natgillin/translations-raw huggingface dataset:
London, 10 April 2006 EMEA/85997/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 30 OF COUNCIL DIRECTIVE 2001/83/EC FOR Prograf and associated names (See Annex I)
London, 10. aprila 2006 EMEA/85983/2006 ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) POVZETEK MNENJA IZ NAPOTITVENEGA POSTOPKA V SKLADU S ČLENOM 30 DIREKTIVE SVETA 2001/83/ES ZA Prograf in z njim povezana imena (glejte Dodatek I)
The CHMP having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/risk ratio of Prograf and associated names is considered to be positive in the following indications:
Upoštevaje poročila o oceni poročevalca in soporočevalca, znanstveno razpravo v okviru Odbora ter pojasnila imetnika dovoljenja za promet z zdravilom je CHMP menil, da je razmerje med tveganji in koristmi za zdravilo Prograf in z njim povezana imena pozitivno za naslednje indikacije:
International Non-Proprietary Name (INN): Tacrolimus BACKGROUND INFORMATION
Mednarodno nelastniško ime (INN): takrolimus OSNOVNE INFORMACIJE
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC in Annex III.
Seznam zadevnih imen izdelkov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II skupaj z dopolnjenim Povzetkom glavnih značilnosti zdravila v Dodatku III.
Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.
Zdravljenje zavrnitve alotransplantata pri rezistenci na druge imunosupresive.
presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the national SPCs of the medicinal product Prograf and associated names.
pri EMEA sprožilo napotitveni postopek za obravnavo v skladu s členom 30 Direktive 2001/83/ES, kot je bila spremenjena, da bi tako uskladili nacionalne Povzetke glavnih značilnosti zdravila za zdravilo Prograf in z njim povezana imena.
Different Summaries of Product Characteristics (SPC) had been authorised, based on national, divergent decisions from the authorisations in the EU Member States.
Na podlagi nacionalnih, razhajajočih se odločitev pristojnih organov v državah članicah EU so bili odobreni različni Povzetki glavnih značilnosti zdravila (SPC).
Pharmaceutical Form Route of administration Packaging
Številka EU zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
5 - 8 x 108 perflutren-containing microspheres with a mean diameter range of 2.5 - 4.5 μm; equivalent to 0.19 mg perflutren gas per ml
5 - 8 x 108 mikrosfer s perflutrenom, s povprečnim premerom v razponu 2,5 - 4,5 µm.
perflutren-containing microspheres with a mean diameter range of 2.5 - 4.5 μm; equivalent to 0.19 mg perflutren gas per ml
mikrosfer s perflutrenom, s povprečnim premerom v razponu 2,5 - 4,5 µm.
The PFS results are given again below:
Rezultati za PFS so znova prikazani spodaj:
Therefore, Annex III may not necessarily represent the current text.
Zaradi tega je možno, da Dodatek III ne predstavlja trenutno veljavnega besedila.
There was no evidence of an overall excess mortality.
Dokazov o preveliki celotni smrtnosti ni bilo.
The 4th analysis of the EPC data will also be provided when available.
Četrta analiza podatkov o EPC bo predložena, takoj ko bo na razpolago.
Analysis population
Populacija za analizo
However, the numbers of cases involved are relatively small, and there is no clear temporal relationship.
Vendar je število vpletenih primerov relativno nizko, poleg tega pa manjka jasno razvidno časovno razmerje.
In the clinical studies this was severe in around 5% of patients.
V kliničnih študijah sta bila ta neželena učinka posebej resna pri približno 5 % bolnikov.
Radical prostatectomy 179/870 (20.6)
Radikalna prostatektomija 179/870 (20,6)
HU - Hungary Pharmaconsult Kft.: 1141 Budapest, Ráskay Lea u. 44.
HU - Madžarska Pharmaconsult Kft.: 1141 Budapest, Ráskay Lea u. 44.
Therefore, Belgium referred the issue on 27 July 2006 for consideration by CHMP under Article 31 of Directive 2001/83/EC, as amended.
