natgillin/translations-raw huggingface dataset:
Kommissionen opgiver dog dermed ikke at sikre den fulde virkning af traktatens bestemmelser om frie varebevægelser.
The Commission is not however, abandoning its responsibility to ensure that full effect is given to the provisions of the Treaty relating to the free movement of goods.
Kommissionen har derfor i forbindelse med denne tilbagetrækning til hensigt at anføre, hvorledes den på eget ansvar påregner at anvende traktatens regler, således som de er blevet fortolket af Domstolen, for at bevare et enhedsmarked inden for Fællesskabet
This is why the Commission wishes to indicate, on the occasion of this withdrawal, the way in which it intends to apply, under its own responsibility, the rules embodied in the Treaty as interpreted by the Court of Justice, in order to preserve the unity of the Community's internal market.
Domstolen konstaterede for det første, at en lovgivning eller praksis, som har til følge, at importen kanaliseres på en sådan måde, at kun visse erhvervsdrivende kan importere, mans andre er afskåret herfra, falder ind under forbudet i EØF-traktatens artikel 30.
The Court first of all established that national rules or practices which result in imports being channelled in such a way that only certain traders can effect these imports, whereas others are prevented from doing so, are caught by the prohibition set out in Article 30 of the EEC Treaty.
(') Direktiv 65/65/EØF af 26. januar 1965 (EFT nr. 22 af 9. 2.
) Directive 65/65/EEC of 26 January 1965, OJ No 22, 9. 2.
1965); direktiv 75/318/EØF af 20.maj 1975 (EFT nr. L 147 af 9. 6.
1965; Directive 75/318/EEC of 20 May 1975, OJ No L 147, 9. 6.
1975); direktiv 75/319/EØF af 20.maj 1975 (EFT nr. L 147 af 9. 6.
1975; Directive 75/319/EEC of 20 May 1975, OJ No L 147, 9. 6.
1975); direktiv 78/25/EØF af 12.december 1977 (EFT nr.L 11 af 14. 1. 1978).
1975; Directive 78/25/EEC of 12 December 1977, OJ No L 11, 14. 1. 1978.
1976, sag 104/75, Sml. 1976, s. 613. )
) CJEC 20 May 1976, Case 104/75, 1976 Report, p. 613.
Forslag til ændring af direktiverne 65/65/EØF og 75/319/EØF af 2. juni 1980, (EFT nr. C 143 af 12. 6. 1980).
(3) Proposal dated 2 June 1980 for a Directive amending Directives 65/65/EEC and 75/319/EEC (OJ No C 143, 12. 6. 1980).
Med umiddelbar tilslutning hertil henviste den til de generelle rammer, inden for hvilke medlemsstaterne skal udøve denne beføjelse: det følger imidlertid af artikel 36, at en national lovgivning eller praksis, som har eller kan have restriktiv virkning pä import af farmaceutiske produkter, kun er forenelig med traktaten, for så vidt den er nødvendig for en effektiv beskyttelse af menneskers liv og sundhed; en national lovgivning eller praksis er altså ikke omfattet af undtagelsen i artikel 36, når menneskers liv og sundhed kan beskyttes lige så effektivt ved foranstaltninger, som er mindre restriktive for samhandelen inden for Fællesskabet; artikel 36 kan navnlig ikke påberåbes til at begrunde en i sig selv nyttig lovgivning eller praksis, men hvis restriktive elementer væsentligst skyldes et ønske om at begrænse den administrative byrde eller de offentlige udgifter, medmindre denne byrde eller disse udgifter uden nævnte lovgivning eller praksis klart ville overskude grænserne for, hvad der med rimelighed kan forlanges;
In particular Article 36 cannot be relied on to justify rules or practices which, even though they are beneficial, contain restrictions which are explained primarily by a concern to lighten the administration's burden or reduce public expenditure, unless, in the absence of the said rules or practices, this burden or expenditure clearly would exceed the limits of what can reasonably be required.
I det foreliggende tilfælde søgte de kompetente nationale myndigheder at hindre en parallelimport i at afsætte et lægemiddel, som svarede til et allerede godkendt lægemiddel og som hidrørte fra samme fremstiller. Der var to årsager hertil.
In the case in point the competent national authorities intended to prevent a parallel importer from marketing a medicinal product that was similar to a medicinal product which had already been authorized and was produced by the same manufacturer for two reasons.
