natgillin/translations-raw huggingface dataset:
Når henses til dette formål med ordningen for differentierede restitutioner er det væsentligt, at de produkter, der støttes af udbetaling af en restitution, faktisk når frem til bestemmelsesstedets marked for at blive forhandlet dér (jf. dommen i sagen Anglo Irish Beef Processors International m.fl., præmis 28).
28 It is essential for that purpose of the system of differentiated refunds that products in respect of which a subsidy is granted in the form of a refund actually reach their market of destination so that they can be marketed there (see Anglo Irish Beef Processors International, paragraph 28).
Det fremgår af bestemmelserne i forordning nr. 3665/87, at for så vidt angår differentierede restitutioner er udbetaling af restitutioner således betinget af, at produktet er indført til et tredjeland, og at formaliteterne for overgang til frit forbrug er afsluttet (jf. dom af 29.9.1998, sag C-263/97, First City Trading m.fl., Sml. I, s. 5537, præmis 27).
29 Thus, in accordance with the provisions of Regulation No 3665/87, payment of refunds is conditional, in the case of differentiated refunds, on the product having been imported into a nonmember country and on the formalities for its release for consumption having been completed (see Case C-263/97 R v Intervention Board for Agricultural Produce, ex parte First City Trading and Others [1998] ECR 1-5537, paragraph 27).
Den omstændighed, at produktet er blevet reeksporteret, før det er bragt i frit forbrug i bestemmelseslandet, udelukker følgelig, at det med henblik på udbetaling af den differentierede restitution kan anses for at være indført i den forstand, hvori udtrykket er anvendt i artikel 5, stk. 1, i forordning nr. 3665/87 (jf. Dimex-dommen, præmis 17, og dommen i sagen Anglo Irish Beef Processors International m.fl., præmis 23).
30 The fact that the product is re-exported before being released for consumption in the country of destination therefore rules out the possibility of its being regarded, for the purposes of payment of the differentiated refund, as having been imported within the meaning of Article 5(1) of Regulation No 3665/87 (see Hauptzollamt Hamburg-Jonas v Dimex, paragraph 17, and Anglo Irish Beef Processors International, paragraph 23).
31 Hvad for det første angår DAT-SCHAUB's anbringende om, at GCC-landene skal betragtes som et og samme tredjeland ved anvendelsen af artikel 17, stk. 2, andet afsnit, andet led, i forordning nr. 3665/87 bemærkes indledningsvis, at denne bestemmelses ordlyd er klar og utvetydig, idet den i ental henviser til »det tredjeland, hvor alle ... produkter ... er blevet indført« som angivelse af det sted, hvor en eventuel forudgående forarbejdning kan finde sted, uden at dette fører til fortabelse af retten til restitution.
31 In the first place, as regards DAT-SCHAUB's argument that the GCC countries should be regarded as forming a single nonmember country for the purposes of applying the second indent of the second subparagraph of Article 17(2) of Regulation No 3665/87, it must be observed, to begin with, that the wording of that provision is clear and unambiguous in referring, in the singular, to 'the nonmember country into which all the products ... were imported' to designate the place where the products may first be processed without the right to the refund being lost.
Denne konstatering modsiges ikke af ordlyden af artikel 17, stk. 1, i forordning nr. 3665/87, som taler om »tredjelande« og således anvender flertal ved angivelsen af det sted, hvor produktet skal være blevet indført i uforandret stand.
That conclusion is not invalidated by the wording of Article 17(1) of Regulation No 3665/87, which mentions 'non-member countries', thus using the plural to designate the place into which the product must have been imported in the unaltered state.
Denne sidstnævnte bestemmelse vedrører nemlig indførsel i uforandret stand, hvor der ikke har fundet forarbejdning sted, og omfatter andre landbrugsprodukter, for hvilke der ved udførsel kan betales restitutioner, som ikke er differentieret efter land, men på grundlag af zoner, der omfatter flere bestem melseslande.
That provision relates to importation in the unaltered state without processing and refers to other agricultural products whose export may attract refunds which are differentiated not by countries but by zones comprising several countries of destination.
Derimod udelukker samme bestemmelses stk. 2 af kontrolhensyn bevidst enhver genudførsel efter forarbejdning.
By contrast, Article 17(2) intentionally, for reasons of supervision, excludes any re-export after processing.
Der er følgelig ingen modsigelse i affattelsen af de to første stykker i artikel 17 i forordning nr. 3665/87.
There is thus no contradiction between the wording of the first two paragraphs of Article 17 of Regulation No 3665/87.
