natgillin/translations-raw huggingface dataset:
Certifikaterne udstedes hurtigst muligt og inden 30 kalenderdage.
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:
I særlige tilfælde, f.eks. hvis en ny inspektion skal foretages, kan denne periode forlænges til 90 dage.
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.
Batchcertificering
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.
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.
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
Dette certifikat skal bevidne, at batchen opfylder sine specifikationer, og skal opbevares af importøren af batchen.
shortcomings in the harmonised standards referred to in Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions.
Det skal foreligge til eftersyn efter anmodning fra den kompetente myndighed.
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.
Ved udstedelsen af et certifikat tager fremstilleren hensyn til bestemmelserne i den gældende WHO-certificeringsordning vedrørende kvaliteten af lægemidler, der cirkulerer i international handel.
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.
Certifikatet skal detaljeret anføre produktets aftalte specifikationer, og det skal indeholde en henvisning til analysemetoderne og analyseresultaterne.
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.
Det skal indeholde en erklæring om, at optegnelserne vedrørende forarbejdning og pakning af batchen er undersøgt og fundet i overensstemmelse med god fremstillingspraksis.
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.
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.
If the national measure relating to an instrument is considered:
Officiel frigivelse af batcher
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,
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.
A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 3.8.
Fremstilleren skal forevise det officielle batchfrigivelsescertifikat.
Compliant instruments which nevertheless present a risk to health and safety
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.
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.
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.
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.
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)
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.
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)
justified, the Parties shall take the measures necessary to ensure that the instrument is withdrawn from their market;
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)
ATTACHMENT G
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)
In Annex 1, Product Sectors, Chapter 15, Medicinal products, GMP Inspection and Batch Certification should be deleted and replaced by the following:
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)
‘CHAPTER 15
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)
MEDICINAL PRODUCTS, GMP INSPECTION AND BATCH CERTIFICATION
Vejledning i god distributionspraksis for humanmedicinske lægemidler (EUT C 343 af 23.11.2013, s. 1)
Scope and coverage
EudraLex bind 4 — Lægemidler til human og veterinær brug:
The provisions of this Sectoral Chapter cover all medicinal products which are industrially manufactured and to which Good Manufacturing Practice (GMP) requirements apply.
EU's retningslinjer for god fremstillingspraksis (offentliggjort på Europa-Kommissionens websted)
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.
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)
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).
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)
The Parties shall cooperate in order to achieve the best use of inspection resources by an appropriate burden sharing.
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).
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.
Forbundslov af 15. december 2000 om lægemidler og medicinsk udstyr (RO 2001 2790), senest ændret den 1. januar 2014 (RO 2013 4137)
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.
Bekendtgørelse af 17. oktober 2001 om etableringslicenser (RO 2001 3399), senest ændret den 1. maj 2016 (RO 2016 1171)
If the above conditions are not met, each Party can require a re-control in its territory.
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)
In addition, official batch releases carried out by an authority of the exporting Party will be recognised by the other Party.
Bekendtgørelse af 20. september 2013 om kliniske forsøg inden for human forskning (RO 2013 3407), senest ændret den 1. maj 2017 (RO 2017 2439)
“Medicinal products” means all products regulated by pharmaceutical legislation in the European Union and Switzerland as listed in Section I of this Chapter.
Ved »overensstemmelsesvurderingsorganer« forstås i forbindelse med dette kapitel hver parts officielle inspektionstjenester for god fremstillingspraksis.
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.
Listen over de officielle inspektionstjenester i medlemsstaterne i Den Europæiske Union og i Schweiz er anført nedenfor.
“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.
For overensstemmelsesvurderingsorganer i Den Europæiske Union
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.
Kompetente myndigheder i Den Europæiske Union er følgende myndigheder i Den Europæiske Unions medlemsstater eller myndigheder, der efterfølger dem:
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.
Land
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 humanmedicinske lægemidler
Operational arrangements are detailed under Section III, paragraph 3.
For veterinærmedicinske lægemidler
Certification of manufacturers
Østrig
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:
Den østrigske styrelse for sundhed og fødevaresikkerhed/Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
is appropriately authorised to manufacture the relevant medicinal product, or to carry out the relevant specified manufacturing operation,
Se myndigheden med ansvar for humanmedicinske lægemidler
is regularly inspected by the authorities,
Belgien
complies with the national GMP requirements recognised as equivalent by the two parties, and which are listed in Section I of this Chapter.
