natgillin/translations-raw huggingface dataset:
Video tuners (excl. electronic assemblies for incorporation into automatic data-processing machines and apparatus with a microprocessor-based device incorporating a modem for gaining access to the internet and having a function of interactive information exchange capable of receiving television signals, i.e. ‘set-top boxes with communication function’)
POGLAVLJE 74 – BAKAR I PROIZVODI OD BAKRA
Reception apparatus for television, whether or not incorporating radio-broadcast receivers or sound or video recording or reproducing apparatus, not designed to incorporate a video display or screen (excl. video tuners and set-top boxes with a communication function)
Šipke od slitina bakra i cinka (mjedi)
Reception apparatus for television, colour, with LCD screen
Žica od rafiniranog bakra, najveće dimenzije poprečnog presjeka veće od 6 mm
Commission Statement related to Article 3
POGLAVLJE 76 – ALUMINIJ I PROIZVODI OD ALUMINIJA
The Commission notes that should it be impossible to implement the suspension of preferential arrangements before full utilisation of the annual zero-tariff rate quotas for agricultural products, the Commission shall endeavour proposing a reduction or suspension of these concessions in the following years.
Nelegirani aluminij, u sirovim oblicima
Title IV of the Association Agreement, which relates to trade and trade-related matters, has been applied provisionally since 1 January 2016 [3].
Slitine aluminija u sirovim oblicima u pločama ili gredicama
In the preamble to the Association Agreement, the Parties thereto expressed their desire to strengthen and widen relations in an ambitious and innovative way.
Slitine aluminija u sirovim oblicima (osim u pločama i gredicama)
Council Implementing Regulation (EU) 2017/1568
Provedbena uredba Vijeća (EU) 2017/1568
Having regard to Council Regulation (EU) 2017/1509 of 30 August 2017 concerning restrictive measures against the Democratic People's Republic of Korea and repealing Regulation (EC) No 329/2007 [1], and in particular Article 47(1) thereof,
uzimajući u obzir Uredbu Vijeća (EU) 2017/1509 od 30. kolovoza 2017. o mjerama ograničavanja protiv Demokratske Narodne Republike Koreje i o stavljanju izvan snage Uredbe (EZ) br. 329/2007 [1], a posebno njezin članak 47. stavak 1.,
On 30 August 2017, the Council adopted Regulation (EU) 2017/1509.
Vijeće je 30. kolovoza 2017. donijelo Uredbu (EU) 2017/1509.
On 11 September 2017 the United Nations Security Council adopted Resolution 2375 (2017), which added 1 person and 3 entities to the list of persons and entities subject to restrictive measures.
Vijeće sigurnosti Ujedinjenih naroda donijelo je 11. rujna 2017.
Annex XIII to Regulation (EU) 2017/1509 should therefore be amended accordingly,
Rezoluciju 2375 (2017) kojom su jedna osoba i tri subjekta dodani na popis osoba i subjekata koji podliježu mjerama ograničavanja.
HAS ADOPTED THIS REGULTION:
Prilog XIII.
Article 1
Uredbi (EU) 2017/1509 trebalo bi stoga na odgovarajući način izmijeniti,
Annex XIII to Regulation (EU) 2017/1509 shall be amended as set out in the Annex to this Regulation.
DONIJELO JE OVU UREDBU:
This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union.
Prilog XIII.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Uredbi (EU) 2017/1509 mijenja se kako je navedeno u Prilogu ovoj Uredbi.
Done at Brussels, 15 September 2017.
Članak 2.
For the Council
Ova Uredba stupa na snagu na dan objave u Službenom listu Europske unije.
OJ L 224, 31.8.2017, p.
Sastavljeno u Bruxellesu 15. rujna 2017.
The persons and entities listed below shall be added to the list of persons and entities subject to restrictive measures set out in Annex XIII to Regulation (EU) 2017/1509.
SL L 224, 31.8.2017., str. 1.