Det bemærkes for det andet, at det fremgår af artikel 3, stk. 5, første afsnit, litra a), i forordning nr. 3665/87, sammenholdt med bilag I til forordning nr. 2253/90 og nr. 656/91, at en erhvervsdrivende, der ansøger om en eksportrestitution for oksekød, skal angive hvert enkelt bestemmelsesland individuelt i sin udførselsangivelse i overensstemmelse med landenomenklaturen i bilaget til forordning nr. 420/90.
It follows, next, from a reading of Article 3(5)(a) of Regulation No 3665/87 in conjunction with Annex I to Regulation No 2253/90 and Annex I to Regulation No 656/91 that an operator seeking a refund for exports of beef and veal is obliged to mention each country of destination individually in his export declaration, in accordance with the country nomenclature in the annex to Regulation No 420/90.
Det bemærkes herved, at nomenklaturen ikke indeholder en kollektiv enhed som f.eks. »GCC-landene«.
That nomenclature does not include any collective entity such as 'the GCC countries'.
Den indeholder derimod en selvstændig angivelse af hvert af GCC-landene, som dermed som sådanne må anerkendes som særskilte bestemmelseslande med henblik på eksportrestitutioner.
On the contrary, it makes separate mention of each of the GCC countries, which must therefore be recognised as such as separate destinations for the purposes of export refunds.
Hvad endelig angår DAT-SCHAUB's anbringende vedrørende samarbejdsaftalens artikel 19, er det tilstrækkeligt at bemærke, at artikel 17, stk. 2, andet afsnit, andet led, i forordning nr. 3665/87 finder anvendelse uden forskel på hvert af GCC-landene og ikke medfører nogen forskelsbehandling mellem disse.
Finally, as regards DAT-SCHAUB's argument based on Article 19 of the Cooperation Agreement, it is sufficient to observe that the second indent of the second subparagraph of Article 17(2) of Regulation No 3665/87 applies without distinction to each of the GCC countries and does not discriminate between them.
Hvad for det andet angår spørgsmålet om nævnte bestemmelses overensstemmelse med proportionalitetsprincippet bemærkes, at en effektiv kontrol er nødvendig, for at restitutionssystemet kan fungere, idet det kun er muligt at udbetale restitutionerne, hvis der kan ske en korrekt identifikation af varen (jf. dom af 12.12.1985, sag 276/84, Metelmann, Sml. s. 4057, præmis 11).
In the second place, as regards the question whether that provision complies with the principle of proportionality, it must be pointed out that effective supervision is essential to the proper functioning of the system of refunds, as the refunds can be paid only if the goods are correctly identified (see Case 276/84 Metelmann ν Hauptzollamt Hamburg-Jonas [1985] ECR 4057, paragraph 11).
I denne dom fastslog Domstolen vedrørende reemballering af en vare i andre enheder, at proportionalitetsprincippet ikke er til hinder for, at enhver ændring af varens ydre kendetegn findes at medføre restitutionens bortfald, når ændringen kan gøre toldkontrollen vanskeligere og derved påvirke restitutionssystemets funktion (Metelmann-dommen, præmis 13).
The Court held in that judgment, with respect to the repackaging of a product in different units, that the principle of proportionality does not preclude it being held that any alteration in the presentation of the goods entails forfeiture of the refund, where it is liable to render customs control more difficult and for that reason to affect the proper functioning of the system of refunds (Metelmann, paragraph 13).
Af tilsvarende grunde vedrørende hensynet til, at toldkontrollen ikke gøres vanskeligere, må det fastslås, at artikel 17, stk. 2, andet afsnit, andet led, i forordning nr. 3665/87 ikke er i strid med proportionalitetsprincippet.
For similar reasons deriving from the need not to render customs controls more difficult, the second indent of the second subparagraph of Article 17(2) of Regulation No 3665/87 does not infringe the principle of proportionality.
Hvad for det tredje angår beslutningen er det ubestridt, at den ifølge selve ordlyden af artikel 2 kun gælder for udførsler, for hvilke udførselsangivelserne er blevet antaget i perioden fra datoen for dens meddelelse og indtil den 31. december 1994, dvs. en periode, der ligger efter den periode, hvorunder hovedsagens faktiske omstændigheder fandt sted.
In the third place, as regards the Decision, it is common ground that, as stated in Article 2 thereof, it applies only to exports for which the export declaration was accepted in the period from its notification until 31 December 1994, that is, a period later than that of the facts at issue in the main proceedings.
