natgillin/translations-raw huggingface dataset:
Desuden bør Kommissionen i tæt samarbejde med medlemsstaterne arbejde sammen med de kompetente myndigheder i tredjelande om effektivt at bekæmpe handel med forfalskede lægemidler på globalt plan.
In addition, the Commission, working closely with Member States, should cooperate with the competent authorities of third countries with a view to effectively combating the trade in falsified medicinal products at a global level.
Dette direktiv berører ikke bestemmelser om intellektuel ejendomsret.
This Directive is without prejudice to provisions concerning intellectual property rights.
Det sigter specifikt på at forhindre forfalskede lægemidler i at komme ind i den lovlige forsyningskæde.
It aims specifically to prevent falsified medicinal products from entering the legal supply chain.
Kommissionen bør i overensstemmelse med artikel 290 i TEUF tillægges beføjelser til at vedtage delegerede retsakter for at supplere bestemmelserne i direktiv 2001/83/EF, som ændret ved dette direktiv, vedrørende god fremstillings- og distributionspraksis for virksomme stoffer, vedrørende detaljerede regler for lægemidler, der føres ind i Unionen uden at blive importeret, og vedrørende sikkerhedsforanstaltninger.
The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to supplement the provisions of Directive 2001/83/EC, as amended by this Directive, concerning good manufacturing and distribution practices for active substances, concerning detailed rules for medicinal products introduced into the Union without being imported and concerning safety features.
For at sikre ensartede betingelser for gennemførelse bør Kommissionen tillægges gennemførelsesbeføjelser til at vedtage foranstaltninger for vurderingen af den lovgivningsmæssige ramme, der finder anvendelse på fremstilling af virksomme stoffer, som eksporteres fra tredjelande til Unionen og med hensyn til et fælles logo, som identificerer websteder, der på lovlig vis tilbyder offentligheden lægemidler ved fjernsalg.
In order to ensure uniform conditions for implementation, implementing powers should be conferred on the Commission as regards the adoption of measures for the assessment of the regulatory framework applicable to the manufacturing of active substances exported from third countries to the Union and as regards a common logo that identifies websites which are legally offering medicinal products for sale at a distance to the public.
Disse beføjelser bør udøves i overensstemmelse med Europa-Parlamentets og Rådets forordning (EU) nr. 182/2011 af 16. februar 2011 om de generelle regler og principper for, hvordan medlemsstaterne skal kontrollere Kommissionens udøvelse af gennemførelsesbeføjelser [9].
Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers [9].
De sikkerhedsforanstaltninger for lægemidler, der indføres ved dette direktiv, kræver omfattende tilpasninger af fremstillingsprocesserne.
The safety features for medicinal products introduced under this Directive require substantial adaptations to manufacturing processes.
For at gøre det muligt for fremstillerne at foretage disse tilpasninger bør fristerne for anvendelsen af bestemmelserne om sikkerhedsforanstaltningerne være tilstrækkeligt lange og bør beregnes fra datoen for offentliggørelsen i Den Europæiske Unions Tidende af de delegerede retsakter, som fastsætter de nærmere regler vedrørende disse sikkerhedsforanstaltninger.
In order to enable manufacturers to make those adaptations, the time limits for the application of the provisions on the safety features should be sufficiently long and should be calculated as from the date of publication in the Official Journal of the European Union of the delegated acts setting out detailed rules in relation to those safety features.
Det bør også tages i betragtning, at nogle medlemsstater allerede har et nationalt system.
It should also be taken into account that some Member States already have a national system in place.
Disse medlemsstater bør bevilges en supplerende overgangsperiode for at kunne tilpasse sig til det harmoniserede EU-system.
Those Member States should be granted an additional transitional period for adapting to the harmonised Union system.