Natural persons
PRILOG
Name
Osobe i subjekti navedeni niže na popisu dodaju se na popis osoba i subjekata koji podliježu mjerama ograničavanja iz Priloga XIII.
Alias
Uredbi (EU) 2017/1509.
Identifiers
Fizičke osobe
Date of UN designation
Ime
Statement of Reasons
Drugo ime
Nationality: DPRK
Podaci za identifikaciju
YOB: 1950
Datum uvrštenja na popis UN-a
Member of the Workers' Party of Korea Central Military Commission, which is responsible for the development and implementation of the Workers' Party of Korea military policies, commands and controls the DPRK's military, and helps direct the country's military defence industries.
Obrazloženje
Legal persons, entities and bodies
Državljanstvo: DNRK
Location
Godina rođenja: 1950.
Other information
Član Središnje vojne komisije Radničke stranke Koreje, koja je odgovorna za razvoj i provedbu vojnih politika Radničke stranke Koreje, zapovijeda i vrši nadzor nad vojskom DNRK-a te pomaže u upravljanju vojnom obrambenom industrijom te zemlje.
Central Military Commission of the Worker's Party of Korea (CMC)
Pravne osobe, subjekti i tijela
Pyongyang, DPRK
Lokacija
The Central Military Commission is responsible for the development and implementation of the Workers' Party of Korea's military policies, commands and controls the DPRK's military, and directs the country's military defence industries in coordination with the State Affairs Commission.
Druge informacije
Organization and Guidance Department (OGD)
Središnja vojna komisija Radničke stranke Koreje
DPRK
Pjongjang, DNRK
The Organization and Guidance Department is a very powerful body of the Worker's Party of Korea.
Središnja vojna komisija odgovorna je za razvoj i provedbu vojnih politika Radničke stranke Koreje, zapovijeda i vrši nadzor nad vojskom DNRK-a te upravlja vojnom obrambenom industrijom te zemlje u koordinaciji sa Komisijom za državne poslove.
It directs key personnel appointments for the Workers' Party of Korea, the DPRK's military, and the DPRK's government administration.
Odjel za organizaciju i usmjeravanje
It also purports to control the political affairs of all of the DPRK and is instrumental in implementing the DPRK's censorship policies.
DNRK
Propaganda and Agitation Department (PAD)
Odjel za organizaciju i usmjeravanje vrlo je moćno tijelo Radničke stranke Koreje.
The Propaganda and Agitation Department has full control over the media, which it uses as a tool to control the public on behalf of the DPRK leadership.
Upravlja glavnim imenovanjima osoblja za Radničku stranku Koreje te vojsku i državnu upravu DNRK-a.
Commission Delegated Regulation (EU) 2017/1569
Delegirana uredba Komisije (EU) 2017/1569
supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections
o dopuni Uredbe (EU) br. 536/2014 Europskog parlamenta i Vijeća utvrđivanjem načela i smjernica za dobru proizvođačku praksu u proizvodnji ispitivanih lijekova za humanu uporabu te utvrđivanjem aranžmana za inspekcije
Having regard to 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 [1], and in particular Article 63(1) thereof,
uzimajući u obzir Uredbu (EU) br. 536/2014 Europskog parlamenta i Vijeća od 16. travnja 2014. o kliničkim ispitivanjima lijekova za primjenu kod ljudi te o stavljanju izvan snage Direktive 2001/20/EZ [1], a posebno njezin članak 63. stavak 1.,
In accordance with Article 61(5) of Regulation (EU) No 536/2014 certain processes do not require the authorisation referred to in Article 61(1) of that Regulation.
U skladu s člankom 61. stavkom 5.
In line with Article 63(2) of Regulation (EU) No 536/2014 good manufacturing practice for investigational medicinal products does not apply to those processes.
Uredbe (EU) br. 536/2014 za određene procese nije potrebno odobrenje iz članka 61. stavka 1. te uredbe.
