natgillin/translations-raw huggingface dataset:
4.4 Special warnings for each target species Vaccinate healthy animals only. 
4.4 Posebna opozorila za vsako ciljno živalsko vrsto Cepite samo zdrave živali.
≥ 3.2 x 106 ELISA units 
≥ 3,2 x 106 enot ELISA
The preferred application site is the neck muscle behind the ear. 
Najboljše mesto injiciranja je vratna mišica za ušesom.
Prior to administration, shake the vaccine carefully. 
Pred uporabo cepivo previdno pretresite.
A single intramuscular injection (1 ml) to pigs from the age of 4 days. 
Ena intramuskularna injekcija (1 ml) za prašičke, stare več kot 4 dni.
PACKAGE SIZE 100 doses 
VELIKOST PAKIRANJA 100 odmerkov
Only vaccinate healthy animals. 
Cepite le zdrave živali.
Commonly very small local reactions such as mild swelling at the injection site (maximum of 5 mm) may be observed, but these reactions are transient and subside within a short time (up to seven days) without treatment. 
Pogosto so opazili majhne lokalne reakcije, kot je blaga oteklina na mestu injiciranja (največ 5 mm), vendar so te reakcije prehodne in čez kratek čas (do sedem dni) izzvenijo brez zdravljenja.
Pharmacotherapeutic group: Immunologicals for suidae, inactivated bacterial vaccines. 
Farmakoterapevtska skupina: Imunološka zdravila za prašiče, inaktivirana bakterijska cepiva.
Commonly a slight rise in body temperature (maximum of 1.7 °C) may occur after injection. 
Pogosto se lahko po injiciranju cepiva pojavi rahel dvig telesne temperature (največ za 1,7 °C).
The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required. 
Pomožne snovi (vključno z dodatki), navedene v poglavju 6.1 SPC tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
It is recommended to use a needle appropriate for the age of the piglets (preferred size 21G length 16 mm). 
Priporoča se uporaba igle, ustrezne za starost prašičkov (najboljša velikost je 21 G, dolžina 16 mm).
Genetically modified recombinant Stx2e antigen: 
Gensko modificirani rekombinantni antigen Stx2e:
PET bottle containing 50 ml or 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium tear-off cap. 
Plastenka PET, ki vsebuje 50 ml ali 100 ml, zaprta z zamaškom iz bromobutilne gume, zatesnjena z aluminijasto odtržno zaporko.
However, these reactions subside within a short time (maximum of two days) without treatment. 
Vendar te reakcije čez kratek čas (največ dva dni) izzvenijo brez zdravljenja.
The vaccine consisting of genetically modified recombinant Stx2e stimulates an active immunity against Shiga toxin 2e produced by the causative agent of oedema disease in pigs. 
Cepivo, sestavljeno iz gensko modificiranega rekombinantnega Stx2e, spodbuja aktivno imunost pred toksinom Shiga 2e, ki ga povzročajo povzročitelji edemske bolezni pri prašičih.
Following the administration of a double dose of vaccine no adverse reactions other than those described in section 4.6 have been observed. 
Po uporabi dvojnega odmerka cepiva niso opazili drugih neželenih učinkov, kot tistih, opisanih v poglavju 4.6.
SPECIAL WARNINGS Special precautions for use in animals: 
Posebni previdnostni ukrepi za uporabo pri živalih:
Do not use this veterinary medicinal product after the expiry date which is stated on the label or carton. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini ali zunanji ovojnini.
Active immunisation of piglets from the age of 4 days, to reduce the mortality and clinical signs of oedema disease caused by Stx2e toxin produced by E. coli (STEC). 
Aktivna imunizacija prašičkov od starosti 4 dni za zmanjšanje smrtnosti in kliničnih znakov edemske bolezni, ki jo povzroča toksin Stx2e, ki ga proizvaja bakterija E. coli (STEC).
Pregnancy and lactation: 
Brejosti in laktacija:
MANUFACTURER'S BATCH NUMBER Lot: {number} 
PROIZVAJALČEVA ŠTEVILKA SERIJE Lot: {številka}
Following the administration of a double dose of vaccine no adverse reactions other than those described in section 6 have been observed. 
Po uporabi dvojnega odmerka cepiva niso opazili drugih neželenih učinkov, kot tistih, opisanih v poglavju 6.
21 days after vaccination Duration of immunity: 105 days after vaccination 
Nastop imunosti: 21 dni po cepljenju Trajanje imunosti: 105 dni po cepljenju
Excipient: Thiomersal max. 0.115 mg For the full list of excipients, see section 6.1. 
