FrancophonIA/ELRC3.0 huggingface dataset:
English: Impaired renal function
Slovenian: Motnje delovanja ledvic
English: The safety of {Invented name} in persons under 18 years has not yet been tested.
Slovenian: [Če se zdravilo ne odobri za novorojenčke in dojenčke, se doda naslednja izjava] Varnost zdravila {lastniško ime} pri osebah, mlajših od 18 let, ni preskušena.
English: Primovist 0,25 mmol/ ml solution for injection
Slovenian: Primovist 0,25 mmol/ ml solution for injection 0,25 mmol/ml
English: If you have moderate kidney problems, you should only receive one dose of {Invented name} during a scan and you should not receive a second injection for at least 7 days.
Slovenian: Če imate zmerno okvaro ledvic, lahko med slikanjem prejmete le en odmerek zdravila {Lastniško ime}.
English: SK - Slovakia
Slovenian: Slovaška
English: As kidney function is immature in infants up to 1 year of age, {Invented name} will only be used in infants after careful consideration by the doctor.
Slovenian: Zaradi nezrelega delovanja ledvic pri dojenčkih do enega leta starosti, se bo zdravilo {Lastniško ime} pri teh bolnikih uporabilo le po skrbni presoji zdravnika.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SECTIONS OF THE PACKAGE LEAFLET FOR HIGH RISK GADOLINIUM-CONTAINING CONTRAST AGENTS (gadodiamide, gadopentetic acid)
Slovenian: DODATEK BO VKLJUČEN V USTREZNA POGLAVJA NAVODIL ZA UPORABO ZDRAVIL, KI VSEBUJEJO GADOLINIJ IN PRI KATERIH OBSTAJA VISOKA STOPNJA TVEGANJA (gadodiamid, gadopentetna kislina)
English: Bracco Imaging Deutschland GmbH Max-Stromeyer-Strasse 116 D-78467 Konstanz
Slovenian: Bracco Imaging Deutschland GmbH Max-Stromeyer-Strasse 116
English: BACKGROUND INFORMATION *
Slovenian: OSNOVNE INFORMACIJE *
English: The Member states competent Authorities will continue to keep the product under regular review.
Slovenian: Pristojni organi držav članic bodo nadaljevali z rednim nadziranjem izdelka.
English: This review was finalised in June 2006.
Slovenian: Ta pregled je bil zaključen junija 2006.
English: The final opinion was converted into a Decision by the European Commission on 7 September 2007.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 7. septembra 2007.
English: The Rapporteur and Co-Rapporteur appointed were Dr Rossi and Dr Calvo-Rojas respectively.
Slovenian: Poročevalec oz. soporočevalec sta bila dr. Rossi oz. dr. Calvo-Rojas.
English: This review, which concluded in October 2005, did not reveal any new safety concerns for the class of NSAIDs as a whole.
Slovenian: Ta pregled, ki je bil zaključen oktobra 2005, ni razkril novih pomislekov glede varnosti razreda NSAID kot celote.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31(2) REFERRAL
Slovenian: MNENJE ODBORA ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP), V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 31(2) ZA
English: On 2 August 2006, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/83/EC, as amended, for piroxicam containing medicinal products.
Slovenian: Dne 2. avgusta 2006 je Evropska komisija Evropski agenciji za zdravila v skladu s členom 31 Direktive 2001/83/ES, kot je bila spremenjena, predložila napotitev za zdravila, ki vsebujejo piroksikam.
English: International Non-Proprietary Name (INN): piroxicam
Slovenian: Mednarodno nelastniško ime (INN): piroksikam
English: ∗ Notes: the information given in this document and annexes reflects only the CHMP Opinion dated 21 June 2007.
Slovenian: * Opombe: Informacije v tem dokumentu in dodatkih odražajo zgolj mnenje CHMP z dne 21 junija 2007.
English: The referral procedure started on the 21 September 2006.
Slovenian: Napotitveni postopek se je začel 21. septembra 2006.