Målet for dette direktiv, nemlig at sikre, at det indre marked for lægemidler fungerer, samtidig med at der sikres et højt niveau for beskyttelse af folkesundheden mod forfalskede lægemidler, kan ikke i tilstrækkelig grad opfyldes af medlemsstaterne, og kan derfor på grund af foranstaltningens omfang bedre nås på EU-plan; Unionen kan derfor vedtage foranstaltninger i overensstemmelse med nærhedsprincippet, jf. artikel 5 i traktaten om Den Europæiske Union.
Since the objective of this Directive, namely to safeguard the functioning of the internal market for medicinal products, whilst ensuring a high level of protection of public health against falsified medicinal products, cannot be sufficiently achieved by the Member States, and can, by reason of the scale of the measure, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Det er vigtigt, at medlemsstaternes kompetente myndigheder, Kommissionen og agenturet samarbejder med det formål at sikre udveksling af oplysninger om de foranstaltninger, der træffes som led i bekæmpelsen af forfalskede lægemidler og om de gældende sanktionsordninger.
It is important that the competent authorities of the Member States, the Commission and the Agency cooperate to ensure the exchange of information on measures taken to combat the falsification of medicinal products and on the penalties systems that are in place.
Denne udveksling finder i øjeblikket sted i den arbejdsgruppe, der er sammensat af repræsentanter for de retshåndhævende myndigheder (Working Group of Enforcement Officers).
Currently, such exchange takes place through the Working Group of Enforcement Officers.
Medlemsstaterne bør sikre, at patient- og forbrugerorganisationer holdes orienteret om håndhævelsesaktiviteter i det omfang, det er foreneligt med de operationelle behov.
Member States should ensure that patients’ and consumers’ organisations are kept informed about enforcement activities to the extent that this is compatible with operational needs.
I overensstemmelse med punkt 34 i den interinstitutionelle aftale om bedre lovgivning [10] tilskyndes medlemsstaterne til, både i egen og Unionens interesse, at udarbejde og offentliggøre deres egne oversigter, der så vidt muligt viser overensstemmelsen mellem dette direktiv og gennemførelsesforanstaltningerne.
In accordance with point 34 of the Interinstitutional Agreement on better law-making [10], Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.
Direktiv 2001/83/EF blev for nylig ændret ved direktiv 2010/84/EU [11] for så vidt angår lægemiddelovervågning.
Directive 2001/83/EC was recently amended by Directive 2010/84/EU [11] as regards pharmacovigilance.
Ved sidstnævnte direktiv ændredes blandt andet artikel 111 for så vidt angår inspektionsbesøg og artikel 116 for så vidt angår suspension, tilbagekaldelse og ændring af markedsføringstilladelser under visse omstændigheder.
That Directive, inter alia, amended Article 111 with regard to inspections and Article 116 with regard to the suspension and revocation and variation of marketing authorisations under certain circumstances.
Desuden indsattes bestemmelser om delegerede retsakter i artikel 121a, 121b og 121c i direktiv 2001/83/EF.
Furthermore, it inserted provisions on delegated acts in Articles 121a, 121b and 121c of Directive 2001/83/EC.
Nærværende direktiv kræver, at disse artikler i direktiv 2001/83/EF yderligere ændres og suppleres.
This Directive requires some further and complementary changes to those Articles of Directive 2001/83/EC.
Virksomt stof:
Active substance:
ethvert stof eller enhver blanding af stoffer, der påtænkes anvendt i fremstillingen af et lægemiddel, og som ved at indgå i produktionen heraf bliver en aktiv bestanddel af det pågældende lægemiddel, der skal udøve en farmakologisk, immunologisk eller metabolisk virkning med henblik på at genoprette, ændre eller påvirke fysiologiske funktioner eller at stille en medicinsk diagnose.
Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis.
enhver bestanddel af et lægemiddel bortset fra det virksomme stof og emballeringsmaterialerne.«
Any constituent of a medicinal product other than the active substance and the packaging material.’;
Formidling af lægemidler:
Brokering of medicinal products:
enhver form for virksomhed i tilknytning til salg eller køb af lægemidler, undtagen engrosforhandling, der ikke indbefatter fysisk håndtering og som består i at forhandle uafhængigt og på vegne af en anden juridisk eller fysisk person.«
All activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person.’;
ethvert lægemiddel med en urigtig beskrivelse af:
Any medicinal product with a false representation of:
dets identitet, herunder dets emballage og etikettering, dets navn eller dets sammensætning, hvad angår enhver af bestanddelene, herunder hjælpestoffer, og styrken af disse bestanddele
its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;
dets oprindelse, herunder dets fremstiller, dets fremstillingsland, dets oprindelsesland eller indehaveren af markedsføringstilladelsen herfor, eller
its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or
dets historie, herunder optegnelser og dokumenter vedrørende de anvendte distributionskanaler.
its history, including the records and documents relating to the distribution channels used.
Denne definition omfatter ikke utilsigtede kvalitetsmangler og berører ikke krænkelser af intellektuelle ejendomsrettigheder.«
This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights.’;
Artikel 2, stk. 3, erstattes af følgende:
in Article 2, paragraph 3 is replaced by the following:
Uanset denne artikels stk. 1 og artikel 3, nr. 4, finder afsnit IV i dette direktiv anvendelse på fremstilling af lægemidler, der alene er bestemt til eksport, og på mellemprodukter, virksomme stoffer og hjælpestoffer.
Notwithstanding paragraph 1 of this Article and Article 3(4), Title IV of this Directive shall apply to the manufacture of medicinal products intended only for export and to intermediate products, active substances and excipients.
Stk. 1 berører ikke artikel 52b og 85a.«
Paragraph 1 shall be without prejudice to Articles 52b and 85a.’;
I artikel 8, stk. 3, indsættes følgende litra:
in Article 8(3), the following point is inserted:
En skriftlig bekræftelse på, at fremstilleren af lægemidlet ved at gennemføre audits, jf. artikel 46, litra f), har kontrolleret, at fremstilleren af det virksomme stof har overholdt principperne og retningslinjerne for god fremstillingspraksis.
A written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practice by conducting audits, in accordance with point (f) of Article 46.
Den skriftlige bekræftelse skal indeholde en henvisning til datoen for auditten og en erklæring om, at resultatet af auditten bekræfter, at fremstillingen overholder principperne og retningslinjerne for god fremstillingspraksis.«
The written confirmation shall contain a reference to the date of the audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.’;
Artikel 40, stk. 4, affattes således:
in Article 40, paragraph 4 is replaced by the following:
Medlemsstaterne indfører oplysningerne vedrørende den i denne artikels stk. 1 omhandlede tilladelse i den EU-database, der er omhandlet i artikel 111, stk. 6.«
Member States shall enter the information relating to the authorisation referred to in paragraph 1 of this Article in the Union database referred to in Article 111(6).’;
Artikel 46, litra f), erstattes af følgende:
in Article 46, point (f) is replaced by the following:
at overholde principperne og retningslinjerne for god fremstillingspraksis for lægemidler og udelukkende at anvende virksomme stoffer, der er fremstillet i overensstemmelse med god fremstillingspraksis for virksomme stoffer og distribueret i overensstemmelse med god distributionspraksis for virksomme stoffer.
to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use only active substances, which have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practices for active substances.
Indehaveren af fremstillingstilladelsen kontrollerer i denne forbindelse, at fremstilleren og distributørerne af virksomme stoffer overholder god fremstillingspraksis og god distributionspraksis, ved at gennemføre audits på fremstilleren og distributørerne af de virksomme stoffers fremstillings- og distributionssteder.
To this end, the holder of the manufacturing authorisation shall verify compliance by the manufacturer and distributors of active substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites of the manufacturer and distributors of active substances.
Indehaveren af fremstillingstilladelsen kontrollerer enten denne overholdelse selv eller, uden at det berører den pågældendes ansvar som fastsat i dette direktiv, gennem en enhed, som den pågældende har indgået aftale med.
