natgillin/translations-raw huggingface dataset:
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.
tootjal on vajalik luba asjaomase ravimi tootmiseks või asjaomase täpsustatud tootmisoperatsiooni tegemiseks;
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.
ametiasutused kontrollivad tootjat regulaarselt;
It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the instrument.
tootja järgib riiklikke hea tootmistava nõudeid, mida kokkuleppeosalised tunnustavad samaväärsetena ja mis on loetletud käesoleva peatüki I jaos.
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.
Kui viitena kasutatakse muid hea tootmistava nõudeid, tuleb seda sertifikaadis mainida.
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.
Kolmandates riikides toimuvate kontrollimiste puhul tõendavad kontrollimise eest vastutavad asutused eksportija, importija või teise kokkuleppeosalise pädeva asutuse taotluse korral, kas tootja vastab või ei vasta hea tootmistava nõuetele, mida kaks kokkuleppeosalist tunnustavad samaväärsetena ja mis on loetletud käesoleva peatüki I jaos.
Procedure for dealing with instruments presenting a risk caused by non-compliance not restricted to the national territory
Sertifikaadis märgitakse ka tootmise asukoht/asukohad (ja olemasolu korral lepingu alusel töötavad kvaliteedikontrollimise laborid) ning kontrollimise kuupäev.
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:
Sertifikaat väljastatakse viivitamata ning selleks ei tohi kuluda rohkem kui 30 kalendripäeva.
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.
Erandjuhtudel, st kui on vaja teha uus kontrollimine, võib seda ajavahemikku pikendada 90 päevani.
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.
Partii sertifitseerimine
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
Iga eksporditud partiiga on kaasas partiisertifikaat (tootja tõend), mille tootja on koostanud pärast täielikku kvalitatiivset analüüsi, kõigi toimeainete kvantitatiivset analüüsi ning kõiki muid katseid ja kontrollimisi, mis on vajalikud toote müügiloa nõuetele vastava kvaliteedi tagamiseks.
shortcomings in the harmonised standards referred to in Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions.
Selle sertifikaadiga tõendatakse, et partii vastab tehnilistele nõuetele, ning see jääb toote importija kätte.
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.
Sertifikaat esitatakse pädeva asutuse taotlusel.
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.
Sertifikaati väljastades võtab tootja arvesse Maailma Tervishoiuorganisatsiooni (WHO) kehtiva rahvusvahelises kaubanduses ringluses olevate farmaatsiatoodete sertifitseerimiskava sätteid.
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.
Sertifikaadis kirjeldatakse üksikasjalikult toote kokkulepitud tehnilisi nõudeid, analüütiliste meetodite võrdlust ning analüüside tulemusi.
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.
Sertifikaat hõlmab ka avaldust selle kohta, et partii töötlemise ja pakendamisega seotud dokumendid on läbi vaadatud ning vastavad heale tootmistavale.
If the national measure relating to an instrument is considered:
Partiisertifikaadile kirjutab alla isik, kes vastutab partii ringlusselaskmise eest müümiseks või tarnimiseks, st Euroopa Liidus direktiivi 2001/83/EÜ artiklis 48 ja direktiivi 2001/82/EÜ artiklis 52 osutatud „asjatundja“ ning Šveitsis asutamislitsentse käsitleva määruse artiklites 5 ja 10 osutatud „vastutav isik“.
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,
Partii ametlik kasutamiseks vabastamine
A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 3.8.
Partii ametliku kasutamiseks vabastamise menetluse kohaldamise korral tunnustab teine kokkuleppeosaline partii ametlikku kasutamiseks vabastamist eksportiva kokkuleppeosalise asutuse (loetletud II jaos) poolt.
Compliant instruments which nevertheless present a risk to health and safety
Tootja esitab partii ametliku kasutamiseks vabastamise sertifikaadi.
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.
Euroopa Liidu puhul on partiide ametliku kasutamiseks vabastamise menetlust kirjeldatud dokumendis „Vaktsineerimistoodete ja verepreparaatide partiide kasutamiseks vabastamine kontrolliasutuste poolt.
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.
2001“ või sellele järgnevates versioonides ja erinevates konkreetsetes partiide kasutamiseks vabastamise menetlustes.
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.
Šveitsi puhul on partiide ametliku kasutamiseks vabastamise menetlust kirjeldatud ravimeid ja meditsiiniseadmeid käsitleva föderaalseaduse artiklis 17 ja Šveitsi ravimiameti ravimite müügilubade nõudeid käsitleva määruse artiklites 18–21.
justified, the Parties shall take the measures necessary to ensure that the instrument is withdrawn from their market;
Euroopa Parlamendi ja nõukogu 31. märtsi 2004. aasta määrus (EÜ) nr 726/2004, milles sätestatakse ühenduse kord inim- ja veterinaarravimite lubade andmise ja järelevalve kohta ning millega asutatakse Euroopa ravimiamet (ELT L 136, 30.4.2004, lk 1), viimati muudetud Euroopa Parlamendi ja nõukogu 25. oktoobri 2012. aasta määrusega (EL) nr 1027/2012, millega muudetakse seoses ravimiohutuse järelevalvega määrust (EÜ) nr 726/2004 (ELT L 316, 14.11.2012, lk 38).