English: Further to a request from the European Commission the CHMP reviewed safety data on non-selective NSAIDs.
Slovenian: Na podlagi zahteve Evropske komisije je CHMP preučil podatke o varnosti neselektivnih NSAID.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended product information in Annex III and the conditions of the Marketing Authorisation in Annex IV.
Slovenian: Seznam zadevnih imen izdelkov je podan v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj z dopolnjenimi informacijami o izdelku v Dodatku III in Pogoji dovoljenja za promet v Dodatku IV.
English: Piroxicam is authorised in the European Union following national marketing procedures.
Slovenian: Piroksikam je v Evropski uniji odobren na podlagi nacionalnih postopkov za pridobitev dovoljenja za promet z zdravilom.
English: The MAHs presented oral explanations to the CHMP on 22 and 23 May 2007.
Slovenian: Ustna pojasnila so odboru CHMP podali 22. in 23. maja 2007.
English: Written explanations were provided by the Marketing Authorisation Holders (MAH) on 18 December 2006 and 13 April 2007.
Slovenian: Imetniki dovoljenj za promet z zdravilom so podali pisna pojasnila 18. decembra 2006 in 13. aprila 2007.
English: PIROXICAM CONTAINING MEDICINAL PRODUCTS
Slovenian: ZDRAVILA, VSEBUJOČA PIROKSIKAM
English: Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties.
Slovenian: Piroksikam je nesteroidno protivnetno zdravilo (NSAID) s protivnetnimi, analgetičnimi in antipiretičnimi lastnostmi.
English: The CHMP considered that the assessment raised concerns on the benefit/risk balance of piroxicam and informed the European Commission accordingly.
Slovenian: CHMP je menil, da ocena vzbuja pomisleke glede razmerja med koristmi in tveganji za piroksikam, ter je skladno s tem obvestil Evropsko komisijo.
English: The reasons for referral concerned the risk of gastrointestinal and skin reactions.
Slovenian: Razlog za napotitev je bilo tveganje za gastrointestinalne in kožne reakcije.
English: However a need to further evaluate the benefit/risk balance of some non-selective NSAIDs including piroxicam was identified.
Slovenian: Ugotovljena pa je bila potreba po nadaljnji presoji razmerja med koristmi in tveganji za nekatera neselektivna nesteroidna protivnetna zdravila, vključno s piroksikamom.
English: The review found that limited epidemiological data and spontaneous adverse drug reaction data provided a signal of increased risk of gastrointestinal and skin reactions (including life-threatening bullous reactions) for piroxicam relative to other non-selective NSAIDs.
Slovenian: Pregled je pokazal, da omejeni epidemiološki podatki in podatki iz spontanih poročil o neželenih učinkih zdravila nakazujejo na povečano tveganje za gastrointestinalne in kožne reakcije (vključno s smrtno nevarnimi buloznimi reakcijami) glede na druge neselektivne NSAID.
English: A number of restrictions on use, contraindications and strengthened warnings have been added to the Summary Product Characteristics and Package Leaflet in relation to gastrointestinal and skin safety.
Slovenian: V Povzetek glavnih značilnosti zdravila in Navodilo za uporabo je bilo dodanih več omejitev uporabe, kontraindikacij in dodatnih opozoril v zvezi z varnostjo za prebavni trakt in kožo.
English: Based on the available data the CHMP considered that the benefit/risk balance for systemic formulations of piroxicam is positive in the treatment of symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; however the CHMP considered that the benefit/risk balance of piroxicam in the treatment of acute conditions is negative and that these indications should be revoked.
Slovenian: Na podlagi predloženih podatkov je CHMP menil, da je razmerje med koristmi in tveganji za sistemske formulacije piroksikama pri simptomatskem lajšanju osteoartritisa, revmatoidnega artritisa ali ankiloznega spondilitisa pozitivno.
English: Treatment can be repeated once a month.
Slovenian: Zdravljenje se lahko ponovi enkrat mesečno.
English: These usually disappear within 24 hours after administration.
Slovenian: Ti znaki običajno izginejo v 24 urah po dajanju zdravila.
