natgillin/translations-raw huggingface dataset:
I svarskriftet har Kongeriget Spanien gjort gældende, at Justitsministeriet har udarbejdet et lovforslag med henbUk på gennemførelse af direktivet.
In the light of the foregoing considerations, it must be held that national legislation under which the withdrawal of the marketing authorisation of reference for a medicinal product on application by the holder thereof means that a parallel import licence for that product automatically ceases to be valid does not comply with the requirements resulting from Article 28 EC.
De relevante formaliteter er tilendebragt, og regeringen har allerede godkendt lovforslaget »om gennemførelse i den spanske retsorden af diverse fællesskabsdirektiver om beskyttelse af brugernes og forbrugernes interesseis.
First, it must be observed that the withdrawal of a marketing authorisation of reference does not mean in itself that the quality, efficacity and nontoxicity of the old version is called into question.
Forslaget skal således blot vedtages i det spanske parlament
In that respect it must be noted that that version continues to be lawfully marketed in the Member State of exportation under the marketing authorisation issued in that State.
De spanske myndigheder svarede ved skrivelse af 25. juni 2001, at de nødvendige nationale foranstaltninger til gennemførelse af direktivet var ved at blive vedtaget.
In view of that answer, there is no need to examine the second question on the possible importance of the fact that for the holder of the marketing authorisation for the old version of the medicinal product there was, under national law, another possibility, which would enable it to waive that authorisation in such a way that the old version would remain marketable for a transitional period.
Dette ændrer imidlertid ikke ved det forhold, at direktivet — således som det fremgår af Kongeriget Spaniensforklaringer— ikke er blevet gennemført inden for den frist, der er fastsat i den begrundede udtalelse. Under disse omstændigheder må der gives Kommissionen medhold.
Next, although the competent authorities of the Member State of importation can, and indeed must, adopt the measures necessary for the purpose of verifying the quality, efficacity and nontoxicity of the old version of the medicinal product, it does not appear from the information before the Court that that objective cannot be attained by other measures having a less restrictive effect on the import of medicinal products than the automatic cessation of the validity of the parallel import licence in consequence of the withdrawal of the marketing authorisation of reference.
Da Kommissionen ikke modtog andre oplysninger om direktivets gennemførelse, besluttede den at anlægge nærværende sag.
In relation to the third question, it need merely be observed that nothing has been put before the Court to show that the fact that the new version has been placed on the market of the Member State of importation alone or is also found on the market in other Member States has any relevance to the answer to the first question.
»1) Kongeriget Spanien tilsidesat sine forpligtelser i henhold til Europa-Parlamentets og Rådets direktiv 98/7/EF af 16. februar 1998 om ændring af direktiv 87/102/EØF om indbyrdes tilnærmelse af medlemsstaternes love og administrative bestemmelser om forbrugerkredit ved ikke inden for den fastsatte frist at have vedtaget de nødvendige love og administrative bestemmelser for at efterkomme direktivet.
Although adequate monitoring of the old version remains necessary and may in certain cases mean that information is requested from the importer, it must be pointed out that pharmacovigilance satisfying the relevant requirements of Directive 75/319 as amended can ordinarily be guaranteed for medicinal products that are the subject of parallel imports, such as those in question in the main proceedings, through cooperation with the national authorities of the other Member States by means of access to the documents and data produced by the manufacturer or other companies in the same group, relating to the old version in the Member States in which that version is still marketed on the basis of a marketing authorisation still in force (see Rhône-Poulenc Rorer and May & Baker, cited above, paragraph 46). It must be pointed out, however, that the question of the existence and the reality of the risk is a matter which is primarily for the competent authorities of that Member State to determine, and the mere assertion by the holder of the marketing authorisation for the new and old versions that there is such a risk is not sufficient to justify prohibition of the importation of the old version.
»1) at fastslå, at Kongeriget Spanien har tilsidesat sine forpligtelser i henhold til EF-traktaten, idet det ikke inden for den fastsatte frist har sat de nødvendige love og administrative bestemmelser til gennemførelse af Europa-Parlamentets og Rådets direktiv 98/7/EF af 16. februar 1998 om ændring af direktiv 87/102/EØF om indbyrdes tilnærmelse af medlemsstaternes love og administrative bestemmelser om forbrugerkredit, i kraft
Finally, it must also be pointed out that, although it is conceivable that there may be reasons relating to the protection of public health which require that a parallel import licence for medicinal products be necessarily linked to a marketing authorisation of reference,
2) at pålægge Kongeriget Spanien at betale sagens omkostninger.«
In that respect, while it is not open to the Court to rule on the question relating to the existence
Sag C-152/00 Kommissionen for De Europæiske Fællesskaber / Den Franske Republik Miljø- og forbrugerbeskyttelse
and reality of a risk to public health finked to the coexistence of the two versions of the medicinal product in question on the German market, it is conceivable that the risk mentioned by Ferring may be of such a nature that it cannot be averted satisfactorily by appropriate labelling.