Zaradi tega je Belgija dne 27. julija 2006 odboru CHMP predložila sporno vprašanje na napotitveni postopek po členu 31 Direktive 2001/83/ES z vsemi spremembami.
National Competent Authorities (NCA), coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Nacionalni pristojni organi, katerih delo usklajuje referenčna država članica (RMS), bodo zagotovili, da imetnik dovoljenja za promet z zdravilom izpolnjuje naslednje pogoje:
These same data were considered by the UK, the Reference Member State (RMS) for the Mutual Recognition Procedure (MRP), in 2003.
Iste podatke so leta 2003 pregledali tudi v Združenem kraljestvu, ki je referenčna država članica (MRP) za postopek medsebojnega priznavanja.
However, an association with bicalutamide cannot be ruled out.
Kljub temu pa povezave z bikalutamidom ni mogoče izključiti.
CS - Czech Republic
CS - Češka
Hazard ratio (95% CI)
Razmerje tveganja (95 % CI)
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
The need to further study cardiovascular morbidity and mortality remains.
Potreba po nadaljnjem raziskovanju kardiovaskularne obolevnosti in smrtnosti ostaja.
Radical prostatectomy
Radikalna prostatektomija
However, some trends were apparent in exploratory subgroup analyses.
Vendar so eksplorativne analize podskupin pokazale nekatere trende.
EL - Greece Dermos Meπε -pharmaceitica 25 Paraschou str.
Dermos Meπε -pharmaceitica 25 Paraschou str.
However, these data do support the Committee's position that the indication should be restricted to selected patients with locally advanced prostate cancer at high risk of disease progression.
Vendar pa ti podatki podpirajo stališče Odbora, da bi morala biti indikacija omejena na izbrane bolnike z lokalno napredovalim rakom prostate in z visokim tveganjem za napredovanje bolezni.
How such patients are identified could be based on criteria such as PSA levels, Gleason score and stage of disease.
Način razpoznavanja takih bolnikov bi lahko bil zasnovan na merilih, kakršna so ravni PSA, Gleasonov indeks in stadij bolezni.
These are also not arbitrary subgroups, but are implicit in the proposed indication, correspond to the way prostate cancer is classified, managed and studied, and the results are consistent with what might be expected.
Poleg tega te podskupine niso poljubne, temveč so vpletene v predlagano indikacijo, ustrezajo načinu razvrščanja, vodenja in raziskovanja raka prostate, rezultati pa so skladni s pričakovanji.
Gynaecomastia and breast pain have been highlighted (mainly in the 1st year of intake) and can be managed in many patients.
Posebej poudarjena sta bili ginekomastija in bolečina v prsih (v glavnem v prvem letu jemanja zdravila), ki se ju da uravnavati pri številnih bolnikih.
NO - Norway AstraZeneca AS Boks 200 Vinderen 0319 Oslo
NO - Norveška AstraZeneca AS Boks 200 Vinderen 0319 Oslo
PT - Portugal AstraZeneca Produtos Farmacêuticos, Lda.
PT - Portugalska AstraZeneca Produtos Farmacêuticos, Lda.
No overall survival difference was seen at 7.4 years median follow up with 22.9% mortality (HR=0.99; 95% CI 0.91 to1.09).
Po mediano 7,4 leta spremljanja ni bilo razlik v celotnem preživetju; umrljivost je bila 22,9% (RO = 0,99; 95% IZ: 0,91-1,09).
Patients and clinicians should decide on the most appropriate treatment on an individual basis, discussing efficacy and tolerability aspects of all available treatments, all available risk factors for disease progression, and taking into account the lifestyle of the patient.
Bolniki in zdravniki bi se morali o najbolj ustreznem zdravljenju odločiti glede na vsaki posamezni primer posebej in se pri tem pogovoriti o vprašanjih učinkovitosti in prenašanju vseh razpoložljivih oblik zdravljenja, o vseh faktorjih tveganja za napredovanje bolezni, ob tem pa upoštevati življenjski stil bolnika.
