnine.
For novel packaging materials in contact with the product, information on their composition, manufacture and safety shall be presented.
Za nove ovojnine, ki pridejo v stik z zdravilom, se predložijo informacije o njihovi sestavi, izdelavi in varnosti.
Specifications and, if appropriate, performance data shall be presented for any dosing or administration device supplied with the veterinary medicinal product.
Za vsak pripomoček za odmerjanje ali dajanje, ki se priloži zdravilu za uporabo v veterinarski medicini, se predložijo specifikacije in po potrebi podatki o uporabnosti.
Where source materials such as microorganisms, tissues of either plant or animal origin, cells or fluids (including blood) of human or animal origin or biotechnological cell constructs are used in the manufacture of veterinary medicinal products, the origin and history of starting materials shall be described and documented.
Kadar se pri izdelavi zdravil za uporabo v veterinarski medicini uporabljajo izvorni materiali, kot so mikroorganizmi, tkiva rastlinskega ali živalskega izvora, celice ali tekočine (vključno s krvjo) človeškega ali živalskega izvora ali biotehnološko spremenjene celice, se opišejo in dokumentirajo izvor in zgodovina izvornih materialov.
The description of the starting material shall include the manufacturing strategy, purification/inactivation procedures with their validation and all in-process control procedures designed to ensure the quality, safety and batch to batch consistency of the finished product.
Opis vhodnih snovi vsebuje strategijo izdelave, postopke čiščenja/inaktivacije, postopke potrditve ter vse kontrolne postopke med izdelavo, ki zagotavljajo kakovost, varnost in konsistentnost med serijami končnega zdravila.
When cell banks are used, the cell characteristics shall be shown to have remained unchanged at the passage level used for the production and beyond.
Kadar se uporabljajo celične banke, se dokaže, da so lastnosti celic ostale nespremenjene v času prenosa v izdelavo in tudi pozneje.
Seed materials, cell banks and pools of serum and, whenever possible, the source materials from which they are derived shall be tested for extraneous agents.
Pri matičnih materialih, celičnih bankah, zbirkah serumov in po potrebi izvornih materialih, iz katerih se te snovi pridobivajo, se ugotavlja prisotnost naključnih snovi.
When starting materials of animal or human origin are used, the measures used to ensure freedom from potentially pathogenic agents shall be described.
Kadar se uporabljajo snovi živalskega ali človeškega izvora, se opišejo ukrepi, ki zagotavljajo odsotnost mogočih patogenih snovi.
If the presence of potentially pathogenic extraneous agents is inevitable, the material shall be used only when further processing ensures their elimination and/or inactivation, and this shall be validated.
Če se ni mogoče izogniti prisotnosti mogočih patogenih naključnih snovi, se material uporabi le, kadar nadaljnja obdelava zagotavlja njihovo odstranitev in/ali inaktivacijo, kar pa se potrdi.
Documentation shall be supplied to demonstrate that the seed materials, cell seeds, batches of serum and other material originating from animal species relevant for the transmission of TSE comply with the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products [12], as well as with the corresponding monograph of the European Pharmacopoeia.
Priloži se dokumentacija, ki dokazuje, da matični materiali, celične linije, serije serumov in drugi materiali, ki izvirajo iz živalskih vrst, pri katerih lahko pride do prenosa transmisivne spongiformne encefalopatije, izpolnjujejo Navodila o zmanjšanju tveganja prenosa povzročiteljev živalske spongiformne encefalopatije z zdravili za uporabo v humani in veterinarski medicini [12] in ustrezne monografije Evropske farmakopeje.
Certificates of Suitability issued by the European Directorate for the Quality of Medicines and HealthCare, with reference to the relevant monograph of the European Pharmacopoeia, may be used to demonstrate compliance.
Kot dokaz izpolnjevanja zahtev se lahko uporabi certifikat o ustreznosti, ki ga je izdala Evropska direkcija za kakovost zdravil in zdravstva, s sklicem na ustrezno monografijo Evropske farmakopeje.
The dossier shall include particulars relating to the product control tests that may be carried out at an intermediate stage of the manufacturing process, with a view to ensuring the consistency of the technical characteristics and the production process.