0,115 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Appearance after shaking: yellowish to brownish, homogenous suspension. 
Videz po stresanju: rumenkasto do rjavkasta, homogena suspenzija.
DATE OF REVISION OF THE TEXT 
DATUM REVIZIJE BESEDILA {MM/LLLL}
Adjuvant: Aluminium (as hydroxide) 
Aluminij (v obliki hidroksida) najv.
NAME OF THE VETERINARY MEDICINAL PRODUCT Ecoporc SHIGA suspension for injection for pigs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ecoporc SHIGA suspenzija za injiciranje za prašiče
Between the withdrawals the vaccine should be stored at 2 °C - 8 °C. 
Med izvleki cepivo shranjujte pri 2 °C - 8 °C.
MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/001 PET bottle of 50 ml EU/2/13/149/002 PET bottle of 100 ml 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/13/149/001 plastenko PET s 50 ml EU/2/13/149/002 plastenko PET s 100 ml
21 days after vaccination 
Nastop imunosti: 21 dni po cepljenju
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. 
B POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
Excipient: Thiomersal max. 0.115 mg Appearance after shaking: yellowish to brownish, homogenous suspension. 
0,115 mg Videz po stresanju: rumenkasto do rjavkasta, homogena suspenzija
Do not use in cases of hypersensitivity to the active substance, to the adjuvant or to any of the excipients. 
Ne uporabite v primerih preobčutljivosti na učinkovino ali na katero koli pomožno snov.
Duration of immunity: 105 days after vaccination 4.3 Contraindications 
Trajanje imunosti: 105 dni po cepljenju
PACKAGE SIZE 50 ml (50 doses) 100 ml (100 doses) 
VELIKOST PAKIRANJA 50 ml (50 odmerkov) 100 ml (100 odmerkov)
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients. 
KONTRAINDIKACIJE Ne uporabite v primerih preobčutljivosti na učinkovino, dodatek ali na katero koli pomožno snov.
Clinical signs such as temporary mild behavioural disturbances can uncommonly be observed after application of Ecoporc SHIGA. 
Občasno je mogoče po uporabi cepiva Ecoporc SHIGA opaziti klinične znake, kot so začasne blage motnje v vedenju.
Shelf life after first opening the container: 24 hours (store at 2 °C - 8 °C). 
Rok uporabnosti po prvem odpiranju vsebnika: 24 ur (shranjujte pri 2 °C - 8 °C).
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009. 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora, namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/001 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/13/149/001
STATEMENT OF ACTIVE SUBSTANCES One dose (1 ml) contains: 
En odmerek 1 ml vsebuje:
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
PACKAGE LEAFLET: Ecoporc SHIGA suspension for injection for pigs 
Ecoporc SHIGA Suspenzija za injiciranje za prašiče
Pregnancy and lactation: The use is not recommended during pregnancy and lactation. 
Uporaba ni priporočljiva v obdobju brejosti in laktacije.
METHOD AND ROUTE(S) OF ADMINISTRATION Shake well before use. 
NAČIN IN POT(I) UPORABE
max. 3.5 mg 
3,5 mg Pomožna snov:
Once opened use within 24 hours (store at 2 °C - 8 °C). 
Odprto cepivo uporabite v roku 24 ur (shranjujte pri 2 °C - 8 °C).
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 
POSEBNO OPOZORILO, ČE JE/SO POTREBNO(A)
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC
In case of accidental self-injection or ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja ali zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/002 PET bottle 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/13/149/002 plastenko PET
Cardboard box with 1 PET bottle of 50 doses (50 ml) or 100 doses (100 ml). 
Kartonasta škatla z 1 plastenko PET s 50 odmerki (50 ml) ali 100 odmerki (100 ml).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (with PET bottle of 50 ml or 100 ml) 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (z 1 plastenko PET s 50 ml ali 100 ml)
Name and address of the manufacturer responsible for batch release 
Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij IDT Biologika GmbH
Pack sizes: Cardboard box with 1 PET bottle of 50 doses (50 ml) or 100 doses (100 ml). 
Velikosti pakiranja: Kartonasta škatla z 1 plastenko PET s 50 odmerki (50 ml) ali 100 odmerki (100 ml).
CONTRAINDICATIONS 
4.3 Kontraindikacije
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 50 ml 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation 10/04/2013 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet:
EXP {month/year} 
{DD/MM/LLLL}.
≥ 3.2 x 106 ELISA units/ml CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 50 doses 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 50 odmerkov
4.6 Adverse reactions (frequency and seriousness) 
4.6 Neželeni učinki (pogostost in resnost) Pogosto so opazili majhne lokalne reakcije, kot je blaga oteklina na mestu injiciranja (največ 5 mm),
Pigs. 