ATTACHMENT G
Euroopa Parlamendi ja nõukogu 6. novembri 2001. aasta direktiiv 2001/83/EÜ inimtervishoius kasutatavaid ravimeid käsitlevate ühenduse eeskirjade kohta (EÜT L 311, 28.11.2001, lk 67), viimati muudetud Euroopa Parlamendi ja nõukogu 25. oktoobri 2012. aasta direktiiviga 2012/26/EL, millega muudetakse seoses ravimiohutuse järelevalvega direktiivi 2001/83/EÜ (ELT L 299, 27.10.2012, lk 1).
In Annex 1, Product Sectors, Chapter 15, Medicinal products, GMP Inspection and Batch Certification should be deleted and replaced by the following:
Euroopa Parlamendi ja nõukogu 27. jaanuari 2003. aasta direktiiv 2002/98/EÜ, millega kehtestatakse inimvere ja verekomponentide kogumise, uurimise, töötlemise, säilitamise ja jaotamise kvaliteedi- ja ohutusnõuded ning muudetakse direktiivi 2001/83/EÜ (ELT L 33, 8.2.2003, lk 30).
‘CHAPTER 15
Euroopa Parlamendi ja nõukogu 6. novembri 2001. aasta direktiiv 2001/82/EÜ veterinaarravimeid käsitlevate ühenduse eeskirjade kohta (EÜT L 311, 28.11.2001, lk 1), viimati muudetud Euroopa Parlamendi ja nõukogu 18. juuni 2009. aasta direktiiviga 2009/53/EÜ, millega muudetakse direktiivi 2001/82/EÜ ja direktiivi 2001/83/EÜ seoses ravimite müügilubade tingimuste muutmisega (ELT L 168, 30.6.2009, lk 33).
MEDICINAL PRODUCTS, GMP INSPECTION AND BATCH CERTIFICATION
Komisjoni 8. oktoobri 2003. aasta direktiiv 2003/94/EÜ, millega kehtestatakse inimestele mõeldud ravimite ning inimestele mõeldud uuritavate ravimite hea tootmistava põhimõtted ja suunised (ELT L 262, 14.10.2003, lk 22).
Scope and coverage
Komisjoni 23. juuli 1991. aasta direktiiv 91/412/EMÜ, millega kehtestatakse veterinaarravimite hea tootmistava põhimõtted ja suunised (EÜT L 228, 17.8.1991, lk 70) ja nõukogu 26. märtsi 1990. aasta direktiiv 90/167/EMÜ, millega kehtestatakse ravimsöötade ühenduses valmistamise, turuleviimise ja kasutamise tingimused (EÜT L 92, 7.4.1990, lk 42).
The provisions of this Sectoral Chapter cover all medicinal products which are industrially manufactured and to which Good Manufacturing Practice (GMP) requirements apply.
Suunised inimtervishoius kasutatavate ravimite hea turustamistava kohta (ELT C 343, 23.11.2013, lk 1).
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.
EudraLexi 4. number — Medicinal Products for Human and Veterinary Use: EU Guidelines to Good Manufacturing Practice (Inimtervishoius kasutatavad ravimid ja veterinaarravimid: ELi hea tootmistava juhend) (avaldatud Euroopa Komisjoni veebisaidil)
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).
4. aprilli 2001. aasta direktiiv 2001/20/EÜ liikmesriikide õigus- ja haldusnormide ühtlustamise kohta, mis käsitlevad hea kliinilise tava rakendamist inimtervishoius kasutatavate ravimite kliinilistes uuringutes (EÜT L 121, 1.5.2001, lk 34) ning Euroopa Parlamendi ja nõukogu 16. aprilli 2014. aasta määrus (EL) nr 536/2014, milles käsitletakse inimtervishoius kasutatavate ravimite kliinilisi uuringuid ja millega tunnistatakse kehtetuks direktiiv 2001/20/EÜ (ELT L 158, 27.5.2014, lk 1).
The Parties shall cooperate in order to achieve the best use of inspection resources by an appropriate burden sharing.
Komisjoni 8. aprilli 2005. aasta direktiiv 2005/28/EÜ, millega kehtestatakse inimtervishoius kasutatavate uuritavate ravimite hea kliinilise tava põhimõtted ja suunised ning nõuded nimetatud ravimite tootmis- ja impordilubadele (ELT L 91, 9.4.2005, lk 13).
