natgillin/translations-raw huggingface dataset:
RHÔNE­POULENC RORER OG MAY & BAKER med hensyn til kontrollen af effektiviteten og uskadeligheden af det lægemiddel, som skal være genstand for en parallelimport. MCA kan ligeledes, i henhold til de gældende bestemmelser om lægemiddelovervågning, fremtidigt opnå de nød­vendige oplysninger for at sikre sig, at den tidligere zimovan ikke skaber problemer for den offentlige sundhed, og det kan MCA, lige så længe der består markedsføringstilladelser i de øvrige medlemsstater. 36
RHÔNE­POULENC RORER AND MAY & BAKER of monitoring the efficacy and safety of the medicinal product which is to be the subject of a parallel importation. It is also in a position, in the future, by virtue of the rules that exist in relation to pharmacovigilance, to acquire the information needed to be sure that the old version of Zimovane does not pose a problem for public health, so long as there are marketing authorisations in other Member States. 36
Det Forenede Kongeriges regering har endelig udtalt, at den almindelige interesse i beskyttelse af den offentlige sundhed, også selv om denne forstås som anført af M & Β og RPR, ikke kræver en foranstaltning som den fuldstændige blokering af parallelimport af den tidligere udgave af det pågældende produkt. 37
The United Kingdom Government observes, finally, that the general interest in safeguarding public health, even if it were understood in the sense relied upon by M & Β and RPR, does not require a measure such as a complete ban on parallel imports of the old version of the product. 37
Den svenske regering har anført, at der foreligger tilstrækkelig lighed mellem de to zimovan­præparater til, at de må anses for ét og samme produkt.
The Swedish Government submits that the two versions of Zimovane are sufficiently alike for them to be treated as the same product.
Ifølge regeringen vil der, såfremt kravet om, at der skal foreligge ens formel, forstås som en fuldstændig ens formel af lægemidlernes bestanddele, blive skabt ubegrundede hindringer for handelen inden for Fællesskabet.
If the obligation for the formulation to be identical were to be understood as meaning the whole formulation of the medicinal products, this would create unjustified obstacles to intra­Community trade.
Begrundelsen for at anfægte de britiske myndigheders afgørelser er således især, at afgørelserne kan være i strid med fællesskabsretten af følgende tre grunde:
It appears, therefore, that the criticism of the contested decisions of the United Kingdom authorities is based, in particular, on the fact that those decisions could be contrary to Community law for the following three reasons:
— De to zimovan­præparater er ikke fremstillet efter samme formel, idet den nye zimovan er fremstillet med andre hjælpestoffer og i en anden fremstil­lingsproces.
— the two versions of Zimovane are not manufactured according to the same formulation, the new version being manufactured using different excipients and by a different manufacturing process;
— Lægemiddelovervågningssystemet vil ikke fungere, idet den forpligtelse, som indehaveren af markedsføringstilladelsen har til regelmæssigt at indgive
— the pharmacovigilance system will not work because after the parent marketing authorisation is revoked the holder of the marketing authorisation
— Den særlige fordel for den offentlige sundhed, som den nye zimovan udgør i forhold til den tidligere, ikke kan opnås, såfremt de to præparater samtidig udbydes på det britiske marked.
— the particular benefit for public health which is provided by the new version of Zimovane as compared with the old version could not be achieved if the old and new versions of the medicinal product were both available on the United Kingdom market at the same time.
Inden der gås over til at behandle disse tre grunde, som er fremført for at anfægte de pågældende parallelimporttilladelser, må der lægges vægt på, at der ikke er grund til at afgøre lovligheden i forhold til de frie varebevægelser af en automatisk tilbagekaldelse af parallelimporttilladelser efter et afkald på den principale markedsføringstilladelse på indehaverens anmodning, idet dette spørgsmål ikke foreligger i sagen, da de britiske myndigheder har accepteret, at parallelimporttilladelserne for den tidligere zimovan vedlægges markedsførings tilladelsen for den nye variant.
Before examining each of those three grounds for criticising the parallel import licences at issue, it is important to note that it is not necessary to rule on the question of lawfulness in the light of the free movement of goods of the automatic revocation of parallel import licences as a result of the revocation of a parent authorisation at the request of the holder of that authorisation. That question does not arise in this case because the United Kingdom authorities have acknowledged that the parallel import licences for the old version of Zimovane are appended to the marketing authorisation issued for the new version.
