natgillin/translations-raw huggingface dataset:
The Secretary General/High Representative has proposed the appointment of Jean-Paul MICHEL as the new Head of Mission for EUSEC RD Congo,
Generalni sekretar/visoki predstavnik je predlagal, da se za novega vodjo misije EUSEC RD Congo imenuje g. Jean-Paul MICHEL –
Jean-Paul MICHEL is hereby appointed Head of Mission for EUSEC RD Congo.
Jean-Paul MICHEL se imenuje za vodjo misije EUSEC RD Congo.
This Decision shall take effect on 1 July 2008.
Ta sklep začne učinkovati 1. julija 2008.
concerning the accession of Bulgaria and Romania to the Convention of 23 July 1990 on the elimination of double taxation in connection with the adjustment of profits of associated enterprises
o pristopu Bolgarije in Romunije h Konvenciji z dne 23. julija 1990 o odpravi dvojnega obdavčevanja v zvezi s preračunom dobička povezanih podjetij
Convention 90/436/EEC of 23 July 1990, on the elimination of double taxation in connection with the adjustment of profits of associated enterprises [1] (the Arbitration Convention) was signed at Brussels on 23 July 1990 and entered into force on 1 January 1995.
Konvencija 90/436/EGS z dne 23. julija 1990 o odpravi dvojnega obdavčevanja v zvezi s preračunom dobička povezanih podjetij [1] („Konvencija o arbitraži“) je bila podpisana 23. julija 1990 v Bruslju in je začela veljati 1. januarja 1995.
The Arbitration Convention was amended by a Protocol [2] signed on 25 May 1999 and which entered into force on 1 November 2004, the Convention of 21 December 1995 [3] signed on 21 December 1995, and the Convention of 8 December 2004 [4] signed on 8 December 2004.
Konvencija o arbitraži je bila spremenjena s Protokolom [2], ki je bil podpisan 25. maja 1999 in je začel veljati 1. novembra 2004, s Konvencijo z dne 21. decembra 1995 [3], ki je bila podpisana 21. decembra 1995, in Konvencijo z dne 8. decembra 2004 [4], ki je bila podpisana 8. decembra 2004.
Article 3(3) of the 2005 Act of Accession provides that Bulgaria and Romania accede to the conventions and protocols concluded between the Member States listed in Annex I to the 2005 Act of Accession.
Člen 3(3) Akta o pristopu iz leta 2005 določa, da Bolgarija in Romunija pristopita h konvencijam in protokolom iz Priloge I k Aktu o pristopu, ki so jih sklenile države članice.
That Annex, as supplemented by Council Decision 2008/493/EC of 23 June 2008 [5] amending Annex I to the Act of Accession of Bulgaria and Romania, includes the Arbitration Convention, the Protocol signed on 25 May 1999, the Convention of 21 December 1995 and the Convention of 8 December 2004.
Navedena priloga, kakor je bila dopolnjena s Sklepom Sveta 2008/493/ES z dne 23. junija 2008 [5] o spremembi Priloge I k Aktu o pristopu Bolgarije in Romunije, vključuje Konvencijo o arbitraži, Protokol, podpisan 25. maja 1999, Konvencijo z dne 21. decembra 1995 in konvencijo z dne 8. decembra 2004.
In accordance with Article 3(4) of the 2005 Act of Accession the Council is to make all adjustments required by reason of accession to those Conventions and Protocol,
V skladu s členom 3(4) Akta o pristopu iz leta 2005 vse prilagoditve navedenih konvencij in protokolov, ki so potrebne zaradi pristopa, sprejme Svet –
The Arbitration Convention is hereby amended as follows:
Konvencija o arbitraži se spremeni:
In Article 2(2), points (a) to (y) shall be replaced by the following:
v členu 2(2) se točke od (a) do (y) nadomestijo z naslednjim:
in Belgium:
v Belgiji:
Gewerbesteuer, insofar as this tax is based on trading profits
Gewerbesteuer, in so far as this tax is based on trading profits
in Estonia:
v Estoniji:
in Ireland:
na Irskem:
in Greece:
v Grčiji:
in Lithuania:
v Litvi:
impôt commercial, insofar as this tax is based on trading profits
impôt commercial, in so far as this tax is based on trading profits
in Slovenia:
v Sloveniji:
in Finland:
na Finskem:
in Sweden:
na Švedskem:
The following indent shall be added to Article 3(1):
v členu 3(1) se dodata naslednji alinei:
The Arbitration Convention and the Protocol of 25 May 1999, together with the Conventions of 21 December 1995 and of 8 December 2004, shall enter into force in relation to Bulgaria and Romania on 1 July 2008.
