natgillin/translations-raw huggingface dataset:
Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (OJ L 18, 23.1.2003, p. 11);
Direktiva Sveta 2002/99/ES z dne 16. decembra 2002 o predpisih v zvezi z zdravstvenim varstvom živali, ki urejajo proizvodnjo, predelavo, distribucijo in uvoz proizvodov živalskega izvora, namenjenih prehrani ljudi (UL L 18, 23.1.2003, str. 11).
Commission Decision 2005/34/EC of 11 January 2005 laying down harmonised standards for the testing for certain residues in products of animal origin imported from third countries (OJ L 16, 20.1.2005, p. 61);
Odločba Komisije 2005/34/ES z dne 11. januarja 2005 o določitvi usklajenih standardov za preizkušanje določenih ostankov v proizvodih živalskega izvora, uvoženih iz tretjih držav (UL L 16, 20.1.2005, str. 61).
Law of 9 October 1992 on foodstuffs (LDAl; RS 817.0);
Zakon z dne 9. oktobra 1992 o živilih (LDAl; RS 817.0).
Ordinance of 23 November 2005 on foodstuffs and consumer products (ODAlOUs, RS 817.02);
Odlok z dne 23. novembra 2005 o živilih in uporabnih predmetih (ODAlOUs; RS 817.02).
Ordinance of 23 November 2005 on the implementation of foodstuffs legislation (RS 817.025.21);
Odlok z dne 23. novembra 2005 o izvajanju zakonodaje o živilih (RS 817.025.21).
Ordinance of the DFI of 26 June 1995 on foreign substances and components in foodstuffs (OSEC; RS 817.021.23).
Odlok DFI z dne 26. junija 1995 o tujih snoveh in sestavinah v živilih (OSEC; RS 817.021.23).
Sub-chapter 2. Switzerland — Legislation, Chapter V. Health requirements and control requirements relating to imports from third countries, Appendix 10 of Annex 11 to the Agriculture Agreement is replaced by the following:
V Dodatku 10 k Prilogi 11 h Kmetijskemu sporazumu se podpoglavje 2 „Švica – zakonodaja“ poglavja V „Zahteve zdravstvenega varstva živali in nadzora uvoza iz tretjih držav“ nadomesti z naslednjim:
Switzerland – Legislation
Švica – zakonodaja
A. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE; RS 916.443.10).
A. Odlok z dne 18. aprila 2007 o uvozu, tranzitu in izvozu živali in živalskih proizvodov (OITE; RS 916.443.10).
Pursuant to the provisions of the Ordinance of 27 August 2008 on the import and transit of animal products by air from third countries (OITPA; RS 916.443.13), the Swiss Confederation shall retain the possibility of importing bovine meat from cattle potentially treated with hormonal growth-promoters.
Švicarska konfederacija v skladu z določbami Odloka z dne 27. avgusta 2008 o uvozu in tranzitu živalskih proizvodov iz tretjih držav po zračni poti (OITPA; RS 916.443.13) ohrani možnost uvoza govejega mesa goveda, ki je bilo morda izpostavljeno hormonskim pospeševalcem rasti.
The export of such meat to the European Union shall be prohibited.
Izvoz takega mesa v Evropsko unijo je prepovedan.
In addition, the Swiss Confederation shall:’.
Sicer pa Švicarska konfederacija:“.
Unless indicated otherwise, any reference to an act shall mean that act as most recently amended.’.
Če ni navedeno drugače, se sklicevanje na kateri koli akt razume kot sklicevanje na ta akt, kakor je bil nazadnje spremenjen.“
European Union legislation on the protection of animals at the time of killing has been amended and Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing [4] entered into force on 8 December 2009 and is to apply from 1 January 2013.
Posodobljena je bila zakonodaja Evropske unije o zaščiti živali pri usmrtitvi in Uredba Sveta (ES) št. 1099/2009 z dne 24. septembra 2009 o zaščiti živali pri usmrtitvi [4] je začela veljati 8. decembra 2009, uporablja pa se od 1. januarja 2013.
For animal products exported to the European Union, third countries are to meet requirements which are at least equivalent to those set out in that Regulation.
Tretje države morajo pri živalskih proizvodih, ki jih izvozijo v Evropsko unijo, spoštovati zahteve, ki so vsaj enakovredne zahtevam iz navedene uredbe.
Implementing rules, Chapter V. Health requirements and control requirements relating to imports from third countries, Appendix 10 of Annex 11 to the Agriculture Agreement is replaced by the following:
V. V Dodatku 10 k Prilogi 11 h Kmetijskemu sporazumu se prva alinea točke D podpoglavja 3 „Izvedbena pravila“ poglavja V „Zahteve zdravstvenega varstva živali in nadzora uvoza iz tretjih držav“ nadomesti z naslednjim:
B. Ordinance of 27 August 2008 on the import and transit of animal products by air from third countries (OITPA; RS 916.443.13). V. The first paragraph of part D in sub-chapter 3.
B. Odlok z dne 27. avgusta 2008 o uvozu in tranzitu živalskih proizvodov iz tretjih držav po zračni poti (OITPA; RS 916.443.13).
Recommendation of the EU-Palestinian Authority Joint Committee
Priporočilo Skupnega odbora EU-Palestinska uprava
of 14 April 2013
z dne 14. aprila 2013
on the implementation of the European Union-Palestinian Authority European Neighbourhood Policy Action Plan
o izvajanju akcijskega načrta Evropska unija-Palestinska uprava v okviru evropske sosedske politike
THE EU-PALESTINIAN AUTHORITY JOINT COMMITTEE,
SKUPNI ODBOR EU-PALESTINSKA UPRAVA –
Having regard to the euro-Mediterranean Interim Association Agreement on trade and cooperation between the European Community, of the one part, and the Palestine Liberation Organisation (PLO) for the benefit of the Palestinian Authority of the West Bank and the Gaza Strip, of the other part [1], and in particular Article 63(2) thereof,
ob upoštevanju Začasnega evro-mediteranskega pridružitvenega sporazuma o trgovini in sodelovanju med Evropsko skupnostjo na eni strani ter Palestinsko osvobodilno organizacijo (PLO) za Palestinsko upravo Zahodnega brega in Gaze na drugi strani [1] in zlasti člena 63(2) Sporazuma,
Pursuant to Article 70 of euro-Mediterranean Interim Association Agreement on trade and cooperation between the European Community, of the one part, and the Palestine Liberation Organisation (PLO) for the benefit of the Palestinian Authority of the West Bank and the Gaza Strip, of the other part (‘the Agreement’), the Parties shall take any general or specific measures required to fulfil their obligations under the Agreement and shall see to it that the objectives set out in the Agreement are attained.
V skladu s členom 70 Začasnega evro-mediteranskega pridružitvenega sporazuma o trgovini in sodelovanju med Evropsko skupnostjo na eni strani ter Palestinsko osvobodilno organizacijo (PLO) za Palestinsko upravo Zahodnega brega in Gaze na drugi strani (v nadaljnjem besedilu: Sporazum) pogodbenici sprejmeta vse splošne ali posebne ukrepe, potrebne za izpolnjevanje obveznosti iz Sporazuma, in poskrbita, da se dosežejo cilji iz Sporazuma.
The Parties to the Agreement have agreed on the text of the European Union – Palestinian Authority European Neighbourhood Policy Action Plan (‘the EU-PA ENP Action Plan’).
Pogodbenici Sporazuma sta se dogovorili glede besedila akcijskega načrta Evropska unija-Palestinska uprava v okviru evropske sosedske politike (v nadaljnjem besedilu: akcijski načrt EU-PA v okviru ESP).
The EU-PA ENP Action Plan should support the implementation of the Agreement through the drawing up and adoption of concrete steps with a view to attaining its objectives.
Akcijski načrt EU-PA v okviru ESP bi moral podpirati izvajanje Sporazuma z določitvijo konkretnih ukrepov in sprejemom teh ukrepov z namenom doseči cilje Sporazuma.
The EU-PA ENP Action Plan serves the dual purpose of setting out concrete steps with a view to the respect, by the parties, of the obligations set out in the Agreement and of providing a broader framework for further strengthening EU-PA relations.
Akcijski načrt EU-PA v okviru ESP ima dvojni namen, in sicer določitev konkretnih ukrepov za izpolnjevanje obveznosti pogodbenic iz Sporazuma ter zagotavljanje širšega okvira za nadaljnjo krepitev odnosov med EU in Palestinsko upravo –
HEREBY RECOMMENDS that the Parties implement the EU-PA ENP Action Plan [2] insofar as such implementation is directed towards attainment of the objectives of the euro-Mediterranean Interim Association Agreement on trade and cooperation between the European Community, of the one part, and the Palestine Liberation Organisation (PLO) for the benefit of the Palestinian Authority of the West Bank and the Gaza Strip, of the other part,
PRIPOROČA da pogodbenici izvajata Akcijski načrt EU-PA v okviru ESP [2], če je to izvajanje usmerjeno v doseganje ciljev Začasnega evro-mediteranskega pridružitvenega sporazuma o trgovini in sodelovanju med Evropsko skupnostjo na eni strani ter Palestinsko osvobodilno organizacijo (PLO) za Palestinsko upravo Zahodnega brega in Gaze na drugi strani.
Done at Brussels, 14 April 2013.
V Bruslju, 14. aprila 2013
Decision No 1/2013 of the EU-EFTA Joint Committee on Common Transit
Sklep št. 1/2013 Skupnega odbora EU-Efta za skupni tranzit
of 1 July 2013
z dne 1. julija 2013
THE EU-EFTA JOINT COMMITEE,
SKUPNI ODBOR EU-EFTA JE –
Having regard to the Convention of 20 May 1987 on a common transit procedure [1] and in particular Article 15(3)(a) thereof,
ob upoštevanju Konvencije z dne 20. maja 1987 o skupnem tranzitnem postopku [1] in zlasti člena 15(3)(a) Konvencije,
Croatia acceded to the Union on 1 July 2013.
Hrvaška je k Uniji pristopila 1. julija 2013.
Accordingly, the Croatian-language versions of the references used in the Convention of 20 May 1987 on a common transit procedure (‘the Convention’) should be moved from the EFTA-countries parts and inserted in the Union Member States parts.
Zato bi bilo treba jezikovne navedbe iz Konvencije z dne 20. maja 1987 o skupnem tranzitnem postopku (v nadaljnjem besedilu: Konvencija) v hrvaškem jeziku prenesti iz delov besedila v zvezi z državami EFTE v dele besedila v zvezi z državami članicami Unije.
Technical amendments to the Convention need also to be introduced as regards the guarantee forms listed in Appendix III, resulting from Croatia’s accession to the Union.
Zaradi pristopa Hrvaške k Uniji so potrebne tudi tehnične spremembe Konvencije, ki zadevajo zavarovalne obrazce, navedene v Dodatku III.
In order to allow the use of guarantee forms printed in accordance with the criteria in force prior to the date of accession of Croatia to the Union, a transitional period should be established during which the printed forms, with some adaptations, could continue to be used.
Da bi se omogočila uporaba zavarovalnih obrazcev, natisnjenih v skladu z merili, ki so veljala pred pristopom Hrvaške k Uniji, bi bilo treba določiti prehodno obdobje, v katerem bi bilo mogoče še naprej uporabljati te natisnjene obrazce z nekaterimi prilagoditvami.
The Convention should therefore be amended accordingly,
Zato bi bilo treba Konvencijo ustrezno spremeniti –
The forms based on the specimen forms in Annexes C1, C2, C3, C4, C5, and C6 to Appendix III of the Convention may continue to be used, subject to the necessary geographical adaptations, until the end of the twelfth month following the date of entry into force of this Decision, at the latest.
Obrazci, ki ustrezajo vzorčnim obrazcem iz prilog C1, C2, C3, C4, C5 in C6 k Dodatku III h Konvenciji, se lahko s potrebnimi prilagoditvami geografskih podatkov še naprej uporabljajo najpozneje do konca dvanajstega meseca po datumu začetka veljavnosti tega sklepa.
Done at Reykjavik, 1 July 2013.
V Reykjaviku, 1. julija 2013
In Annex B1 to Appendix III, the text for box 51 is replaced as follows:
V Prilogi B1 k Dodatku III se besedilo polja 51 nadomesti z naslednjim:
‘Box 51:
„Polje 51:
Intended transit offices
Predvideni uradi tranzita
Country Codes
Oznake držav
This country code is the ISO alpha-2 code (ISO 3166-1).
Ta oznaka države predstavlja oznako ISO alpha-2 (ISO 3166-1).
The applicable codes are:
Veljavne oznake so:
CH Switzerland
CH Švica
GB United Kingdom
GB Združeno kraljestvo
GR Greece
GR Grčija
HR Croatia
HR Hrvaška
TR Turkey’
TR Turčija“.
In Annex B6 to Appendix III, Title III is amended as follows:
V Prilogi B6 k Dodatku III se naslov III spremeni:
in the table of linguistic references to ‘Limited validity — 99200’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Omejena veljavnost – 99200“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Waiver — 99201’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Opustitev – 99201“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Alternative proof — 99202’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Alternativno dokazilo – 99202“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Differences: office where goods were presented … (name and country) — 99203’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Razlike: urad, pri katerem je bilo blago predloženo … (naziv in država) - 99203“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
HR Razlike: Carinarnica kojoj je roba podnesena …(naziv i zemlja)’;
HR Razlike: Carinarnica kojoj je roba podnesena …(naziv i zemlja)“;
in the table of linguistic references to ‘Exit from … subject to restrictions or charges under Regulation/Directive/Decision No … — 99204’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Iznos iz … zavezan omejitvam ali obveznim dajatvam na podlagi Uredbe/Direktive/Odločbe št. … – 99204“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Prescribed itinerary waived — 99205’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Opustitev predpisane poti – 99205“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Authorised consignor — 99206’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Pooblaščeni pošiljatelj – 99206“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Signature waived — 99207’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Opustitev podpisa – 99207“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Comprehensive guarantee prohibited — 99208’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Prepovedano splošno zavarovanje – 99208“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Unrestricted use — 99209’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Neomejena uporaba – 99209“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Issued retroactively — 99210’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Izdano naknadno – 99210“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Various — 99211’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Razno – 99211“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Bulk — 99212’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Razsuto – 99212“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
in the table of linguistic references to ‘Consignor — 99213’, the following indent is inserted between the linguistic references of FR and IT and deleted from its current position:
v razpredelnici jezikovnih navedb „Pošiljatelj – 99213“ se med jezikovni navedbi za FR in IT vstavi naslednja alinea in se črta s sedanjega mesta navedbe:
In paragraph 1 of point I of Annex C1 to Appendix III, the term ‘the Republic of Croatia,’ is inserted between the terms ‘the French Republic,’ and ‘the Italian Republic’.
V odstavku 1 točke I Priloge C1 k Dodatku III se med izrazoma „Francosko republiko“ in „Italijansko republiko“ vstavi izraz „Republiko Hrvaško“.
The term ‘the Republic of Croatia,’ between the word ‘and’ and the term ‘the Republic of Iceland’ is deleted.
Izraz „Republike Hrvaške“ med besedo „ter“ in izrazom „Republike Islandije“ se črta.
In paragraph 1 of point I of Annex C2 to Appendix III, the term ‘the Republic of Croatia,’ is inserted between the terms ‘the French Republic,’ and ‘the Italian Republic’.
V odstavku 1 točke I Priloge C2 k Dodatku III se med izrazoma „Francosko republiko“ in „Italijansko republiko“ vstavi izraz „Republiko Hrvaško“.
In paragraph 1 of point I of Annex C4 to Appendix III, the term ‘the Republic of Croatia,’ is inserted between the terms ‘the French Republic,’ and ‘the Italian Republic’.
V odstavku 1 točke I Priloge C4 k Dodatku III se med izrazoma „Francosko republiko“ in „Italijansko republiko“ vstavi izraz „Republiko Hrvaško“.
In box 7 of Annex C5 to Appendix III, the term ‘Croatia,’ between the words ‘European Community,’ and ‘Iceland’ is deleted.
V polju 7 Priloge C5 k Dodatku III se izraz „Hrvaška“ med besedami „Evropska skupnost“ in „Islandija“ črta.