V vlogo se vključijo podrobni podatki v zvezi s kontrolnimi preskusi zdravila, ki se lahko izvajajo med katero koli vmesno stopnjo postopka izdelave, da se zagotovi konsistentnost tehničnih značilnosti in postopka izdelave.
These tests are essential for checking the conformity of the veterinary medicinal product with the formula when, exceptionally, an applicant proposes an analytical method for testing the finished product which does not include the assay of all the active substances (or of all the excipient components subject to the same requirements as the active substances).
Ti preskusi so ključnega pomena za preverjanje skladnosti zdravila za uporabo v veterinarski medicini s sestavo, ko predlagatelj izjemoma predlaga analitsko metodo za preskušanje končnega zdravila, ki ne vključuje določanja vsebnosti vseh zdravilnih učinkovin (ali vseh sestavin pomožnih snovi, za katere veljajo iste zahteve kot za zdravilne učinkovine).
The same applies where the quality control of the finished product depends on in-process control tests, particularly if the substance is essentially defined by its manufacturing method.
Isto velja za končna zdravila, kadar so za nadzor kakovosti ključni kontrolni preskusi med stopnjami izdelave, zlasti če je učinkovina v bistvu opredeljena s postopkom izdelave.
Where an intermediate product may be stored prior to further processing or primary assembly, a shelf life for the intermediate product shall be defined on the basis of the data resulting from stability studies.
Kadar se vmesno zdravilo lahko shrani pred nadaljnjo obdelavo ali primarnim sestavljanjem, se na podlagi podatkov iz študij stabilnosti določi rok uporabnosti.
For the control of the finished product, a batch of a finished product comprises all the units of a pharmaceutical form which are made from the same initial quantity of material and have undergone the same series of manufacturing and/or sterilisation operations or, in the case of a continuous production process, all the units manufactured in a given period of time.
Za kontrolo končnega zdravila obsega serija končnega zdravila vse enote farmacevtske oblike, ki so izdelane iz iste začetne količine snovi in z istimi postopki izdelave in/ali sterilizacije, ali v primeru neprekinjenega postopka izdelave vse enote, ki so bile izdelane v določenem časovnem obdobju.
The application for marketing authorisation shall list those tests, which are carried out routinely on each batch of finished product.
V vlogi za pridobitev dovoljenja za promet z zdravilom se navede seznam navedenih preskusov, ki se opravljajo rutinsko pri vsaki seriji končnega zdravila.
The frequency of the tests which are not carried out routinely shall be stated.
Navede se pogostost preskusov, ki se ne opravljajo rutinsko.
Release limits shall be indicated.
Navedejo se meje za sproščanje.
The dossier shall include particulars relating to control tests on the finished product at release.
Vloga vključuje podrobne podatke o kontrolnih preskusih končnega zdravila pri sproščanju.
They shall be submitted in accordance with the following requirements.
Predložijo se v skladu z naslednjimi zahtevami.
The provisions of the relevant monographs and general chapters of the European Pharmacopoeia, or failing that, of a Member State, shall be applicable to all products defined therein.
Določbe iz ustreznih monografij in splošnih poglavij Evropske farmakopeje ali, kadar ta ne obstaja, farmakopeje države članice se uporabljajo za vsa zdravila, ki so tam navedena.
If test procedures and limits other than those mentioned in the relevant monographs and general chapters of the European Pharmacopoeia, or failing this, in the pharmacopoeia of a Member State are used, this shall be justified by providing proof that the finished product would, if tested in accordance with those monographs, meet the quality requirements of that pharmacopoeia for the pharmaceutical form concerned.
Če se uporabljajo postopki preskušanja ter mejne vrednosti, ki se razlikujejo od tistih, ki so navedene v ustreznih monografijah in splošnih poglavjih Evropske farmakopeje ali, kadar ta ne obstaja, farmakopeji države članice, se utemeljijo s predložitvijo dokaza, da bi končno zdravilo, če bi bilo preskušano v skladu z navedenimi monografijami, ustrezalo zahtevam kakovosti iz farmakopeje za zadevno farmacevtsko obliko.
Certain tests of the general characteristics of a product shall always be included among the tests on the finished product.
