natgillin/translations-raw huggingface dataset:
I forbindelse med dette kapitel omfatter god fremstillingspraksis det system, hvorved fremstilleren modtager specifikationen for varen og processen fra indehaveren af eller ansøgeren om markedsføringstilladelsen.
for the purpose of the obligations in Articles 6(3) and 8(8) of Directive 2014/31/EU, respectively Articles 8(3) and 10(8) of Directive 2014/32/EU and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keep the technical documentation and the EU declaration of conformity or, where applicable, the attestation of conformity for 10 years after the instrument has been placed on the market in either the European Union or Switzerland.
Det skal samtidig sikre, at lægemidlet er fremstillet i overensstemmelse med denne specifikation.
In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient that the importer established within the territory of either the European Union or Switzerland keep a copy of the EU declaration of conformity or, where applicable, the attestation of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request for 10 years after the instrument has been placed on the market in either the European Union or Switzerland;
For så vidt angår lægemidler, som er omfattet af den ene parts lovgivning, men ikke af den anden parts lovgivning, kan fremstillingsvirksomheden i forbindelse med denne aftale anmode om, at den lokalt kompetente inspektionstjeneste foretager en inspektion.
for the purpose of the obligations in Articles 6(4), second subparagraph, and 8(6) of Directive 2014/31/EU, respectively Articles 8(4), second subparagraph, and 10(6) of Directive 2014/32/EU and the corresponding Swiss provisions, it shall be sufficient that such obligations be fulfilled by the manufacturer established within the territory of either the European Union or Switzerland, or, in case the manufacturer is not established within the territory of either the European Union or Switzerland, by the importer established within the territory of either the European Union or Switzerland.
Denne bestemmelse finder bl.a. anvendelse på fremstillingen af aktive lægemiddelbestanddele og mellemprodukter og produkter bestemt til anvendelse i kliniske forsøg samt på inspektioner forud for en markedsføring.
For the purpose of the obligation in Article 7(2) of Directive 2014/31/EU, respectively Article 9(2) of Directive 2014/32/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 7(1) of Directive 2014/31/EU, respectively Article 9(1) of Directive 2014/32/EU or the corresponding Swiss provisions.
Nærmere oplysninger om operationelle arrangementer fremgår af afsnit III, stk. 3.
The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of instrument with the legislation in Section I.
Certificering af fabrikanter
It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the instrument.
Efter anmodning fra en eksportør, importør eller den kompetente myndighed i den anden part certificerer de myndigheder, som er ansvarlige for at udstede fremstillingstilladelser og for at føre tilsyn med fremstillingen af lægemidler, at fremstilleren:
Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 34 of Directive 2014/31/EU and Article 39 of Directive 2014/32/EU.
er behørigt autoriseret til at fremstille det relevante lægemiddel eller til at gennemføre den relevante specificerede fremstillingsproces
Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 35 of Directive 2014/31/EU, respectively Article 40 of Directive 2014/32/EU, directly or by means of designated representatives.
regelmæssigt inspiceres af myndighederne, og
Procedure for dealing with instruments presenting a risk caused by non-compliance not restricted to the national territory
overholder de nationale krav til god fremstillingspraksis, som anerkendes som ækvivalente af de to parter, og som er anført i afsnit I i dette kapitel.
Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that an instrument covered by this chapter presents a risk to aspects of public interest protection covered by Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:
Anvendes der forskellige krav til god fremstillingspraksis som reference, skal dette angives i certifikatet.
where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the instrument's being made available on their national market, to withdraw the instrument from that market or to recall it.
Hvad angår inspektioner i tredjelande, certificerer de myndigheder, der er ansvarlige for inspektionen, på anmodning af en eksportør, en importør eller den anden parts kompetente myndighed, hvorvidt fabrikanten er i overensstemmelse eller ikke er i overensstemmelse med de krav til god fremstillingspraksis, der anerkendes som ækvivalente af de to parter, og som er anført i afsnit I i dette kapitel.
This information shall include all available details, in particular the data necessary for the identification of the non-compliant instrument, the origin of the instrument, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
Certifikaterne skal endvidere angive fremstillingssted(er) (og eventuelle kontraktlaboratorier til udførelse af kvalitetskontrol) samt inspektionsdatoen.
failure of the instrument to meet requirements relating to aspects of public interest protection laid down in Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions, or
Certifikaterne udstedes hurtigst muligt og inden 30 kalenderdage.
shortcomings in the harmonised standards referred to in Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions.
I særlige tilfælde, f.eks. hvis en ny inspektion skal foretages, kan denne periode forlænges til 90 dage.
Switzerland, or Member States shall without delay inform the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the instrument concerned.