Følgelig kan beslutningen, der ikke har tilbagevirkende gyldighed, ikke finde anvendelse på disse.
The Decision, which has no retroactive effect, therefore cannot apply to those facts.
DAT-SCHAUB's anbringende om, at den nævnte beslutning blot indeholder en udtrykkelig bekræftelse af en allerede gældende fortolkning af artikel 17, stk. 2, andet afsnit, andet led, i forordning nr. 3665/87, modsiges af beslutningens egen ordlyd.
DAT-SCHAUB's argument that the Decision merely confirms explicitly a previously accepted interpretation of the second indent of the second subparagraph of Article 17(2) of Regulation No 3665/87 is precluded by the very wording of the Decision.
Det bemærkes således, at som det anføres i beslutningens anden betragtning, udelukkede den ovennævnte bestemmelse, at et EF-produkt, der i et bestemmelsestredjeland blev forarbejdet under en procedure for aktiv forædling, siden kunne udføres til et andet tredjeland og dermed give ret til udbetaling af eksportrestitutioner.
As stated in the second recital in the preamble to the Decision, the above provision precluded the possibility of processing a Community product in the nonmember country of destination under a temporary admission procedure in order then to export it to another nonmember country while being entitled to an export refund.
41 Eftersom denne situation kunne medføre, at EF-produkter mistede markeder, samt efter anmodning fra Kongeriget Danmark, jf. beslutningens ottende betragtning, blev det besluttet for en bestemt periode at tillade genudførsel af forarbejdede produkter til andre GCC-lande og herved yde de restitutioner, der er fastsat for et af dem, De Forenede Arabiske Emirater, som er det bestemmelses land, der nævnes i udførselsangivelsen.
41 It was because that situation might entail the loss of markets for Community products, and, according to the eighth recital in the preamble to the Decision, at the request of the Kingdom of Denmark, that it was decided to allow for a fixed period the re-export of processed products to other GCC countries with the benefit of the refunds prescribed for one of them, the United Arab Emirates, which is the country mentioned in the export declaration.
Det fremgår herefter såvel af beslutningens ordlyd som af dens formål, at den er en tidsbegrænset undtagelse til artikel 17, stk. 2, andet afsnit, andet led, i forordning nr. 3665/87.
It therefore follows from the wording and from the objective of the Decision that it constitutes a derogation for a limited time from the second indent of the second subparagraph of Article 17(2) of Regulation No 3665/87.
Beslutningen har derfor ikke den rækkevidde, som DAT-SCHAUB tillægger den, nemlig at bekræfte en allerede bestående situation, som fulgte af anvendelsen af nævnte bestemmelse.
The Decision thus does not have the scope attributed to it by DAT-SCHAUB, namely a confirmation of a previously existing situation resulting from the application of that provision.
DAT-SCHAUB har endelig gjort gældende, at en almindelig erhvervsdrivende i god tro måtte opfatte den ovennævnte bestemmelse således, at den gav mulighed for genudførsel til andre GCC-lande fra et af dem, eftersom de restitutionssatser, der gælder for alle disse lande, er de samme.
Finally, DAT-SCHAUB submits that a typical operator could in good faith have understood the provision as allowing re-exports to other GCC countries from one of them, as the rates of refunds applicable to all those countries were the same.
Hertil skal blot bemærkes, at det, således som det er fastslået i denne doms præmis 31 og 32, tilstrækkelig klart fremgår af ordlyden af artikel 17, stk. 2, andet afsnit, andet led, i forordning nr. 3665/87, at den skal forstås således, at den kun omfatter forarbejdning, der har fundet sted i det samme land, hvor de produkter, der er resultatet af denne forarbejdning, derefter er overgået til frit forbrug.
On this point, it is sufficient to observe that, as stated in paragraphs 31 and 32 above, the wording of the second indent of the second subparagraph of Article 17(2) of Regulation No 3665/87 is sufficiently clear to be understood as referring only to processing operations in the territory of the country in which the resulting products are then released for consumption.
De erhvervsdrivende kunne følgelig ikke støtte nogen berettiget forventning om en videre fortolkning af denne bestemmelse på dennes egen ordlyd.
Consequently, no legitimate expectation as to a broader interpretation of that provision could have been drawn by economic operators from its wording.