Konvencija o arbitraži in Protokol z dne 25. maja 1999, skupaj s Konvencijama z dne 21. decembra 1995 in 8. decembra 2004, začnejo za Bolgarijo in Romunijo veljati 1. julija 2008.
OJ L 225, 20.8.1990, p. 10.
UL L 225, 20.8.1990, str. 10.
OJ C 202, 16.7.1999, p. 1.
UL C 202, 16.7.1999, str. 1.
OJ C 26, 31.1.1996, p. 1.
UL C 26, 31.1.1996, str. 1.
OJ C 160, 30.6.2005, p. 1.
UL C 160, 30.6.2005, str. 1.
The Bulgarian and Romanian texts of the Conventions and Protocol shall be published in a special edition of the Official Journal at a later date.
Bolgarska in romunska besedila Konvencij in Protokola se bodo naknadno objavila v posebni izdaji Uradnega lista.
UNILATERAL DECLARATIONS CONCERNING THE CONVENTION OF 23 JULY 1990 ON THE ELIMINATION OF DOUBLE TAXATION IN CONNECTION WITH THE ADJUSTMENT OF PROFITS OF ASSOCIATED ENTERPRISES
ENOSTRANSKE IZJAVE O KONVENCIJI Z DNE 23. JULIJA 1990 O IZOGIBANJU DVOJNEGA OBDAVČEVANJA V ZVEZI S PRILAGODITVIJO DOBIČKA POVEZANIH PODJETIJ
Unilateral Declarations on Article 7 of the Convention on the elimination of double taxation in connection with the adjustment of profits of associated enterprises:
Enostranske izjave o členu 7 Konvencije o izogibanju dvojnega obdavčevanja v zvezi s prilagoditvijo dobička povezanih podjetij:
Italy, Lithuania and Malta declare that they will apply Article 7(3).
Italija, Litva in Malta izjavljajo, da bodo uporabljale člen 7(3).
Unilateral Declarations on Article 8 of the Convention on the elimination of double taxation in connection with the adjustment of profits of associated enterprises:
Enostranske izjave o členu 8 Konvencije o izogibanju dvojnega obdavčevanja v zvezi s prilagoditvijo dobička povezanih podjetij:
Declaration by Bulgaria
Izjava Bolgarije:
The term ‘serious penalties’ means penalties of every kind, imposed for actions constituting administrative or tax infringements, including infringements of procedural law concerning tax assessment and tax collection, as well as for crimes against the tax system.
Izraz „stroge kazni“ pomeni vse vrste kazni za dejanja, ki predstavljajo upravne ali davčne kršitve, vključno s kršitvami procesnega prava glede odmere davkov in pobiranja davkov, ter kazniva dejanja zoper davčni sistem.
‘Serious penalties’ imposed on the enterprise are also deemed to exist when penalties are imposed for offences committed against the tax system on an individual from that enterprise whose actions have influenced the amount of tax liabilities of the enterprise or the collection therewith.
„Stroge kazni“ za podjetja veljajo, ko so kazni za prekrške zoper davčni sistem naložene posamezniku iz tega podjetja, čigar dejanja so vplivala na višino davčne obveznosti podjetja ali pobiranje teh davkov.
Declaration by Romania
Izjava Romunije:
The term ‘serious penalty’ includes the commission of any criminal act provided by the tax evasion law or the accountancy law or the company law or the tax legislation.
Izraz „stroga kazen“ zajema storitev kaznivega dejanja po zakonu o izogibanju davkov ali zakonu o računovodstvu ali pravu družb ali davčni zakonodaji.