Nekateri preskusi splošnih lastnostih zdravila se vedno vključijo med preskuse končnega zdravila.
These tests shall, wherever applicable, relate to the control of average masses and maximum deviations, to mechanical, physical or microbiological tests, organoleptic characteristics, physical characteristics such as density, pH, refractive index.
Ti preskusi, kakor je primerno, zadevajo kontrolo povprečne mase in največjih odstopanj, mehanske, fizikalne ali mikrobiološke preskuse, organoleptične lastnosti in fizikalne lastnosti, kot so gostota, pH in lomni količnik.
For each of these characteristics, standards and tolerance limits shall be specified by the applicant in each particular case.
Pri vsakem posameznem primeru predlagatelj navede standarde in meje tolerance za vsako od teh lastnosti.
The conditions of the tests, where appropriate, the equipment/apparatus employed and the standards shall be described in precise details whenever they are not given in the European Pharmacopoeia or the pharmacopoeia of the Member States; the same shall apply in cases where the methods prescribed by such pharmacopoeias are not applicable.
Kadar pogoji preskušanja, uporabljena oprema/instrumenti, kakor je ustrezno, in standardi niso opisani v Evropski farmakopeji ali farmakopeji države članice, se natančno opišejo; isto se uporablja v primerih, kadar se ne uporabljajo predpisane metode iz teh farmakopej.
Furthermore, solid pharmaceutical forms having to be administered orally shall be subjected to in vitro studies on the liberation and dissolution rate of the active substance or substances, unless otherwise justified.
Poleg tega se za trdne farmacevtske oblike za peroralno dajanje izvedejo in vitro študije o sproščanju in hitrosti raztapljanja zdravilnih učinkovin, razen če za to ni ustrezne utemeljitve.
Those studies shall also be carried out where administration is by another means if the competent authorities of the Member State concerned consider this necessary.
Navedene študije se prav tako izvedejo, ko se zdravilo daje na kak drug način, če pristojni organi zadevne države članice menijo, da je to potrebno.
Identification and assay of the active substance(s) shall be carried out either in a representative sample from the production batch or in a number of dosage units analysed individually.
Identifikacija in določanje vsebnosti zdravilnih učinkovin se izvede na reprezentativnem vzorcu proizvodne serije ali na več enotah odmerka, ki se analizirajo posamično.
Unless there is appropriate justification, the maximum acceptable deviation in the active substance content of the finished product shall not exceed ± 5 % at the time of manufacture.
Pri izdelavi največja dopustna meja odstopanja vsebnosti zdravilne učinkovine v končnem zdravilu ne sme presegati ± 5 %, razen če je za to ustrezna utemeljitev.
On the basis of the stability tests, the manufacturer shall propose and justify maximum acceptable deviation limits in the active substance content of the finished product up to the end of the proposed shelf life.
Na podlagi preskusov stabilnosti izdelovalec do izteka predlaganega roka uporabnosti predloži ter utemelji največje dopustne meje odstopanja vsebnosti zdravilne učinkovine v končnem zdravilu.
In certain cases of particularly complex mixtures, where assay of active substances which are very numerous or present in very low amounts would necessitate an intricate investigation difficult to carry out in respect of each production batch, the assay of one or more active substances in the finished product may be omitted, on the express condition that such assays are made at intermediate stages in the production process.
V nekaterih primerih zlasti kompleksnih mešanic in kadar bi bila zaradi številnih zdravilnih učinkovin ali zaradi nizkih vsebnosti potrebna zapletena raziskava, težko izvedljiva za vsako serijo posebej, se lahko opusti določanje vsebnosti ene ali več zdravilnih učinkovin v končnem zdravilu, pod jasnim pogojem, da se taka določanja količine izvedejo na vmesnih stopnjah postopka izdelave.
This simplified technique may not be extended to the characterisation of the substances concerned.
Ta poenostavljena metoda se ne sme razširiti na opredelitev zadevnih učinkovin.
It shall be supplemented by a method of quantitative evaluation, enabling the competent authority to have the conformity of the medicinal product with its specification verified after it has been placed on the market.