For det første var parallelimportøren ikke i stand til at forelægge myndighederne den komplette dokumentation (*) vedrørende kvaliteten, effektiviteten og uskadeligheden af lægemidlet i almindelighed, som den af fremstilleren autoriserede importør allerede havde forelagt samme myndigheder med det formal at opnå markedsføringstilladelse for dette lægemiddel.
First, the parallel manufacturer was not able to provide the authorities with the complete file (l) relating to the quality, efficacy and safety of the product in general, which the manufacturer's authorized importer had already supplied to those same authorities with a view to obtaining a marketing authorization for that medicinal product.
For det andet kunne parallelimportøren ikke i modsætning til den autoriserede importør fra fabrikanten fremskaffe kontrolbeviseme vedrørende hvert enkelt parti.
Secondly, the parallel importer could not, unlike the authorized importer, obtain from the manufacturer the reports on checks made on each manufacturing batch.
I De Peijper-dommen udtalte Domstolen, at »en national lovgivning eller praksis, som gør det muligt for fremstilleren og hans autoriserede repræsentanter at monopolisere varens indførsel og afsætning ved en simpel nægtelse af at udlevere oplysningerne om lægemidlet i almindelighed eller om et bestemt parti heraf, må betragtes som mere restriktiv end nødvendigt, medmindre det med sikkerhed bevises, at enhver anden lovgivning eller praksis klart vil ligge uden for den kreds af rimelige midler, som anvendes i normal forvaltningspraksis... «
In the judgment on the 'De Peijper' case, the Court ruled that 'national rules or practices which make it possible for a manufacturer of the pharmaceutical product in question and his duly appointed representative, simply by refusing to produce the documents relating to the medicinal preparation in general or to a specific batch of that preparation, to enjoy a monopoly of the importing and marketing of the product must be regarded as being unnecessarily restrictive, unless it is clearly proved that any other rules or practices would obviously be beyond the means which can be reasonably expected of an administration operating in a normal manner...'
»Det er kun, når det af de oplysninger eller dokumenter, som skal fremlægges af fremstilleren eller hans autoriserede importør, fremgår, at der findes flere varianter af lægemidlet, og at forskellene mellem disse varianter har terapeutisk betydning, at det vil være berettiget at behandle varianterne som forskellige lægemidler med henblik pä tilladelse til salg samt fremlæggelse af de hertil hørende oplysninger...«
'It is only if the information or documents to be produced by the manufacturer or his duly appointed importer show that there are several variants of the medicinal preparation and that the differences between these variants have a therapeutic effect that there would be any justification for treating the variants as different medicinal preparations, for the purpose of authorizing them to be placed on die market and as regards producing the relevant documents...'
Som traktatens vogter vil Kommissionen påse, at den lovgivning og praksis, der af medlemsstaterne anvendes på parallelimport af lægemidler, og især medicinske specialiteter, som tegner sig for størstedelen af samhandelen med lægemidler inden for Fællesskabet, holdes inden for grænser, der er forenelige med artikel 30-36.
The Commission, in its role as guardian of the Treaty, will ensure that the rules and practices applied by Member States to parallel imports of medicinal products, and in particular proprietary medicinal products which account for the majority of intra-Community trading operations in medicinal products, will remain within limits compatible with Articles 30 to 36.
) Denne dokumentation omfatter bl.a. en beskrivelse af fremstillingen, fremstillernes kontrolmetoder samt resultaterne af de udførte analytiske, toksikologiske, farmakologiske og kliniske forsøg vedrørende lægemidlet i almindelighed.
(') This file comprises inter alia a description of the manufacturer's production and control methods and the results of the analytical, toxico-pharmacological and clinical tests conducted on the medicinal product in general.
De pågældende fonmstaltninger skal især: - være strengt nødvendige ud fra et sundhedsmæssigt synspunkt
In particular, such measures must - be strictly necessary from the health standpoint obstruct intra-Community trade as little as possible, - require Member States to adopt an active and vigilant attitude towards pharmaceutical companies.
Kommissionen minder om, at medlemsstaternes kompetente myndigheder ikke kan modsætte sig salg af et parallelt indført lægemiddel, for hvilket der allerede foreligger markedsføringstilladelse, med den begrundelse, at parallelimportøren ikke k¡m fremskaffe de dokumenter som kun fremstilleren eller hans autoriserede repræsentant har adgang til.
