natgillin/translations-raw huggingface dataset:
Det er det punkt, der drejer sig om fortolkningen af Forretningsordenen.
On the other hand essential aspects must be laid down both in the transitional period and in the subsequent development of the agency to avoid distortion in the sector.
I går eftermiddags læste formanden for Europa-Parlamentet et forslag fra Udvalget for Forretningsordenen om fortolkning af artikel 40, stk. 2 i overensstemmelse med artikel 131.
As regards the registration procedures proposed by the Commission, I have already said that I think the centralized procedure should be used very restrictively.
Jeg er ikke uenig i selve fortolkningen, men der er, efter min opfattelse, en meget alvorlig fejl i første afsnit.
In respect of the decentralized procedure, amendments have been proposed so as to make it the Community's ordinary procedure, a mixed system consisting of a cross between the present multi-state system and the concertation system.
Her står der følgende: »Formålet med bestemmelserne i artikel 40, stk. 2 er at drage alle konsekvenser af Domstolens retspraksis i »isoglukose«-sagen.
It has therefore been proposed that the decentralized procedure should have two inter related stages : the Community procedure — with effects limited to one Member State, which is what the Commission calls the 'national stage' and which I call the 'initial stage' — and the mutual recognition stage in which the evaluation and initial authorization is accepted in other Member States in accordance with the original evaluation carried out in the final stage.
Bestemmelserne vedrører hen visning til fornyet udvalgsbehandling i det i arti kel 40, stk. 1, omhandlede tilfælde, og de har«, — og det er disse ord, jeg angriber — »i perioden mellem afstemningen om Kommissionens forslag som hel hed og afstemningen om den lovgivningsmæssige beslutning forrang fremfor andre bestemmelser«.
This small change of concept does not change the Com mission's proposals, but I think it gives the proposals an institutional meaning and consistency and in this way we should have a single Community procedure operating on three levels.
Ford (S). — (EN) Hr. formand, jeg er enig med Sir Christopher Prout i hans fortolkning af forretningsordenen.
On the institutional aspect — and making it clear that I regard the setting up of the European Agency for the Evaluation of Medicinal Products as a positive step — I think that centralizing mechanisms must be reduced to the absolute minimum.
Men af hensyn til dem, som ikke helt forstod alt, hvad han sagde, kan jeg sige, at det, vi gerne vil, er at forsvare det menige medlems, og ikke kun udvalgsformandens eller ordførerens, ret til at anvende denne artikel, idet Udvalget for Forretningsordenens fortolkning ville udelukke alle andre end ordføreren og udvalgsformanden fra at anvende denne artikel under en afstemning.
As a counterbalance, improve ments must be made in the mutual recognition procedure, which in my view constitutes a cooperation procedure between the various Member States by which complementary and mutually supporting teams of national scientists may be kept alive and active.
Det andet spørgsmål, jeg gerne vil rejse, drejer sig også om anvendelsen af forretningsordenen, specielt, anvendelsen af artikel 56, stk. 3, skønt Udvalget for Forretningsordenens fortolkning umiddelbart kan synes svær at drage i tvivl.
As regards the amendments submitted, debated and approved in our Committee on the Environment, Public Health and Consumer Protection, I can tell the Assembly that all the political groups made a great effort to agree and that majority support was obtained for certain amendments which I shall mention.
Jeg glæder mig imidlertid over, at der er udnævnt en ordfører, og håber, der
For example there are references to the directives on genetically modified organisms, and other amendments
Jeg finder det derfor nødvendigt med en ændring af artiklen, men jeg accepterer Udvalget for Forretningsordenens for tolkning og støtter Sir Christopher Prout, hvad angår artikel 40, stk. 2.
VALVERDE LOPEZ spread of market pollution elements but has caused a lack of safety in the use of medicinal products, the monitoring of which has been made difficult for Member States.
Jeg bad Dem holde Dem til det punkt, vi drøfter, Jeg vil nu give ordet til hr. Wijsenbeek, som er næstformand i Udvalget for Forretningsordenen, så han kan fremlægge udvalgets synspunkter, og jeg vil ikke acceptere en generel debat.
We have some doubts on this : in principle it is perhaps possible to interpret this change as bringing more 'politicization' into the procedure, but the authors of these amendments see them as strengthening the powers of the agency.
Wijsenbeek (LDR). — (EN) Hr. formand, i denne sag taler jeg ikke kun i egenskab af næstformand i Udvalget for Forretningsordenen, men også som talsmand for dette udvalg.