Ved stævning indleveret til Domstolens Justitskontor den 19. april 2000 har Kommissionen for De Europæiske Fællesskaber i medfør af artikel 226 EF anlagt sag med påstand om, at det fastslås, at Den Franske Republik har tilsidesat sine forpligtelser i henhold til EF-traktaten, idet den ikke fuldstændigt og korrekt har gennemført Rådets direktiv 86/609/EØF af 24. november 1986 om indbyrdes tilnærmelse af medlemsstaternes love og administrativebestemmelser om beskyttelse af dyr, der anvendes til forsøg og andre videnskabelige formål, navnlig dets artikel 4, 7, 11, 12, 18 og 22.
The fact that the new version of the medicinal product has been placed on the market of the Member State of importation alone or is also found on the market in other Member States does not alter the answer to the first question.
Kommissionen konstaterede, at medlemsstaten ikke havde efterkommet den begrundede udtalelse inden for den heri fastsatte frist, hvorefter den har anlagt denne sag.
Advocate General L. A Geelhoed delivered his Opinion at the sitting of the Sixth Chamber on 7 February 2002.
Søgsmålet
Not available.
Manglende gennemføreke af direktivets artikel 4
Case C-312/01 Commission of the European Communities ν Hellenic Republic Company law
Kommissionen har i det første klagepunkt gjort gældende, at Den Franske Republik ikke har gennemført direktivets artikel 4.
(Failure by a Member State to fulfil its obligations — Directive 98/78/CE — Failure to transpose within the prescribed time-limit) (First Chamber)
Eftersom Kommissionen ikke fandt, at disse bestemmelse sikrede en korrekt og fuldstændig gennemførelse af direktivets artikel 4, 7, 11, 12, 18 og 22, opfordrede den ved skrivelse af 24.
European Communities brought an action under Article 226 EC for a declaration
Under disse omstændigheder skal Kommissionens første klagepunkt tiltrædes.
measures necessary to comply with its obligations under the Directive within two months of the date of notification of that opinion.
Den franske regering har hævdet, at de kompetente myndigheder ved behandling af ansøgningerom tilladelse til forsøg i henhold til artikel 5 i dekret nr. 87848 er i stand til at sikre, at betingelserne i direktivets artikel 7, stk. 3, er opfyldt.
Since the Directive was not transposed within the timelimit prescribed in the reasoned opinion, the action brought by the Commission must be considered to be well founded.
For det andet har den franske regering gjort gældende, at de beskyttede arter, der er omfattet af direktivets artikel 4, kun sjældent bliver opdrættet i fangenskab i Frankrig, mens betingelserne for import fra et tredjeland af disse arter, der er fastsat i Rådets forordning (EF) nr. 338/97 af 9. december 1996 om beskyttelse af vilde dyr og planter ved kontrol af handelen hermed, er tilstrækkelige til at opnå det i denne bestemmelse forskrevne resultat.
Declares that, by failing to bring into force or to communicate to the Commission within the prescribed time-limit, all of the laws, regulations and administrative provisions necessary to comply with Directive 98/78/EC of the European Parliament and of the Council of 27 October 1998 on the supplementary supervision of insurance undertakings in an insurance group, the Hellenic Republic has failed to fulfil its obligations under that directive;
igangværende forsøg, i det omfang dyrene er taget fra deres naturlige omgivelser.
Case C-386/01 Commission of the European Communities ν Kingdom of Spain Environment and consumers
Manglende gennemførelse af direktivets artikel 11
The Spanish authorities replied by letter of 25 June 2001 stating that the national measures necessary to transpose the Directive were in the process of being adopted.
Kommissionen har i det tredje klagepunkt gjort gældende, at der i den franske lovgivning ikke er bestemmelser, der, som fastsat i direktivets artikel 11, gør udsætning af et forsøgsdyr i frihed betinget af, at den kompetente myndighed foretager en forudgående kontrol af, om betingelserne, der er fastsat i denne bestemmelse, er opfyldt.
