FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Immunologicals for suidae, inactivated bacterial vaccines.
Croatian: IMUNOLOŠKA SVOJSTVA Farmakoterapijska grupa: imunološki preparati za svinje, inaktivirana bakterijska cjepiva.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjujes bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: Genetically modified recombinant Stx2e antigen:
Croatian: Genetski modificirani rekombinantni antigen Stx2e:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 50 ml
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA 50 ml
English: It is recommended to use a needle appropriate for the age of the piglets (preferred size 21G length 16 mm).
Croatian: Preporučuje se uporaba igle prikladne za dob praščića (preferirana veličina 21G, duljina 16 mm).
English: PACKAGE SIZE 50 ml (50 doses) 100 ml (100 doses)
Croatian: 50 ml (50 doza) 100 ml (100 doza)
English: Date of latest renewal:
Croatian: Datum posljednjeg produljenja odobrenja:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna doza od 1 ml sadrži:
English: The use is not recommended during pregnancy and lactation.. Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kad se koristi s bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: PET bottle containing 50 ml or 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium tear-off cap.
Croatian: PET bočica od 50 ili 100 ml zatvorene čepom od bromobutil-gume i zapečaćene aluminijskom tear-off kapicom.
English: Onset of immunity:
Croatian: Trajanje imuniteta:
English: 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.
Croatian: Cjepivo se sastoji od genetski modificiranog rekombinantnog Stx2e koji stimulira aktivni imunitet na toksin Shiga 2e koji proizvodi uzročnik edemske bolesti svinja.
English: Between the withdrawals the vaccine should be stored at 2 °C - 8 °C.
Croatian: Između navlačenja cjepivo treba čuvati na temperaturi od 2 °C - 8 °C.
English: BATCH NUMBER Lot: {number}
Croatian: BROJ PROIZVODNE SERIJE Lot: {broj}
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/001 PET bottle of 50 ml EU/2/13/149/002 PET bottle of 100 ml
Croatian: EU/2/13/149/001 PET bočica od 50 ml EU/2/13/149/002 PET bočica od 100 ml
English: Disposal: read package leaflet.
Croatian: Zbrinjavanje: pročitajte Uputu o VMP.
English: PHARMACEUTICAL FORM Suspension for injection
Croatian: OBLIK Suspenzija za injekcije
English: 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).
Croatian: Aktivna imunizacija praščića u dobi od četiri dana radi smanjenja smrtnosti i kliničkih znakova edemske bolesti uzrokovanih toksinom Stx2e koji proizvodi E. coli (STEC).
English: In case of accidental self-injection or ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju samoinjiciranja ili gutanja odmah potražite liječničku pomoć i pokažite mu uputu ili etiketu
English: PACKAGE SIZE 100 doses
Croatian: 100 doza
English: 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.
Croatian: Tablica 1 Priloga Uredbe Komisije (EU) broj 37/2010 prikazuje da MRL nije potreban.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Croatian: Posebne mjere koje treba uzeti u obzir osoba koja primjenjuje veterinarsko medicinski proizvod na životinjama:
English: MARKETING AUTHORISATION HOLDER
Croatian: BROJ ODOBRENJA ZA STAVLJANJE U PROMET
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Croatian: Ne koristiti u slučaju preosjetljivosti na djelatnu tvar, na adjuvans ili na bilo koju pomoćnu tvar.
English: SPECIAL WARNINGS Special precautions for use in animals:
Croatian: Posebne mjere opreza za primjenu na životinjama:
English: Appearance after shaking: yellowish to brownish, homogenous suspension.
Croatian: Izgled nakon protresanja: žućkasta do smećkasta homogena suspenzija.
English: Once opened use within 24 hours (store at 2 °C - 8 °C).
Croatian: Nakon otvaranja primijeniti unutar 24 sata (čuvati na temperaturi od 2 °C - 8 °C).
English: 4.4 Special warnings for each target species Vaccinate healthy animals only.
Croatian: 4.4 Posebna upozorenja za svaku od ciljnih vrsta životinja
English: STATEMENT OF ACTIVE SUBSTANCES 1 dose (1 ml) contains:
Croatian: SASTAV DJELATNIH TVARI 1 doza (1 ml) sadrži:
English: Pack sizes: Cardboard box with 1 PET bottle of 50 doses (50 ml) or 100 doses (100 ml).
Croatian: Veličine pakovanja: Kartonska kutija s jednom PET bočicom od 50 doza (50 ml) ili 100 doza (100 ml).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml
Croatian: OSNOVNI PODACI NAPISANI NA UNUTARNJEM PAKOVANJU 100 ml
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation 10/04/2013
Croatian: DATUM PRVOG ODOBRENJA/PRODULJENJA ODOBRENJA
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label or carton.