Det må dernæst fremhæves, at selv om det, som Domstolen har fastslået i De Peijper samt Smith & Nephew og Primecrown-dommene, af traktatens artikel 30 og 36 følger, at de nationale myndigheder ikke må hindre parallelimport ved at kræve, at en parallelimportør skal overholde de samme krav, som gælder for virksomheder, der for første gang ansøger om markedsføringstilladelse for et lægemiddel, gælder dette dog kun, såfremt denne undtagelse fra de regler, der normalt gælder for markedsføringstilladelser for lægemidler, ikke indebærer en fare for beskyttelsen af den offentlige sundhed. Som det fremgår af første betragtning til direktivet skal alle bestemmelser angående fremstilling og distribution af farmaceutiske specialiteter have som hovedformål at beskytte I - 8832
Next, it should be noted that although, as the Court held in De Peijper and Smith & Nephew and Primecrown, it follows from Articles 30 and 36 of the Treaty that national authorities must not obstruct parallel imports by requiring parallel 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, that principle is subject to the condition 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. As is clear from the first recital in the preamble to the Directive, the primary purpose of any rules concerning the production and distribution of medicinal products must be to safeguard public health. The criteria which must be met by a product imported I - 8832
RHÔNE-POULENC RORER OG MAY & BAKER den offentlige sundhed. De kriterier, som et parallelt indført produkt skal opfylde, for at parallelimportøren ikke er forpligtet til at indgive de i direktivet angivne oplysninger må altså ikke føre til en opblødning af sikkerhedskravene (jf. herved Generics (UK) m.fl.-dommen, præmis 22). 41 Dernæst skal det understreges, at der ville bestå en reel hindring for handelen inden for Fællesskabet, såfremt importørerne af den tidligere zimovan, som stadig er tilladt i de øvrige medlemsstater, og som lovligt markedsføres dér, ikke kunne være omfattet af den forenklede procedure, der står til rådighed for parallelimportører i henhold til MAL 2 (PI).
RHÔNE-POULENC RORER AND MAY & BAKER as a parallel import for the parallel importer to be under no obligation to supply the particulars referred to in the Directive must not, therefore, lead to a relaxation of safety requirements (see, to that effect, Generics (UK), paragraph 22). 41 It must also be borne in mind that there would be a real obstacle to intraCommunity trade if importers of the old version of Zimovane, which is still authorised in other Member States and lawfully marketed there, were not able to use the simplified procedure open to parallel importers in accordance with MAL 2 (PI).
Selv om, som anført af Det Forenede Kongeriges regering, forskelle med hensyn til lægemidlernes hjælpestoffer normalt ikke påvirker deres sikkerhed, er det ubestridt, at dette kan forekomme.
Although, as the United Kingdom Government has submitted, differences in the excipients used in medicinal products do not normally have any effect on safety, it is not disputed that such effects can exist.
Det kan ikke udelukkes, at et parallelt importeret lægemiddel, der indeholder samme virksomme stoffer og har samme terapeutiske virkninger, men hvori der ikke er anvendt de samme hjælpestoffer som i det lægemiddel, der omfattes af importmedlemsstatens markedsførings tilladelse, kan frembyde væsentlige forskelle i forhold til sidstnævntes sikker hedsniveau, idet ændringer i lægemidlets formel med hensyn til dets hjælpestoffer
It is possible for a medicinal product imported as a parallel import, which contains the same active ingredients and has the same therapeutic effect but does not use the same excipients as the medicinal product which is the subject of the marketing authorisation in the Member State of importation, to show significant differences from the authorised product in terms of safety, given that modifications to the formulation of a medicinal product in respect of the excipients may have an effect on the shelf-life and the
Denne eventuelle påvirkning af sikkerheden betyder imidlertid ikke, at forskelle med hensyn til anvendte hjælpestoffer ganske afskærer de nationale myndigheder fra at anvende forenklede procedurer hvad angår tilladelser til parallelimportører.
However, the possibility of such effects on safety does not mean that as a consequence of differences relating to the excipients used the national authorities may never resort to simplified procedures for the licences granted to parallel importers.
