natgillin/translations-raw huggingface dataset:
To allow the lodging of applications for out-of-quota sugar export licences, the suspension of the lodging of applications provided for in Article 1(3) of Commission Implementing Regulation (EU) No 1061/2014 [4] should be abolished.
Da bi omogočili vložitev zahtevkov za izvozna dovoljenja za izvenkvotni sladkor, bi bilo treba opustiti začasno odložitev vlaganja zahtevkov za izvozna dovoljenja iz člena 1(3) Izvedbene uredbe Komisije (EU) št. 1061/2014 [4].
As Implementing Regulation (EU) No 1061/2014 has exhausted its effects, it is appropriate to repeal it.
Ker je Izvedbena uredba (EU) št. 1061/2014 postala brezpredmetna, jo je primerno razveljaviti.
In Article 1 of Implementing Regulation (EU) No 776/2014, paragraph 1 is replaced by the following:
V členu 1 Izvedbene uredbe (EU) št. 776/2014 se odstavek 1 nadomesti z naslednjim:
For the 2014/2015 marketing year, the quantitative limit referred to in point (d) of the first subparagraph of Article 139(1) of Regulation (EU) No 1308/2013 shall be 1350000 tonnes for exports without refund of out-of-quota white sugar falling within CN code 170199.’
Količinska omejitev iz točke (d) prvega pododstavka člena 139(1) Uredbe (EU) št. 1308/2013 za tržno leto 2014/2015 znaša 1350000 ton za izvoz izvenkvotnega belega sladkorja iz oznake KN 170199 brez nadomestila.“
Implementing Regulation (EU) No 1061/2014 is repealed.
Izvedbena uredba (EU) št. 1061/2014 se razveljavi.
OJ L 178, 1.7.2006, p. 24.
UL L 178, 1.7.2006, str. 24.
Commission Implementing Regulation (EU) No 776/2014 of 16 July 2014 fixing the quantitative limit for exports of out-of-quota sugar and isoglucose until the end of the 2014/2015 marketing year (OJ L 210, 17.7.2014, p. 11).
Izvedbena uredba Komisije (EU) št. 776/2014 z dne 16. julija 2014 o določitvi količinske omejitve za izvoz izvenkvotnega sladkorja in izvenkvotne izoglukoze do konca tržnega leta 2014/2015 (UL L 210, 17.7.2014, str. 11).
Commission Implementing Regulation (EU) No 1061/2014 of 8 October 2014 fixing an acceptance percentage for the issuing of export licences, rejecting export-licence applications and suspending the lodging of export-licence applications for out-of-quota sugar (OJ L 293, 9.10.2014, p. 24).
Izvedbena uredba Komisije (EU) št. 1061/2014 z dne 8. oktobra 2014 o določanju odstotka sprejetja za izdajo izvoznih dovoljenj, o zavračanju zahtevkov za izvozna dovoljenja in začasni odložitvi vlaganja zahtevkov za izvozna dovoljenja za izvenkvotni sladkor (UL L 293, 9.10.2014, str. 24).
Commission Implementing Regulation (EU) No 1249/2014
Izvedbena uredba Komisije (EU) št. 1249/2014
concerning the authorisation of inositol as a feed additive for fish and crustaceans
o izdaji dovoljenja za inozitol kot krmni dodatek za ribe in rake
Inositol was authorised without a time limit in accordance with Directive 70/524/EEC as a nutritional additive for use in all animal species as part of the group ‘Vitamins, pro-vitamins and chemically well-defined substances having similar effect’.
V skladu z Direktivo 70/524/EGS je bilo izdano dovoljenje brez časovne omejitve za inozitol kot krmni dodatek za vse živalske vrste v okviru skupine „vitamini, provitamini in kemijsko dobro definirane snovi s podobnim učinkom“.
That substance was subsequently entered in the Community Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
Navedena snov je bila v skladu s členom 10(1) Uredbe (ES) št. 1831/2003 naknadno vpisana v register krmnih dodatkov Skupnosti kot obstoječ proizvod.
