natgillin/translations-raw huggingface dataset:
Det er derfor nødvendigt, at de offentlige myndigheder i importmedlemsstaten på importtidspunktet og på grundlag af de oplysninger, de råder over, sikrer sig, at det parallelt indførte lægemiddel, selv om det ikke på alle punkter er identisk med det af myndighederne allerede tilladte, besidder samme virksomme stof og har samme terapeutiske virkninger, og ikke udgør noget problem med hensyn til kvalitet, effektivitet og uskadelighed.
The competent authorities in the United Kingdom considered it possible to authorise the placing on the market of those medicinal products imported as parallel imports by using as a parent marketing authorisation the authorisation for the new version of Zimovane and they have taken the view that, on the basis of the information in their possession, in spite of the different excipients used, the old version of Zimovane clearly remained effective and safe.
Denne eventuelle påvirkning af sikkerheden betyder imidlertid ikke, at forskelle med hensyn til anvendte hjælpestoffer ganske afskærer de nationale myndigheder fra at anvende forenklede
Accordingly, the competent authorities of the Member State of importation must ensure, at the time of import and on the basis of information in their possession, that the medicinal product imported as a parallel product, even if not identical in all respects to that already authorised by them, has the same active ingredient and the same therapeutic effect and does not pose a problem of quality, efficacy or safety.
Det hedder i domskonklusionen:
Although differences in the excipients used in medicinal products do not normally have any effect on safety, it is not disputed that such
— de ovennævnte markedsføringstilladelser er udstedt til forskellige selskaber i samme gruppe, hvortil også hører fremstillerne af lægemidlet X og Y, og
efficacy and safety in normal conditions of use and is in a position to ensure normal pharmacovigilance;
— de selskaber, der tilhører den samme gruppe som indehaveren af markedsføringstilladelsen for lægemidlet X der er blevet tilbagekaldt i medlemsstaten B, fortsat fremstiller og markedsfører lægemidlet i andre medlemsstater end medlemsstaten B.
— 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 ofthat group of companies; and 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.
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 offentage sundhed ikke kan nås, såfremt produkterne X og Y samtidig afsættes på medlemsstaten B's marked*
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 product X and product Y were both on the market in Member State Β at the same time.'
Dansk tekst foreligger endnu ikke.
He proposed that the Court give the following answers to the questions referred to it by the High Court of Justice:
Ved beslutning af 12. marts 1998 har Østre Landsret forelagt et præjudicielt spørgsmål vedrørende fortolkningen af artikel 17, stk. 2, i Kommissionens forordning (EØF) nr. 3665/87 af 27. november 1987.
(iii) the marketing authorisations mentioned under (i) and (ii) above were granted to different members of the same group of companies and the manufacturers of the medicinal products X and Y are also members of that group of companies,
Med det præjudicielle spørgsmål ønsker den forelæggende ret nærmere bestemt fastslået, om artikel 17, stk. 2, andet afsnit, andet led, i forordning nr. 3665/87 skal fortolkes således, at GCC-landene, såfremt varerne forarbejdes, før toldformaliterne er afsluttet i et af landene, og derefter udføres til andre af disse lande, skal betragtes som et og samme tredjeland, hvor alle de produkter, der er resultatet af denne forarbejdning, er blevet indført.
(iv) the formulation of medicinal product Y was developed and introduced in order to secure a benefit for the health of humans which medicinal product X (produced according to a different formulation) does not provide,
Det bemærkes, at ordningen, hvorefter der ved eksport af oksekød til tredjelande ydes restitutioner, der dækker forskellen mellem
(vi) companies in the same group as the holder of the MA for medicinal product X continue to manufacture and market that product in Member States other than Member State B, provided that
priserne på verdensmarkedet og priserne inden for Fællesskabet, skal sikre Fællesskabets deltagelse i den internationale handel med oksekød.
the holder of the MA is able to prove, on the basis of objective justifications, that the marketing of medicinal product X in those Member States does not present risks for human health similar to those to which it would give rise in Member State B.