Croatian: Ne koristiti poslije isteka roka valjanosti naznačenog na etiketi ili kutiji.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/002 PET bottle
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/13/149/002 PET bočica
English: Following the administration of a double dose of vaccine no adverse reactions other than those described in section 6 have been observed.
Croatian: Predoziranje (simptomi, hitna pomoć, antidoti): Nakon primjene dvostruke doze cjepiva nisu primijećene nuspojave različite od onih opisanih u odjeljku 6.
English: Marketing authorisation holder and manufacturer responsible for batch release:
Croatian: Nositelj odobrenja za stavljanje u promet i nositelj odobrenja za proizvodnju za puštanje proizvodne serije:
English: ≥ 3.2 x 106 ELISA units/ml CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 50 doses
Croatian: SADRŽAJ: TEŽINA, VOLUMEN ILI BROJ DOZA 50 doza
English: 4.11 Withdrawal period Zero days.
Croatian: KARENCIJA Nula dana.
English: Name and address of the manufacturer responsible for batch release
Croatian: Njemačka Naziv i adresa proizvođača odgovornog(ih) za puštanje serije u promet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (with PET bottle of 50 ml or 100 ml)
Croatian: Kartonska kutija (s PET bočicom od 50 ili 100 ml)
English: Following the administration of a double dose of vaccine no adverse reactions other than those described in section 4.6 have been observed.
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nakon primjene dvostruke doze cjepiva nisu primijećene nuspojave osim obih opisanih u odjeljku 4.6. 4.11 Karencija
English: WITHDRAWAL PERIOD(S) Withdrawal period(s): zero days
Croatian: KARENCIJA Karencija: nula dana
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 24 hours Between the withdrawals, the vaccine should be stored at 2 °C - 8 °C.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 3 godine.
English: Shelf life after first opening the container: 24 hours (store at 2 °C - 8 °C).
Croatian: Rok valjanosti nakon prvog otvaranja spremnika: 24 sata.
English: Pregnancy and lactation: The use is not recommended during pregnancy and lactation.
Croatian: Ne preporuča se primjena tijekom graviditeta ili laktacije.
English: STATEMENT OF ACTIVE SUBSTANCES One dose (1 ml) contains:
Croatian: Jedna doza od 1 ml sadrži:
English: 21 days after vaccination Duration of immunity: 105 days after vaccination
Croatian: 105 dana nakon cijepljenja.
English: WITHDRAWAL PERIOD(S) Withdrawal period(s): zero days.
Croatian: KARENCIJA Karencija: nula dana.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Prior to administration, shake the vaccine carefully.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)
English: 6.3 Shelf life
Croatian: Ecoporc SHIGA
English: IM.
Croatian: maks.
English: • Reanalysis and audits of data for specific studies did not point to any irregularity.
Croatian: • Ponovne analize i provjere podataka iz određenih ispitivanja nisu upućivale na nepravilnosti.
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP concludes that:
Croatian: Stoga je CHMP u skladu s člancima 31. i 32. Direktive 2001/83/EZ zaključio sljedeće:
English: 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.
Croatian: Zaključak je WHO-a da nalazi upućuju na postojanje općih ili sustavnih odstupanja od općeprihvaćenih standarda kvalitete te da se ne mogu pripisati postupanju jedne osobe ili dviju osoba izvan sustava upravljanja kvalitetom.
English: 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.
Croatian: Predloženo je ili već provedeno više korektivnih i preventivnih mjera (CAPA) za rješavanje pitanja povezanih s nalazima inspekcija FDA-a i WHO-a.
English: 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.
Croatian: Nalazi prijavljeni tijekom te inspekcije bacaju ozbiljnu sumnju na pouzdanost podataka iz ispitivanja bioekvivalencije (kliničkih i bioanalitičkih) koji su prikupljeni na toj lokaciji.
English: Therefore, bioequivalence of the products concerned by this procedure has to be established using alternative data.
Croatian: Stoga bioekvivalenciju lijekova koji su obuhvaćeni ovim postupkom treba utvrditi primjenom alternativnih podataka.
English: The inspection found significant instances of misconduct, including the substitution and manipulation of study subject samples.
Croatian: Inspekcijom su utvrđeni primjeri znatnih lošeg postupanja, uključujući zamjenu uzoraka iz ispitivanja i manipulaciju njima.
English: 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).
Croatian: S obzirom na navedene nalaze i potrebu za zaštitom javnog zdravlja u EU-u, Ujedinjena Kraljevina, Njemačka, Španjolska, Nizozemska i Danska ocijenile su da je u interesu Unije da se predmet uputi CHMP-u te traže da se provede procjena učinka navedenih nalaza na omjer koristi i rizika lijekova koje su države članice odobrile na temelju relevantnih ispitivanja provedenih na tim lokacijama, kao i na zahtjeve za odobrenje za stavljanje lijeka u promet koji su u tijeku.