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of Inositol as feed additive for fish, crustaceans, cats and dogs.
V skladu s členom 10(2) Uredbe (ES) št. 1831/2003 in v povezavi s členom 7 navedene uredbe je bil vložen zahtevek za ponovno oceno inozitola kot krmnega dodatka za ribe, rake, mačke in pse.
The applicant requested that additive to be classified in the additive category ‘nutritional additives’.
Vložnik je zahteval, da se dodatek uvrsti v kategorijo dodatkov „nutritivni dodatki“.
That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
V skladu s členom 7(3) Uredbe (ES) št. 1831/2003 so bili navedenemu zahtevku priloženi zahtevani podatki in dokumenti.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 April 2014 [3] that, under the proposed conditions of use in feed, Inositol does not have an adverse effect on animal health, human health or the environment.
Evropska agencija za varnost hrane („Agencija“) je v mnenju z dne 9. aprila 2014 [3] navedla, da inozitol pod predlaganimi pogoji uporabe nima škodljivega vpliva na zdravje živali in ljudi ali okolje.
The Authority also concluded that Inositol is regarded as an effective source of essential micronutrient for fish and crustaceans.
Agencija je tudi sklenila, da se inozitol šteje kot učinkovit vir esencielnih mikrohranil za ribe in rake.
It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
Potrdila je tudi poročilo o analitski metodi krmnega dodatka, ki ga je predložil referenčni laboratorij, ustanovljen z Uredbo (ES) št. 1831/2003.
The assessment of Inositol shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Ocena inozitola je pokazala, da so pogoji za dovoljenje iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for the disposal of existing stocks of the additives, pre-mixtures and compound feed containing them, as authorised by Directive 70/524/EEC.
Ker ni varnostnih razlogov, ki bi zahtevali takojšnjo uporabo sprememb pogojev dovoljenja, je primerno, da se omogoči prehodno obdobje za porabo obstoječih zalog dodatkov ter premiksov in krmnih mešanic, ki ju vsebujejo, kot je dovoljeno z Direktivo 70/524/EGS.
The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Snov iz Priloge, ki spada v kategorijo dodatkov „nutritivni dodatki“ in funkcionalno skupino „vitamini, provitamini in kemijsko natančno definirane snovi s podobnimi učinki“, se dovoli kot dodatek v prehrani živali v skladu s pogoji iz navedene priloge.
The substance specified in the Annex and feed containing that substance, and which are produced and labelled before 12 June 2015 in accordance with the rules applicable before 12 December 2014 may continue to be placed on the market and used until the existing stocks are exhausted.
Snov iz Priloge in krma, ki vsebuje navedeno snov, proizvedeni in označeni pred 12. junijem 2015 v skladu s pravili, ki se uporabljajo pred 12. decembrom 2014, se lahko še naprej dajeta na trg in uporabljata do porabe obstoječih zalog.
Done at Brussels, 21 November 2014.
V Bruslju, 21. decembra 2014
Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).
Direktiva Sveta 70/524/EGS z dne 23. novembra 1970 o dodatkih v krmi (UL L 270, 14.12.1970, str. 1).
mg of active substance of kg of complete feedingstuff with a moisture content of 12 %.
Nutritivni dodatki:
Nutritional additives:
vitamini, provitamini in kemijsko natančno opredeljene snovi s podobnim učinkom
Vitamins, provitamins and chemically well-defined substances having similar effect
Inozitol
Inositol
Sestava dodatka
Chemical formula:
Št.
Inositol, solid form, produced by chemical synthesis.
Inozitol, v trdni obliki, pridobljen s kemijsko sintezo.
min.
najmanj 97 %.
97 %.
Analitska metoda [1]Za določanje inozitola v krmnem dodatku:
Analytical methods [1]: For identification of inositol in the feed additive:
tekočinska kromatografija in infrardeča absorpcijska spektrometrija (Ph.