English: Further information on Vectra 3D can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/vectra-3d.
Slovenian: Nadaljnje informacije o zdravilu Vectra 3D so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/vectra-3d.
English: This means that they kill parasites that come into contact with the skin or fur of animals, such as fleas, ticks or flying insects.
Slovenian: To pomeni, da uničijo parazite, ki pridejo v stik s kožo ali dlako živali, kot so bolhe, klopi ali leteči insekti.
English: Treated dogs should not be permitted to sleep with their owners, especially children, on the day of treatment.
Slovenian: Psi, ki so prejeli zdravilo, na dan zdravljenja ne smejo spati s svojimi lastniki, zlasti ne z otroki.
English: The European Medicines Agency decided that Vectra 3D's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Vectra 3D večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Vectra 3D received a marketing authorisation valid throughout the EU on 4 December 2013.
Slovenian: Zdravilo Vectra 3D je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji 4. decembra 2013.
English: People with known hypersensitivity (allergy) to any of the ingredients should avoid contact with the product.
Slovenian: Osebe z znano preobčutljivostjo za (alergijo na) katero koli sestavino zdravila naj se izogibajo stiku z zdravilom.
English: People applying the medicine should not smoke, eat or drink and should wash their hands thoroughly after handling the product.
Slovenian: Osebe med nanosom zdravila ne smejo kaditi, jesti ali piti, po uporabi zdravila pa si morajo temeljito umiti roke.
English: Other information about Vectra 3D
Slovenian: Druge informacije o zdravilu Vectra 3D
English: The effectiveness of Vectra 3D against fleas, ticks, mosquitoes and flies was investigated in 24 laboratory studies and in two field studies.
Slovenian: Učinkovitost zdravila Vectra 3D proti bolham, klopom, komarjem in muham so proučevali v 24 laboratorijskih študijah in dveh študijah na terenu.
English: The active substances in Vectra 3D act as ‘ectoparasiticides'.
Slovenian: Učinkovine v zdravilu Vectra 3D delujejo kot „ektoparaziticidi“.
English: Its actions last for up to a month, and it prevents fleas from hatching and developing for two months.
Slovenian: Zdravilo deluje največ en mesec, izvalitev in razvoj bolh pa preprečuje dva meseca.
English: Pyriproxyfen is an insect growth regulator which stops the flea life cycle by causing production of infertile eggs as well as blocking development of juvenile flea stages into adults.
Slovenian: Piriproksifen je regulator rasti insektov, ki prekine življenjski cikel bolh, tako da povzroči proizvodnjo neplodnih jajčec ter obenem zatre razvoj mladih bolh v odrasle bolhe.
English: The application site should be allowed to dry before the dog is allowed to come into contact with fabrics or furnishings.
Slovenian: Mesto nanosa se mora posušiti, preden se psu dovoli stik s tkaninami ali pohištvom.
English: Other side effects with Vectra 3D (which may affect up to 1 in 1000 dogs) are behavioural disorders such as increased activity, barking or signs of anxiety, lethargy (lack of energy), or anorexia (loss of appetite), and nervous system signs such as muscle tremor (shaking).
Slovenian: Drugi neželeni učinki zdravila Vectra 3D (ki se lahko pojavijo pri največ 1 od 1000 psov) so vedenjske motnje, kot so povečana aktivnost, lajanje ali znaki tesnobe, letargija (pomanjkanje energije) ali anoreksija (izguba teka) in znaki živčnega sistema, kot je mišični tremor (tresenje).
English: Vectra 3D is a veterinary medicine used on dogs to treat and prevent flea and tick infestations and to repel sand flies, mosquitoes and stable flies.
Slovenian: Vectra 3D je zdravilo za uporabo v veterinarski medicini, ki se uporablja pri psih za zdravljenje in preprečevanje infestacij z bolhami in klopi ter za odganjanje peščenih muh, komarjev in hlevskih muh.