The holder of the manufacturing authorisation shall verify such compliance either by himself or, without prejudice to his responsibility as provided for in this Directive, through an entity acting on his behalf under a contract.
Indehaveren af fremstillingstilladelsen sikrer, at hjælpestofferne er egnede til brug i lægemidler, ved at fastlægge, hvad der er passende god fremstillingspraksis.
The holder of the manufacturing authorisation shall ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice is.
Dette fastlægges på grundlag af en formaliseret risikovurdering i overensstemmelse med de retningslinjer, der finder anvendelse, jf. artikel 47, stk. 5.
This shall be ascertained on the basis of a formalised risk assessment in accordance with the applicable guidelines referred to in the fifth paragraph of Article 47.
Denne risikovurdering sker under hensyntagen til kravene ifølge andre passende kvalitetssystemer samt hjælpestoffernes oprindelse og deres tilsigtede anvendelse samt tidligere tilfælde af kvalitetsdefekter.
Such risk assessment shall take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects.
Indehaveren af fremstillingstilladelsen sikrer, at den således fastlagte passende gode fremstillingspraksis anvendes.
The holder of the manufacturing authorisation shall ensure that the appropriate good manufacturing practice so ascertained, is applied.
Indehaveren af fremstillingstilladelsen dokumenterer de foranstaltninger, der er truffet i henhold til dette stykke
The holder of the manufacturing authorisation shall document the measures taken under this paragraph;
straks at underrette den kompetente myndighed og indehaveren af markedsføringstilladelsen, hvis han får kendskab til, at lægemidler, der er omfattet af hans fremstillingstilladelse, er eller mistænkes for at være forfalskede, uanset om disse lægemidler blev distribueret i den lovlige forsyningskæde eller med ulovlige midler, herunder ulovligt salg gennem tjenester i informationssamfundet
to inform the competent authority and the marketing authorisation holder immediately if he obtains information that medicinal products which come under the scope of his manufacturing authorisation are, or are suspected of being, falsified irrespective of whether those medicinal products were distributed within the legal supply chain or by illegal means, including illegal sale by means of information society services;
at kontrollere, at fremstillere, importører eller distributører, fra hvilke han aftager virksomme stoffer, er registreret hos den kompetente myndighed i den medlemsstat, hvor de er etableret
to verify that the manufacturers, importers or distributors from whom he obtains active substances are registered with the competent authority of the Member State in which they are established;
at kontrollere de virksomme stoffers og hjælpestoffernes ægthed og kvalitet.«
to verify the authenticity and quality of the active substances and the excipients.’;
»Artikel 46b
‘Article 46b
Medlemsstaterne træffer passende foranstaltninger til at sikre, at fremstilling, import og distribution på deres område af virksomme stoffer, herunder virksomme stoffer bestemt til eksport, overholder god fremstillingspraksis og god distributionspraksis for virksomme stoffer.
Member States shall take appropriate measures to ensure that the manufacture, import and distribution on their territory of active substances, including active substances that are intended for export, comply with good manufacturing practice and good distribution practices for active substances.
Virksomme stoffer må kun importeres, hvis følgende betingelser er opfyldt:
Active substances shall only be imported if the following conditions are fulfilled:
de virksomme stoffer er fremstillet i overensstemmelse med standarder for god fremstillingspraksis, der mindst svarer til de af Unionen fastsatte standarder, jf. artikel 47, stk. 3, og
the active substances have been manufactured in accordance with standards of good manufacturing practice at least equivalent to those laid down by the Union pursuant to the third paragraph of Article 47; and
de virksomme stoffer ledsages af en skriftlig bekræftelse fra den kompetente myndighed i det eksporterende tredjeland på følgende:
the active substances are accompanied by a written confirmation from the competent authority of the exporting third country of the following:
at de standarder for god fremstillingspraksis, der finder anvendelse på den fabrik, hvor det eksporterede virksomme stof er fremstillet, mindst svarer til de af Unionen fastsatte standarder, jf. artikel 47, stk. 3
the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Union pursuant to the third paragraph of Article 47;
at den fabrik, der har stået for fremstillingen, er underkastet regelmæssig, streng og gennemsigtig kontrol og effektiv håndhævelse af god fremstillingspraksis, herunder gentagne og uanmeldte inspektionsbesøg, med henblik på at sikre et beskyttelsesniveau for folkesundheden, som mindst svarer til det i Unionen gældende, og
the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the Union; and
at det eksporterende tredjeland i tilfælde af konstateringer vedrørende manglende overholdelse straks fremsender oplysninger om sådanne konstateringer til Unionen.