Progression-free survival and overall survival data for patients with locally advanced disease are summarised in the following tables:
Podatki o preživetju brez napredovanja in celotnem preživetju za bolnike z lokalno napredovalo boleznijo so povzeti v naslednjih dveh tabelah:
- For all MAHs, in addition to routine pharmacovigilance activities, identified and potential risks highlighted for increased monitoring and follow-up should include:
- Vsi imetniki dovoljenj za promet z zdravilom bi morali poleg rutinskih aktivnosti farmakovigilance za poostreno opazovanje izpostaviti tudi prepoznana in morebitna tveganja, ki vključujejo:
For patients with localised disease receiving CASODEX alone, there was no significant difference in progression free survival.
Pri bolnikih z lokalizirano boleznijo, ki so dobivali samo zdravilo CASODEX, ni bilo bistvenih razlik pri preživetju brez napredovanja.
In 2004, 2 publications were published detailing a pre-planned 2nd analysis of the Casodex (bicalutamide) Early Prostate Cancer (EPC) study programme.
V letu 2004 sta bili izdani dve publikaciji, ki podrobno opisujeta predhodno načrtovano drugo analizo raziskovalnega programa za zdravilo Casodex (bikalutamid) pri zgodnjem raku prostate (EPC).
Due to a small number of relevant subjects, no conclusions could be drawn regarding the contribution of tamoxifen or radiotherapy to cardiovascular outcomes, or on whether tamoxifen exposure had a synergistic effect on efficacy.
Zaradi majhnega števila oseb, udeleženih na testiranju, ni bilo mogoče priti do zaključka o prispevku tamoksifena ali radioterapije k kardiovaskularnim rezultatom ali glede vprašanja, ali ima izpostavljenost tamoksifenu sinergijski vpliv na učinkovitost.
Benefit/ Risk considerations
Pomisleki ob razmerju med koristmi in tveganji
However, it is not possible to entirely “rule out” thromboembolic events as contributory explanation of increased cardiovascular mortality.
Kljub temu pa ni mogoče povsem izključiti vpliva tromboemboličnih dogodkov, kot razlage za povečano kardiovaskularno smrtnost.
To address this concern, a new epidemiological study will be performed, as part of an agreed Risk Management Plan.
Za odgovor na to vprašanje se bo izvedla nova študija, ki bo del dogovorjenega načrta za obvladovanje tveganja.
Disease progression may be associated with problems such as painful bone metastases, cord compression, pathological fractures and urinary obstruction.
Napredovanje bolezni je lahko povezano s težavami, kakršne so boleče kostne metastaze, stiskanje hrbtenjače, patološki zlomi in oviranje urinarnega pretoka.
The median PSA levels on initiation of active therapy for each subgroup are above the thresholds in current European Association of Urology (EAU) guidance.
Mediane ravni PSA ob uvajanju aktivnega zdravljenja so pri vsaki izmed podskupin nad pražnimi vrednostmi, opredeljenimi v trenutno veljavnih smernicah Evropskega združenja za urologijo (EAU).
As a consequence, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products and to grant Marketing Authorisations for all applications referred to in Annex I of the Opinion in accordance with the amendments to the relevant sections of the Summary of Product Characteristics, set out in Annex III of the Opinion.
Kot posledica tega je CHMP predlagal, da družba zadrži dovoljenja za promet za vsa zdravila in da se ji odobri dovoljenja za vse aplikacije, ki so bile omenjene v Dodatku I mnenja, v skladu z dopolnili predmetnih poglavij Povzetka glavnih značilnosti zdravila, kot so bile zastavljene v Dodatku III mnenja.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BICALUTAMIDE 150 mg CONTAINING MEDICINAL PRODUCTS (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO BIKALUTAMID 150 mg (glejte Dodatek I)
Bicalutamide 150 mg is marketed in the EU following national and Mutual Recognition application procedures.
