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51–62/62
CMS
51 Prevajalska redakcija
RS
EMEA
In September 2006, a Mutual Recognition Procedure was started for Lansoprazole involving 16 CMS with the UK as Reference Member State (RMS).
Septembra leta 2006 se je za zdravilo Lansoprazol začel postopek medsebojnega priznavanja, v katerega je vključenih 16 zadevnih držav članic in Združeno kraljestvo kot referenčna država članica.
52 Prevajalska redakcija
RS
EMEA
At the end of the MRP procedure there was a discrepancy between CMS regarding the wording of the indication that adequately reflects the EUROPA data.
Ob koncu postopka medsebojnega priznavanja je prišlo do razlik med zadevnimi državami članicami v zvezi z besedilom indikacije, ki ustrezno odraža podatke iz študije EUROPA.
53 Prevajalska redakcija
RS
EMEA
In the repeat use of the Mutual Recognition procedure, which started on 11 October 2005, the application was submitted to the Concerned Member States (CMS):
Pri ponovni uporabi postopka medsebojnega priznavanja, ki se je začel 11. oktobra 2005, je bila vloga predložena zadevnim državam članicam:
54 Prevajalska redakcija
RS
EMEA
Although the applicant was willing to remove the indications objected to by the objecting CMS, the RMS and the other positive CMSs were in favour of retaining these indications.
Čeprav je bil predlagatelj pripravljen odstraniti indikacije, ki jim je nasprotovala ugovarjajoča zadevna država članica, so referenčna država članica in zadevne države članice, ki so bile pozitivnega mnenja, zagovarjale ohranitev teh indikacij.
55 Prevajalska redakcija
izobraževanje
CELEX: 31991R1796
Pieces of non-wovens and of stitch-bonded goods, of various textile fibres, of small dimensions, roughly cut, either square or rectangular (generally 30-35 cms) or irregularly shaped.
Kosi netkanega blaga in blaga, dobljenega s prepletanjem vlaken iz koprene, iz raznih tekstilnih vlaken, manjši, grobo rezani, kvadratni ali pravokotni (na splošno 30 - 35 cm) ali nepravilnih oblik.
56 Prevajalska redakcija
izobraževanje
CELEX: 32001D0912
The ECB provides for the conditions that ensure the appropriate procedures for access to the relevant data of the CMS in compliance with Regulations (EC) No 1338/2001 and (EC) No 1339/2001.
ECB predvideva pogoje, ki zagotavljajo primerne postopke za dostop do ustreznih podatkov CMS v skladu z uredbama (ES) št. 1338/2001 in (ES) št. 1339/2001.
57 Prevajalska redakcija
izobraževanje
CELEX: 32001D0912
Access by the European Commission, the European Technical and Scientific Centre (ETSC) and Europol to the relevant data of the CMS is granted in accordance with Regulation (EC) No 1338/2001.
Dostop Evropski komisiji, Evropskemu tehničnemu in znanstvenemu centru (ETSC) ter Europolu do ustreznih podatkov CMS se dodeli v skladu z Uredbo (ES) št. 1338/2001.
58 Prevajalska redakcija
izobraževanje
CELEX: 32001D0912
The ECB also reaches the necessary arrangements and agreements with the Commission and Europol in order to provide for their appropriate access to the data of the CMS and for the access of the European Technical and Scientific Centre also in compliance with Regulation (EC) No 1338/2001.
ECB prav tako sklene potrebne dogovore in sporazume s Komisijo in Europolom, da jima zagotovi ustrezen dostop do podatkov CMS in dostop do Evropskega tehničnega in znanstvenega centra v skladu z Uredbo (ES) št. 1338/2001.
59 Prevajalska redakcija
izobraževanje
CELEX: 32001D0912
The Executive Board of the ECB shall take any measures to implement this Decision which are necessary for the efficiency and the security of the CMS, including any measures relating to the manual of procedures or the minimum security standards respectively mentioned in Articles 4 and 6.
Izvršilni odbor ECB sprejme za izvajanje tega sklepa vse ukrepe, potrebne za učinkovitost in varnost CMS, vključno s kakršnimi koli ukrepi v zvezi s priročnikom o postopkih ali minimalnimi varnostnimi standardi iz členov 4 in 6.
60 Prevajalska redakcija
RS
EMEA
This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Actira film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, DK, EL, ES, FI, IT, LU, PT and SE on 5 December 2006.
Ta postopek je napotitev na podlagi postopka medsebojnega priznavanja v zvezi z zgornjo vlogo za spremembo, ki je bila za zdravilo Actira – filmsko obložene tablete Nemčiji kot referenčni državi članici in zadevnim državam članicam AT, BE, DK, EL, ES, FI, IT, LU, PT in SE predložena dne 5. decembra 2006.
61 Prevajalska redakcija
RS
EMEA
Following the referral to the CHMP, the Committee noted the position of the RMS and the objecting CMS and decided to adopt a List of Questions addressed to the Blood Products Working Party (BPWP), in order to receive the view of the working party, on both specific issues related to this specific product and on issues related to immunoglobulins in general.
Po napotitvi zadeve odboru CHMP je Odbor upošteval stališči referenčne države članice in ugovarjajoče zadevne države članice ter se odločil, da sprejme seznam vprašanj, ki ga je predal Delovni skupini za krvne proizvode, da bi mu ta podala svoje stališče glede točno določenih vprašanj, ki se nanašajo na to zdravilo, in glede vprašanj, ki se nanašajo na imunoglobuline na splošno.
62 Prevajalska redakcija
RS
EMEA
This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Avalox film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, SE, SI, SK and UK on 5 December 2006.
Ta postopek je napotitev na podlagi postopka medsebojnega priznavanja v zvezi z zgornjo vlogo za spremembo, ki je bila za zdravilo Avalox – filmsko obložene tablete Nemčiji kot referenčni državi članici in zadevnim državam članicam AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, SE, SI, SK in UK predložena dne 5. decembra 2006.
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