Dopolni se z metodo količinskega vrednotenja, kar pristojnemu organu omogoča, da preveri skladnost zdravila s specifikacijo potem, ko je bilo zdravilo že dano v promet.
An in vivo or in vitro biological assay shall be obligatory when physico-chemical methods cannot provide adequate information on the quality of the product.
Biološko določanje vsebnosti in vivo ter in vitro je obvezno, kadar fizikalno-kemijske metode ne morejo zagotoviti ustreznih informacij o kakovosti zdravila.
Such an assay shall, whenever possible, include reference materials and statistical analysis allowing calculation of confidence limits.
Tako določanje vsebnosti, kadar koli je mogoče, vključuje referenčne snovi ter statistične analize, ki omogočajo izračunavanje mej zaupanja.
Where these tests cannot be carried out on the finished product, they may be performed at an intermediate stage, as late as possible in the manufacturing process.
Kadar se ti preskusi ne morejo izvesti na končnem zdravilu, se lahko opravijo na vmesni stopnji, čim pozneje v postopku izdelave.
Where degradation occurs during manufacture of the finished product, the maximum acceptable levels of individual and total degradation products immediately following manufacture shall be indicated.
Kadar pri izdelavi končnega zdravila pride do razpada, se navedejo največje dovoljene ravni posameznih in vseh razgradnih produktov neposredno po izdelavi.
Where the particulars given in Section B show that a significant overage of an active substance is employed in the manufacture of the medicinal product or where the stability data show that the assay of the active substance declines on storage, the description of the control tests on the finished product shall include, where appropriate, the chemical and, if necessary, the toxico-pharmacological investigation of the changes that this substance has undergone, and possibly the characterisation and/or assay of the degradation products.
Kadar podrobni podatki iz oddelka B kažejo, da je bil pri izdelavi zdravila uporabljen znaten presežek zdravilne učinkovine, ali kadar podatki stabilnosti kažejo, da se je vsebnost zdravilne učinkovine pri shranjevanju zmanjšala, opis kontrolnih preskusov končnega zdravila vsebuje, kadar je to ustrezno, kemijske in po potrebi toksikološko-farmakološke raziskave sprememb, do katerih je prišlo v tej snovi, in po možnosti še opis lastnosti in/ali določanje vsebnosti razpadnih produktov.
An identification test and an upper and lower limit test shall be obligatory for each individual antimicrobiological preservative and for any excipient that is liable to affect the bioavailability of the active substance, unless the bioavailability is guaranteed by other appropriate tests.
Za vsak posamezen protimikroben konzervans in vsako pomožno snov, ki lahko vpliva na biološko uporabnost zdravilne učinkovine, sta obvezna preskus identifikacije in preskus zgornje in spodnje meje, razen če biološko uporabnost potrjujejo drugi ustrezni preskusi.
An identification test and an upper limit test shall be obligatory for any antioxidant and for any excipient liable to adversely affect physiological functions, with a lower limit test also included for antioxidants at time of release.
Preskus identifikacije in preskus zgornje in spodnje meje sta obvezna tudi za vse antioksidante in vse pomožne snovi, ki škodljivo vplivajo na fiziološke funkcije, za antioksidante pa je obvezen tudi preskus spodnje meje ob sproščanju.
Apart from the toxico-pharmacological tests submitted with the application for marketing authorisation, particulars of safety tests, such as sterility and bacterial endotoxins, shall be included in the analytical particulars wherever such tests must be undertaken as a matter of routine in order to verify the quality of the product.
Poleg toksikološko-farmakoloških preskusov, ki spremljajo vlogo za pridobitev dovoljenja za promet z zdravilom, se povsod tam, kjer so taki preskusi obvezni kot rutinski, da se preveri kakovost zdravila, v analitske podatke vključijo tudi podrobni podatki o preskusih varnosti, kot so preskusi sterilnosti in bakterijskih endotoksinov.
A retest period and storage conditions for the active substance shall be specified except in the case where the active substance is the subject of a monograph in the European Pharmacopoeia and the manufacturer of the finished product fully retests the active substance immediately before its use in the manufacture of the finished product.