Liquid Chromatography and infrared absorption spectrophotometry (Ph. Eur.
Eur.
01/2008:1805).
01/2008:1805).
For the quantification of inositol in the feed additive, premixtures and feedingstuffs microbiological activity analysis.
Za določanje količine inozitola v krmnem dodatku, premiksih in krmi: analiza mikrobiološke aktivnosti.
For safety:
12. december 2014
breathing protection, safety glasses and gloves should be worn during handling.
Podrobnosti o analitskih metodah so na voljo na naslednjem naslovu referenčnega laboratorija Skupnosti:
12 December 2024.
https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.
Commission Implementing Regulation (EU) No 1250/2014
Izvedbena uredba Komisije (EU) št. 1250/2014
amending Regulation (EC) No 891/2009 as regards tariff quotas for sugar originating in Serbia
o spremembi Uredbe (ES) št. 891/2009 glede tarifnih kvot za sladkor s poreklom iz Srbije
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 [1], and in particular Articles 180 and 187 thereof,
ob upoštevanju Uredbe (EU) št. 1308/2013 Evropskega parlamenta in Sveta z dne 17. decembra 2013 o vzpostavitvi skupne ureditve trgov kmetijskih proizvodov in razveljavitvi uredb Sveta (EGS) št. 922/72, (EGS) št. 234/79, (ES) št. 1037/2001 in (ES) št. 1234/2007 [1], ter zlasti členov 180 in 187 Uredbe,
The Protocol to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the Republic of Serbia, of the other part, to take account of the accession of the Republic of Croatia to the European Union [4] (‘the Protocol’) was signed on 25 June 2014.
Zato bi moralo povečanje obstoječih tarifnih kvot za sladkor s poreklom iz Srbije začeti veljati s 1. avgustom 2014.
Its signature on behalf of the European Union, the European Atomic Energy Community and the Member States has been authorised by Council Decisions 2014/517/EU [5] and 2014/518/Euratom [6].
Uredba Komisije (ES) št. 891/2009 [7] določa odprtje in upravljanje tarifnih kvot v sektorju sladkorja, vključno s tistimi za proizvode s poreklom iz Srbije.
Article 2 of the Protocol provides for an amendment to Article 26(4) of the SAA to increase the existing tariff quotas for sugar originating in Serbia within a limit of an annual tariff quota of 181000 tonnes.
Navedeno uredbo je zato treba spremeniti, tako da bo skladna s Protokolom.
In accordance with Article 3 of Decision 2014/517/EU, the Protocol is to be applied on a provisional basis, in accordance with its Article 14, as from the first day of the second month following the date of its signature, pending the completion of the procedures for its conclusion.
Glede na to, da se v skladu s členom 3(1) Uredbe (ES) št. 891/2009 tarifne kvote upravljajo za posamezno tržno leto v navedenem sektorju, je treba v skladu s Protokolom upoštevati sorazmerno povečanje obsega tarifnih kvot, odprtih za tržno leto 2013/2014, in obseg, dodeljen za tržno leto 2014/2015.
Therefore, the increase of the existing tariff quotas for sugar originating in Serbia should take effect as from 1 August 2014.
Sorazmerno povečanje letne količine za avgust in september 2014 znaša 167 ton sladkorja.
It is therefore necessary to amend that Regulation to take account of the Protocol.
V skladu z drugim odstavkom člena 135 SPS se SPS ne uporablja za Kosovo [8].
In accordance with Article 11 of the Protocol, in the first year of provisional application of the Protocol the volumes of the new tariff quotas and the increases in the volumes of existing tariff quotas are to be calculated as a pro rata of the basic annual volumes specified in the Protocol, taking into account the part of the period elapsed before 1 August 2014.
Uredba Sveta (ES) št. 2007/2000 [9] je bila razveljavljena z Uredbo (ES) št. 1215/2009 [10].