Under hensyn til alt det ovenfor anførte skal det præjudicielle spørgsmål besvares med, at artikel 17, stk. 2, andet afsnit, andet led, i forordning nr. 3665/87 skal fortolkes således, at GCC-landene, såfremt varerne forarbejdes, før toldformaliteterne er afsluttet i et af landene, og derefter udføres til andre af disse lande,
Accordingly, the answer to the Østre Landsret's question must be that the second indent of the second subparagraph of Article 17(2) of Regulation No 3665/87 must be interpreted as meaning that the GCC countries are not regarded, where products are processed before being cleared through customs on the territory of one of those countries and then exported to others, as a single nonmember
DAT-SCHAUB ikke skal betragtes som et og samme tredjeland, hvor alle de produkter, der er resultatet af denne forarbejdning, er blevet indført.
DAT-SCHAUB country into which all the products resulting from that processing have been imported.
46 De udgifter, der er afholdt af Kommissionen, som har afgivet indlæg for Domstolen, kan ikke erstattes.
46 The costs incurred by the Commission, which has submitted observations to the Court, are not recoverable.
DOMSTOLEN (Første Afdeling) vedrørende det spørgsmål, der er forelagt af Østre Landsret ved beslutning af 12. marts 1998, for ret:
THE COURT (First Chamber), in answer to the question referred to it by the Østre Landsret by order of 12 March 1998, hereby rules:
Artikel 17, stk. 2, andet afsnit, andet led, i Kommissionens forordning (EØF) nr. 3665/87 af 27. november 1987 om fælles gennemførelsesbestemmelser for eksportrestitutioner for landbrugsprodukter skal fortolkes således, at deltager-
The second indent of the second subparagraph of Article 17(2) of Commission Regulation (EEC) No 3665/87 of 27 November 1987 laying down common detailed rules for the application of the system of export refunds on agricultural products must be interpreted as meaning that the countries parties to the Charter of the Cooperation Council for the Arab States of the Gulf are not regarded,
Afsagt i offentligt retsmøde i Luxembourg den 16. december 1999.
Delivered in open court in Luxembourg on 16 December 1999.
Sag C-94/98
Case C­94/98
Forslag til afgørelse fra generaladvokat A. La Pergola fremsat den 19. maj 1999 Domstolens dom af 16. december 1999
Opinion of Advocate General La Pergola delivered on 19 May 1999 Judgment of the Court, 16 December 1999
Tilnærmelse af lovgivningerne — farmaceutiske specialiteter — direktiv 65/65 — markedsføringstilladelse — lægemiddel som allerede omfattet af en tilladelse i flere medlemsstater — tilbagekaldelse af tilladelsen i en medlemsstat efter tildeling af en tilladelse for ny variant af lægemidlet med samme virksomme stoffer og samme terapeutiske virkninger — import i denne medlemsstat af det tidligere lægemiddel efter en forenklet procedure i forhold til direktivets procedure for parallelimport — tilladt — betingelser
Approximation of laws — Proprietary medicinal products — Directive 65/65 — Market­ing authorisation — Medicinal product that has been authorised in several Member States — Withdrawal of authorisation in a Member State following grant of authorisation for a new version of the medicinal product containing the same active ingredients and having the same therapeutic effects — Importation into that Member State of the previous version of the medicinal product under a simplified procedure as compared with the procedure provided for by the directive and applicable to parallel imports — Whether permissible — Conditions (Council Directive 65/65)
SAMMENDRAG — SAG C­94/98 ikke indeholder samme hjælpestoffer og er fremstillet ved en anden fremstillingspro­ces, når den kompetente myndighed i medlemsstat B dels kan kontrollere, at lægemidlet X overholder kravene om kva­litet, effektivitet og uskadelighed under normale anvendelsesbetingelser, og dels kan sikre en sædvanlig lægemiddelovervåg­ning
SUMMARY — CASE C­94/98 excipients and is manufactured by a differ­ent manufacturing process, where the com­petent authority in Member State Β is in a position to verify that medicinal product X complies with the requirements relating to quality, efficacy and safety in normal conditions of use and is in a position to ensure normal pharmacovigilance;
En person, der ønsker at importere og markedsføre et lægemiddel X på medlems­stat B's marked fra medlemsstat A, kan ansøge og, uden at opfylde alle kravene i direktiv 65/65 om farmaceutiske speciali­teter, opnå en tilladelse til parallelimport fra medlemsstat B's kompetente myndighed ved anvendelse af en forenklet procedure, som er indført i medlemsstat B, hvorunder ansøgeren skal fremlægge færre oplysnin­ger end dem, der kræves ved en ansøgning om markedsføringstilladelse i henhold til direktivet, såfremt
Where it is sought to import medicinal product X from Member State A into Member State B, it is permissible for the person who proposes to place the imported product upon the market in Member State Β to seek and obtain a parallel import licence from the competent authority in Member State B, without complying with all the requirements of Directive 65/65 relating to medicinal products, under a simplified procedure provided for in Mem­ber State Β under which the applicant needs to provide less information than is required for an application for a marketing author­isation made in accordance with Directive 65/65 if:
— de ovennævnte markedsføringstilladel­ser er udstedt til forskellige selskaber i samme gruppe, hvortil også hører frem­stillerne af lægemidlet X og Y, og
— the marketing authorisations referred to above were granted to different members of the same group of compa­nies and the manufacturers of medic­inal products X and Y are also mem­bers of that group of companies; and
— de selskaber, der tilhører den samme gruppe som indehaveren af markedsfø­ringstilladelsen for lægemidlet X, der er blevet tilbagekaldt i medlemsstat B, fortsat fremstiller og markedsfører lægemidlet i andre medlemsstater end medlemsstat B.