Since the Commission did not receive any other information regarding transposition of the Directive, it decided to bring the present action.
I den forbindelse har den franske regering henvist til artikel 2 i dekret nr. 87848, der bestemmer, at »[fjølgende skal ikke betragtes som forsøg i den forstand, hvori udtrykket er anvendt i dette dekret: [...] b) forsøg, der består i at iagttage dyr anbragt under forhold, der ikke indebærer nogen lidelse; [...]«.
By application lodged at the Court Registry on 8 October 2001, the Commission of the European Communities brought an action under Article 226 EC for a declaration that, by failing to adopt the laws, regulations and administrative provisions necessary to comply with Directive 98/7/EC of the European Parliament and of the Council of 16 February 1998 amending Directive 87/102/EEC for the approximation of the laws, regulations and administrative provisions of the Member States concerning consumer credit or, in any event, by failing to inform the Commission of the adoption of such provisions, the Kingdom of Spain has failed to fulfil its obligations under Article 2(1) of that directive.
Dels angiver artikel 11, at når dens strenge betingelser er opfyldt, har den kompetente myndighed mulighed for — men ikke pligt til — at give tilladelse til, at dyr slippes løs.
In its statement of defence, the Kingdom of Spain submitted that the Ministry of Justice had prepared a draft law intended to transpose the Directive.
Dels står det fast, at medlemsstaterne i henhold til direktivets artikel 24 frit kan anvende eller vedtage strengere foranstaltninger for at beskytte dyr, der anvendes til forsøg, eller for at kontrollere og begrænse anvendelsen af dyr til forsøg.
All the relevant procedural requirements had been met and the Government had already approved the draft law 'transposing into Spanish law various community directives on the protection of the interests of consumers and users'.
For så vidt angår udsætning af dyr i frihed under forsøg har den franske regering anført, at den gældende nationale lovgivning udelukker dette.
Those circumstances do not in any way alter the fact that, as is apparent from the explanations given by the Kingdom of Spain, the Directive was not transposed within the period laid down in the reasoned opinion.
De nationale bestemmelser, som Den Franske Republik har påberåbt sig, sikrer nemlig på ingen måde, at dyr kun slippes løs i direktivets artikel U's forstand under de i denne artikel nævnte betingelser. Imidlertid udgør bestemmelsen, hvilket fremgår af præmissen ovenfor, den mindstebeskyttelse, som medlemsstaterne er forpligtet til at sikre forsøgsdyr i direktivets forstand.
In accordance with the procedure laid down in the first paragraph of Article 226 EC, the Commission, having given the Kingdom of Spain the opportunity to submit its observations, sent a reasoned opinion to that Member State, by letter of 9 March 2001, requesting it to take the measures necessary to fulfil its obligations under the Directive within two months of notification of the opinion.
I den forbindelse skal det for det første bemærkes, at artikel 2, litra b), i dekret nr. 87848, der omhandler iagttagelse af dyr anbragt under betingelser, der ikke medfører nogen lidelse, er uden betydning for afgørelsen af den foreliggende sag, da direktivets artikel 11 kun vedrører dyr, der slippes løs under et forsøg i direktivets artikel 2, litra d)'s, forstand, dvs. til brug til videnskabelige formål, som kan påføre dyret smerte, lidelse, angst eller varigt men.
Declares that, by failing to adopt within the prescribed period the laws, regulations and administrative provisions necessary to comply with Directive 98/7/EC of lhe European Parliament and of the Council of 16 February 1998 amending Directive 87/102/EEC for the approximation of the laws, regulations and administrative provisions of the Member
leverandørv i rksom heder for forsøgsdyr] skal være kendetegnet med en individuel og varig mærkning«.
States concerning consumer credit, the Kingdom of Spain has failed to fulfil its obligations under Article 2(1) of that directive
Det skal i den forbindelse tilføjes, at begrebet dyr, der slippes løs, af hensyn til forsøgets formål i direktivets artikel U's forstand ikke svarer til begrebet forsætlig udsættelse.
Advocate General S. Alber delivered his Opinion at the sitting of the First Chamber on 30 May 2002.
Endelig har den franske regering for så vidt angår hunde og katte påberåbt sig artikel 276-2 i code rural og artikel 19 i dekret nr. 91-823 af 28. august 1991 om identifikation af hunde, katte og andre kødædende husdyr og om driften af lokaler, hvor der regelmæssigt udføres opdræt med henblik på salg, afsætning, pleje, transit eller opbevaring af disse dyr.