Bikalutamid 150 mg se trži v EU po odobritvi vloge za dovoljenje za promet v skladu z nacionalnimi postopki in postopki medsebojnega priznavanja.
In these patients there was also a trend toward decreased survival compared with placebo patients (HR=1.16; 95% CI 0.99 to 1.37).
Pri teh bolnikih je obstajal trend h krajšemu preživetju v primerjavi z bolniki, ki so dobivali placebo (RO = 1,16; 95% IZ: 0,99 - 1,37).
None of the EPC trials mandated that treatment be withheld from patients in the placebo group until clinical progression.
V nobenem od preizkušanj EPC niso zahtevali, da bi bolnikom v placebo skupini odrekli zdravljenje do kliničnega napredovanja bolezni.
Whilst the pattern of adverse events argues against a role for raised oestrogen levels, it is known that the myocardium has androgen receptors, and it might be affected by long-term androgen deprivation.
Čeprav vzorec neželenih dogodkov ne podpira vloge povišanih ravni estrogena pri tem, pa je znano, da ima miokard androgene receptorje in da nanj lahko vpliva dolgotrajna odtegnitev androgena.
Based on the concerns raised, the following questions were posed to the Applicants/ MAHs as part of the consolidated CHMP List of Questions, the responses to which were the basis of the CHMP reassessment of the benefit/risk balance:
Na temelju spornih vprašanj so predlagateljem/imetnikom dovoljenj za promet z zdravilom zastavili naslednja vprašanja, ki so bila del konsolidiranega seznama vprašanj CHMP, odgovori nanje pa so bili osnova za ponovno oceno razmerja med koristmi in tveganji:
With reference to heart failure mortality, the MAHs have submitted a limited amount of new data since this issue was last assessed, namely results from a further clinical study, an updated literature review and an updated review of their safety database.
Glede smrtnosti zaradi odpovedi srca so imetniki dovoljenj za promet z zdravilom predložili omejeno količino podatkov, ki bi bili novejši od tistih, pridobljenih ob zadnjemu ocenjevanju tega spornega vprašanja in so se v glavnem nanašali na nadaljnjo klinično študijo, posodobljen pregled literature in posodobljen pregled njihove podatkovne baze o varnosti zdravila.
The numbers involved are relatively small, there is no consistent pattern for heart failure deaths over the longer term, and there is some unreliability in selecting this as a cause of death.
Predstavljena števila so relativno nizka, dolgoročno ni doslednega vzorca umrljivosti zaradi odpovedi srca, prav tako pa je prisotne tudi nekaj nezanesljivosti pri izbiri odpovedi srca za vzrok smrti.
A reduction in risk of objective disease progression was seen across most patient groups but was most evident in those at highest risk of disease progression.
Tveganje za objektivno napredovanje bolezni se je zmanjšalo v večini skupin bolnikov, a najočitneje pri bolnikih z največjim tveganjem za napredovanje bolezni.
- In view of the available data, the CHMP concluded that a potential association between the use of bicalutamide 150 mg and heart failure cannot be ruled out and therefore considered that the need to further study cardiovascular morbidity and mortality remains.
- Glede na razpoložljive podatke je CHMP zaključil, da morebitne povezave med uporabo bikalutamida 150 mg in srčno odpovedjo ni mogoče izključiti in je zato mnenja, da potreba po nadaljnjem raziskovanju kardiovaskularne obolevnosti in smrtnosti ostaja.
At 7.4 years median follow up, 27.4% and 30.7% of all CASODEX and placebo-treated patients, respectively, had experienced objective disease progression.
Po mediano 7,4 leta spremljanja se je objektivno napredovanje bolezni pojavilo pri 27,4% vseh bolnikov, ki so dobivali CASODEX, in pri 30,7% vseh bolnikov, ki so dobivali placebo.
A more specific target population is hard to define from the EPC data, and the general term “high risk” better accommodates wide differences in local practice and inevitable changes in the standard of care, and takes into account the many variables in the individual patient which may contribute to risk of progression.