Den føderale styrelse for lægemidler og sundhedsprodukter/Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/Agence fédérale des médicaments et produits de santé
Should different GMP requirements be used as reference, this is to be mentioned in the certificate.
Bulgarien
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.
Den bulgarske lægemiddelstyrelse/
The certificates shall also identify the site(s) of manufacture (and contract quality control laboratories, if any) and the date of the inspection.
Den bulgarske styrelse for fødevaresikkerhed/
Certificates shall be issued expeditiously, and the time taken should not exceed 30 calendar days.
Cypern
In exceptional cases, i.e. when a new inspection has to be carried out, this period may be extended to 90 days.
Sundhedsministeriet — Afdelingen for lægemidler/
Batch certification
Ministeriet for landbrug, udvikling af landdistrikter og miljø-veterinærafdelingen/
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.
Tjekkiet
This certificate shall attest that the batch meets its specifications and shall be kept by the importer of the batch.
Instituttet for statens kontrol med biologiske veterinærlægemidler og andre lægemidler/
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.
Kroatien
The certificate shall detail the agreed specifications of the product, the reference of the analytical methods and the analytical results.
Styrelsen for lægemidler og medicinsk udstyr/
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.
Landbrugsministeriet, Direktoratet for veterinær- og fødevaresikkerhed/
Official Batch Release
Danmark
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.
Lægemiddelstyrelsen
The manufacturer shall provide the certificate of the official batch release.
Tyskland
For the European Union, the official batch release procedure is specified in document “Control Authority Batch Release of Vaccination and Blood Products, 2001” or subsequent versions and in different specific batch release procedures.
Forbundsinstituttet for lægemidler og medicinsk udstyr/
For Switzerland, the official batch release procedure is specified in Article 17 of the Federal Law on medicinal products and medical devices and in Articles 18-21 of the Ordinance of the Swiss Agency for Therapeutic Products on the requirements for the marketing authorisation of medicinal products.
Paul-Ehrlich-Institute (PEI), Forbundsinstituttet for vacciner og biomedicin/Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p.
Forbundsministeriet for sundhed/Bundesministerium für Gesundheit (BMG)/Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)
1) as last amended by Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance (OJ L 316, 14.11.2012, p.
Forbundskontoret for forbrugerbeskyttelse og fødevaresikkerhed/
38)
Forbundsministeriet for fødevarer og landbrug, Bundesministerium für Ernährung und Landwirtschaft
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p.
Estland
67) as last amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L 299, 27.10.2012, p.
Statens styrelse for lægemidler/
1)
Grækenland
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p.
Den nationale lægemiddelorganisation/
30)
Spanien
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p.
Den spanske styrelse for lægemidler og medicinsk udstyr/
1) as last amended by Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products (OJ L 168, 30.6.2009, p.
Frankrig
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p.
Den franske nationale styrelse for lægemiddel- og sundhedsproduktsikkerhed Agence nationale de sécurité du médicament et des produits de santé (ANSM)
22)
Den franske styrelse for sundhed og sikkerhed inden for fødevarer, miljø og på arbejdspladsen — Den nationale styrelse for veterinærlægemidler/
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p.
Ungarn
70) and Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (OJ L 92, 7.4.1990, p.
Det nationale kontor for fødevarekædesikkerhed, direktoratet for veterinærlægemidler/Nemzeti Élelmiszerlánc-biztonsági Hivatal,
Guidelines on Good Distribution Practice of medicinal products for human use (OJ C 343, 23.11.2013, p.
Irland
1)
Reguleringsmyndighed for sundhedsvarer/Health Products Regulatoty Authority (HPRA)
EudraLex Volume 4 — Medicinal Products for Human and Veterinary Use:
Italien
EU Guidelines to Good Manufacturing Practice (published on website of the European Commission)
Den italienske lægemiddelstyrelse/Agenzia Italiana del Farmaco
Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p.
Generaldirektoratet for dyresundhed og veterinærlægemidler
34) and Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p.
Fødevare- og veterinærtjenestens afdeling for evaluering og registrering/Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p.
Litauen
13)