For the manufacturer to be able to comply with good manufacturing practice for investigational medicinal products, cooperation between the manufacturer and the sponsor is necessary.
U skladu s člankom 63. stavkom 2.
Likewise, for the sponsor to comply with the requirements of Regulation (EU) No 536/2014 cooperation with the manufacturer is necessary.
Uredbe (EU) br. 536/2014 dobra proizvođačka praksa za ispitivane lijekove ne primjenjuje se na te postupke.
Where the manufacturer and the sponsor are different legal entities, the obligations of the manufacturer and sponsor vis-à-vis each other should be specified in a technical agreement between them.
Da bi proizvođač mogao postupati u skladu s dobrom proizvođačkom praksom za ispitivane lijekove, neophodna je suradnja između proizvođača i naručitelja ispitivanja.
Such an agreement should provide for the sharing of inspection reports and exchange of information on quality issues.
Potrebno je i da naručitelj ispitivanja surađuje s proizvođačem kako bi mogao ispuniti zahtjeve Uredbe (EU) br. 536/2014.
Investigational medicinal products imported into the Union should be manufactured by applying quality standards at least equivalent to those in the Union.
Ako su proizvođač i naručitelj ispitivanja različite pravne osobe, međusobne obveze proizvođača i naručitelja trebalo bi definirati u zajedničkom tehničkom sporazumu.
For this reason, only products manufactured by a third country manufacturer that is entitled or authorised to do so in accordance with the laws of the country where the manufacturer is located, should be allowed to be imported into the Union.
U tom bi sporazumu trebalo predvidjeti razmjenu izvješća o inspekciji te razmjenu informacija o pitanjima kvalitete.
All manufacturers should operate an effective quality assurance system of their manufacturing or import operations.
Ispitivani lijekovi koji se uvoze u Uniju trebali bi se proizvoditi primjenom standarda kvalitete koji su barem istovjetni standardima koji se primjenjuju u Uniji.
Such a system in order to be effective requires the implementation of a pharmaceutical quality system.
Zbog navedenog razloga za uvoz u Uniju trebali bi se odobriti samo proizvodi koje je proizveo proizvođač iz treće zemlje koji ima pravo ili je ovlašten proizvoditi te proizvode u skladu sa zakonima zemlje u kojoj ima poslovni nastan.
Good documentation constitutes an essential part of a quality assurance system.
Svi bi proizvođači trebali primjenjivati učinkovit sustav osiguranja kvalitete proizvodnje ili uvoza.
The documentation system of manufacturers shall enable the history of the manufacture of each batch and any changes introduced during the development of an investigational medicinal product to be traced.
Da bi taj sustav bio učinkovit potrebno je primjenjivati sustav farmaceutske kvalitete.
Principles and guidelines of good manufacturing practice for investigational medicinal products should be set out in relation to quality management, personnel, premises, equipment, documentation, production, quality control, outsourced operations, complaints and recall, and self-inspections.
Dobra dokumentacija bitan je dio sustava osiguranja kvalitete.
It is appropriate to require a product specification file which brings together and contain all of the essential reference documents to ensure that investigational medicinal products are manufactured according to good manufacturing practice for investigational medicinal products and the clinical trial authorisation.
Dokumentacijski sustav proizvođača omogućuje praćenje tijeka proizvodnje svake serije te svih promjena uvedenih tijekom razvoja ispitivanog lijeka.
Due to the special characteristics of advanced therapy investigational medicinal products, the provisions on good manufacturing practice should be adapted to those products in accordance with a risk-based approach.
Načela i smjernice dobre proizvođačke prakse u proizvodnji ispitivanih lijekova trebalo bi utvrditi s obzirom na upravljanje kvalitetom, osoblje, pogone, opremu, dokumentaciju, proizvodnju, kontrolu kvalitete, izdvojene djelatnosti, pritužbe i opozive te unutarnju inspekciju.