The acceptance of our approach has finally meant the abandonment of the system of individual directives, so as at last to come to grips with a policy for the entire sector.
Sir Christopher har helt ret, når han påpeger forskellen mellem artikel 103 og artikel 40, stk. 2.
Today, in fact, we are talking about a first concrete step towards a future European health system.
Jeg mener dog ikke, at den ene udelukker den anden. En henvisning til fornyet udvalgsbehandling i henhold til artikel 40, stk. 2, er mere en specifik teknisk henvisning, medens arti kel 103 er en generel henvisning.
I think that this is the most important, most interesting political consideration, and with this in mind I intend now to assess the content of the directives that we are specifically examining.
Collins (S). — (EN) Hr. formand, vedrørende side 30 og 31 i gårsdagens protokol.
They must, then, be assessed as a whole and in the context of the positive work done by the Committee on the Environment.
De vil se, at der var nogen uenighed sent i aftes om fortolkningen af diverse artikler. Det, der blev drøftet, var Sir Leon Brittan's redegørelse om stålindustrien.
Here, in fact, more than simply as a rapporteur, I feel I can support the work of the entire Committee and say that the result, achieved also thanks to the amendments tabled by many political groups, deserves the support of this Chamber.
Vi forsøgte ihærdigt at få den redegørelse i aftes, fordi Sir Leon ikke vil være til stede det meste af resten af ugen. På side 31 vil De se, at jeg i henhold til artikel 105, stk. 1, foreslog en udsættelse af forhandlingen om hr. Verniers betænkning: Meningen hermed var ganske simpelt, at vi på denne måde kunne få tid til at behandle Sir Leons redegørelse.
Having said that, I should like to call the Commission's attention to the need to provide for a reasonable transitional period and also to give a warning about the need for new measures in the sector to secure true freedom of movement of medicinal products in our Community because, in spite of the importance and farreaching nature of the provisions we are debating today, I believe that they are still insufficient.
Som følge af dette forslag anmodede hr. Pimenta, med støtte fra over 13 medlemmer, om at få fastslået, om det fornødne antal medlemmer var til stede.
This call should be regarded as support for putting the finishing touches to the Community's 'legal statute for medicinal products' — which may serve as an example to the international community — and not as a criticism of the Commission, which I congratulate on this set of proposals.
Formanden foretog en optælling og konstaterede, at det fornødne antal medlemmer ikke var til stede, hvorfor han afviste at sætte mit forslag i henhold til artikel 105 bortfalde under afstemningen.
Seeing that a number of elements have constituted the logical thread of our discussion, I intend to draw the Commission's attention to them, particularly request ing Commissioner Bangemann to take account of them in his replies.
Hvis De ser på artikel 89 — og jeg beklager, hvis det kommer til at ligne en kappestrid med Sir Christopher Prout — vil De se, at det ikke er lovligt at fastslå om det fornødne antal medlemmer er til stede i forbindelse med indlæg til forretningsordenen, og mit forslag var et indlæg til forretningsordenen. Derfor handlede formanden for kert i aftes.
Just as our work has been complex, I hopethat the consideration and attention that the Commission gives to the amendments tabled will be equally exhaustive, and that it will not merely accept those that in substance do not change anything but will try to accept those that in fact represent the common intention of the Committee on the Environment, which it reached by way of debate and also conflict — sometimes bitter.
Da det forholder sig således, vil jeg gerne foreslå forsamlingen under henvisning til arti kel 105, stk. 1, at Sir Leon, da denne ikke kan være til stede resten af ugen, og da det er vigtigt for mange, at han giver sin redegørelse om stålindustrien, anmodes om at afgive sin redegørelse for Parlamentet, før han forlader Strasbourg, på et tidspunkt, som aftales nærmere mellem Præsidiet og Sir Leon. jeg vil foreslå kl. 15 i dag som et godt tidspunkt, hvis han har tid.
CECI (GUE), rapporteur. — (IT) I very much appreciated the statement made by Commissioner Ban gemann a few days ago at Cannes, to the effect that the future system of registration — which Mr Valverde has just been talking about — is the crucial point in the programme dsigned to set up a single system of distribution of medicinal products in the Community.
Vi har hørt et indlæg for hr. Prouts synspunkt og et imod, og jeg vil nu sætte spørgsmålet til afstemning i overensstemmelse med artikel 131, stk. 4, som fastslår, at, såfremt der er tvivl om udvalgets fortolkning, forelægges spørgsmålet for Parlamentet, der træffer afgørelse ved simpelt flertal.