Iz podatkov o EPC je težko opredeliti še bolj specifično ciljno populacijo, tako da splošni izraz „visoko tveganje“ bolj odgovarja velikim razlikam v lokalni praksi in neizbežnim spremembam v standardu oskrbe, pri tem pa upošteva mnoge spremenljivke pri posameznem bolniku, ki lahko prispevajo k tveganju za napredovanje bolezni.
These results should of course be balanced against the well-known tolerability issues of Casodex (bicalutamide).
Seveda bi bilo treba te rezultate pretehtati ob upoštevanju dobro znanih težav s prenašanjem zdravila Casodex (bikalutamid).
Further, the referral concerned only the locally advanced prostate cancer indication based on the Early Prostate Cancer study programme, and the directly related wording in sections 4.1 and 5.1 of the SPC.
Poleg tega se je nanašal samo na indikacijo v zvezi z lokalno napredovalim rakom prostate, ki temelji na programu preučevanja zgodnjega raka prostate, in na besedilo, neposredno povezano s tem, ki se nahaja v poglavju 4.1 in 5.1 Povzetka glavnih značilnosti zdravila.
The majority of patients with heart failure had confounding factors at study entry, and the causality assessment of investigators for all deaths ascribed to heart failure was “not related”.
Večina bolnikov z odpovedjo srca je imela pri vstopu v študijo zmedene faktorje, tako da je bila ocena preiskovalcev o vzročnosti pri vseh primerih smrti zaradi domnevne odpovedi srca „ni povezave“.
The requested additional analyses of the EPC trial data confirm an increased risk for deaths coded as heart failures (however, with no overall excess risk in the cardiovascular system), an increased risk of urogenital symptoms (including gynaecomastia and breast pain) mainly during the first year of intake, and further indicate the absence of an adverse effect on thromboembolic events during the follow-up (supported by a pattern of events inconsistent with hormonal effects).
Zahtevane dodatne analize podatkov preizkušanj EPC potrjujejo povečano tveganje smrti, označenih kot odpovedi srca (vendar brez celotnega prekomernega tveganja v kardiovaskularnem sistemu), povečano tveganje pojava urogenitalnih simptomov (vključno z ginekomastijo in bolečinami v prsih) predvsem med prvim letom jemanja, poleg tega pa še odsotnost neželenega učinka na tromboembolične dogodke med spremljanjem po koncu študije (podpira ga vzorec dogodkov, ki niso skladni z učinki hormonov).
For these reasons, the CHMP considers that the progression-free survival results are important and can be considered on their merits.
Zaradi omenjenih razlogov CHMP misli, da so rezultati o preživetju brez napredovanja bolezni pomembni in jih je treba preveriti same po sebi.
In addition, the survival advantage observed in patients with locally advanced disease receiving radiotherapy appears to be consistent with that seen in previous studies, and a synergistic effect with radiotherapy is plausible.
Poleg tega se zdi prednost v preživetju pri bolnikih z lokalno napredovalo boleznijo, ki so prejemali radioterapijo, dosledna s preživetjem, ki so ga opazili v prejšnjih študijah, tako da je sinergijski učinek z radioterapijo verjeten.
EL - Greece Astrazeneca SA 4 Theotocopoulou & Astronauton 151 25 Marousi-Athens
4 Theotocopoulou & Astronauton 151 25 Marousi-Athens
In view of the concerns related to safety and efficacy for bicalutamide 150 mg the National Competent Authority (NCA) in Belgium considered it to be in the interest of public health to perform a new benefit/risk assessment.
Zaradi zadržkov glede varnosti in učinkovitosti bikalutamida 150 mg je pristojni nacionalni organ (NCA) v Belgiji zaključil, da bi bila izvedba nove ocene tveganj in koristi v interesu javnega zdravja.