As regards the advanced therapy medicinal products marketed in the Union, Article 5 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council [2] provides for such adaptation.
Primjereno je zahtijevati specifikaciju proizvoda koja sadržava sve ključne referentne dokumente kako bi se osiguralo da su ispitivani lijekovi proizvedeni u skladu s dobrom proizvođačkom praksom u proizvodnji ispitivanih lijekova te u skladu s odobrenjem kliničkog ispitivanja.
The Commission guidelines referred to in Article 5 of Regulation (EC) No 1394/2007 should also set out the requirements on good manufacturing practice applicable to advanced therapy investigational medicinal products.
Zbog posebnih svojstava ispitivanih lijekova za naprednu terapiju, odredbe o dobroj proizvođačkoj praksi trebalo bi prilagoditi tim proizvodima u skladu s pristupom koji se temelji na ocjeni rizika.
In order to ensure conformity with the principles and guidelines of good manufacturing practice for investigational medicinal products, provisions on inspections by the competent authorities of the Member States should be established.
U pogledu lijekova za naprednu terapiju koji se stavljaju na tržište u Uniji, takva je prilagodba predviđena člankom 5.
Member States should not be obliged to inspect third country manufacturers of investigational medicinal products routinely.
Uredbe (EZ) br. 1394/2007 Europskog parlamenta i Vijeća [2].
The need for such inspections should be established according to a risk-based approach but third country manufacturers should be inspected at least if there is a suspicion that the investigational medicinal products are not manufactured by applying quality standards at least equivalent to those applicable in the Union.
U smjernicama Komisije iz članka 5.
Inspectors should consider the Commission guidelines on good manufacturing practice for investigational medicinal products for human use.
Uredbe (EZ) br. 1394/2007 trebalo bi utvrditi i zahtjeve u pogledu dobre proizvođačke prakse koji se primjenjuju na lijekove za naprednu terapiju.
To achieve and maintain mutual recognition of inspection findings in the Union and facilitate the cooperation of the Member States, commonly recognised standards on the conduct of inspections on good manufacturing practice for investigational medicinal products in the form of procedures should be developed.
Kako bi se osigurala usklađenost s načelima i smjernicama za dobru proizvođačku praksu u proizvodnji ispitivanih lijekova, trebalo bi utvrditi odredbe o inspekcijama koje provode nadležna tijela država članica.
The Commission guidelines and these procedures should be maintained and regularly updated, according to technical and scientific developments.
Države članice ne bi trebale biti obvezne provoditi rutinsku inspekciju proizvođača ispitivanih lijekova iz trećih zemalja.
During inspections of a site the inspectors should check whether a site respects good manufacturing practice as regards both investigational medicinal products and medicinal products authorised to be placed on the market.
Potreba za takvim inspekcijama trebala bi se utvrditi u skladu s pristupom koji se temelji na ocjeni rizika, međutim inspekcija proizvođača iz trećih zemalja trebala bi se provoditi barem ako postoji sumnja da se ispitivani lijekovi ne proizvode u skladu sa standardima kvalitete koji su barem istovjetni onima koji se primjenjuju u Uniji.
For that reason, and in order to ensure the effective supervision, procedures and powers to carry out inspections to verify that good manufacturing practice for investigational medicinal products for human use is followed should be aligned as much as possible to those for medicinal products for human use.
Inspektori bi trebali uzeti u obzir smjernice Komisije za dobru proizvođačku praksu u proizvodnji ispitivanih lijekova za humanu uporabu.
To ensure that inspections are effective, inspectors should be appropriately empowered.
Kako bi se postiglo i održavalo uzajamno priznavanje nalaza inspekcije u Uniji te olakšala suradnja država članica, trebalo bi razviti općepriznate standarde u obliku postupaka za provedbu inspekcija u vezi s dobrom proizvođačkom praksom u proizvodnji ispitivanih lijekova.