— companies within the same group as the holder of the marketing authorisa­tion for product X which has been withdrawn in Member State Β continue to manufacture and market product X in Member States other than Member State B.
— lægemidlet X indeholder de samme virksomme stoffer og har samme terapeu­tiske virkninger som lægemidlet Y, men
—medicinal product X has the same active ingredients and therapeutic effect as med­icinal product Y, but does not use the same
I en sådan situation er den kompetente myndighed ikke forpligtet til at tage hensyn til, at lægemidlet Y er blevet udviklet og markedsført med henblik på at give den offentlige sundhed en særlig fordel, som lægemidlet X ikke giver, og/eller at dettes særlige fordele for den offentlige sundhed ikke kan nås, såfremt lægemidlerne X og Y
In such a situation, the competent authority is not required to take into consideration the fact that medicinal product Y was developed and introduced in order to provide a particular benefit to public health which medicinal product X does not pro­vide and/or that that particular benefit to public health would not be achieved if
RHÔNE-POULENC RORER OG MAY & BAKER samtidig afsættes på medlemsstat B's marked. ked. Nationale myndigheder må ikke hindre parallelimport ved at kræve, at en parallel importør skal overholde de samme krav, som gælder for virksomheder, der for første gang ansøger om en markedsføringstilla delse for et lægemiddel, såfremt en sådan undtagelse fra de regler, der normalt gælder for markedsføringstilladelser for lægemidler, ikke indebærer en fare for beskyttelsen af den offentlige sundhed.
RHÔNE­POULENC RORER AND MAY & c BAKER product X and product Y were both on the market in Member State Β at the same time. importers to satisfy the same requirements as those which are applicable to under­takings applying for the first time for a marketing authorisation for a medicinal product, provided that an exception of that kind to the rules normally applicable to marketing authorisations for medicinal products does not undermine the protec­tion of public health.
FORSLAG TIL AFGØRELSE FRA GENERALADVOKAT LA PERGOLA — SAG C-94/98
OPINION OF MR LA PERGOLA — CASE C-94/98
FORSLAG TIL AFGØRELSE FRA GENERALADVOKAT ANTONIO LA PERGOLA fremsat den 19. maj 1999 * ii) vedrørende traktatens bestemmelser om frie varebevægelser.
OPINION OF ADVOCATE GENERAL LA PERGOLA delivered on 19 May 1999 * provisions of the Treaty concerning the free movement of goods.
I — Den retlige og faktiske baggrund for tvisten i hovedsagen og de præjudicielle spørgsmål
I — The factual and legislative context of the main proceedings and the questions referred
Ved kendelse registreret på Domstolens Justitskontor den 2. april 1998 har High Court of Justice (England Sc Wales), Queen's Bench Division (Det Forenede Kongerige), forelagt to præjudicielle for tolkningsspørgsmål: i) vedrørende Rådets direktiv 65/65/EØF af 26. januar 1965 om tilnærmelse af lovgivning om farmaceutiske specialiteter som ændret flere gange under hensyntagen til indvunden erfaring efter direktivets vedtagelse og den videnskabelige udvikling 1(herefter »direktivet«), og
By an order received at the Court Registry on 2 April 1998, the High Court of Justice, Queen's Bench Division, submitted two questions, concerning the inter pretation of (i) Council Directive 65/65/ EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, as repeatedly amended on the basis of the experience acquired after its adoption and in order to bring it into line with scientific progress ('the Directive') 1 and (ii) of the