Določijo se obdobje ponovnega preskušanja in pogoji shranjevanja zdravilne učinkovine, razen kadar je zdravilna učinkovina opisana v monografiji Evropske farmakopeje in kadar je izdelovalec končnega zdravila v celoti ponovno preskusil zdravilno učinkovino, tik preden jo je uporabil pri izdelavi končnega zdravila.
Stability data shall be presented to support the defined retest period and storage conditions.
Predložijo se podatki o stabilnosti, ki podpirajo določeno obdobje ponovnega preskušanja in pogoje shranjevanja.
The type of stability studies conducted, protocols used, the analytical procedures used and their validation together with the detailed results shall be presented.
Skupaj s podrobnimi rezultati se predložijo vrsta izvedenih študij stabilnosti, uporabljeni protokoli, uporabljeni analitski postopki in njihova potrditev.
The stability commitment with a summary of the protocol shall be provided.
Skupaj s povzetkom protokola se predloži zaveza o spremljanju stabilnosti.
However, where a Certificate of Suitability for the active substance from the proposed source is available and specifies a retest period and storage conditions, stability data for the active substance from that source are not required.
Kadar pa je na voljo certifikat o ustreznosti zdravilne učinkovine iz predlaganega vira in so v njem določeni obdobje ponovnega preskušanja in pogoji shranjevanja, podatki o stabilnosti zdravilne učinkovine iz navedenega vira niso potrebni.
A description shall be given of the investigations by which the shelf life, the recommended storage conditions and the specifications at the end of the shelf life proposed by the applicant have been determined.
Opišejo se raziskave, na podlagi katerih je bil določen rok uporabnosti, priporočeni pogoji shranjevanja ter specifikacije po izteku roka uporabnosti, ki jih predlaga predlagatelj.
Where a finished product requires reconstitution or dilution prior to administration, details of the proposed shelf life and specification for the reconstituted/diluted product are required, supported by relevant stability data.
Kadar končno zdravilo zahteva rekonstitucijo ali razredčitev pred dajanjem zdravila, se zahtevajo podatki o predlaganem roku uporabnosti za rekonstituirano/razredčeno zdravilo, ki jih podpirajo ustrezni podatki o stabilnosti.
In the case of multi-dose containers, where relevant, stability data shall be presented to justify a shelf life for the product after it has been broached for the first time and an in-use specification shall be defined.
Za vsebnike z večkratnim odmerkom se po potrebi predložijo podatki o stabilnosti, ki upravičujejo rok uporabnosti za zdravilo potem, ko je bil zamašek prvič predrt, in določijo se specifikacije po odprtju.
Where a finished product is liable to give rise to degradation products, the applicant shall declare these and indicate the identification methods and test procedures.
Kadar je verjetno, da bodo v končnem zdravilu nastali razpadni produkti, predlagatelj to prijavi in navede metode identifikacije ter postopke preskušanja.
The conclusions shall contain the results of analyses, justifying the proposed shelf life and if appropriate, the in-use shelf life, under the recommended storage conditions and the specifications of the finished product at the end of the shelf life, and in-use shelf life if appropriate, of the finished product under these recommended storage conditions.
Sklepne ugotovitve vsebujejo rezultate analiz, ki utemeljujejo predlagani rok uporabnosti in po potrebi rok uporabnosti po odprtju v priporočenih pogojih shranjevanja ter specifikacije končnega zdravila ob izteku roka uporabnosti in po potrebi roka uporabnosti po odprtju v teh priporočenih pogojih shranjevanja.
The maximum acceptable level of individual and total degradation products at the end of shelf life shall be indicated.
Navedejo se najvišja dopustna meja posameznih in vseh razpadnih produktov ob izteku roka uporabnosti.
A study of the interaction between product and container shall be submitted wherever the risk of such interaction is regarded as possible, especially where injectable preparations are concerned.
Študija o medsebojnih vplivih med zdravilom in vsebnikom se predloži, kadar koli obstaja možnost tveganja za takšne medsebojne vplive, zlasti pri pripravkih za vbrizgavanje.
Information relating to the quality of the veterinary medicinal product not covered in the previous sections may be included in the dossier.
V vlogo se lahko vključijo informacije o kakovosti zdravila za uporabo v veterinarski medicini, ki niso zajete v predhodnih oddelkih.