Member States should be able to take action in case of non-compliance with good manufacturing practice for investigational medicinal products for human use.
Smjernice Komisije i te postupke trebalo bi održavati i redovito ažurirati u skladu s napretkom u znanosti i tehnologiji.
The competent authorities should be required to set up quality systems to ensure that the inspection procedures are observed and consistently monitored.
Tijekom inspekcije mjesta proizvodnje inspektori bi trebali provjeriti poštuje li se na mjestu proizvodnje dobra proizvođačka praksa u pogledu ispitivanih lijekova i lijekova koji su odobreni za stavljanje na tržište.
A well-functioning quality system should comprise an organisational structure, clear processes and procedures, including standard operating procedures to be followed by inspectors when performing their tasks, clearly defined details of the inspectors' duties and responsibilities and ongoing training requirements, as well as adequate resources and mechanisms which aim to eliminate non-compliance.
Iz tog razloga, te kako bi se osigurao djelotvoran nadzor, postupci i ovlasti za provedbu inspekcija za provjeru poštovanja dobre proizvođačke prakse u proizvodnji ispitivanih lijekova za humanu uporabu trebali bi u što većoj mjeri biti usklađeni s postupcima i ovlastima za lijekove za humanu uporabu.
This Regulation should apply from the same date as Commission Directive (EU) 2017/1572 [3],
Kako bi se osiguralo da pregledi budu djelotvorni, inspektori trebaju biti odgovarajuće osposobljeni.
HAS ADOPTED THIS REGULATION:
Države članice trebale bi biti u mogućnosti poduzeti mjere u slučaju nepoštovanja dobre proizvođačke prakse u proizvodnji ispitivanih lijekova za humanu uporabu.
CHAPTER I
Od nadležnih tijela trebalo bi zahtijevati da uspostave sustave kvalitete kako bi se osiguralo da se poštuju i dosljedno prate inspekcijski postupci.
GENERAL PROVISIONS
Dobro funkcionirajući sustav kvalitete trebao bi obuhvaćati organizacijsku strukturu, jasne postupke i procese, uključujući standardne operativne postupke kojih se trebaju pridržavati inspektori pri obavljanju svojih zadaća, jasno definirane dužnosti i odgovornosti inspektora i zahtjeve u pogledu trajnog usavršavanja, te odgovarajuće resurse i mehanizme za uklanjanje neusklađenosti.
Article 1
Ova bi se Uredba trebala primjenjivati od istog datuma kao i Direktiva Komisije (EU) 2017/1572 [3],
This Regulation specifies the principles and guidelines of good manufacturing practice for investigational medicinal products for human use the manufacture or import of which requires an authorisation as referred to in Article 61(1) of Regulation (EU) No 536/2014 and lays down arrangements for inspections of manufacturers in relation to compliance with good manufacturing practice in accordance with Article 63(4) of that Regulation.
POGLAVLJE I.
For the purposes of this Regulation, the following definitions shall apply:
Predmet
‘manufacturer’ means any person engaged in activities for which an authorisation is required in accordance with Article 61(1) of Regulation (EU) No 536/2014;
Ovom se Uredbom utvrđuju načela i smjernice dobre proizvođačke prakse u proizvodnji ispitivanih lijekova za humanu uporabu za čiju je proizvodnju ili uvoz potrebno odobrenje iz članka 61. stavka 1.
‘third country manufacturer’ means any person established in a third country and engaged in manufacturing operations in that third country;
Uredbe (EU) br. 536/2014 te aranžmani za inspekcije proizvođača u pogledu usklađenosti s dobrom proizvođačkom praksom u skladu s člankom 63. stavkom 4. te uredbe.
‘product specification file’ means a reference file containing, or referring to files containing, all the information necessary to draft detailed written instructions on processing, packaging, quality control, testing and batch release of an investigational medicinal product and to perform batch certification;
Članak 2.
‘validation’ means action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity or system actually leads to the expected results.
Definicije
GOOD MANUFACTURING PRACTICE
„proizvođač” znači svaka osoba koja se bavi djelatnostima za koje je potrebno odobrenje u skladu s člankom 61. stavkom 1.
Article 3
Uredbe (EU) br. 536/2014;
Conformity with good manufacturing practice
„proizvođač iz treće zemlje” znači svaka osoba koja ima poslovni nastan u trećoj zemlji i bavi se proizvodnim djelatnostima u toj trećoj zemlji;
The manufacturer shall ensure that manufacturing operations are carried out in accordance with good manufacturing practice for investigational medicinal products specified in this Regulation and subject to an authorisation as referred to in Article 61(1) of Regulation (EU) No 536/2014.
„specifikacija proizvoda” znači referentna dokumentacija koja sadržava, ili upućuje na dokumentaciju koja sadržava, sve informacije potrebne za izradu detaljnih pisanih uputa za preradu, pakiranje, kontrolu kvalitete, ispitivanje i puštanje u promet serije ispitivanog lijeka te potvrđivanje serije lijekova;
When importing an investigational medicinal products, the holder of the authorisation referred to in Article 61(1) of Regulation (EU) No 536/2014 shall ensure that the products have been manufactured by applying quality standards at least equivalent to those laid down by this Regulation and in Regulation (EU) No 536/2014, and that the third country manufacturer is authorised or entitled to in accordance with the laws of that country to manufacture that investigational medicinal products in that third country.
„validacija” znači postupak dokazivanja, u skladu s načelima dobre proizvođačke prakse, da određeni postupak, proces, oprema, materijal, djelatnost ili sustav daje očekivane rezultate.
Article 4
POGLAVLJE II.
Compliance with clinical trial authorisation
DOBRA PROIZVOĐAČKA PRAKSA
The manufacturer shall ensure that all manufacturing operations for investigational medicinal products are carried out in accordance with the documentation and information provided by the sponsor pursuant to Article 25 of Regulation (EU) No 536/2014 and as authorised in accordance with the procedure laid down in Chapter II, or if documentation and information was subsequently amended, in Chapter III of abovementioned Regulation (EU) No 536/2014.
Članak 3.
The manufacturer shall regularly review his manufacturing methods in the light of scientific and technical progress and experience gained by the sponsor during the development of the investigational medicinal product.
Usklađenost s dobrom proizvođačkom praksom
The manufacturer shall inform the sponsor of his reviews of the manufacturing methods.
Proizvođač osigurava odvijanje proizvodnog procesa u skladu s dobrom proizvođačkom praksom za ispitivane lijekove iz ove Uredbe te u skladu s odobrenjem iz članka 61. stavka 1.
Where, following a review, an amendment to the clinical trial authorisation is necessary, the application for the amendment shall be submitted in accordance with Article 16 of Regulation (EU) No 536/2014 where the change to the clinical trial is a substantial modification or the amendment shall be carried out in accordance with Article 81(9) of that Regulation where the change to the clinical trial is not a substantial modification.
Uredbe (EU) br. 536/2014.
Article 5
Pri uvozu ispitivanih lijekova nositelj odobrenja iz članka 61. stavka 1.
Pharmaceutical quality system
Uredbe (EU) br. 536/2014 osigurava da su proizvodi proizvedeni u skladu sa standardima kvalitete koji su barem istovjetni onima koji su utvrđeni u ovoj Uredbi i Uredbi (EU) br. 536/2014 te da je proizvođač iz treće zemlje ovlašten ili ima pravo proizvoditi ispitivane lijekove u toj trećoj zemlji u skladu sa zakonima te zemlje.
The manufacturer shall establish, implement and maintain effective organised arrangements to ensure that the investigational medicinal products are of the quality required for their intended use.
Članak 4.
Those arrangements shall include the establishment of a good manufacturing practice and a quality control.
Usklađenost s odobrenjem za kliničko ispitivanje