It also includes administrative penalties in regard to:
Zajema tudi upravne kazni v zvezi z:
refusal to submit the tax statements (declarations) or the informative statements at the request of the tax bodies,
zavrnitvijo oddaje davčne napovedi (izjave) ali informativne izjave na zahtevo davčnih organov,
refusal to supply documents and records requested by the tax inspection authorities,
zavrnitvijo predložitve dokumentacije in evidenc, ki jih zahtevajo davčni inšpekcijski organi,
failing to submit the periodical financial documents and the accounting reports or, submitting such documents or reports which include incorrect data,
neoddajo redne finančne dokumentacije in računovodskih poročil ali oddajo takšne dokumentacije ali poročil, ki vsebujejo nepravilne podatke,
actions included in the tax record, according to the legislation in force.
dejanji iz davčne evidence v skladu z veljavno zakonodajo.
Declaration by Slovakia
Izjava Slovaške republike:
The term ‘serious penalty’ means a penalty imposed according to the Criminal Code for criminal offences committed with respect to the infringement of the pertinent tax laws, Tax Administration Act or Act on Accounting.
Izraz „stroga kazen“ pomeni kazen, naloženo po kazenskem zakoniku za kazniva dejanja v zvezi s kršitvami relevantne davčne zakonodaje, tj. zakona o davčni upravi oziroma zakona o računovodstvu.
Declaration by Spain
Izjava Kraljevine Španije:
‘Serious penalties’ shall include administrative penalties for serious and very serious tax infringements, as well as sentences for offences affecting public finances.
„Stroge kazni“ vključujejo upravne kazni za hude in zelo hude kršitve ter kazni za kazniva dejanja z učinkom na javne finance.
The texts of the Arbitration Convention and the Protocol of 25 May 1999, together with the Conventions of 21 December 1995 and of 8 December 2004, drawn up in the Bulgarian and Romanian languages [6] shall be authentic under the same conditions as the other language versions of these Conventions and Protocol.
Besedila Konvencije o arbitraži in Protokola z dne 25. maja 1999, skupaj s Konvencijama z dne 21. decembra 1995 in 8. decembra 2004, sestavljena v bolgarskem in romunskem jeziku [6], so verodostojna pod enakimi pogoji kot druge jezikovne različice navedenih konvencij in protokola.
amending Annex I to the Act of Accession of Bulgaria and Romania
o spremembi Priloge I k Aktu o pristopu Bolgarije in Romunije
Article 3(3) of the 2005 Act of Accession provides that Bulgaria and Romania accede to the conventions and protocols concluded between the Member States, listed in its Annex I.
Člen 3(3) Akta o pristopu iz leta 2005 določa, da Bolgarija in Romunija pristopita h konvencijam in protokolom, navedenim v Prilogi I, ki so jih sklenile države članice.
On 8 December 2004, the Member States signed a Convention on the accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia [1] to the Convention of 23 July 1990 on the elimination of double taxation in connection with the adjustment of profits of associated enterprises [2] (the Arbitration Convention).
Dne 8. decembra 2004 so države članice podpisale Konvencijo o pristopu Češke, Estonije, Cipra, Latvije, Litve, Madžarske, Malte, Poljske, Slovenije in Slovaške [1] h Konvenciji z dne 23. julija 1990 o odpravi dvojnega obdavčevanja v zvezi s preračunom dobička povezanih podjetij [2] („Konvencija o arbitraži“).
It is appropriate to provide for the accession of Bulgaria and Romania to the Arbitration Convention as amended by the Convention of 8 December 2004.
Primerno je, da Bolgarija in Romunija pristopita h Konvenciji o arbitraži, kakor je bila spremenjena s Konvencijo z dne 8. decembra 2004.
To that effect, the Convention of 8 December 2004 should be added to Annex I of the 2005 Act of Accession,
Konvencijo z dne 8. decembra 2004 bi bilo zato treba dodati v Prilogo I k Aktu o pristopu iz leta 2005 –
The following indent shall be added to point 2 of Annex I to the 2005 Act of Accession:
V točki 2 Priloge I k Aktu o pristopu iz leta 2005 se doda naslednja alinea:
Convention of 8 December 2004 on the accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic to the Convention on the elimination of double taxation in connection with the adjustment of profits of associated enterprises (OJ C 160, 30.6.2005, p. 1).’