Rp-Vet.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Prior to administration, shake the vaccine carefully. 
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
This period of deferral shall not exceed twenty-four months from the Commission Decision. 
Ta odlog je mogoč za obdobje največ štiriindvajsetih mesecev od sklepa Komisije.
This does not change the fact that any data generated at Semler is considered unreliable and therefore cannot be used to demonstrate bioequivalence. 
To ne spremeni dejstva, da štejejo vsi podatki iz podjetja Semler za nezanesljive in jih zato ni mogoče uporabiti za dokaz biološke enakovrednosti;
The CHMP was requested in particular to provide its opinion under Article 31 of Directive 2001/83/EC as to whether marketing authorisations of these products should be maintained, varied, suspended, or revoked. 
Odbor CHMP je bil posebej zaprošen, naj v skladu s členom 31 Direktive 2001/83/ES poda svoje mnenje o tem, ali naj se dovoljenja za promet s temi zdravili ohranijo, spremenijo, začasno prekličejo ali ukinejo.
The inspection found significant instances of misconduct, including the substitution and manipulation of study subject samples. 
Pri inšpekcijskem pregledu so bile ugotovljene resne nepravilnosti, vključno z nadomeščanjem in manipulacijo vzorcev proučevanih oseb.
Therefore, bioequivalence of the products concerned by this procedure has to be established using alternative data. 
Biološka enakovrednost v tem postopku obravnavanih zdravil mora biti torej dokazana z alternativnimi podatki.
In their own investigation and analysis of the studies concerned by the FDA inspection, and also in their investigation for similar anomalies or patterns in other studies, Semler found no conclusive evidence of inappropriate data manipulation, substitution or dilution. 
V svoji lastni preiskavi in analizi študij, ki jih je zajel inšpekcijski pregled FDA, ter pri iskanju podobnih nepravilnosti in vzorcev v drugih študijah podjetje Semler ni našlo zanesljivih dokazov o neprimernem ravnanju s podatki, njihovem nadomeščanju ali redčenju.
In view of the findings described above and the necessity to protect public health in the EU, the United Kingdom, Germany, Spain, the Netherlands and Denmark considered that it is in the interest of the Union to refer the matter to the CHMP and request that it assesses the impact of the findings mentioned above on the benefit-risk balance of the medicinal products which have been authorised by the Member States on the basis of relevant trials performed at these sites and also that of pending marketing authorisation applications (MAA). 
Zaradi teh ugotovitev in nujnosti zaščite javnega zdravja v EU so Združeno kraljestvo, Nemčija, Španija, Nizozemska in Danska menile, da je v interesu Unije napotitev zadeve na odbor CHMP, in odbor zaprosile, da oceni vpliv zgoraj omenjenih ugotovitev na razmerje med tveganji in koristmi zdravil, ki so jih države članice odobrile na podlagi preskušanj, izvedenih na teh lokacijah, ter še nezaključenih vlog za dodelitev dovoljenja za promet.
Between 29 September 2015 and 9 October 2015, the United States Food and Drug Administration (FDA) performed a Good Clinical Practice (GCP) inspection at the bioanalytical facility Semler Research Centre Private Ltd, 75A, 15th Cross, 1st Phase, J.P. Nagar, Bangalore - 560 078 India. 
Med 29. septembrom 2015 in 9. oktobrom 2015 je ameriška Agencija za hrano in zdravila (FDA) izvedla inšpekcijski pregled dobre klinične prakse (GCP) v bioanalitičnem objektu Semler Research Centre Private Ltd, 75A, 15th Cross, 1st Phase, J.P. Nagar, Bangalore - 560 078 Indija.
The findings reported during this inspection cast serious doubts on the reliability of the data of bioequivalence studies (clinical and bioanalytical part) generated at the site. 
Ugotovitve inšpekcijskega pregleda porajajo resen dvom o zanesljivosti podatkov študij biološke enakovrednosti (kliničnega in bioanalitičnega dela), pridobljenih na tej lokaciji.
• In some cases, MAHs pointed out that only certain parts of the study had been conducted at Semler, with the remaining tasks conducted at a different site. 
• v nekaterih primerih so imetniki dovoljenja za promet z zdravilom izpostavili, da so bili v podjetju Semler izvedeni samo nekateri deli raziskave, preostale naloge pa na drugi lokaciji.