For så vidt angår differentierede restitutioner er udbetaling af restitutioner betinget af, at produktet er indført til et tredjeland, og at formaliteterne for overgang til frit forbrug er afsluttet.
In the absence of Community harmonisation of national requirements for the placing of parallel imports of medicinal products on the market, it is incumbent on the authority responsible for issuing marketing authorisations, and if appropriate the national courts, to determine whether the reasons for which the formulation of medicinal product Y was developed and introduced can be linked with the general interest in protecting human life and health, as that concept is understood in national law.'
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.
Preliminary ruling (Agriculture — Common organisation of the market — Beef and veal —Export refunds Beef processed before entering the country of import — International agreements — Effects Cooperation Agreement between the European Economic Community, of the one part, and the countries parties to the Charter of the Cooperation Council for the Arab States of the Gulf, of the other part) (First Chamber)
Det må fastslås, at artikel 17, stk. 2, andet afsnit, andet led, i forordning nr. 3665/87 ikke er i strid med proportionalitetsprincippet.
Cooperation Council for the Arab States of the Gulf (hereinafter 'GCC countries').
Denne konstatering modsiges ikke af ordlyden af artikel 17, stk. 1, i forordning nr. 3665/87, som
By order of 12 March 1998, the Østre Landsret (Eastern Regional Court) referred to the Court for a preliminary ruling a question on the interpretation of Article 17(2) of Commission Regulation (EEC) No 3665/87 of 27 November 1987.
Det fremgår tilstrækkelig klart 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. De erhvervsdrivende kunne følgelig ikke støtte nogen berettiget forventning om en videre fortolkning af denne bestemmelse på dennes egen ordlyd.
By its question the national court is essentially asking whether the second indent of the second subparagraph of Article 17(2) of Regulation No 3665/87 is to be interpreted as meaning that the GCC countries are 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 country into which all the products resulting from that processing have been imported.
»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 deltagerlandene i charteret for Samarbejdsrådet for De Arabiske Golfstater, såfremt varerne forarbejdes, før toldforrnatiteteme er afsluttet i et af landene, og derefter udføres til andre af disse lande, ikke skal betragtes som et og samme tredjeland, hvor alle de produkter, der er resultatet af denne forarbejdning, er blevet indført*
That question was raised in proceedings between DAT-SCHAUB amba and the Ministeriet for Fødevarer, Landbrug og Fiskeri (the Danish Ministry of Food, Agriculture and Fisheries) concerning the Ministry's refusal to grant it export refunds for beef exported to the United Arab Emirates which, after being processed there without first being cleared through customs for release for consumption, was exported to other countries parties to the Charter of the
Generaladvokat J. Mischo fremsatte forslag til afgørelse i retsmødet (Første Afdeling') den 3. juni 1999.
It should be pointed out that the granting of refunds on exports of beef and veal to nonmember countries, equal to the difference between prices on the world market and those within the Community, is intended to safeguard
Han foreslog Domstolen følgende besvarelse:
Community participation in international trade in beef and veal.
Sag C-137/99 Kommissionen for De Europæiske Fællesskaber / Den Hellenske Republik Landbrug
By contrast, Article 17(2) intentionally, for reasons of supervision, excludes any re-export after processing.
»Traktatbrud — manglende gennemførelse af direktiv 961431EF* (Første Afdeling)
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.
Rådets direktiv 85/73/EØF af 29. januar 1985 om finansiering af veterinærundersøgelse og -kontrol som omhandlet i direktiv 89/662/EØF, 90/425/EØF, 90/675/EØF og 91/496/EØF.
The second indent of the second subparagraph of Article 17(2) of Regulation No 3665/87 does not infringe the principle of proportionality.