English: The content of one full Vectra 3D applicator is applied directly to the dog's skin, after parting its fur, either in one or more spots on the back, depending on the dog's weight, or in a continuous line along the centre of the back from the base of the tail to the shoulder blades.
Slovenian: Vsebina enega celotnega aplikatorja zdravila Vectra 3D se nanese neposredno na kožo psa po razmiku dlake na eno ali več mest na hrbtu, odvisno od telesne mase psa, ali v neprekinjeni liniji po sredini hrbta od korena repa do lopatic.
English: An overview of Vectra 3D and why it is authorised in the EU
Slovenian: Pregled zdravila Vectra 3D in zakaj je odobreno v EU
English: For a full list of all side-effects reported with Vectra 3D, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vectra 3D, glejte navodilo za uporabo.
English: Vectra 3D (dinotefuran / pyriproxyfen / permethrin)
Slovenian: Vectra 3D (dinotefuran/piriproksifen/permetrin)
English: If skin or eye irritation persists, or if the veterinary medicine is accidentally swallowed, immediate medical advice should be sought and the package leaflet or label shown to the doctor.
Slovenian: Če draženje kože ali očesa ne preneha ali če pride do nenamernega zaužitja zdravila za uporabo v veterinarski medicini, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
English: Why is Vectra 3D authorised in the EU?
Slovenian: Zakaj je zdravilo Vectra 3D odobreno v EU?
English: What is Vectra 3D and what is it used for?
Slovenian: Kaj je zdravilo Vectra 3D in za kaj se uporablja?
English: What are the risks associated with Vectra 3D?
Slovenian: Kakšna tveganja so povezana z zdravilom Vectra 3D?
English: Children must not handle treated dogs for at least four hours after application of the veterinary medicine.
Slovenian: Psi, ki so prejeli zdravilo, vsaj štiri ure po nanosu zdravila za uporabo v veterinarski medicini ne smejo priti v stik z otroki.
English: What benefits of Vectra 3D have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Vectra 3D izkazalo v študijah?
English: Dinotefuran acts on nerve receptors called nicotinic acetylcholine receptors and permethrin interferes with sodium channels on nerves that play a role in transmitting signals; when given together, they reinforce each other's action.
Slovenian: Dinotefuran deluje na živčne receptorje, imenovane nikotinski acetilholinski receptorji, permetrin pa deluje na natrijeve kanalčke na živcih, ki sodelujejo pri prenašanju signalov.
English: The second field study involved 278 dogs with flea infestations which were treated three times at monthly intervals either with Vectra 3D or another spot-on product containing fipronil and (s)methoprene.
Slovenian: V drugo študijo na terenu je bilo vključenih 278 psov z infestacijami bolh, ki so v enomesečnih intervalih trikrat prejeli zdravilo Vectra 3D ali drugo zdravilo za kožni nanos, ki vsebuje fipronil in (s)-metopren.
English: The most common side effects with Vectra 3D (which may affect up to 1 in 1000 dogs) are short-lived redness, itching or other signs of discomfort at the application site.
Slovenian: Najpogostejši neželeni učinki zdravila Vectra 3D (ki se lahko pojavijo pri največ 1 od 1000 psov) so kratkotrajna rdečica, srbenje ali drugi znaki neugodja na mestu nanosa.
English: The dogs treated with Vectra 3D had an average tick reduction of 94% over 4 weeks compared with 97% with the other product.
Slovenian: Pri psih, zdravljenih z zdravilom Vectra 3D, je v štirih tednih povprečno zmanjšanje klopov znašalo 94 % v primerjavi s 97 % pri psih, ki so bili zdravljeni z drugim zdravilom.
English: The first field study involved 485 dogs with flea and/or tick infestations.
Slovenian: V prvo študijo na terenu je bilo vključenih 485 psov z infestacijami bolh, klopov ali obojega.
English: Dinotefuran and permethrin are insecticides which kill insects by acting on their nervous system by different mechanisms; permethrin also acts similarly on ticks.
Slovenian: Dinotefuran in permetrin sta insekticida, ki insekte uničita tako, da z različnimi mehanizmi delujeta na njihov živčni sistem.