Konvencija z dne 8. decembra 2004 o pristopu Češke republike, Republike Estonije, Republike Ciper, Republike Latvije, Republike Litve, Republike Madžarske, Republike Malte, Republike Poljske, Republike Slovenije in Slovaške republike h Konvenciji o odpravi dvojnega obdavčevanja v zvezi s preračunom dobička povezanih podjetij (UL C 160, 30.6.2005, str. 1)“.
This Decision shall take effect on the day of its publication in the Official Journal of the European Union.
Ta sklep začne učinkovati dan po objavi v Uradnem listu Evropske unije.
concerning the provisional prohibition of the use and sale in Austria of genetically modified maize (Zea mays L. line MON810) pursuant to Directive 2001/18/EC of the European Parliament and of the Council
o začasni prepovedi uporabe in prodaje gensko spremenjene koruze (Zea mays L. linija MON810) v Avstriji v skladu z Direktivo 2001/18/ES Evropskega parlamenta in Sveta
(notified under document number C(2008) 1718)
(notificirano pod dokumentarno številko C(2008) 1718)
By Commission Decision 98/294/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line MON810), pursuant to Council Directive 90/220/EEC [2] it was decided that consent was to be given for the placing on the market of that product.
Z Odločbo Komisije 98/294/ES z dne 22. aprila 1998 o dajanju v promet gensko spremenjene koruze (Zea mays L. linija MON810) na podlagi Direktive Sveta 90/220/EGS [2] je bilo sklenjeno, da se odobri dajanje v promet navedenega proizvoda.
On 2 June 1999 Austria informed the Commission of its decision to prohibit provisionally the use and sale of Zea mays L. line MON810 for all uses and gave reasons for that decision in accordance with Article 16(1) of Directive 90/220/EEC.
Dne 2. junija 1999 je Avstrija v skladu s členom 16(1) Direktive 90/220/EGS obvestila Komisijo o svoji odločitvi, da začasno prepove uporabo in prodajo koruze Zea mays L. linija MON810 za vse vrste uporabe in navedla razloge zanjo.
Products derived from Zea mays L. line MON810 (food and food ingredients produced from maize flour, maize gluten, maize semolina, maize starch, maize glucose and maize oil produced from Zea mays L. line MON810) are authorised under Regulations (EC) No 258/97 [4] and (EC) No 1829/2003 of the European Parliament and of the Council [5].
Proizvodi iz koruze Zea mays L. linija MON810 (živila in živilske sestavine iz koruzne moke, glutena, zdroba, škroba, glukoze in olja, pridobljenih iz koruze Zea mays L. linija MON810) so dovoljeni v skladu z uredbama (ES) št. 258/97 [4] in (ES) št. 1829/2003 Evropskega parlamenta in Sveta [5].
The Scientific Committee on Plants concluded on 24 September 1999 that the information submitted by Austria did not constitute new relevant scientific evidence which had not been taken into account during the original evaluation of the dossier and which would occasion a review of that Committee’s original opinion on this product.
Znanstveni odbor za rastline je 24. septembra 1999 sklenil, da informacije, ki jih je predložila Avstrija, niso vsebovale novih pomembnih znanstvenih izsledkov, ki ne bi bili upoštevani že pri prvotnem vrednotenju dokumentacije in ki bi sprožili presojo prvotnega mnenja odbora o tem proizvodu.
On 9 January 2004, as well as on 9 and 17 February 2004, Austria submitted to the Commission additional information in support of its national measures concerning maize line MON810.
Dne 9. januarja 2004 ter 9. in 17. februarja 2004 je Avstrija Komisiji predložila dodatne informacije v podporo nacionalnim ukrepom glede koruze linije MON810.
The EFSA concluded on 8 July 2004 [7] that the information submitted by Austria did not constitute new scientific evidence sufficient to invalidate the environmental risk assessment of maize line MON810, justifying a prohibition of the use and sale of that product in Austria.
EFSA je 8. julija 2004 [7] sklenila, da informacije, ki jih je predložila Avstrija, niso vsebovale novih pomembnih znanstvenih izsledkov, ki bi ovrgli oceno tveganja za okolje za koruzo linije MON810, in bi tako upravičili prepoved uporabe in prodaje navedenega proizvoda v Avstriji.