Therefore, for the year 2014 the increase of the volume of the existing quotas for sugar originating in Serbia should be available for the period from 1 August 2014 until 31 December 2014.
Ker Uredba (ES) št. 1215/2009 ne določa več koncesij za uvoz proizvodov pod tarifnima številkama 1701 in 1702 kombinirane nomenklature s poreklom iz Kosova v Unijo, bi bilo treba sklicevanji na Uredbo (ES) št. 2007/2000 in na Kosovo v Uredbi (ES) št. 891/2009 črtati.
Considering that in accordance with Article 3(1) of Regulation (EC) No 891/2009 tariff quotas are administered per marketing year in that sector, account has to be taken of the pro rata increase in volumes of the tariff quotas opened for the 2013/2014 marketing year and of the volumes to be granted for the 2014/2015 marketing year, in accordance with the Protocol.
Uredbo (ES) št. 891/2009 bi bilo zato treba ustrezno spremeniti.
The pro rata increase in the annual volume for the months of August and September 2014 corresponds to 167 tonnes of sugar.
Ker se tržno leto 2014/2015 začne s 1. oktobrom 2014, bi se morale spremembe k Uredbi (ES) št. 891/2009 začeti uporabljati čim prej in zato bi morala ta uredba začeti veljati takoj.
As it will not be possible to use that quantity before the end of the 2013/2014 marketing year, it should be made available in the 2014/2015 marketing year.
Ukrepi iz te uredbe so v skladu z mnenjem Upravljalnega odbora za skupno ureditev kmetijskih trgov –
Pursuant to the second paragraph of its Article 135, the SAA does not apply to Kosovo [8].
SPREJELA NASLEDNJO UREDBO:
Council Regulation (EC) No 2007/2000 [9] has been repealed by Regulation (EC) No 1215/2009 [10].
Člen 1
As Regulation (EC) No 1215/2009 no longer provides for concessions on imports into the Union for products of headings 1701 and 1702 of the Combined Nomenclature originating in Kosovo, the references to Regulation (EC) No 2007/2000 and to Kosovo in Regulation (EC) No 891/2009 should therefore be deleted.
Uredba (ES) št. 891/2009 se spremeni:
Regulation (EC) No 891/2009 should therefore be amended accordingly.
točka (b) v členu 1 se črta;
Since the 2014/2015 marketing year starts from 1 October 2014, the amendments to Regulation (EC) No 891/2009 should apply as soon as possible and this Regulation should therefore enter into force immediately.
točka (g) v členu 1 se nadomesti z naslednjim:
The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,
v členu 26(4) Stabilizacijsko-pridružitvenega sporazuma med Evropskima skupnostma in njunimi državami članicami na eni strani ter Republiko Srbijo na drugi strani, kot je bil spremenjen s Protokolom k Stabilizacijsko-pridružitvenemu sporazumu med Evropskima skupnostma in njunimi državami članicami na eni strani ter Republiko Srbijo na drugi strani zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji.
HAS ADOPTED THIS REGULATION:
v točki (b) člena 2 se izraz „Kosova“ in pripadajoča opomba črtata;
Article 1
del II v Prilogi I se nadomesti z besedilom iz Priloge k tej uredbi.
Regulation (EC) No 891/2009 is amended as follows:
Člen 2
In Article 1, point (b) is deleted;
Ta uredba začne veljati na dan objave v Uradnem listu Evropske unije.
In Article 1, point (g) is replaced by the following:
Uporablja se od tržnega leta 2014/2015.
Article 26(4) of the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the Republic of Serbia, of the other part, as amended by the Protocol to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the Republic of Serbia, of the other part, to take account of the accession of the Republic of Croatia to the European Union.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
In point (b) of Article 2, the term ‘Kosovo’ and the related footnote are deleted;
V Bruslju, 21. novembra 2014
In Annex I, Part II is replaced by the text in the Annex to this Regulation.
Za Komisijo
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
UL L 347, 20.12.2013, str. 671.
It shall apply as from the 2014/2015 marketing year.