English: This does not change the fact that any data generated at Semler is considered unreliable and therefore cannot be used to demonstrate bioequivalence.
Croatian: To ne mijenja činjenicu da se svi podaci prikupljeni u tvrtki Semler smatraju nepouzdanima te stoga ne mogu poslužiti u dokazivanju bioekvivalencije.
English: 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.
Croatian: Vlastitom istragom i analizom ispitivanja obuhvaćenih inspekcijom FDA-a, te vlastitom istragom sličnih anomalija ili obrazaca u drugim ispitivanjima, u tvrtki Semler nisu utvrdili postojanje uvjerljivih dokaza o neprimjerenoj manipulaciji podacima, njihovoj zamjeni ili razrjeđivanju.
English: 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.
Croatian: Uz to obrazloženje, ekipa WHO-a za predodabir (PQT) preporučila je trenutačan prekid podnošenja svih dosjea koji se u cijelosti ili djelomično temelje na podacima koje je prikupila tvrtka Semler sve dok se ne dobije potvrda da su utvrđeni problemi riješeni na odgovarajući način.
English: • The CHMP reviewed available data and information provided by the MAHs/applicants, as well as information provided by Semler Research Centre Private Ltd;
Croatian: • CHMP je pregledao sve dostupne podatke i informacije koje su dostavili nositelji odobrenja za stavljanje lijeka u promet/podnositelji zahtjeva, kao i informacije koje je dostavila tvrtka Semler Research Centre Private Ltd;
English: 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.
Croatian: Od CHMP-a je posebice zatraženo da dostavi svoje mišljenje u skladu s člankom 31. Direktive 2001/83/EZ o tome treba li zadržati, izmijeniti, suspendirati ili ukinuti odobrenja za stavljanje lijeka u promet za te lijekove.
English: Nevertheless, any CAPAs implemented after the FDA and WHO inspections cannot retrospectively correct the quality system failures observed during these two inspections.
Croatian: Međutim, nijedna od korektivnih i preventivnih mjera koje su provedene nakon inspekcija FDA-a i WHO-a ne može retrospektivno ispraviti nedostatke sustava upravljanja kvalitetom koji su primijećeni tijekom tih inspekcija.
English: The condition for the lifting of the suspension of the marketing authorisations is set out in Annex III.
Croatian: Uvjet za ukidanje suspenzije odobrenja za stavljanje lijeka u promet naveden je u Prilogu III.
English: • 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.
Croatian: • Podaci o farmakovigilanciji određenih lijekova obuhvaćenih ovim postupkom nisu upućivali na probleme koji bi se mogli pripisati nepostojanju bioekvivalencije, poput smanjene djelotvornosti ili pogoršanja sigurnosti primjene i podnošljivosti.
English: 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.
Croatian: Nalazi inspekcija FDA-a i WHO-a izazivaju ozbiljnu zabrinutost u vezi s primjerenošću uspostavljenog sustava upravljanja kvalitetom na lokacijama Semler JP Nagar i Sakar Nagar.
English: 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.
Croatian: Svjetska zdravstvena organizacija (WHO) također je u razdoblju od 27. do 31. siječnja 2015. provela inspekciju istog objekta za bioanalitička ispitivanja i objekta za klinička ispitivanja tvrtke Semler, na adresi PA Arcade #21,22,23 Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, Indija, te je u razdoblju od 2. do 5. prosinca 2015. provela naknadnu inspekciju kako bi provjerila usklađenost s načelima dobre laboratorijske prakse (GLP) i dobre kliničke prakse (GCP).
English: 1 http://www.fda.gov/Drugs/DrugSafety/ucm495778.htm 2 http://apps.who.int/prequal/info_applicants/NOC/2016/NOC_Semler12April2016.pdf substance between the two medicinal products may differ.
Croatian: 1 http://www.fda.gov/Drugs/DrugSafety/ucm495778.htm 2 http://apps.who.int/prequal/info_applicants/NOC/2016/NOC_Semler12April2016.pdf
English: • 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;
Croatian: • CHMP je razmotrio postupak proveden sukladno s člankom 31. Direktive 2001/83/EZ za odobrenja za stavljanje lijeka u promet i zahtjeve za odobrenje za stavljanje lijeka u promet za lijekove za koje su klinički i/ili bioanalitički dijelovi ispitivanja provedeni u tvrtki Semler u Bangaloreu u Indiji;
English: The inspections revealed critical and major deviations which led to the publishing of a WHO notice of concern2.
Croatian: Provedenim inspekcijama utvrđena su kritična i značajna odstupanja, zbog kojih je objavljena obavijest o zabrinutosti WHO-a2.
English: 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.