In box 6 of Annex C6 to Appendix III, the term ‘Croatia,’ between the words ‘European Community,’ and ‘Iceland’ is deleted.
V polju 6 Priloge C6 k Dodatku III se izraz „Hrvaška“ med besedami „Evropska skupnost“ in „Islandija“ črta.
Decision No 1/2013 of the EU-Monaco Joint Committee established under the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco
Sklep št. 1/2013 Skupnega odbora EU-Monako ustanovljenega s Sporazumom med Evropsko skupnostjo in Kneževino Monako o uporabi nekaterih aktov Skupnosti na ozemlju Kneževine Monako
of 12 July 2013
z dne 12. julija 2013
amending the Annex to the Agreement
o spremembi Priloge k navedenem Sporazumu
Having regard to the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco [1], signed in Brussels on 4 December 2003 (hereinafter referred to as ‘the Agreement’), and in particular Article 1(1) thereof,
ob upoštevanju Sporazuma med Evropsko skupnostjo in Kneževino Monako o uporabi nekaterih aktov Skupnosti na ozemlju Kneževine Monako [1], podpisanega 4. decembra 2003 v Bruslju (v nadaljnjem besedilu: Sporazum) in zlasti člena 1(1) Sporazuma,
Since the entry into force of the Agreement on 1 May 2004, the Union has adopted a number of acts that fall within its scope and some acts appearing in the Annex have been repealed.
Od začetka veljavnosti Sporazuma 1. maja 2004 je Unija sprejela številne akte, ki sodijo na področje uporabe Sporazuma, nekatere akte iz Priloge pa razveljavila.
A Decision of the Joint Committee is therefore necessary to update the Annex to include the new acts and to delete the acts that have been repealed.
Zato je potreben Sklep Skupnega odbora, da se Priloga posodobi z vključitvijo novih aktov in izbrisom tistih, ki so bili razveljavljeni.
It is recalled that acts of the European Commission adopted in application of the acts listed in the Annex to the Agreement are applicable on the territory of Monaco without the need for a Joint Committee Decision, as provided for by Article 1(2) of the Agreement,
Opozoriti je treba, da za uporabo aktov Evropske komisije, sprejetih na podlagi aktov iz Priloge k Sporazumu, na ozemlju Monaka v skladu s členom 1(2) Sporazuma ni potreben Sklep Skupnega odbora –
The text set out in the Annex to the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco is replaced by the text set out in the Annex to this Decision.
Besedilo iz Priloge k Sporazumu med Evropsko skupnostjo in Kneževino Monako o uporabi nekaterih aktov Skupnosti na ozemlju Kneževine Monako se nadomesti z besedilom iz Priloge k temu Sklepu.
Done at Monaco, 12 July 2013.
V Monaku, 12. julija 2013
OJ L 332, 19.12.2003, p. 42.
UL L 332, 19.12.2003, str. 42.
I. MEDICINAL PRODUCTS
I. ZDRAVILA
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, as amended by:
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini, kakor je bila spremenjena z:
Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L 299, 27.10.2012, p. 1);
Direktivo 2012/26/EU Evropskega parlamenta in Sveta z dne 25. oktobra 2012, o spremembi Direktive 2001/83/ES kar zadeva farmakovigilanco (UL L 299, 27.10.2012, str. 1),
Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ L 174, 1.7.2011, p. 74);
Direktivo 2011/62/EU Evropskega parlamenta in Sveta z dne 8. junija 2011 o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini glede preprečevanja vstopa ponarejenih zdravil v zakonito dobavno verigo (UL L 174, 1.7.2011, str. 74),
Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 348, 31.12.2010, p. 74);
Direktivo 2010/84/EU Evropskega parlamenta in Sveta z dne 15. decembra 2010 o spremembah Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini, glede farmakovigilance (UL L 348, 31.12.2010, str. 74),
Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (OJ L 242, 15.9.2009, p. 3);
Direktivo Komisije 2009/120/ES z dne 14. septembra 2009 o spremembi Direktive 2001/83/ES Evropskega parlamenta in Sveta o zakoniku Skupnosti o zdravilih za uporabo v humani medicini v zvezi z zdravili za napredno zdravljenje (UL L 242, 15.9.2009, str. 3),