However, that Committee did not deliver an opinion and, in accordance with Article 5(4) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [8], the Commission submitted to the Council a proposal relating to the measures to be taken.
Vendar odbor ni izdal mnenja in Komisija je v skladu s členom 5(4) Sklepa Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [8] Svetu predložila predlog ukrepov, ki naj se sprejmejo.
The Council, in its declaration, stated that ‘there is still a degree of uncertainty in relation to the national safeguard measures on the market of [the] genetically modified maize variet[y] […] MON810’ and called on the Commission ‘to gather further evidence on the GMO in question and further assess, whether the measure taken by [Austria] aimed at suspending as a temporary precautionary measure [its] placing on the market [is] justified and, whether the authorisation of such [an] organism still meets the safety requirements of Directive 2001/18/EC’.
Svet je v izjavi navedel, da „še vedno obstaja nekaj negotovosti glede nacionalnih zaščitnih ukrepov na trgu z gensko spremenjeno koruzo sorte […] MON810“ in Komisijo pozval, „naj pridobi dodatne izsledke o zadevnem GSO in dodatno oceni upravičenost ukrepa, ki ga je sprejela [Avstrija] z namenom ukinitve začasnega preventivnega ukrepa dajanja proizvoda v promet, in ali odobritev takšnega organizma še vedno izpolnjuje varnostne zahteve Direktive 2001/18/ES“.
In November 2005, the EFSA was consulted again by the Commission as to whether there was any scientific reason to believe that the continued placing on the market of MON810 maize was likely to cause any adverse effects to human health or the environment under the conditions of consent.
Novembra 2005 se je Komisija znova posvetovala z EFSA, ali obstaja morebitni znanstveni razlog za domnevo, da lahko nadaljnje dajanje v promet koruze MON810 povzroči kakršne koli škodljive učinke na zdravje ljudi ali okolje, če se upoštevajo pogoji odobritve.
In its opinion of 29 March 2006 [9], EFSA concluded that there is no reason to believe that the continued placing on the market of MON810 maize is likely to cause any adverse effects for human and animal health or the environment under the conditions of its consent.
V mnenju z dne 29. marca 2006 [9] je EFSA sklenila, da ni razloga za domnevo, da lahko nadaljnje dajanje v promet koruze MON810 povzroči kakršne koli škodljive učinke na zdravje ljudi in živali ter na okolje, če se upoštevajo pogoji njegove odobritve.
Austria has initiated work to collect any relevant scientific evidence on these aspects, which in the view of Austria justifies provisionally the maintenance of the safeguard clause, in particular in reference to ‘the different agricultural structures and regional ecological characteristics’ as indicated in recital 3 of the abovementioned Council decision.
Avstrija je začela zbirati pomembne znanstvene izsledke o teh vidikih, kar po mnenju Avstrije upravičujejo začasno ohranitev zaščitne klavzule, zlasti glede na „različne kmetijske strukture in regionalne ekološke značilnosti“, kakor je navedeno v uvodni izjavi 3 zgoraj navedene odločbe Sveta.
On the basis of Austria's submission and its scientific assessment, the Commission will act in accordance with Article 23 of Directive 2001/18/EC on these aspects of the Austrian measure.
Komisija bo na podlagi izsledkov, ki jih bo predložila Avstrija, in njihove znanstvene ocene ukrepala v skladu s členom 23 Direktive 2001/18/ES glede teh vidikov ukrepa Avstrije.
The food and feed safety aspects of Zea mays L. line MON810 covered by the consent granted under Directive 90/220/EEC (including import and processing) are identical throughout Europe and have been assessed by the EFSA, which concluded that this product is unlikely to cause any adverse effects for human and animal health.
Varnostni vidiki v zvezi z živili in krmo za koruzo Zea mays L. linije MON810, ki jih zajema odobritev v skladu z Direktivo 90/220/EGS (vključno z uvozom in predelavo), so povsod po Evropi enaki in jih je ocenila EFSA, ki je zaključila, da ta proizvod verjetno ne bo imel škodljivih učinkov na zdravje ljudi in živali.