Batchcertificering
Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the instrument concerned, such as withdrawal of an instrument from their market, without delay.
Hver eksporteret batch ledsages af et batchcertifikat udarbejdet af fremstilleren (selvcertificering) efter en fuldstændig kvalitativ analyse, en kvantitativ analyse af alle de aktive bestanddele og alle andre prøver eller kontroller, som er nødvendige for at sikre produktets kvalitet i overensstemmelse med markedsføringstilladelsens krav.
Should it disagree with the notified national measure, Switzerland or a Member State shall inform the European Commission of its objections within three months of the receipt of the information.
Dette certifikat skal bevidne, at batchen opfylder sine specifikationer, og skal opbevares af importøren af batchen.
Where, on completion of the procedure set out in paragraph 3.4, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State or where the Commission considers a national measure to be contrary to Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators.
Det skal foreligge til eftersyn efter anmodning fra den kompetente myndighed.
If the national measure relating to an instrument is considered:
Ved udstedelsen af et certifikat tager fremstilleren hensyn til bestemmelserne i den gældende WHO-certificeringsordning vedrørende kvaliteten af lægemidler, der cirkulerer i international handel.
justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant instrument is withdrawn from their markets, and shall inform the Commission accordingly,
Certifikatet skal detaljeret anføre produktets aftalte specifikationer, og det skal indeholde en henvisning til analysemetoderne og analyseresultaterne.
A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 3.8.
Det skal indeholde en erklæring om, at optegnelserne vedrørende forarbejdning og pakning af batchen er undersøgt og fundet i overensstemmelse med god fremstillingspraksis.
Compliant instruments which nevertheless present a risk to health and safety
Batchcertifikatet underskrives af den person, som er ansvarlig for at frigive batchen til salg eller levering, hvilket i Den Europæiske Union vil sige den »sagkyndige person«, der er omhandlet i artikel 48 i direktiv 2001/83/EF og artikel 52 i direktiv 2001/82/EF, og i Schweiz den »ansvarlige person«, der er omhandlet i artikel 5 og 10 i bekendtgørelsen om etableringslicenser.
Where a Member State or Switzerland finds that, although an instrument that an economic operator has been made available on the EU and on the Swiss market is in compliance with Directive 2014/31/EU or Directive 2014/32/EU, respectively the relevant Swiss legislation, presents a risk to aspects of public interest protection, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland.
Officiel frigivelse af batcher
That information shall include all available details, in particular the data necessary for the identification of the instrument concerned, the origin and the supply chain of the instrument, the nature of the risk involved and the nature and duration of the national measures taken.
Når en officiel batchfrigivelsesprocedure finder anvendelse, anerkendes officielle batchfrigivelser, som er foretaget af en myndighed i den eksporterende part (anført i afsnit II), af den anden part.
In case of a disagreement between the Parties on measures at stake in subparagraphs 3.6 and 3.7 above, the issue will be forwarded to the Committee, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.
Fremstilleren skal forevise det officielle batchfrigivelsescertifikat.
justified, the Parties shall take the measures necessary to ensure that the instrument is withdrawn from their market;
For så vidt angår Den Europæiske Union, er den officielle procedure for frigivelse af batcher angivet i dokument »Control Authority Batch Release of Vaccination and Blood Products, 2001« eller efterfølgende udgaver samt i forskellige særlige procedurer for frigivelse af batcher.
ATTACHMENT G
For så vidt angår Schweiz, er den officielle procedure for frigivelse af batcher angivet i artikel 17 i forbundsloven om lægemidler og medicinsk udstyr og i artikel 18-21 i bekendtgørelsen fra det schweiziske agentur for terapeutiske produkter om kravene vedrørende markedsføringstilladelse for lægemidler.
In Annex 1, Product Sectors, Chapter 15, Medicinal products, GMP Inspection and Batch Certification should be deleted and replaced by the following:
Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 af 31. marts 2004 om fastlæggelse af fællesskabsprocedurer for godkendelse og overvågning af human- og veterinærmedicinske lægemidler og om oprettelse af et europæisk lægemiddelagentur (EUT L 136 af 30.4.2004, s. 1), senest ændret ved Europa-Parlamentets og Rådets forordning (EU) nr. 1027/2012 af 25. oktober 2012 om ændring af forordning (EF) nr. 726/2004 for så vidt angår lægemiddelovervågning (EUT L 316 af 14.11.2012, s. 38)
‘CHAPTER 15
Europa-Parlamentets og Rådets direktiv 2001/83/EF af 6. november 2001 om oprettelse af en fællesskabskodeks for humanmedicinske lægemidler (EFT L 311 af 28.11.2001, s. 67), senest ændret ved Europa-Parlamentets og Rådets direktiv 2012/26/EU af 25. oktober 2012 om ændring af direktiv 2001/83/EF for så vidt angår lægemiddelovervågning (EUT L 299 af 27.10.2012, s. 1)
MEDICINAL PRODUCTS, GMP INSPECTION AND BATCH CERTIFICATION
Europa-Parlamentets og Rådets direktiv 2002/98/EF af 27. januar 2003 om fastsættelse af standarder for kvaliteten og sikkerheden ved tapning, testning, behandling, opbevaring og distribution af humant blod og blodkomponenter og om ændring af direktiv 2001/83/EF (EUT L 33 af 8.2.2003, s. 30)
Scope and coverage
Europa-Parlamentets og Rådets direktiv 2001/82/EF af 6. november 2001 om oprettelse af en fællesskabskodeks for veterinærlægemidler (EFT L 311 af 28.11.2001, s. 1), senest ændret ved Europa-Parlamentets og Rådets direktiv 2009/53/EF af 18. juni 2009 om ændring af direktiv 2001/82/EF og direktiv 2001/83/EF, for så vidt angår ændringer af betingelserne i markedsføringstilladelser for lægemidler (EUT L 168 af 30.6.2009, s. 33)
The provisions of this Sectoral Chapter cover all medicinal products which are industrially manufactured and to which Good Manufacturing Practice (GMP) requirements apply.
Kommissionens direktiv 2003/94/EF af 8. oktober 2003 om principper og retningslinjer for god fremstillingspraksis for humanmedicinske lægemidler og testpræparater til human brug (EUT L 262 af 14.10.2003, s. 22)
For medicinal products covered by this Chapter, each party shall recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party.
Kommissionens direktiv 91/412/EØF af 23. juli 1991 om principper og retningslinjer for god fremstillingspraksis for veterinærmedicinske præparater (EFT L 228 af 17.8.1991, s. 70) og Rådets direktiv 90/167/EØF af 26. marts 1990 om fastsættelse af betingelserne for tilberedning, markedsføring og anvendelse af foderlægemidler i Fællesskabet (EFT L 92 af 7.4.1990, s. 42)
This includes that each Party recognises conclusions of inspections of manufacturers in third countries carried out by the relevant inspection services of the other Party, inter alia, within the framework of the European Directorate for the Quality of Medicines & HealthCare (EDQM).
Vejledning i god distributionspraksis for humanmedicinske lægemidler (EUT C 343 af 23.11.2013, s. 1)
The Parties shall cooperate in order to achieve the best use of inspection resources by an appropriate burden sharing.
EudraLex bind 4 — Lægemidler til human og veterinær brug: EU's retningslinjer for god fremstillingspraksis (offentliggjort på Europa-Kommissionens websted)
The manufacturer's certification of the conformity of each batch to its specifications shall be recognised by the other Party without re-control at import.
Europa-Parlamentets og Rådets direktiv 2001/20/EF af 4. april 2001 om indbyrdes tilnærmelse af medlemsstaternes love og administrative bestemmelser om anvendelse af god klinisk praksis ved gennemførelse af kliniske forsøg med lægemidler til human brug (EFT L 121 af 1.5.2001, s. 34) og Europa-Parlamentets og Rådets forordning (EU) nr. 536/2014 af 16. april 2014 om kliniske forsøg med humanmedicinske lægemidler og om ophævelse af direktiv 2001/20/EF (EUT L 158 af 27.5.2014, s. 1)
To the products imported from a third country and further exported to the other Party this provision applies only (1) if each batch of the medicinal products has been subject to the re-control in the territory of one of the Parties; and (2) if the manufacturer in the third country has been subject to the inspection by the competent authority of either Party of which the outcome has been that for the products or products category the manufacturer complies with Good Manufacturing Practice.
Kommissionens direktiv 2005/28/EF af 8. april 2005 om principper og detaljerede retningslinjer for god klinisk praksis i forbindelse med testpræparater til human brug og om krav i forbindelse med tilladelse til fremstilling eller import af sådanne præparater (EUT L 91 af 9.4.2005, s. 13)
If the above conditions are not met, each Party can require a re-control in its territory.
Kommissionens delegerede forordning (EU) nr. 1252/2014 af 28. maj 2014 om supplerende regler til Europa-Parlamentets og Rådets direktiv 2001/83/EF for så vidt angår principper og retningslinjer for god fremstillingspraksis for virksomme stoffer til humanmedicinske lægemidler (EUT L 337 af 25.11.2014, s. 1).