English: Vectra 3D contains three active substances: dinotefuran, pyriproxyfen and permethrin.
Slovenian: Zdravilo Vectra 3D vsebuje tri učinkovine: dinotefuran, piriproksifen in permetrin.
English: Vectra 3D must not be used on cats and they must not be allowed to groom dogs recently treated with the medicine, as it may cause harmful effects that could be fatal.
Slovenian: Prav tako je treba preprečiti njihov stik s psi, ki so pred kratkim prejeli zdravilo, saj lahko to povzroči škodljive učinke, ki so lahko usodni.
English: Vectra 3D can be obtained without a prescription and is available as a spot-on solution in applicators of five different strengths for use on dogs of different weights.
Slovenian: Zdravilo Vectra 3D je na voljo v obliki raztopine za kožni nanos, v aplikatorjih s petimi različnimi jakostmi za uporabo pri psih različnih telesnih mas, njegova izdaja pa je brez recepta.
English: It showed that Vectra 3D-treated dogs had an average flea count reduction of 95% compared with 97% for the dogs treated with fipronil and (s)-methoprene.
Slovenian: Študija je pokazala, da je pri psih, ki so prejeli zdravilo Vectra 3D, zmanjšanje povprečnega števila bolh znašalo 95 % v primerjavi s 97 % pri psih, ki so prejeli fipronil in (s)-metopren.
English: How does Vectra 3D work?
Slovenian: Kako zdravilo Vectra 3D deluje?
English: How is Vectra 3D used?
Slovenian: Kako se zdravilo Vectra 3D uporablja?
English: If accidental exposure to the eyes occurs, the eyes should be thoroughly rinsed with water and in case of accidental exposure to the skin, the skin should be washed immediately with soap and water.
Slovenian: V primeru nenamernega stika zdravila s kožo je treba kožo nemudoma sprati z milom in vodo.
English: It showed that dogs treated once with Vectra 3D had fleas reduced by 79% over the 4 week study period compared with a reduction of 57% for dogs treated once with another spot-on product containing two other substances
Slovenian: Študija je pokazala, da se je pri psih, ki so prejeli enkratni odmerek zdravila Vectra 3D, v času štiritedenske študije število bolh zmanjšalo za 79 % v primerjavi s 57 % pri psih, ki so prejeli enkratni odmerek drugega zdravila za kožni nanos, ki vsebuje dve drugi učinkovini za zatiranje bolh in klopov, tj. fipronil in (s)-metopren.
English: The requested Community contribution of €46m will be reduced to €37m.
Slovenian: Zahtevani prispevek Skupnosti v višini 46 milijonov EUR se bo zmanjšal na 37 milijonov EUR.
English: Good progress was made in the field of international collaboration on inspections.
Slovenian: Dober napredek je bil dosežen na področju mednarodnega sodelovanja pri inšpekcijskem nadzoru.
English: − 1 member of the Commission.
Slovenian: 1 član Komisije.
English: The number of applications is also in line with forecasts.
Slovenian: Tudi število vlog je v skladu s predvidevanji.
English: Simplification of the contractual arrangements between the EMEA and the national competent authorities of the Member States: development of a cooperation agreement
Slovenian: Poenostavitev pogodbenih ureditev med agencijo EMEA in nacionalnimi pristojnimi organi držav članic: priprava sporazuma o sodelovanju
English: Alternates and other participants
Slovenian: Namestniki in drugi udeleženci
English: London, 1 October 2009
Slovenian: London, 1. oktobra 2009
English: Amendments to the fee implementing rules
Slovenian: Spremembe izvedbenih pravil o pristojbinah
English: Having reviewed the level of cooperation between the EU and FDA, all parties concluded that the cooperation between the two regulators is successful and both parties regard each other as primary international partners in the regulatory field.
Slovenian: Potem ko so vse strani pregledale stopnjo sodelovanja med EU in uradom FDA, so sklenile, da je sodelovanje med obema regulatorjema uspešno in da obe strani štejeta druga drugo kot glavna mednarodna partnerja na regulativnem področju.