We wanted also to emphasize the subjective aspect, not only that of the manufacturer but above all that of the consumer, because it is to him that these directives on the rational use of medicinal products are addressed, remembering at the same time that the consumer of medicinal products is himself different from the consumer of any other good : he is a sick subject and, as such, he needs treating with the maximum caution and protection that Article 100 A of the Treaty allows us to give him.
Vi går nu over til afstemning om anmodning fra hr. Prout om henvisning til fornyet behandling i Udvalget for Forretningsordenen.
We can discern in this some evidence of compliance with the invitation, made by Parliament, to speed up the complex work that has been going on now for over 35 years.
Formanden. — Hr. Collins, jeg har lyttet til Deres redegørelse med stor opmærksomhed, men mener ikke, at dette er et passende tidspunkt til at indlede drøftelser om fortolkningen af forretningsordenen.
The 'slowly, slowly' policy has in fact of course produced some results, but these results are today no longer sufficient.
De har også tidligere foreslået at ændre dagsordenen, skønt De ved, at De ikke har ret til dette, i hvert fald ifølge manges fortolkning.
After so long has elapsed we are still facing an extremely unharmonious market, with different national systems and above all degrees of regulation.
Hvad angår det spørgsmål, De nævner, kan jeg sige, at man allerede, også fra Præsidiets side, har gjort Kommissionen opmærksom på, at spørgsmålet må behandles og Sir Leon Brittan give redegørelse herom.
This is something that can only cause concern in those countries that feel themselves in a weaker position than for example Germany, Great Britain and France, which already have a solid system operating in the pharmaceutical field.
Jeg kan ikke sige hvornår, men den er gjort opmærksom på dette, og jeg ser nu, at hr. Bangemann har anmodet om ordet i denne forbindelse.
The 'slowly, slowly' policy has not only been unable to prevent the
(Parlamentet besluttede at henvise spørgsmålet til fornyet behandling i Udvalget for Forretningsorde nen)
Some parts of the individual directives deserve par ticular attention.
Bangemann, næstformand i Kommissionen. — (DE) Hr. formand, Sir Leon samt naturligvis hele Kom missionen, beklager meget, at det ikke var muligt at
The distributor is no longer therefore merely a wholesaler : as such he becomes in fact a link in
Der er dog den mulighed, at vores kollega Matutes giver denne redegørelse på fredag.
I consider, in fact, that under the specific responsibilities placed upon the Agency, this aspect must be further improved.
opmærksomt, lyder sidste afsnit af anmærkningerne fra Udvalget for Forretningsordenen, Valgs Prøvelse og Medlemmernes Immunitet således: »Stk. 3, sidste punktum, finder ikke anvendelse i forbindelse med afstemninger om indlæg til forretningsordenen, men kun i forbindelse med afstemninger om selve sagen.« Det er dette afsnit, som hr. Kenneth Collins klynger sig til for at gå i rette med formandens fremgangsmåde i går.
a chain that provides a service, and this aspect of service carried out for the Community is one of the most important elements of the alterations that the Commission has made to the directive on distribution.
Imidlertid ser vi, at artikel 89 vedrører afstemninger, og det fremgår helt klart af en nær mere fortolkning, at der er tale om afstemninger vedrørende betænkninger, når det anføres, at afstemningen opføres »på dagsordenen for det følgende møde.«
He has to ensure the availability of the product, at the time and place where that availability is needed, and Member States must superintend compliance with these con ditions.
Ewing (ARC). — (EN) Hr. formand, jeg vil gerne støtte hr. Collins.
We know that in the case of some alterations to the proposal for a directive — including some substantial ones — the Commission, as we have also been told in the debate, would undertake to make them operative at a later date.
Han har bedt om, at en artikel tages i brug, og De siger, at det ikke kan lade sig gøre. Der blev anmodet om det samme i aftes, hvor forretningsordenen blev anvendt forkert, som vi lige har hørt.
I consider — and the entire committee takes this view — that this delay is in fact useless.
Mener De, hr. formand, at det er Præsidiet, der er herre over dette Parlament, og ikke medlemmerne, som er til stede her og kan foretage en afstemning? Jeg mener ikke, vi kan tillade dette.
Moreover, the distributor's organisations themselves did not want to evade the obligations proposed in this way, and have supported our text.
Det giver ingen mening at opføre en afstemning vedrørende et indlæg til forretningsordenen på dags ordenen for det følgende møde og da især ikke en udsættelse eller ændring af arbejdets tilrettelæggelse.
Finally, I should like to add a few brief comments on the most innovative improvements that the Committee on the Environment has made to the proposal for an Agency.