In addition, official batch releases carried out by an authority of the exporting Party will be recognised by the other Party.
Forbundslov af 15. december 2000 om lægemidler og medicinsk udstyr (RO 2001 2790), senest ændret den 1. januar 2014 (RO 2013 4137)
“Medicinal products” means all products regulated by pharmaceutical legislation in the European Union and Switzerland as listed in Section I of this Chapter.
Bekendtgørelse af 17. oktober 2001 om etableringslicenser (RO 2001 3399), senest ændret den 1. maj 2016 (RO 2016 1171)
The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radio-pharmaceuticals, stable medicinal products derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feedingstuffs and, where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products.
Bekendtgørelse fra det schweiziske agentur for terapeutiske produkter af 9. november 2001 om kravene vedrørende markedsføringstilladelse for lægemidler (RO 2001 3437), senest ændret den 1. maj 2016 (RO 2016 1171)
“GMP” is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation and products specifications.
Bekendtgørelse af 20. september 2013 om kliniske forsøg inden for human forskning (RO 2013 3407), senest ændret den 1. maj 2017 (RO 2017 2439)
For the purpose of this Chapter it includes the system whereby the manufacturer receives the specification of the product and the process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification.
Ved »overensstemmelsesvurderingsorganer« forstås i forbindelse med dette kapitel hver parts officielle inspektionstjenester for god fremstillingspraksis.
With respect to medicinal products covered by the legislation of one Party but not the other, the manufacturing company can request, for the purpose of this Agreement, an inspection be made by the locally competent inspection service.
Listen over de officielle inspektionstjenester i medlemsstaterne i Den Europæiske Union og i Schweiz er anført nedenfor.
This provision shall apply i.a. to the manufacture of active pharmaceutical ingredients, intermediate products and investigational medicinal products, as well as to pre-marketing inspections.
For overensstemmelsesvurderingsorganer i Den Europæiske Union
Operational arrangements are detailed under Section III, paragraph 3.
Kompetente myndigheder i Den Europæiske Union er følgende myndigheder i Den Europæiske Unions medlemsstater eller myndigheder, der efterfølger dem:
Certification of manufacturers
Land
At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products shall certify that the manufacturer:
For humanmedicinske lægemidler
is appropriately authorised to manufacture the relevant medicinal product, or to carry out the relevant specified manufacturing operation,
For veterinærmedicinske lægemidler
is regularly inspected by the authorities,
Østrig
complies with the national GMP requirements recognised as equivalent by the two parties, and which are listed in Section I of this Chapter.
Den østrigske styrelse for sundhed og fødevaresikkerhed/Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Should different GMP requirements be used as reference, this is to be mentioned in the certificate.
Se myndigheden med ansvar for humanmedicinske lægemidler
For inspections in third countries, at the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for the inspection shall certify that the manufacturer complies or does not comply with the GMP requirements recognised as equivalent by the two Parties, and which are listed in Section I of this Chapter.
Belgien
The certificates shall also identify the site(s) of manufacture (and contract quality control laboratories, if any) and the date of the inspection.
Den føderale styrelse for lægemidler og sundhedsprodukter/Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/Agence fédérale des médicaments et produits de santé
Certificates shall be issued expeditiously, and the time taken should not exceed 30 calendar days.
Bulgarien
In exceptional cases, i.e. when a new inspection has to be carried out, this period may be extended to 90 days.
Den bulgarske lægemiddelstyrelse/
Batch certification
Den bulgarske styrelse for fødevaresikkerhed/
Each batch exported shall be accompanied by a batch certificate established by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active ingredients and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation.
Sundhedsministeriet — Afdelingen for lægemidler/
It will be made available upon request of the competent authority.
Ministeriet for landbrug, udvikling af landdistrikter og miljø-veterinærafdelingen/
When issuing a certificate, the manufacturer shall take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce.
Tjekkiet
The certificate shall detail the agreed specifications of the product, the reference of the analytical methods and the analytical results.
Statens institut for kontrol med lægemidler/
It shall contain a statement that the batch processing and packaging records were reviewed and found in conformity with GM P. The batch certificate shall be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Union the “qualified person” referred to in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC, and in Switzerland the “responsible person” referred to in Articles 5 and 10 of the Ordinance on establishment licences.
Instituttet for statens kontrol med biologiske veterinærlægemidler og andre lægemidler/
Official Batch Release
Kroatien
When an official batch release procedure applies, official batch releases carried out by an authority of the exporting Party (listed in Section II) will be recognised by the other Party.
Styrelsen for lægemidler og medicinsk udstyr/
The manufacturer shall provide the certificate of the official batch release.