Ί) declare that, by failing to adopt within the prescribed period the laws, regulations and administrative provisions necessary to comply with Directive 98/7/EC of the European Parliament and of the Council of 16 February 1998 amending Directive 87/102/EEC for the approximation of the laws, regulations and administrative provisions of the Member States concerning consumer credit, the Kingdom of Spain has failed to fulfil its obligations under the Treaty;
Manglende gennemførelse af direktivets artikel 12, stk 2
2) order the Kingdom of Spain to pay the costs.'
Da Den Franske Republik ikke har bestridt, at denne bestemmelse ikke er blevet gennemført i national ret, skal Kommissionens fjerde klagepunkt følgelig tiltrædes.
Case C-152/00 Commission of the European Communities ν French Republic Environment and consumers
Kommissionen har i det femte klagepunkt gjort gældende, at Den Franske Republik ikke fuldstændig har gennemført direktivets artikel 18, stk. 1 og 3, om mærkning af katte, hunde og primater (bortset fra mennesker), der befinder sig på en opdrætter-, leverandør- eller brugervirksomhed i direktivets forstand.
(Failure by a Member State to fulfil its obligations transposition) (Fifth Chamber)
Manglende gennemførebe af direktivets artikel 22, stk. 1
Relevant provisions and pre-litigation procedure
Kommissionen har i det sjette klagepunkt gjort gældende, at Den Franske Republik ikke har vedtaget nogen foranstaltninger for at sikre gennemførelse af direktivets artikel 22, stk. 1.
The French authorities notified the Commission of the measures adopted to transpose the Directive, namely, first, Decree No 87-848 of 19 October 1987 regarding the application of Article 454 of the Criminal Code and of Article 276(3) of the Agricultural Code and relating to animal experiments, secondly, three Interministerial Orders of 19 April 1988 applying that decree and laying down, respectively, the conditions for the supply to approved laboratories of animals used for the purposes of scientific or experimental
Den franske regering har indledningsvis anført, at artikel 9 i dekret nr. 87848, der bl.a. bestemmer, at »fravænnede hunde, katte og primater, der befinder sig på [forsøgs-, opdrætter- eller
By application lodged at the Registry of the Court on 19 April 2000, the Commission of the European Communities brought an action under Article 226 EC for a declaration that, by failing to transpose fully and correctly Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, and in particular Articles 4, 7, 11, 12, 18 and 22 thereof, the French Republic has failed to fulfil its obligations under the EC Treaty.
Heroverfor har den franske regering påberåbt sig bekendtgørelse af 20. juni 2001 om god laboratoriepraksis for dyremedicin og bekendtgørelse af 14. marts 2000 om god laboratoriepraksis, idet den nærmere har anført, at de var blevet vedtaget med hjemmel i artikel R. 5118 i code de la santé publique, der bemyndiger sundhedsministeren til at fastsætte de regler og metoder, der skal anvendes ved medicinske forsøg, samt de principper om god la bora toriepraksis og god klinisk praksis, der skal overholdes ved udførelsen af forsøg.
research, the conditions for the allocation of licences to carry out experiments on animals, and the conditions for approval, equipping and functioning of establishments for animal experiments and, thirdly, Article R. 5118 of the Code of Public Health.
Der skal herved henvises til Domstolens praksis, hvorefter direktivets artikel 22, der vedrører medlemsstaternes anerkendelse af gyldigheden af data hidrørende fra dyreforsøg, der er udført på en anden medlemsstats område med et af de i direktivets artikel 3 nævnte formål, nemlig udvikling og fremstilling af samt kvalitets-, effektivitets- og sikkerhedskontrol ikke blot med lægemidler, men også med fødevarer og andre stoffer eller produkter samt miljøbeskyttelse, bestemt kræver vedtagelse af egnede gennemførelsesforanstaltninger (jf. dom af 15.10.1998, sag C-268/97, Kommissionen mod Belgien, præmis 14).
That Government submits that it follows from the combined effect of those provisions that, if a researcher intends to carry out experiments on animals belonging to an endangered species covered by Article 4 of the Directive, his licence application must make mention of that circumstance and contain evidence to show that the experiment is for an essential medical purpose and that such species is the only one which is suitable, in default of which the licence must be refused, as required by Article 4 of the Directive.
Det må imidlertid fastslås, at Den Franske Republik ved udløbet af fristen i den begrundede udtalelse ikke har vedtaget foran s takninger for at give direktivets artikel 22, stk. 1, virkning.