UL L 278, 18.10.2013, str. 16.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Sklep Sveta in Komisije 2013/490/EU, Euratom z dne 22. julija 2013 o sklenitvi Stabilizacijsko-pridružitvenega sporazuma med Evropskima skupnostma in njunimi državami članicami na eni strani ter Republiko Srbijo na drugi strani (UL L 278, 18.10.2013, str. 14).
Done at Brussels, 21 November 2014.
UL L 233, 6.8.2014, str. 3.
For the Commission
Sklep Sveta 2014/517/EU z dne 14. aprila 2014 o podpisu, v imenu Evropske unije in njenih držav članic, ter začasni uporabi Protokola k Stabilizacijsko-pridružitvenemu sporazumu med Evropskima skupnostma in njunimi državami članicami na eni strani ter Republiko Srbijo na drugi strani zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji (UL L 233, 6.8.2014, str. 1).
The President
Sklep Sveta 2014/518/Euratom z dne 14. aprila 2014 o odobritvi sklenitve, s strani Evropske Komisije v imenu Evropske skupnosti za atomsko energijo, Protokola k Stabilizacijsko-pridružitvenemu sporazumu med Evropskima skupnostma in njunimi državami članicami na eni strani ter Republiko Srbijo na drugi strani zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji (UL L 233, 6.8.2014, str. 20).
OJ L 347, 20.12.2013, p. 671.
Uredba Komisije (ES) št. 891/2009 z dne 25. septembra 2009 o odprtju in upravljanju nekaterih tarifnih kvot Skupnosti v sektorju sladkorja (UL L 254, 26.9.2009, str. 82).
OJ L 278, 18.10.2013, p. 16.
To poimenovanje ne posega v stališča glede statusa ter je v skladu z RVSZN 1244/1999 in mnenjem Meddržavnega sodišča o razglasitvi neodvisnosti Kosova.
Council and Commission Decision 2013/490/EU, Euratom of 22 July 2013 on the conclusion of the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and Serbia, of the other part (OJ L 278, 18.10.2013, p. 14).
Uredba Sveta (ES) št. 2007/2000 z dne 18. septembra 2000 o uvedbi izjemnih trgovinskih ukrepov za države in ozemlja, ki sodelujejo ali so povezana s stabilizacijsko-pridružitvenim procesom Evropske unije, o spremembi Uredbe (ES) št. 2820/98 ter o razveljavitvi uredb (ES) št. 1763/1999 in (ES) št. 6/2000 (UL L 240, 23.9.2000, str. 1).
OJ L 233, 6.8.2014, p. 3.
Uredba Sveta (ES) št. 1215/2009 z dne 30. novembra 2009 o uvedbi izjemnih trgovinskih ukrepov za države in ozemlja, ki sodelujejo ali so povezana s stabilizacijsko-pridružitvenim procesom Evropske unije (UL L 328, 15.12.2009, str. 1).
Council Decision 2014/517/EU of 14 April 2014 on the signing, on behalf of the European Union and its Member States, and provisional application of the Protocol to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the Republic of Serbia, of the other part, to take account of the accession of the Republic of Croatia to the European Union (OJ L 233, 6.8.2014, p. 1).
UL L 233, 6.8.2014, str. 3.“
Commission Regulation (EC) No 891/2009 of 25 September 2009 opening and providing for the administration of certain Community tariff quotas in the sugar sector (OJ L 254, 26.9.2009, p. 82).
Del II v Prilogi I k Uredbi (ES) št. 891/2009 se nadomesti z naslednjim:
This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.
„Del II:
Council Regulation (EC) No 2007/2000 of 18 September 2000 introducing exceptional trade measures for countries and territories participating in or linked to the European Union's Stabilisation and Association process, amending Regulation (EC) No 2820/98, and repealing Regulations (EC) No 1763/1999 and (EC) No 6/2000 (OJ L 240, 23.9.2000, p. 1).
balkanski sladkor
Council Regulation (EC) No 1215/2009 of 30 November 2009 introducing exceptional trade measures for countries and territories participating in or linked to the European Union's Stabilisation and Association process (OJ L 328, 15.12.2009, p. 1).