• The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for marketing authorisations and marketing authorisation applications for medicinal products for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Semler, Bangalore, India; 
• odbor je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za dovoljenja za promet z zdravilom in vloge za pridobitev dovoljenja za promet z zdravilom za zdravila, za katera so bili klinični in/ali bioanalitični deli študij biološke enakovrednosti izvedeni v podjetju Semler, Bangalore, Indija;
• Pharmacovigilance data on specific products included in this procedure have not indicated any problems which could be attributed to non-bioequivalence, such as reduced efficacy or worsened safety and tolerability. 
• farmakovigilančni podatki o posameznih zdravilih, vključenih v ta postopek, niso pokazali nobenih težav, ki bi jih lahko pripisali odsotnosti biološke enakovrednosti, kot so manjša učinkovitost, varnost ali prenašanje.
On these grounds, the WHO pre-qualification team (PQT) recommended an immediate stop to all submissions of dossiers relying in whole or in part on involvement from Semler until the underlying issues have been verified to have been adequately resolved. 
Na tej podlagi je predizbirna ekipa SZO priporočila takojšnje prenehanje vsakršnega predlaganja dokumentacije, ki v celoti ali deloma temelji na udeležbi podjetja Semler, dokler ne bo potrjeno, da so bili osnovni problemi ustrezno odpravljeni.
The findings of the FDA and WHO inspections raise serious concerns relating to the suitability of the quality management system in place at the Semler JP Nagar and Sakar Nagar sites. 
Ugotovitve inšpekcijskih pregledov FDA in SZO so vzbudile resne pomisleke o primernosti sistema upravljanja kakovosti na lokacijah Semler JP Nagar in Sakar Nagar.
• The CHMP reviewed available data and information provided by the MAHs/applicants, as well as information provided by Semler Research Centre Private Ltd; 
• odbor je pregledal vse razpoložljive podatke in informacije, ki so jih zagotovili imetniki dovoljenj za promet z zdravilom/predlagatelji, ter informacije, ki jih je predložilo podjetje Semler Research Centre Private Ltd;
Therefore the FDA concluded that clinical and bioanalytical studies conducted by Semler Research Private Limited in Bangalore, India are not acceptable as a result of data integrity concerns1. 
Agencija FDA je zato zaključila, da klinične in bioanalitične študije, ki jih je izvedlo podjetje Semler Research Private Limited v Bangaloreju, Indija, zaradi pomislekov o celovitosti podatkov niso sprejemljive.1
The findings of the FDA and WHO inspections raise serious concerns relating to the suitability of the quality management system at these sites and, consequently, the reliability of data submitted in applications for marketing authorisations submitted in European Union (EU) Member States. 
Ugotovitve inšpekcijskih pregledov FDA in SZO so vzbudile resne pomisleke o primernosti sistema upravljanja kakovosti na teh lokacijah in posledično tudi o zanesljivosti podatkov, ki so bili predloženi v vlogah za dodelitev dovoljenja za promet v državah članicah Evropske unije (EU).
The World Health Organisation (WHO) also inspected the same bioanalytical facility and the Semler clinical facility located at PA Arcade #21,22,23 Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, India between 27 and 31 January 2015, and performed a follow-up inspection between 2 and 5 December 2015 to verify compliance with GLP and GCP. 
Isti bioanalitični objekt in kliniko podjetja Semler na naslovu PA Arcade #21,22,23 Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, Indija, je med 27. in 31. januarjem 2015 pregledala tudi Svetovna zdravstvena organizacija (SZO).
A number of corrective and preventive actions (CAPA) are proposed or have already been already implemented to address the findings of the FDA and WHO inspections. 
Za obravnavo ugotovitev inšpekcijskih pregledov FDA in SZO je bila predlagana ali že izvedena vrsta korektivnih in preventivnih ukrepov.
Data from all bioequivalence studies performed at Semler Research Private Limited in Bangalore India and submitted to the Competent Authorities to demonstrate bioequivalence of medicinal products with their originator is considered unreliable. 
Podatki iz študij biološke enakovrednosti, ki so bile opravljene v podjetju Semler Research Private Limited v Bangaloreju, Indija, in predložene pristojnim oblastem kot dokaz biološke enakovrednosti zdravil z originatorjem, štejejo za nezanesljive.
The condition for the lifting of the suspension of the marketing authorisations is set out in Annex III. 
Pogoj za preklic začasnega umika dovoljenj za promet z zdravilom, kot je ustrezno, je določen v Prilogi III.
Nevertheless, any CAPAs implemented after the FDA and WHO inspections cannot retrospectively correct the quality system failures observed during these two inspections. 