Ved stævning indleveret til Domstolens Justitskontor den 19. april 1999 har Kommissionen for De Europæiske Fællesskaber anlagt sag med påstand om, at det fastslås, at Den Hellenske Republik har tilsidesat sine forpligtelser i henhold til EF-traktaten og Rådets direktiv 96/43/EF af 26. juni 1996 om ændring og kodifikation af direktiv 85/73/EØF med henblik på finansiering af veterinærundersøgelse og -kontrol af levende dyr og visse animalske produkter og om ændring af direktiv 90/675/EØF og 91/496/EØF, idet den ikke har vedtaget de love og administrative bestemmelser, der er nødvendige for at efterkomme dette direktiv.
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.
Den Hellenske Republik har gjort gældende, at landbrugsministeriet har indføjet enbestemmelse, der regulerer de i direktiv 96/43 behandlede spørgsmål, i et allerede underskrevet lovforslag.
That conclusion is not invalidated by the wording of Article 17(1) of Regulation No 3665/87, which
Ifølge dette forslag skal størrelsen og opkrævningen af gebyrer til finansiering af veterinærundersøgelse og -kontrol fastsættes i bekendtgørelser, der udstedes af finansministeren og landbrugsministeren i fællesskab.
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.
I henhold til direktiv 96/43 erstattes titlen, artiklerne og bilagene i Rådets direktiv 85/73/EØF af 29. januar 1985 om finansiering af sundhedsmæssig undersøgelse og kontrol af fersk kød og fjerkrækød af teksten i bilaget til direktiv 96/43. Direktiv 85/73's nye titel er herefter
'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, 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 country into which all the products resulting from that processing have been imported'
Det fremgår af disse udtalelser, at bestemmelserne i artikel 4, stk. 1, første afsnit, i direktiv 96/43 ikke er blevet gennemført inden for den i artiklen fastsatte frist.
Advocate General J. Mischo delivered his Opinion at the sitting of the First Chamber on 3 June 1999.
Den sag, som Kommissionen i denne forbindelse har anlagt, må derfor anses for berettiget.
He proposed that the Court give the following answer to the question submitted by the Østre Landsret:
Den Hellenske Republik for at efterkomme den begrundede udtalelse, skal Kommissionens påstand ikke tages til følge, for så vidt den tillige angår vedtagelsen af de foranstaltninger, der er nødvendige for at efterkomme artikel 4, stk. 1, andet afsnit, i direktiv 96/43.
'Having regard to the Cooperation Agreement between the European Economic Community and the countries parties to the Charter of the Cooperation Council for the Arab States of the Gulf (the State of the United Arab Emirates, the State of Bahrain, the Kingdom of Saudi Arabia, the Sultanate of Oman, the State of Qatar and the State of Kuwait), approved by Council Decision 89/147/EEC of 20 February 1989, the term "non-member country" in the second subparagraph of Article 17(2) of 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 may not be construed as meaning that the countries parties to the Charter are treated as one single nonmember country, which would have the result that a product which, after processing in the Jebel Ali Free Zone in the United Arab Emirates, was imported and released for free circulation in another of the countries parties to the Charter would be regarded as having been imported in the unaltered state within the meaning of Article 17 of Regulation No 3665/87.'
Da gennemførelsesfristen endnu ikke var udløbet på det tidspunkt, som Kommissionen havde fastsat som frist over for
Case C-137/99 Commission of the European Communities ν Hellenic Republic Agriculture
Det hedder i domskonklusionen:
16 December 1999
Den Hellenske Republik betaler sagens omkostninger.*
Directive 96/43.
Generaladvokat N. Fennelly fremsatte forslag til afgørelse i retsmødet CFørste Afdeling") den 28. oktober 1999.
The new title of Directive 85/73 is henceforth Council Directive 85/73/EEC of 29 January 1985 on the financing of veterinary inspections and controls covered by Directives 89/662/EEC, 90/425/EEC, 90/675/EEC and 91/496/EEC.
Sag C-150/98 Ρ De Europæiske Fællesskabers Økonomiske og Social Udvalg / E Tjenestemandsvedtægten
The Hellenic Republic states that the Ministry of Agriculture has included, in a draft law which has already been signed, a provision laying down rules concerning the matters addressed by Directive 96/43.
»Appel — tjenestemænd —ytringsfrihed overfor overordnede — loyalitetspligt og den værdighed, stillingen kræver — disciplinær sanktion — indplacering på lavere løntrin« (Anden Afdeling)
According to that draft, decrees are to be enacted jointly by the Ministries of Finance and Agriculture, providing for the fixing and collection of fees in order to ensure financing of veterinary inspections and controls.
Ved appelskrift indleveret til Domstolens Justitskontor den 17. april 1998 har De
14) are to be replaced by the text set out in the annex to
Respekten for denne ret er navnlig vigtig, når en tjenestemand udnytter sin adgang efter vedtægtens artikel 43, stk. 2, til at tilføje de bemærkninger vedrørende den ham meddelte bedømmelse, som han finder nødvendige.
provisions in question. Since that period had not yet expired on the date by which the Hellenic Republic was required by the Commission to comply with the reasoned opinion, the action must be dismissed in so far as it also concerns adoption of the measures necessary in order to comply with the provisions referred to in the second subparagraph of Article 4(1) of Directive 96/43.
afsagt den 17. februar 1998 af Retten i Første Instans i sag T-183/96, E mod Det Økonomiske og Sociale Udvalg (herefter »den anfægtede dom«), hvorved Retten annullerede afgørelsen truffet den 18. januar 1996 af Det Økonomiske og Sociale Udvalgs generalsekretær—ved hvilken afgørelse E var blevet pålagt en disciplinær sanktion i form af indplacering på lavere løntrin (herefter »den anfægtede afgørelse«) — og pålagde Det Økonomiske og Sociale Udvalg at afholde sagens omkostninger.
As regards, on the other hand, the provisions referred to in the second subparagraph of Article 4(1) of Directive 96/43, it should be noted that, according to the wording of that article, Member States are to have a further period, which may extend to 1 July 1999, in which to transpose the
Retten har derfor begået en retlig fejl ved den retlige kvalifikation af de i sagen foreliggende omstændigheder, eftersom den betegnede den adfærd, som E bebrejdedes at have udvist — og som bestod i, at hun havde anvendt en aggressiv og utilbørlig tone, da hun tilføjede sine bemærkninger til bedømmelsesrapporten — som en tilsidesættelse af vedtægtens artikel 12 og 21, hvorimod Retten fastslog, at den af E anvendte sprogbrug ikke var groft krænkende.
Decfares that, by failing to adopt within the prescribed period the laws, regulations and administrative provisions necessary to comply with the provisions referred to in the first subparagraph of Article 4(1) of Council Directive 96/43/EC of 26 June 1996 amending and consolidating Directive 85/73/EEC in order to ensure financing of veterinary inspections and controls on live animals and certain animal products and amending Directives 90/675/EEC and 91/496/EEC, the Hellenic Republic has failed to fulfil its obligations under that article;
Det hedder i domskonklusionen:
Advocate General N. Fennelly delivered his Opinion at the sitting of the First Chamber on 28 October 1999.
Økonomiske og Sociale Udvalg betaler appelsagens
Order the Hellenic Republic to pay the costs of these proceedings.'
De Europæiske omkostninger.*
Case C-150/98 Ρ Economic and Social Committee of the European Communities ν E Staff Regulations of Officials
Sag C-26/99 Kommissionen for De Europæiske Fællesskaber / Storhertugdømmet Luxembourg Socialpolitik
(Appeal — Officials — Freedom of expression in relation to hierarchical superiors — Duty of loyalty and obligation to uphold the dignity of the service —Disciplinary measure — Relegation in step) (Second Chamber)
efterkomme direktivet, eller at denne gennemførelse er blevet forsinket.
Orders the Economic and Social Committee to pay the costs.'
Dette udkast er blevet ændret på visse punkter, og en ny tekst har derfor først kunnet forelægges Conseil d'État til udtalelse den 27. januar 1999.