Following their own review of these data carried out in 2004 and due to their resulting concerns over the benefit/risk balance of bicalutamide 150 mg in locally advanced prostate cancer, the Belgian Regulatory Authority suspended their national Marketing Authorisation for Casodex (bicalutamide) 150 mg in August
Na podlagi lastnega pregleda teh podatkov, opravljenega leta 2004, in zaradi posledičnih zadržkov glede razmerja med koristmi in tveganji bikalutamida 150 mg pri lokalno napredovalem raku prostate, je belgijski regulativni organ avgusta leta 2005 začasno razveljavil dovoljenje za promet z zdravilom Casodex (bikalutamid) 150 mg.
15 Stanhope Gate London, W1K 1LN United Kingdom
15 Stanhope Gate London, W1K 1LN United Kingdom tableta
EAU guidelines suggest the use of prophylactic breast radiation, tamoxifen or aromatase inhibitors to manage these symptoms, although they are not licensed in this use.
V smernicah EAU je predlagano, da bi za urejanje teh simptomov uporabljali obsevanje prsi, tamoksifen ali zaviralce aromataze, čeprav slednji niso odobreni za uporabo v te namene.
In conclusion, the heart failure data remain a concern and are inconclusive, but do not significantly alter the benefit/risk balance in locally advanced prostate cancer patients.
Podatki o odpovedi srca ostajajo s tem sporni in ne omogočajo jasnega zaključka, vendar ne pomenijo znatne spremembe razmerja med koristmi in tveganji pri bolnikih z lokalno napredovalim rakom prostate.
- The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bicalutamide 150 mg.
- Odbor je upošteval napotitev v skladu s členom 31 Direktive 2001/83/ES z vsemi dopolnili za zdravila, ki vsebujejo bikalutamid 150 mg.
Note: This Annex III (Amendments to the Summary of Product Characteristics) is the one that was Annexed to the Commission Decision on this Article 31 referral for bicalutamide 150 mg containing medicinal products.
Opomba: Ta Dodatek III (Spremembe Povzetka glavnih značilnosti zdravila) je identičen tistemu, ki je bil priložen odločbi Komisije v zvezi z napotitvenim postopkom, sproženim v skladu s členom 31, za zdravila, ki vsebujejo bikalutamid 150 mg.
Watchful waiting
Oprezno čakanje
Other aspects of the SPC and the other indication for bicalutamide 150 mg, which is approved in some EU member states, were not within the scope of the referral.
Drugi vidiki Povzetka glavnih značilnosti zdravila in druga indikacija za bikalutamid 150 mg, odobrena v nekaterih državah članicah EU, niso bili predmet te napotitve.
Gynaecomastia may not resolve spontaneously following cessation of therapy, particularly after prolonged treatment.
Spontan izzven ginekomastije po končanem zdravljenju ni nujen, kar velja še posebej za dolgotrajno zdravljenje.
- The outcome of the 4th analysis of the EPC data should be provided to the RMS and the NCAs where bicalutamide 150 mg is authorised.
- Izide četrte analize podatkov o EPC bi moral predložiti RMS in nacionalnim pristojnim organom, kjer je bikalutamid 150 mg odobren.
How does the company justify the absence of adjustment for tests of multiplicity in the analysis of the EPC results?
Kako družba utemeljuje odsotnost prilagajanj za teste multiplikativnosti pri analizi rezultatov za zgodnji rak prostate?
- A new pharmacoepidemiological study(ies) should be undertaken to get a better understanding of cardiovascular risk.
- Imetnik mora opraviti novo farmakoepidemiološko študijo (ali študije), ki bodo pripomogle k boljšemu razumevanju kardiovaskularnega tveganja.
The scope of the referral included all pending Marketing Authorisation applications as well as all Marketing Authorisations for medicinal products containing 150 mg bicalutamide.
Napotitveni postopek se je nanašal na vse vloge za izdajo dovoljenja za promet, ki so bile v postopku odobritve, kot tudi na dovoljenja za promet za zdravila, ki vsebujejo 150 mg bikalutamida.
After the Commission Decision, the Member State competent authorities will update Annex III as required.
Pristojne oblasti držav članic bodo posodobile Dodatek III v skladu z zahtevami, ko bo podana odločba Komisije.