De nationale myndigheder skal i henhold til reglerne om parallelimport give tilladelse til et parallelt importeret lægemiddel, når de er overbevist om, at midlet, trods forekomsten af forskelle i hjælpestofferne, ikke indebærer nogen fare for den offentlige sundhed.
The national authorities are required to authorise, in accordance with the rules relating to parallel imports, a medicinal product imported as a parallel product where they are convinced that that product, in spite of differences relating to the excipients, does not pose a problem for public health.
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 importerede 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 (jf. herved dom af 11.3.1999, sag C-100/96, British Agrochemicals Association, Sml. I, s. 1499, præmis 40).
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 (see, to that effect, Case C-100/96 British Agrochemicals Association [1999] ECR1-1499, paragraph 40).
Med hensyn til det rejste problem om lægemiddelovervågningen bemærkes blot, at en lægemiddelovervågning, der overholder kravene hertil i henhold til direktiv 75/319 som ændret, kan sikres for parallelt indførte lægemidler som dem i hovedsagen ved et samarbejde med de øvrige medlemsstaters nationale myndigheder i kraft af adgangen til dokumenter og til oplysninger, som producenten eller andre virksomheder i vedkommendes gruppe har indgivet for det tidligere præparat i de medlemsstater, hvori præparatet stadig afsættes på grundlag af en gyldig markedsføringstilladelse.
As regards the problem raised in relation to pharmacovigilance, it is sufficient that pharmacovigilance satisfying the relevant requirements of Directive 75/319 as amended can be ensured for medicinal products imported as parallel imports, like those in this case, 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.
Desuden kan indehaveren af markedsførings-
In addition, it is possible to compel the
Endelig skal der tages stilling til det af M & Β og RPR fremsatte argument, hvorefter den særlige fordel for den offentlige sundhed, som den nye zimovan frembyder i forhold til den tidligere, ikke kan nås, såfremt den tidligere zimovan fortsat blev solgt på det britiske marked. Hertil bemærkes kun, at selv om argumentet måtte anses for begrundet, indebærer dette ikke, at de nationale myndigheder under de i hovedsagen foreliggende omstændigheder nødvendigvis skal kræve af parallelimportører, at de overholder proceduren efter direktivet, når myndighederne skønner, at det parallelt indførte lægemiddel under normale anvendelsesbetingelser, således som det anføres i direktivets artikel 5, ikke udgør nogen risiko med hensyn til kvalitet, effektivitet og uskadelighed. 48
Finally, it is necessary to examine the argument put forward by M & Β and RPR that the particular benefit to public health provided by the new version of Zimovane as compared with the old version would not be achieved if the old version of Zimovane were present on the United Kingdom market. In that regard, it is sufficient to state that, even if the argument were well founded, it does not follow that, in circumstances such as those of the main case, the national authorities are compelled to require parallel importers to follow the procedure laid down in the Directive if they take the view that, in normal conditions of use, as referred to in Article 5 of the Directive, the medicinal product imported as a parallel import does not pose a risk as to quality, efficacy or safety. 48
På grundlag af det anførte må spørgsmålene besvares således, at en person, der ønsker at importere og markedsføre et lægemiddel X på medlemsstats B's marked fra medlemsstat A, kan ansøge og, uden at opfylde alle kravene i direktivet, opnå en tilladelse til parallelimport fra medlemsstat B's kompetente myndighed, såfremt
In the light of the foregoing, the answer to the questions referred for a preliminary ruling must be that where it is sought to import medicinal product χ 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 Β without complying with all the requirements of the Directive if:
— der for lægemidlet X er opnået en markedsføringstilladelse i medlemsstat A, og lægemidlet var omfattet af en markedsføringstilladelse, som ikke længere var gyldig i medlemsstat Β
— medicinal product X is the subject of a marketing authorisation granted in Member State A and was the subject of a marketing authorisation which has ceased to have effect in Member State B;
— lægemidlet X indeholder de samme virksomme stoffer og har samme terapeutiske virkninger som lægemidlet Y, men ikke indeholder samme hjælpestoffer og er fremstillet ved en anden fremstillingsproces, når den kompetente myndighed i medlemsstat Β dels kan kontrollere, at lægemidlet X overholder kravene om kvalitet, effektivitet og uskadelighed under normale anvendelsesbetingelser, og dels kan sikre en sædvanlig lægemiddelovervåg­ning
— medicinal product X has the same active ingredients and therapeutic effect as medicinal product Y, but does not use the same 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;
— 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 en markedsføringstilladelse 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.