Advocate General J. Mischo delivered his Opinion at the sitting of the Second Chamber on 10 June 1999.
Den luxembourgske regering har ikke bestridt, at de foranstaltninger i national ret, der er fornødne for gennemførelse af direktivet, endnu ikke er blevet truffet.
Case C-26/99 Commission of the European Communities ν Grand Duchy of Luxembourg Social policy
En medlemsstat kan ikke påberåbe sig bestemmelser, fremgangsmåder eller forhold i sin nationale retsorden til støtte for, at forpligtelser og frister, der følger af et direktiv, ikke overholdes.
(Failure by a Member State to fulfil its obligations — Failure to transpose Directive 951301EC) (Third Chamber)
Det hedder i domskonklusionen:
Ducal Regulation was not adopted until 6 February 1998.
»1) Storhertugdømmet Luxembourg har tilsidesat sine forpligtelser i henhold til artikel 2, stk 1, i Kommissionens direktiv 95/30/EF af 30. juni 1995 om tilpasning til den tekniske udvikling af Rådets direktiv 90/679/EØF om beskyttelse af arbejdstagerne mod farerne ved at være udsat for biologiske agenser under arbejdet (syvende særdirektiv i henhold til artikel 16, stk 1, i direktiv 89/391/EØF), idet det ikke inden for den fastsatte frist har vedtaget de nødvendige love og administrative bestemmelser for at efterkomme direktivet
Article 2(1) of the Directive provides that the Member States are to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 November 1996 and that they are immediately to inform the Commission thereof.
Generaladvokat N. Fennellv fremsatte forslag til afgørelse i retsmødet (Tredje Afdeling') den 28. oktober 1999.
It nevertheless contends that the delay in adopting the abovementioned draft regulation can be explained by the fact that, since it had held the Presidency of the Council of Ministers of the European Union, the first draft of the Grand
Dansk tekst foreligger endnu ikke.
The Court:
Sag C-138/99 Kommissionen for De Europæiske Fællesskaber / Storhertugdømmet Luxembourg Transport
Declares that, by fatting to adopt, within the prescribed period, the laws, regulations and administrative provisions necessary to comply with Commission Directive 95I30/EC of 30 June 1995 adapting to technical progress Council Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC), the Grand Duchy of Luxembourg has failed to fulfil its obligations under Article 2(1) ofthat Directive;
»Traktatbrud — direktiv 94/56/EF —flytransport civil luftfart—undersøgelser af flyvehavarier og flyvehændelser — gennemførelse« (Tredje Afdeling)
Advocate General N. Fennelly delivered his Opinion at the sitting of the Third Chamber on 28 October 1999.
Ved stævning indleveret til Domstolens Justitskontor den 19. april 1999 har Kommissionen for De Europæiske Fællesskaber anlagt sag med påstand om, at det fastslås, at Storhertugdømmet Luxembourg har tilsidesat sine forpligtelser efter Rådets direktiv 94/56/EF af 21. november 1994 om fastlæggelse af de grundlæggende principper for undersøgelse af flyvehavarier og flyvehændelser inden for civil luftfart (herefter »direktivet«), da det ikke har vedtaget de nødvendige love og administrative bestemmelser for at efterkomme direktivet.
'(1) Declare that, by not adopting the legislative, regulatory or administrative measures necessary to comply with its obligations under Commission Directive 95/30/EC of 30 June 1995 adapting to technical progress Council Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC), the Grand Duchy of Luxembourg has failed to fulfil its obligations under the EC Treaty;
Den luxembourgske regering har ikke bestridt, at den ikke har gennemført direktivet i national ret inden for den fastsatte frist.
(2) Order the Grand Duchy of Luxembourg to pay the costs of these proceedings.'
En medlemsstat kan ikke påberåbe sig bestemmelser, fremgangsmåder eller forhold i sin nationale retsorden til støtte for, at forpligtelser
Case C-138/99 Commission of the European Communities ν Grand Duchy of Luxembourg Transport