The Commission points out that the competent authorities in the Member States are not entitled to oppose the marketing of any medicinal product the subject of parallel importation, that already has a marketing authorization, on the grounds that the parallel importer is not able to obtain documents which only the manufacturer or his approved representative can have at their disposal.
I mangel af en harmoniseret lovgivning om parallelimportordningen tilkommer det Kommissionen i overensstemmelse med reglerne i traktatens artikel 169 samt de berørte parter i overensstemmelse med de retsmidler, de har til rådighed, at påse, at parallelimport af lægemidler gøres mulig pik de betingelser, der er fastsat ved Domstolens praksis.
In the absence of any harmonized rules governing the system of parallel imports, it is up to the Commission, in accordance with the procedure under Article 169, and to the interested parties, in accordance with the means of redress which they have at their disposal, to ensure that parallel imports of medicinal products are made possible under the conditions laid down by the rulings of the Court.
Efter høring af højtstående sundhedseksperter tilknyttet medlemsstatemes administration og forsamlet i Lægemiddeludvalget 0) foreslog Kommissionen en ensartet ordning for parallelimport af medicinske specialiteter.
After consulting senior experts in public health matters from the Member States' administrations meeting in the Pharmaceutical Committee ('), the Commission had proposed a uniform system for parallel imports of proprietary medicinal products.
Kommissionen finder det trods tilbagetrækningen af sit forslag hensigtsmæssigt at påpege visse midler til overvågning af parallelimporten, der med forbehold af Domstolens praksis forekommer den berettigede med henblik pä beskyttelse af menneskers liv og sundhed i den i traktatens artikel 36 anførte betydning.
Despite the withdrawal of its proposal, the Commission considers it useful to indicate safe ways of monitoring parallel imports which, subject to the rulings of the Court, seem to it to be justified for the purpose of protecting the health and Ufe of humans pursuant to Article 36 of the Treaty.
Kommissionen henleder opmærksomheden pä, at de kompetente nationale myndigheder sundhedsmæssigt set allerede har to vigtige garantier i forbindelse med parallelimport af medicinske specialiteter.
The Commission points out that the competent authorities of the Member States already have at their disposal two important safeguards for health in the case of parallel imports of proprietary medicinal products.
For det første finder den nationale lovgivning vedrørende importørers, grossisters og i givet fald fremstilleres virksomhed med hensyn til medicinske specialiteter lige så vel anvendelse pä parallelimportører.
On the one hand, the national rules governing the activities of importers, wholesalers and, where applicable, manufacturers of proprietary medicinal products apply equally to parallel importers.
Denne lovgivning vedrører i almindelighed erhvervsmæssigt ansvar og erhvervsmæssige beføjelser, lokaler og påkrævet teknisk udstyr, regler for drift af sådanne virksomheder og tillige fremgangsmåder for opbevaring af dokumenter til brug for den kontrol og det tilsyn, der gennemføres fra officiel side.
These rules usually cover professional competence and responsibilities, the technical premises and equipment required and the rules for the operation of such establishments, in particular the procedures relating to the preservation of documents to facilitate official checks and inspections.
For det andet er de myndigheder, der udsteder markedsføringstilladelser for medicinske specialiteter, i princippet allerede i besiddelse af den dokumentation vedrørende kvaliteten, effektiviteten og uskadeligheden af lægemidlet i almindelighed som fabrikanten eller hans autoriserede importør har forelagt dem med angivelse i henhold til artikel 4, nr. 11, i direktiv 65/65/EØF af de tilladelser, der allerede er opnået for specialiteten i en anden medlemsstat.
On the other hand, the authorities competent to issue marketing authorizations for proprietary medicinal products already, as a rule, possess the dossier relating to the quality, efficacy and safety of the medicinal products in general, which has been supplied by the manufacturer or his approved importer and which states, in pursuance of Article 4(11) of Directive 65/65/EEC, the authorizations already obtained for the product in any other Member State.
I bekræftende fald er det kun, når det af de af fremstilleren meddelte oplysninger fremgår, at der findes forskelle af terapeutisk betydning, at det vil være berettiget at behandle varianterne som forskellige lægemidler med henblik på tilladelse til salg.
If this is so, it is only if the documents submitted by the manufacturer show that there are differences having a therapeutic effect that there would be any justification for treating the variants as different medicinal products for the purpose of marketing authorization.