Having received no reply from the French Republic, the Commission, on 18 December 1998, sent a reasoned opinion to that Member State requesting it to adopt the measures necessary to comply with it within two months from the date of notification of the opinion.
Kommissionens sjette klagepunkt skal derfor ligeledes tiltrædes.
By letter of 28 June 1999, the French Republic rejected the complaints made against it in the reasoned opinion.
Under retsmødet har den franske regering desuden gjort gældende, at direktivets artikel 22 kun pålægger medlemsstaterne at iværksætte bestemte foranstaltninger, hvilket fremgår af anvendelsen af udtrykket »i så vid udstrækning som muligt« i bestemmelsens stk. 1.
Since it considered that that Member State had not complied with the reasoned opinion within the period laid down therein, the Commission brought this action.
»1) Den Franske Republik har tilsidesat sine forpligtelser i henhold til Rådets direktiv 86/609/EØF af 24. november 1986 om indbyrdes tilnærmelse af medlemsstaternes love og administrative bestemmelser om beskyttelse af dyr, der anvendes til forsøg og andre videnskabelige formål, idet den ikke har truffet alle de foranstaltninger, der er nødvendige for at sikre en korrekt gennemførelse af direktivets artikel 4, artikel 7, stk 3, artikel 11, artikel 12, stk 2, artikel 18, stk 1 og 3, samt artikel 22, stk 1.
Second, the French Government submits that the protected species covered by Article 4 of the Directive are only rarely bred in captivity in France, whereas the conditions relating to their importation from third countries, laid down by Articles 4 and 8 of Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein, are sufficient to guarantee the result required by that provision.
Generaladvokat L. A. Geelhoed fremsatte forslag til afgørelse i retsmødet (Femte Afdeling) den 7. februar 2002.
It is sufficient, in this case, to observe that those provisions concern the import of, and trade in, the species they cover and not experiments on such species.
Dansk tekst foreligger endnu ikke.
In those circumstances, the Commission's first complaint must be upheld.
Præjudiciel »Socialpolitik - ligebehandling af mænd og kvinder - anvendelse af EF-traktatens artikel 119 (EF-traktatens artikel 117-120 er blevet erstattet af artikel 136 EF-143 EF) eller af direktiv 79/7/EØF — begrebet løn — pensionsordning for tjenestemænd* (Femte Afdeling) instanstræffer afgørelser vedrørende ansøgninger om pension.
The French Government submits that, when the licence application for an experiment under Article 5 of Decree No 87-848 is considered, the competent authority is in a position to check that the conditions set out in Article 7(3) of the Directive are satisfied.
Ved dom af 18. januar 2000, indgået til Domstolen den 21. september 2000, har vakuutusoikeus (forsikringsretten) i medfør af artikel 234 EF forelagt et præjudicielt spørgsmål vedrørende fortolkningen af EF-traktatens artikel 119 (EF-traktatens artikel 117-120 er blevet erstattet af artikel 136 EF-143 EF) og af Rådets direktiv 79/7/EØF af 19. december 1978 om gradvis gennemførelse af princippet om ligebehandling af mænd og kvinder med hensyn til social sikring.
By its third complaint, the Commission claims that the French legislation contains no provision subjecting, as required by Article 11 of the Directive, every setting free of an animal which is being used for an experiment, to the prior verification, by the competent authority, that the conditions laid down by that provision have been met.
Spørgsmålet er blevet rejst under en sag mellem Pirkko Niemi og Valtiokonttori (statens pensionsanstalt) vedrørende lovligheden af en bindende forhåndsafgørelse fra sidstnævnte om, fra hvilken alder Pirkko Niemi kunne gøre krav på alderspension.
In that regard, the French Government relies upon Article 2 of Decree No 87-848 which provides that '[t]he following are not to be regarded as experiments within the meaning of this Decree: ... (b) [t]hose that consist of the observation of animals under conditions that do not cause them any suffering'.
Tvisten i hovedsagen og det præjudicielle spørgsmål
With regard to the setting free of animals in the course of experiments, the French Government submits that the effect of the applicable national regulations is to exclude it.
Pirkko Niemi anmodede om at få fastslået ved hvilken alder hun kunne gøre krav på alderspension. Pirkko Niemi, der fra den 1. april 1969 har gjort tjeneste som tjenestemand i Forsvaret fyldte 55 år den 1. november 1993 og 60 år den 1. november 1998.
In order to adjudicate on the complaint put forward by the Commission, it is necessary, at the outset, to define the scope of Article 11 of the Directive.