Kljub temu noben po inšpekcijskih pregledih FDA in SZO izveden ukrep ne more retrospektivno odpraviti med inšpekcijskima pregledoma ugotovljenih napak v sistemu upravljanja kakovosti.
For a medicinal product with a marketing authorisation or marketing authorisation application under Article 10(1) of Directive 2001/83/EC as amended, bioequivalence is crucial for the conclusion that efficacy and safety are similar to that of the reference product. 
Za zdravilo z dovoljenjem za promet ali vlogo za dovoljenje za promet v skladu s členom 10(1) Direktive 2001/83/ES, kakor je bila spremenjena, je biološka enakovrednost nujna za zaključek o podobni učinkovitosti in varnosti v primerjavi z referenčnim zdravilom.
The Committee recommends that these marketing authorisations (annex IB) should be suspended unless the medicinal product is considered critical by the relevant national competent authorities. 
Odbor zato priporoča, da se ta dovoljenja za promet z zdravilom (Priloga IB) začasno umaknejo, razen v primeru, da je zadevno zdravilo po mnenju ustreznega nacionalnega pristojnega organa kritičnega pomena.
The CHMP therefore recommends the suspension of the marketing authorisations for all remaining medicinal products concerned by this referral procedure (annex IB), as bioequivalence vis-à-vis the EU reference medicinal products has not been demonstrated. 
Odbor CHMP zato priporoča začasen umik dovoljenj za promet z vsemi preostalimi zdravili, ki jih zadeva ta napotitveni postopek (Priloga IB), saj biološka enakovrednost z referenčnimi zdravili, odobrenimi v EU, ni bila dokazana.
• For some products, results from bioequivalence data using non-EU Reference Medicinal Products may be available. 
• za nekatera zdravila so morda na voljo rezultati iz podatkov o biološki enakovrednosti ob uporabi referenčnih zdravil, ki v EU niso bila odobrena.
For those products for which no alternative data is available to establish bioequivalence to an EU reference medicinal product, the main arguments put forward by the MAHs/applicants were as follows: 
Pri zdravilih, pri katerih niso na voljo nobeni alternativni podatki, ki bi potrdili biološko enakovrednost z referenčnimi zdravili EU, so bili glavni argumenti, ki so jih predložili imetniki dovoljenja za promet z zdravilom oz. predlagatelji, naslednji:
The WHO concluded that the findings indicate the existence of a general or systematic deviation from commonly accepted quality standards, and cannot be ascribed to a single person or two working outside of the quality management system. 
Inšpekcijski pregledi so razkrili kritična in velika odstopanja, ki so privedla do objave obvestila o zaskrbljenosti.2 SZO je zaključila, da ugotovitve kažejo na obstoj splošnega ali sistematičnega odstopanja od splošno sprejetih standardov kakovosti, ki ga ni mogoče pripisati eni sami ali dvema zunaj sistema upravljanja kakovosti delujočima osebama.
However, pharmacovigilance activities may lack the ability to detect a signal with regard to efficacy or safety and tolerability, therefore CHMP is of the opinion that the absence of any pharmacovigilance signal does not offer sufficient reassurance to conclude on a positive benefit-risk balance in the absence of the demonstration of bioequivalence with the EU reference medicinal product. 
Vendar pa farmakovigilančne aktivnosti morda ne morejo zaznati signala v zvezi z učinkovitostjo ali varnostjo in prenašanjem, zato odbor CHMP meni, da odsotnost farmakovigilančnega signala ob odsotnosti dokaza biološke enakovrednosti z referenčnim zdravilom, odobrenim v EU, ne omogoča zanesljivega zaključka o pozitivnem razmerju med tveganji in koristmi;
Under Article 10(1) of Directive 2001/83/EC, these data are not acceptable to support a positive benefit-risk balance for the concerned products and cannot substitute the requirement to demonstrate bioequivalence between test product and a suitable EU reference product. 
2001/83/ES ti podatki niso sprejemljivi za podporo pozitivnega razmerja med tveganji in koristmi in ne morejo nadomestiti zahteve za dokaz biološke enakovrednosti med testnim zdravilom in primernim referenčnim zdravilom, odobrenim v EU.
For marketing authorisation(s) of a medicinal product considered critical, the suspension may be deferred in the relevant EU Member State(s) for a period which shall not exceed twenty-four months from the Commission Decision. 
Za dovoljenja(-e) za promet z zdravilom, ki šteje za zdravilo kritičnega pomena, se lahko začasni umik v eni ali več zadevnih državah članicah odloži za obdobje največ štiriindvajsetih mesecev od sklepa Komisije.