Tværtimod fremgår det tydeligt af artikel 103, hvad forretningsordenen sigter til, når det siges: »Forslaget om henvisning til fornyet udvalgsbehandling sættes straks under afstemning (såfremt det efter en anmodning herom konstateres, at der ikke er et beslutningsdygtigt antal til stede, finder bestemmelserne i artikel 89, stk. 3, sidste punktum, ikke anvendelse, og Parlamentet fortsætter forhandlin gen)«. Det var dette, der skete.
The rapporteur will support the majority of these amendments, which are aimed not at removing those elements of caution that the Commission proposed in the directive, but at giving concrete support to the Commission itself.
At spise os af med en kommissær, der ikke har den nødvendige tekniske viden, er klart det samme som at sige, at det er en sag, der ikke vedkommer Parlamentet.
With regard to the procedure, it will be clear to everyone that the objective is single European registration, either in centralised form or on a multistatal basis.
Vi misbrugte den ikke, den blev brugt uretfærdigt imod os.
Support for innovation is what must be read into Parliament's amendments.
Dette er tidspunktet, hvor artikel 105, stk. 1 bør tages i brug, så vi kan vedtage en udsættelse af forhandlingen, indtil vedkommende kommissær kan være til stede.
It seems to me that they have not been sufficiently carefully read, if, as is the case, the European industry has recently expressed some doubts as to the total acceptance of the proposals that we are now making.
Der er regler, som vi alle bør respektere og over holde.
I think that there is already agreement on this.
McMahon (S). — (EN) Hr. formand, hvis De ser på artikel 74, stk. 2, er hr. Collins' forslag helt acceptabelt. Når dagsordenen en gang er vedtaget, bør den ikke ændres, med mindre artikel 75, 102, 105 og 106 tages i anvendelse, eller efter forslag fra formanden.
Careful reading of Parliament's amendments reveals, instead, that the intention is to qualify and make totally competitive an industry that is missing out and will continue to miss out unless the structural obstacles — compared with the system in industries outside Europe, particularly the United States and Japan — are removed.
Jeg vil gerne bede Dem gøre dette nu.
This is the European medicinal product.
Vi vil ikke have hr. Matutes.
Lastly, the package leaflet.
Vi vil ikke have bugtalerens dukke, vi ønsker, at bugtaleren selv skal udtale sig om dette stålspørgsmål.
This too is of a highly innovative character, because it constitutes a fundamental instrument for the direct information of the consumer.
Der er både tekniske og politiske årsager til, at Sir Leon Brittan bør stå til ansvar over for Parlamentet og de europæiske vælgere for denne beslutning.
In this case, we have specified that the clarity of the information already in the packaging must make it immediately clear what the correct use of the medicinal product is.
Jeg tror, det er vigtigt, for som hr. Collins sagde, er der over 1 000 arbejdspladser på spil i hans valgkreds, og jeg har 80-100 vælgere, der arbejder på Hunterston-stationen, hvis arbejde vil blive berørt af lukningen af Ravenscraig.
I call the Commission's attention to a series of amendments : Nos 28, 34, which says that a doctor must be consulted, in some cases, 39, 40, 42 — active pharmaco-monitoring, the need for information to be always referred to the patient, and finally No 45.
Så jeg har stor interesse i denne sag, og jeg vil derfor gerne have en rigtig, åben og ærlig meningsudveksling med den kommis sær, der har truffet denne skrækkelige beslutning.
On the basis of this consideration I call on the Commission to accept the new proposals of the Committee on the Environment on these two essential points : strong support for the Agency, as the seat of centrality, and above all support for the guarantees of the European medicinal product, with a directive that protects the health of the consumer, wherever that may be necessary.
Pimenta (LDR). — (PT) Hr. formand, jeg har al mulig sympati for spørgsmålet om stålindustrien i Skotland, og jeg er desuden en af underskriverne af hr. Kenneth Collins' forslag. Følgelig går jeg i mit indlæg slet ikke imod drøftelsen af det vigtige spørgsmål angående lukningen af British Steels fabrik i Skotland.
One of the points that, in my view, has not been completely resolved goes beyond the present directives and instead concerns advertising discipline where a clear distinction must be made between the manufacturer's right to carry out advertising of his own products, and the right to protect the correct use of the medicinal product, preserving the information.
Jeg ønsker, at dette står klart, hvad protokollen og det fuldstændige forhandlingsreferat angår.
I refer in particular to the scientific information about the product, which cannot be easily embodied in advertising terms.