The Commission proposal takes into account only food and feed aspects of the Austrian prohibition namely the prohibition on import and processing of unprocessed kernels as source materials for further processing or for direct food or feed use.
Predlog Komisije zajema samo tiste vidike prepovedi Avstrije, ki se nanašajo na živila in krmo, tj. prepoved uvoza in predelave nepredelanih zrn kot surovin za nadaljnjo predelavo ali za neposredno uporabo za živila ali krmo.
Under these circumstances Austria should repeal its safeguard measures at least with regard to import and processing into food and feed of Zea mays L. line MON810.
Avstrija bi zato morala razveljaviti svoje zaščitne ukrepe vsaj za uvoz koruze Zea mays L. linije MON810 ter njeno predelavo v živila in krmo.
Since on the expiry of the period laid down in Article 30(2) of Directive 2001/18/EC, the Council had neither adopted the proposed measures nor indicated its opposition to them, in accordance with Article 5(6) of Decision 1999/468/EC, the measures should be adopted by the Commission,
Ker po izteku obdobja iz člena 30(2) Direktive 2001/18/EC Svet ni niti sprejel predlaganih ukrepov niti jim ni nasprotoval v skladu s členom 5(6) Sklepa 1999/468/ES, mora ukrepe sprejeti Komisija –
The measures taken by Austria to prohibit the import and the processing into food and feed products of the Zea mays L. line MON810, authorised for placing on the market by Decision 98/294/EC are not justified under Article 23 of Directive 2001/18/EC.
Ukrepi Avstrije za prepoved uvoza koruze Zea mays L. linija MON810, katere dajanje v promet je bilo odobreno z Odločbo 98/294/ES, ter njene predelave v živila in krmo v skladu s členom 23 Direktive 2001/18/ES niso upravičeni.
Austria shall take the necessary steps to terminate the prohibition of import and processing into food and feed products of Zea mays L. line MON810 at the latest 20 days after its notification.
Avstrija sprejme potrebne ukrepe za ukinitev prepovedi uvoza koruze Zea mays L. linija MON810 ter njene predelave v živila in krmo najpozneje 20 dni po njeni uradni priglasitvi.
Regulation as amended by Regulation (EC) No 298/2008 (OJ L 97, 9.4.2008, p. 64).
Uredba, kakor je bila spremenjena z Uredbo (ES) št. 298/2008 (UL L 97, 9.4.2008, str. 64).
Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to genetically modified crops (Bt176 maize, MON810 maize, T25 maize, Topas 19/2 oilseed rape and Ms1xRf1 oilseed rape) subject to safeguard clauses invoked according to Article 16 of Directive 90/220/EEC, The EFSA Journal (2006) 338, 1-15.
Mnenje Znanstvenega odbora o gensko spremenjenih organizmih na zahtevo Komisije v zvezi z gensko spremenjenimi pridelki (koruza Bt176, koruza MON810, koruza T25, oljna repica Topas 19/2 in oljna repica Ms1xRf1), ki so predmet uveljavljene zaščitne klavzule v skladu s členom 16 Direktive 90/220/EGS, The EFSA Journal (2006) 338, 1–15.
of 1 July 2008
z dne 1. julija 2008
Having regard to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products [1], and in particular Article 4(3) thereof,
ob upoštevanju Uredbe (ES) št. 141/2000 Evropskega parlamenta in Sveta z dne 16. decembra 1999 o zdravilih sirotah [1] in zlasti člena 4(3) Uredbe,
Having regard to the recommendation of the European Medicines Agency of 19 December 2007,
ob upoštevanju priporočila Evropske agencije za zdravila z dne 19. decembra 2007,
Three members of the Committee for Orphan Medicinal Products, hereinafter ‘the Committee’ were appointed by the Commission Decision 2006/286/EC of 12 April 2006 [2] on the recommendation of the European Medicines Agency for a term of three years from 16 April 2006.
Komisija je tri člane Odbora za zdravila sirote (v nadaljnjem besedilu: odbor) imenovala s Sklepom 2006/286/ES z dne 12. aprila 2006 [2] na priporočilo Evropske agencije za zdravila, in sicer za obdobje treh let, ki se je začelo 16. aprila 2006.