English: Budget 2010 update
Slovenian: Posodobljen proračun za leto 2010
English: The assessment of cost-effectiveness and subsequent decisions on reimbursement, on the other hand, should be left at the level of individual Member States.
Slovenian: Ocena stroškovne učinkovitosti in naknadne odločitve o povračilu pa morajo ostati na ravni posameznih držav članic.
English: Fifteen national competent authorities participate in the work of the costing group, and ten of them have submitted costing data.
Slovenian: Petnajst nacionalnih pristojnih organov sodeluje v delu skupine za stroške in deset jih je predložilo podatke o razčlenitvi stroškov.
English: Draft agenda for 1 October 2009 meeting
Slovenian: Osnutek dnevnega reda za sestanek 1. oktobra 2009
English: The Board generally supported the introduction of quantitative indicators.
Slovenian: Upravni odbor je na splošno podprl uvedbo količinskih kazalnikov.
English: The Agency's Committee for Advanced Therapies, inaugurated at the beginning of the year, has issued its first opinions.
Slovenian: Odbor Agencije za napredno zdravljenje (Committee for Advanced Therapies), ustanovljen na začetku leta, je izdal prva mnenja.
English: The EU (European Commission/EMEA) - FDA meeting The meeting took place on the 27-29 September.
Slovenian: Sestanek med EU (Evropsko komisijo/agencijo EMEA) in Uradom za živila in zdravila (FDA) Sestanek je potekal od 27. do 29. septembra.
English: In March 2009, the Management Board adopted a preliminary draft budget for 2010 of €211m.
Slovenian: Upravni odbor je marca 2009 sprejel predhodni predlog proračuna za leto 2010 v višini 211 milijonov EUR.
English: Apologies
Slovenian: Opravičen
English: The proposed rules transpose the rules that are applied in the European Commission for secondment of their staff to organisations outside the EU.”
Slovenian: S predlaganimi pravili se prenašajo pravila, ki se uporabljajo pri Evropski komisiji za dodelitev njenega osebja organizacijam zunaj EU.“
English: The approval of vaccines was based on the concept of H5N1 mock-up vaccines developed by the Agency in 2003.
Slovenian: Cepivi sta bili odobreni na podlagi zasnove H5N1 modelnih cepiv, ki jih je agencija razvila leta 2003.
English: The information on conflicts of interests will also constitute a part of the documentation submitted during the formal consultation process.
Slovenian: Informacija o navzkrižju interesov bo tudi sestavni del dokumentacije, ki se predloži med formalnim posvetovalnim postopkom.
English: The Agency's revenue and expenditure is in line with the plans.
Slovenian: Njeni prihodki in odhodki so v skladu z načrti.
English: − 2 members of the EMEA;
Slovenian: 2 člana agencije EMEA;
English: Pandemic vaccines
Slovenian: Pandemična cepiva
English: The Board will send a summary of this discussion to the Director General of DG Enterprise and Industry.
Slovenian: Upravni odbor bo poslal povzetek te razprave generalnemu direktorju GD za podjetništvo in industrijo.
English: The first draft is undergoing internal consultation with the Agency's staff, members of the scientific committees and the working parties.
Slovenian: O prvem osnutku poteka notranje posvetovanje z osebjem agencije, člani znanstvenih odborov in delovnimi skupinami.
English: The Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on two pandemic vaccines.
Slovenian: Odbor za zdravila za uporabo v humani medicini (Committee for Medicinal Products for Human Use, CHMP) je podal pozitivno mnenje o dveh pandemičnih cepivih.
English: Work-sharing and collaboration among the Member States is necessary, since the evaluation of added therapeutic value is scientific work whose results can be used by all interested Member States.
Slovenian: Potrebna je delitev dela in sodelovanje med državami članicami, saj je vrednotenje dodane terapevtske vrednosti znanstveno delo, katerega rezultate lahko uporabljajo vse zainteresirane države članice.