Croatian: Nalazi inspekcija FDA-a i WHO-a izazivaju ozbiljnu zabrinutost u vezi s primjerenošću sustava upravljanja kvalitetom na tim lokacijama i, posljedično, u pogledu pouzdanosti podataka koji su dostavljeni u zahtjevima za davanje odobrenja za stavljanje lijeka u promet podnesenima u državama članicama EU-a.
English: 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.
Croatian: Stoga je zaključak FDA-a da klinička i bioanalitička ispitivanja koja je provela tvrtka Semler Research Private Limited iz Bangalorea u Indiji nisu prihvatljiva s obzirom na dvojbe koje se odnose na integritet podataka1.
English: 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.
Croatian: Podaci iz svih ispitivanja bioekvivalencije koja su provedena u tvrtki Semler Research Private Limited u Bangaloreu u Indiji i podneseni nadležnim tijelima kako bi se dokazala bioekvivalencija lijekova s izvornim lijekovima smatraju se nepouzdanima.
English: • 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.
Croatian: • Nositelji odobrenja za stavljanje lijeka u promet istaknuli su u nekim slučajevima da su samo određeni dijelovi ispitivanja provedeni u tvrtki Semler, dok su ostali dijelovi provedeni na drugoj lokaciji.
English: • The CHMP concluded that the particulars supporting the marketing authorisation/marketing authorisation application are incorrect and that the benefit-risk balance is considered not favourable for:
Croatian: • CHMP je zaključio da su određeni podaci kojima se potkrepljuje odobrenje za stavljanje lijeka u promet/zahtjev za odobrenje za stavljanje lijeka u promet netočni i da se omjer koristi i rizika ne smatra povoljnim za:
English: In view of the failures of the quality management system in place at the sites, results and controls of data integrity of individual studies by MAHs cannot make the bioequivalence studies performed at Semler Research Center acceptable as basis for a marketing authorisation.
Croatian: S obzirom na nedostatke uspostavljenog sustava upravljanja kvalitetom na navedenim lokacijama, rezultati i kontrole integriteta podataka iz pojedinih ispitivanja koje su proveli nositelji odobrenja za stavljanje lijeka u promet ne čine ispitivanja bioekvivalencije provedena u tvrtki Semler Research Center prihvatljivom osnovom za davanje odobrenja za stavljanje u promet.
English: Where on the basis of these criteria the relevant national competent authorities of the EU Member States consider that a medicinal product is critical, the suspension of the concerned marketing authorisation(s) may be deferred by the period for which the medicinal product is considered critical.
Croatian: Ako na temelju tih kriterija relevantna nacionalna nadležna tijela država članica EU-a smatraju da je lijek izrazito važan, suspenzija dotičnog/dotičnih odobrenja za stavljanje lijeka u promet može se odgoditi u razdoblju tijekom kojega se lijek smatra izrazito važnim.
English: If the bioavailability of the generic product is lower than the bioavailability of the reference medicinal product, this may result in a lower than intended exposure to the active substance, leading potentially to a decrease in efficacy, a delay or even a lack of therapeutic effect.
Croatian: Ako je bioraspoloživost generičkog lijeka niža od bioraspoloživosti referentnog lijeka, to može dovesti do manjeg od namjeravanog izlaganja djelatnoj tvari, što može dovesti do smanjene djelotvornosti te kašnjenja ili čak izostanka terapijske učinkovitosti.
English: 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.
Croatian: Sukladno članku 10. stavku 1. Direktive 2001/83/EZ, takvi podaci nisu prihvatljiva osnova za pozitivan omjer koristi i rizika za te lijekove i ne mogu nadomjestiti obvezu dokazivanja bioekvivalencije između ispitivanog lijeka i odgovarajućeg referentnog lijeka koji je odobren u EU-u.
English: 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.
Croatian: Odbor preporučuje da se ta odobrenja za stavljanje lijeka u promet (Prilog I.B) suspendiraju ako relevantna nacionalna nadležna tijela taj lijek ne smatraju izrazito važnim.
English: 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.
Croatian: Uprava za hranu i lijekove (FDA) SAD-a provela je inspekciju dobre kliničke prakse (GCP) u objektu za bioanalitička ispitivanja Semler Research Centre Private Ltd, 75A, 15th Cross, 1st Phase, J.P.
English: • For some products, results from bioequivalence data using non-EU Reference Medicinal Products may be available.
Croatian: • Za neke lijekovi možda su dostupni rezultati podataka o bioekvivalenciji primjenom lijekova koji nisu referentni lijekovi odobreni u EU-u.
English: 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.
Croatian: U slučaju odobrenja za stavljanje u promet lijeka koji se smatra izrazito važnim suspenzija se može odgoditi u relevantnoj državi članici (ili više njih) za razdoblje od najviše 24 mjeseca od dana donošenja odluke Komisije.