Hvis vi læser forretningsordenens artikel 89
The committee has tabled an amendment that defines the scientific information about the
Vernier (RDE). — (FR) Hr. formand, kære kolleger, jeg vil bare ganske kort bekræfte hr. Pimentas
SCHLEICHER (PPE), rapporteur. — (DE) Mr Pre sident, ladies and gentlemen, the combination of
Vernier udtalelser: Forretningsordenen blev ikke overtrådt i går. Hr. Collins har ikke ret i, at der ikke kan anmodes om at få fastslået, om det fornødne antal medlemmer er til stede, når det drejer sig om indlæg til Forretningsordenen!
SCHLEICHER medicinal products and advertising arouses strong feelings, given the wealth of written material and the interest in both public health and advertising, and it is something that has provoked a similarly strong reaction in this House also.
Det eneste, der er om det, er, at der står, at når der er tale om indlæg til forretningsordenen, gælder en enkelt sætning i artikel 89 ikke, hvilket så vil sige, at resten af artikel 89 gælder, når der anmodes om at få fastslået, om det fornødne antal medlemmer er til stede.
preventive monitoring should then be required in the case of advertising claims also, is something I fail to understand, given that the advertising claims permitted are set down at the time of authorization.
Vi anmodede om at få fastslået, om det fornødne antal medlemmer var til stede; alle regler blev respekteret, også forretningsordenen. denen.
I fail to understand why so many are calling for additional monitoring which is, in my view, unnecessary and more likely to cause confusion.
Cornelissen (PPE). — (NL) Hr. formand, jeg hen ledte i går Deres opmærksomhed på de betydelige forsinkelser for flyet fra Bruxelles til Strasbourg mandag eftermiddag.
All twelve Member States of the European Community have legislation governing the advertising of medicinal products able to be sold without a prescription.
De sidste tre mødeperioder udgjorde denne forsinkelse henholdsvis to timer, tre timer og tre kvarter. I protokollen har jeg læst, at De ikke mener, at dette er Parlamentets anliggende, og at De overlader det til individuelle medlemmer eventuelt at rette henvendelse til Air France.
The agency referred to in the advertising directive does not yet exist.
Jeg har svært ved at acceptere denne undvigende reaktion.
As it is not, it simply cannot regulate matters.
Sådanne store forsinkelser gør det i stigende grad vanskeligt for os at fungere ordentligt.
Hitherto, there have not been any cases of obstacles to trade or distortion of competition as a result of the differing legislation.
Derfor vil jeg endnu en gang spørge, om De er villig til at kontakte Air France vedrørende dette anliggende, som er af væsentlig betydning for, at vi kan fungere ordentligt. ligt.
The issue is therefore not whether legislation covering the advertising of over-the-counter medicinal products is required but whether harmonization of national legislation at EC level is necessary.
Vi har en parlamentsformand, som er den, der udlægger forretningsordenen, og et Udvalg for For retningsordenen, og jeg må anmode om, at Præsidiet for fremtiden ikke tillader den slags diskussioner.
I am, however against the many warnings envisaged, as I consider it counterproductive that in the case of an over-the-counter product, which is to be advertised on the market, 20% of the advertising claims — and this is what the Committee is demanding — should actually warn against the product.
Formanden. — Hr. Cornelissen, jeg er enig med Dem i Deres anmodning, men på grund af den begrænsede tid, vi har på vore møder, vil jeg anbefale Dem at rejse spørgsmålet uden for plenarmøderne.
As we have just learnt from the reports of Mr Valverde Lopez and Mrs Ceci, we are in the process of harmonizing the international market in medicinal products, but advertising in fact comes right at the end, for this is a process that takes years.
De kan sagtens forelægge det for formanden eller andre uden at ulejlige plenarforsamlingen.
I assume that that was why the Commission did not consider it necessary, in 1985, to include this directive on advertising in its White Paper.
Gruppeformænd bør heller ikke længere tillades at holde forelæsninger om udlægningen af forretningsordenen.
This does not, however, accord with the text of the directive on advertising, and I am concerned that this is likely to cause confusion rather than increase clarity.
Jeg har naturligvis ingen indvendinger mod, hvad De her sagde.
They are to be subject to stricter monitoring in the future.
Det er noget, jeg vil give Dem helt ret i.
Here too, the Committee held differing views.
Landa Mendibe (NI). — (ES) Hr. formand, jeg vil også gerne tage ordet vedrørende protokollen.
The current majority on the Committee would like to put into effect very farreaching ideas.