TRETJA DRŽAVA ali carinska območja
OJ L 233, 6.8.2014, p. 3’
Zaporedna številka
Part II of Annex I of Regulation (EC) No 891/2009 is replaced by the following:
Količina (v tonah)
‘Part II:
Stopnja v okviru kvote (EUR/tono)
Balkans sugar
Albanija
Third Country or Custom Territories
1701 in 1702
Order number
in Hercegovina
CN code
jugoslovanska republika Makedonija
Quantities (tonnes)
Količina za tržno leto 2014/2015 znaša 181167 ton.“
In quota rate (EUR/ton)
Stabilizacijsko-pridružitveni sporazum med Evropskima skupnostma in njunimi državami članicami na eni strani ter Srbijo na drugi strani [2] (v nadaljnjem besedilu „SPS“) je bil odobren s Sklepom Sveta in Komisije 2013/490/EU, Euratom [3] in je začel veljati 1. septembra 2013.
Albania
Člen 26(4) SPS določa dajatev prost dostop za uvoz proizvodov pod tarifnima številkama 1701 in 1702 kombinirane nomenklature s poreklom iz Srbije v Unijo, do meje letne tarifne kvote 180000 ton.
1701 and 1702
Protokol k Stabilizacijsko-pridružitvenemu sporazumu med Evropskima skupnostma in njunimi državami članicami na eni strani ter Republiko Srbijo na drugi strani zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji [4] (v nadaljnjem besedilu: Protokol) je bil podpisan 25. junija 2014.
and Herzegovina
Podpis Protokola v imenu Evropske unije, Evropske skupnosti za atomsko energijo in držav članic je bil odobren s sklepoma Sveta 2014/517/EU [5] in 2014/518/Euratom [6].
Yugoslav Republic of Macedonia
V skladu s členom 11 Protokola se za prvo leto začasne uporabe Protokola obseg novih tarifnih kvot in povečanje obsega obstoječih tarifnih kvot izračuna sorazmerno z osnovnimi letnimi količinami iz Protokola, ob upoštevanju dela obdobja, ki je poteklo pred 1. avgustom 2014.
For the 2014/2015 marketing year the quantity shall be 181167 tonnes.’
Zato bi moralo biti za leto 2014 povečanje obsega obstoječih kvot za sladkor s poreklom iz Srbije na voljo za obdobje od 1. avgusta 2014 do 31. decembra 2014.
Commission Implementing Regulation (EU) No 1251/2014
Izvedbena uredba Komisije (EU) št. 1251/2014
Done at Brussels, 21 November 2014.
V Bruslju, 21. novembra 2014
Commission Delegated Regulation (EU) No 1252/2014
Delegirana uredba Komisije (EU) št. 1252/2014
supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use
o dopolnitvi Direktive 2001/83/ES Evropskega parlamenta in Sveta v zvezi z načeli in smernicami dobre proizvodne prakse za zdravilne učinkovine zdravil za uporabo v humani medicini
Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [1], and in particular the third paragraph of Article 47 thereof,
ob upoštevanju Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [1] in zlasti tretjega odstavka člena 47 Direktive,
All active substances manufactured in the Union, including active substances intended for export, should be manufactured in accordance with the principles and guidelines of good manufacturing practice for active substances which at present are set out in the technical guidelines on manufacturing of active substances published by the Commission.
Vse zdravilne učinkovine, ki so proizvedene v Uniji, tudi zdravilne učinkovine, namenjene za izvoz, bi morale biti proizvedene v skladu z načeli in smernicami dobre proizvodne prakse za zdravilne učinkovine, ki so trenutno določene v tehničnih smernicah o proizvodnji zdravilnih učinkovin, ki jih je objavila Komisija.