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.
Komisjoni 28. mai 2014. aasta delegeeritud määrus (EL) nr 1252/2014, millega täiendatakse Euroopa Parlamendi ja nõukogu direktiivi 2001/83/EÜ seoses inimtervishoius kasutatavate ravimite toimeainete head tootmistava käsitlevate põhimõtete ja suunistega (ELT L 337, 25.11.2014, lk 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.
15. detsembri 2000. aasta föderaalseadus ravimite ja meditsiiniseadmete kohta (RO 2001 2790), viimati muudetud 1. jaanuaril 2014 (RO 2013 4137)
If the above conditions are not met, each Party can require a re-control in its territory.
17. oktoobri 2001. aasta määrus litsentside väljastamise kohta (RO 2001 3399), viimati muudetud 1. mail 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.
Šveitsi ravimiameti 9. novembri 2001. aasta määrus ravimite müügilubade nõuete kohta (RO 2001 3437), viimati muudetud 1. mail 2016 (RO 2016 1171)
“Medicinal products” means all products regulated by pharmaceutical legislation in the European Union and Switzerland as listed in Section I of this Chapter.
20. septembri 2013. aasta määrus kliiniliste katsete kohta inimuuringutes (RO 2013 3407), viimati muudetud 1. mail 2017 (RO 2017 2439)
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.
Käesoleva peatüki kohaldamisel tähendab termin „vastavushindamisasutused“ kummagi kokkuleppeosalise ametlikke hea tootmistava järelevalvetalitusi.
“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.
Euroopa Liidu liikmesriikide ja Šveitsi ametlike hea tootmistava järelevalvetalituste loetelu on esitatud allpool.
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.
Euroopa Liidu vastavushindamisasutused
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.
Euroopa Liidu pädevad asutused on järgmised Euroopa Liidu liikmesriikide ametiasutused või nende õigusjärglased:
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.
Riik
Certification of manufacturers
Veterinaarravimid
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:
Austria tervise- ja toiduohutuse amet/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,
Vt inimravimite eest vastutav asutus
is regularly inspected by the authorities,
Belgia
complies with the national GMP requirements recognised as equivalent by the two parties, and which are listed in Section I of this Chapter.
Ravimite ja tervisetoodete föderaalne asutus/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.
Bulgaaria
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.
Bulgaaria ravimiamet/
The certificates shall also identify the site(s) of manufacture (and contract quality control laboratories, if any) and the date of the inspection.
Bulgaaria toiduohutusamet/
Certificates shall be issued expeditiously, and the time taken should not exceed 30 calendar days.
Küpros
In exceptional cases, i.e. when a new inspection has to be carried out, this period may be extended to 90 days.
Tervishoiuministeerium – ravimiteenistus/
Batch certification
Põllumajandus-, maaelu arendamise ja keskkonnaministeerium – veterinaarteenistus/
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.
Tšehhi
It will be made available upon request of the competent authority.
Bioloogiliste veterinaarravimite ja veterinaarravimite riikliku kontrolli instituut/
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.
Horvaatia
The certificate shall detail the agreed specifications of the product, the reference of the analytical methods and the analytical results.
Ravimite ja meditsiiniseadmete amet/
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.
Põllumajandusministeerium, veterinaaria ja toiduohutuse direktoraat/
Official Batch Release
Taani
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.
Taani ravimiamet/
The manufacturer shall provide the certificate of the official batch release.
Saksamaa
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.
Saksamaa Liitvabariigi ravimi- ja meditsiiniseadmete instituut/
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 Ehrlichi Instituut (PEI) – Saksamaa Liitvabariigi vaktsiinide ja bioravimite instituut/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.
Saksamaa Liitvabariigi tervishoiuministeerium/Bundesministerium für Gesundheit (BMG)/Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG [1])
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.
Saksamaa Liitvabariigi tarbijakaitse ja toiduohutuse amet/
38)
Saksamaa Liitvabariigi toidu ja põllumajanduse ministeerium/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.
Eesti
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.
Ravimiamet/
1)
Kreeka
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.
Riiklik Ravimiamet/
30)
Hispaania
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.
Hispaania ravimite ja meditsiiniseadmete amet/
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.
Soome
33)
Soome ravimiamet/
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.
Prantsusmaa
22)
Prantsusmaa riiklik ravimite ja tervisetoodete ohutuse amet/Agence nationale de sécurité du médicament et des produits de santé (ANSM)
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.
Prantsusmaa toidu-, keskkonna-ja tööohutuse riiklik amet – Veterinaarravimite riiklik amet/
42)
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet/Riiklik farmaatsia ja toitumise instituut