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 samtidig afsættes på medlemsstat 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.
49 De udgifter, der er afholdt af Det Forenede Kongeriges regering, og af den franske og svenske regering samt af Kommissionen, som har afgivet indlæg for Domstolen, kan ikke erstattes.
49 The costs incurred by the United Kingdom, French and Swedish Governments and by the Commission, which have submitted observations to the Court, are not recoverable.
Da sagens behandling i forhold til hovedsagens
Since these proceedings are, for the parties to the main proceedings,
RHÔNE­POULENC RORER OG MAY & BAKER parter udgør et led i den sag, der verserer for den nationale ret, tilkommer det denne at træffe afgørelse om sagens omkostninger. På grundlag af disse præmisser kender
RHÔNE­POULENC RORER AND MAY & BAKER a step in the proceedings pending before the national court, the decision on costs is a matter for that court. On those grounds,
DOMSTOLEN vedrørende de spørgsmål, der er forelagt af High Court of Justice (England & Wales), Queen's Bench Division ved kendelse af 31. juli 1997, for ret: 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 Rådets direktiv 65/65/EØF 26. januar 1965 om tilnærmelse af lovgivning om farmaceutiske specialiteter, som ændret ved Rådets direktiv 93/39/EØF af 14. juni 1993, opnå en tilladelse til parallelimport fra medlemsstat B's kompetente myndighed, såfremt
THE COURT, in answer to the questions referred to it by the High Court of Justice of England & Wales, Queen's Bench Division, by order of 31 July 1997, hereby rules: 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 Β without complying with all the requirements of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ, English Special Edition 1965­1966, p. 20), as amended by Council Directive 93/39/EEC of 14 June 1993, if:
— lægemidlet X indeholder de samme virksomme stoffer og har samme terapeutiske virkninger som lægemidlet Y, men 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
— medicinal product X has the same active ingredients and therapeutic effect as medicinal product Y, but does not use the same 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;
— 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.
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
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
RHÔNE-POULENC RORER OG MAY & BAKER 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 samtidig afsættes på medlemsstat B's marked. Rodríguez Iglesias
RHÔNE­POULENC RORER AND MAY & BAKER 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 χ and product Y were both on the market in Member State Β at the same time. Rodríguez Iglesias
Sag C-101/98
Case C-101/98
(anmodning om præjudiciel afgørelse indgivet af Bundesgerichtshof)
(Reference for a preliminary ruling from the Bundesgerichtshof)
»Beskyttelse af benævnelserne for mælk og mejeriprodukter i forbindelse med afsætning — forordning (EØF) nr. 1898/87 — direktiv 89/398/EØF — anvendelse af benævnelsen 'ost' som betegnelse for et diætetisk produkt, hvori der anvendes plante- i stedet for mælkefedt«
(Protection of designations used in marketing of milk and milk products — Regulation (EEC) No 1898/87 — Directive 89/398/EEC — Use of the designation 'cheese' to describe a dietary product in which the natural fat has been replaced by vegetable fat)
Forslag til afgørelse fra generaladvokat A. Saggio fremsat den 10. juni 1999 Domstolens dom (Sjette Afdeling) af 16. december 1999
Opinion of Advocate General Saggio delivered on 10 June 1999 Judgment of the Court (Sixth Chamber), 16 December 1999
Artikel 3, stk. 1, i Rådets forordning nr. 1898/87 om beskyttelse af benævnelserne for mælk og mejeriprodukter i for bindelse med afsætning, sammenholdt med artikel 3, stk. 2, i Rådets direktiv 89/398/ EØF om indbyrdes tilnærmelse af med lemsstaternes lovgivning om levnedsmidler bestemt til særlig ernæring, skal fortolkes således, at et mejeriprodukt, hvori der af diætetiske grunde anvendes plante- i stedet for mælkefedt, ikke kan betegnes som en »ost«.
Article 3(1) of Regulation No 1898/87 on the protection of designations used in marketing of milk and milk products, read in conjunction with Article 3(2) of Directive 89/398 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, is to be interpreted as meaning that a milk product in which the milk fat has been replaced by vegetable fat for dietetic reasons may not be designated as 'cheese'.