Ud over disse garantier har myndighederne en berettiget interesse i til enhver tid at kunne fastslå med sikkerhed, om de importerede partier af medicinske specialiteter er i overensstemmelse med oplysningerne i dokumentationsmaterialet i1
In addition to these safeguards, the authorities have a legitimate interest in being able to verify, at all times and beyond doubt whether the batches of imported medicinal products are in conformity with the particulars contained in the dossier.
Kommissionen erkender, at parallelimportøren kan være forpligtet til at give importmedlemsstatens kompetente myndigheder visse oplysninger, som han har nem adgang til, når han for første gang ønsker at afsætte en medicinsk specialitet, som allerede afsættes af fremstilleren eller hans autoriserede repræsentant.
The Commission concedes that the parallel importer may be required to supply the competent authorities in the Member State into which the product is imported with certain information readily accessible to him when he wants to market for the first time a proprietary medicinal product already marketed by the manufacturer or his duly appointed representative.
Disse oplysninger skal gøre det muligt for importmedlemsatatens kompetente myndigheder inden for en rimelig frist at konstatere, om den parallelt importerede medicinske specialitet faktisk er dækket af den markedsføringstilladelse, der allerede er meddelt fremstilleren eller hans autoriserede repræsentant.
This information must allow the competent authorities in the Member State into which the product is imported to check, within a reasonable period, that the proprietary medicinal product that is the subject of parallel importation is effectively covered by the marketing authorization already granted to the manufacturer or his duly appointed representative.
Ifølge Kommissionen bør denne frist ikke overstige 45 dage, efter at parallelimportøren har meddelt de kompetente myndigheder følgende oplysningen a) den pågældende specialitets navn i importmedlemsstaten og i den medlemsstat, hvorfra den kommer; b) navn eller firma og bopæl eller hovedsæde for den for markedsføringen ansvarlige i importmedlemsstaten og i den medlemsstat, hvorfra specialiteten kommer, i givet fald for fremstilleren eller fremstillerne; c) navn eller finna og bopæl eller hovedsæde for parallelimportøren; φ markedsføringstilladelsens nummer i importmedlemsstaten og i den medlemsstat hvorfra specialiteten kommer; e) øvrige almindelige oplysninger, der er nyttige for afsætningen af specialiteten i importmedlemsstaten, dvs:
In the Commission's view, this period should not exceed 45 days from the time the parallel importer gives the following information to the competent authorities: a) name of the proprietary medicinal product in the Member State into which it is imported and in the Member State from which it comes; b) name or corporate name and permanent address of the person responsible for placing the product on the market in the Member State into which it is imported and in the Member State from which it comes, and where appropriate, of the manufacturers); name or corporate name and permanent address of the parallel importer, c) d) numbers of the marketing authorizations in the Member State into which the product is imported and in the Member State from which it comes; e) any other general information useful for the marketing of the proprietary medicinal product in the Member State into which it is imported, i.e.
­ kvalitativ og kvantitativ sammensætning af virksomme stoffer pr. dosisenhed eller i procent,ved anvendelse af de af Verdenssundhedsorganisationen anbefalede internationale fællesbetegnelser, nar sådume findes,
- qualitative and quantitative composition in terms of active principles, by dosage unit or in percentage, using the international nonproprietary names recommended by the World Health Organization where such names exist
­ i givet fidel særlige forholdsregler vedrørende opbevaring; f) en eller flere prøver eller modeller af den medicinske specialitet, således som den vil blive solgt i importmedlemsstaten, og i givet fald dilige pakningsbrochure.
- - - - pharmaceutical form and route of administration, therapeutic indications and normal dosage, contra-indications and main side-effects, storage precautions, if any; f) one or more specimens or mock-ups of the proprietary product in the form in which it will be marketed in the Member State into which it is imported, including the package leaflet if any.
For at myndighederne faktisk kan lå oplysning om afsætningen af hvert enkelt importeret vareparti bør parallelimportøren efter Kommissionens opfattelse ved hver importtransaktion registrere oprindelse, mængde og partiets nummer for de importerede lægemidler, säledes at han kan stille disse oplysninger til rådighed for de kompetente myndigheder.
To enable the authorities to be effectively informed of the marketing of each batch of the product imported, the parallel importer should, in the Commission's view, register the origin, quantity and batch numbers of the imported medicinal products whenever he imports them, and hold this information at the disposal of the competent authorities.
Kommissionen henleder opmærksomheden på, at i medfør af kapitel IV i direktiv 75/319/EØF kontrolleres hvert specialitetparti, der fremstilles i en medlemsstat, af fremstilleren, som udarbejder en attest og registrerer de udførte processer i dokumenter, som stilles til rådighed for de kompetente myndigheders repræsentanter i en periode på mindst fem år.
The Commission points out that pursuant to Chapter IV of Directive 75/319/EEC each batch of proprietary medicinal products manufactured in a Member State is checked by the manufacturer who makes out a certificate and registers the operations carried out in documents that remain at the disposal of the agents of the competent authority for at least five years.
På grundlag af disse kontroljournaler, som fremstilleren tilsender den autoriserede importør, er den autoriserede importør fritaget for at gentage kontrollen i importmedlemsstaten.
Because these control reports are sent to him by the manufacturer, the duly appointed importer is exempt from repeating the controls in the Member State into which the product is imported.
Eftersom parallelimporløren ikke h;ir adgang til disse kontroljournaler, bør de nationale administrationer, når de ønsker at undersøge den af' fremstilleren udførte kontrol for et bestemt parti, føre en mere aktiv politik.
Since the parallel importer does not have access to these control reports, the national authorities have to adopt a more active policy when they wish to verify the controls carried out by the manufacturer on a given batch.
- at opnå journalerne over fremstillingskontrollen ved at træffe lovgivningsmæssige eller administrative foranstaltninger, der kan tvinge fremstilleren selv eller hans autoriserede repræsentant til at forelægge dem;
They can choose for this purpose one of the four approaches given in the De Peijper judgment, i.e.: they can obtain the manufacturing control reports by taking legislative or administrative measures compelling the manufacturer himself, or his duly appointed representative, to supply them; they can obtain these reports through the authorities in the country of manufacture; they can, whenever possible, lay down a presumption of conformity with the specifications of the medicament and it would be up to them, in appropriate cases, to rebut this presumption after verification of the conformity; as far as this presumption is fully impracticable, they can allow the parallel importer to provide proof of conformity by any means other than by documents to which he has no access.
Parallelimportøren er naturligvis i lighed med den for markedsføringen ansvarlige underlagt de foranstaltninger med hensyn til tilbagekaldelse, suspendering af tilladelse og forbud mod udlevering, som medlemsstaterne træffer i medfør af artikel 28 i direktiv 75/319/EØF.
The parallel importer is liable, in the same way as the person responsible for marketing, to the measures taken by the Member States to withdraw the product, to suspend or revoke the authorization or to prohibit supply of the product pursuant to Article 28 of Directive 75/319/EEC.
Et passende samarbejde mellem medlemsstaternes myndigheder ville give mulighed for om nødvendigt at supplere de med traktatens artikel 36 forenelige kontrolforanstaltninger med henblik pä at undersøge overensstemmelsen af parallelt importerede lægemidler.
By appropriate cooperation between the Member State authorities, it would be possible to supplement, if necessary, the monitoring measures compatible with Article 36 of the Treaty, designed to check the conformity of medicinal products imported in parallel.
I De Peijper-dommen udtalte Domstolen i den forbindelse, at et simpelt samarbejde mellem medlemsstaternes myndigheder ville sætte disse i st'md til for visse mere eller mindre standardiserede varer med stor udbredelse at skaffe de for en undersøgelse nødvendige oplysninger hos hinanden.
In the De Peijper judgment, the Court held that simple cooperation between the authorities of the Member States would enable them to obtain on a reciprocal basis the documents necessary for checking certain largely standardized and widely distributed products.
Ud over de forpligtelser, der følger af EØF-traktatens artikel 5, er forpligtelsen for de kompetente myndigheder til at udveksle passende oplysninger med henblik på at sikre, at betingelserne for udstedelse af fremstillings- eller markedsføringstilladelser overholdes, udtrykkeligt nævnt i artikel 30 i direktiv 75/319/EØF.
In addition to the obligations resulting from Article 5 of the EEC Treaty, the obligation for the competent authorities to communicate to each other such information as Is appropriate to guarantee that the requirements for the marketing or manufacturing authorizations are fulfilled is specifically spelled out in Article 30 of Directive 75/319/EEC.