in the event of findings relating to non-compliance, information on such findings is supplied by the exporting third country to the Union without any delay.
Denne skriftlige bekræftelse berører ikke forpligtelserne i artikel 8 og i artikel 46, litra f).
This written confirmation shall be without prejudice to the obligations set out in Article 8 and in point (f) of Article 46.
Kravet i denne artikels stk. 2, litra b), finder ikke anvendelse, hvis eksportlandet er opført på den i artikel 111b omhandlede liste.
The requirement set out in point (b) of paragraph 2 of this Article shall not apply if the exporting country is included in the list referred to in Article 111b.
Kravet i denne artikels stk. 2, litra b), kan undtagelsesvist, og hvor det er nødvendigt for at sikre tilgængeligheden af lægemidler, fraviges af enhver medlemsstat for en periode, der ikke overstiger gyldigheden af attesten for god fremstillingspraksis, når det af en medlemsstat efter et inspektionsbesøg er konstateret, at en fabrik, der fremstiller et virksomt stof til eksport, overholder de i artikel 47, stk. 3, fastlagte principper og retningslinjer for god fremstillingspraksis.
Exceptionally and where necessary to ensure the availability of medicinal products, when a plant manufacturing an active substance for export has been inspected by a Member State and was found to comply with the principles and guidelines of good manufacturing practice laid down pursuant to the third paragraph of Article 47, the requirement set out in point (b) of paragraph 2 of this Article may be waived by any Member State for a period not exceeding the validity of the certificate of Good Manufacturing Practice.
Medlemsstater, der benytter sig af muligheden for en sådan fravigelse, giver Kommissionen meddelelse herom.«
Member States that make use of the possibility of such waiver, shall communicate this to the Commission.’;
Artikel 47, stk. 3 og 4, erstattes af følgende:
in Article 47, the third and fourth paragraphs are replaced by the following:
»Kommissionen vedtager ved hjælp af delegerede retsakter i overensstemmelse med artikel 121a og med forbehold af betingelserne i artikel 121b og 121c de i artikel 46, litra f), første afsnit, og artikel 46b omhandlede principper og retningslinjer for god fremstillingspraksis for virksomme stoffer.
‘The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, the principles and guidelines of good manufacturing practice for active substances referred to in the first paragraph of point (f) of Article 46 and in Article 46b.
De i artikel 46, litra f), første afsnit, omhandlede principper for god distributionspraksis for virksomme stoffer vedtages af Kommissionen i form af retningslinjer.
The principles of good distribution practices for active substances referred to in the first paragraph of point (f) of Article 46 shall be adopted by the Commission in the form of guidelines.
Kommissionen vedtager retningslinjer for den i artikel 46, litra f), andet afsnit, omhandlede formaliserede risikovurdering til fastlæggelse af, hvad der er passende god fremstillingspraksis for hjælpestoffer.«
The Commission shall adopt guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients referred to in the second paragraph of point (f) of Article 46.’;
»Artikel 47a
‘Article 47a
De i artikel 54, litra o), omhandlede sikkerhedsforanstaltninger må ikke fjernes eller tildækkes helt eller delvist, medmindre følgende betingelser er opfyldt:
The safety features referred to in point (o) of Article 54 shall not be removed or covered, either fully or partially, unless the following conditions are fulfilled: