natgillin/translations-raw huggingface dataset:
Grape juice (including grape must), of a Brix value not exceeding 30, of a value not exceeding 18 EUR per 100 kg net weight
Grozdni sok (vključno grozdni mošt), z Brix vrednostjo več kot 67, z vrednostjo do vključno 22 EUR za 100 kg neto mase
Grape juice (including grape must), of a Brix value exceeding 67, of a value not exceeding 22 EUR per 100 kg net weight
Grozdni sok (vključno grozdni mošt), z Brix vrednostjo več kot 30 do vključno 67, z vrednostjo do vključno 18 EUR za 100 kg neto mase
Grape juice (including grape must), of a Brix value exceeding 30 but not exceeding 67, of a value not exceeding 18 EUR per 100 kg net weight
Oves
Oats
TARIC koda 1103192010.
TARIC code 1103192010.
TARIC kode 1104290400, 1104290500, 1104290800, 1104291790,1104293090, 1104295100, 1104295990, 1104298100 in 1104298990.
TARIC codes 1104290400, 1104290500, 1104290800, 1104291790, 1104293090, 1104295100, 1104295990, 1104298100 and 1104298990.
PRILOGA II
ANNEX II
NIČNE TARIFNE KVOTE ZA KMETIJSKE PROIZVODE IZ TOČKE (b) ČLENA 1(1)
ZERO-TARIFF QUOTAS FOR AGRICULTURAL PRODUCTS REFERRED TO IN POINT (b) OF ARTICLE 1(1)
Proizvod
Product
Tarifna uvrstitev
Tariff classification
Navadna pšenica, pirjevica in soržica, moka, drobljenci, zdrob in peleti
Common wheat, spelt and meslin, flour, groats, meal and pellets
65000 ton/leto
65000 tonnes/year
Koruza, razen semena, moke, drobljenca, zdroba, peletov in zrna
Maize, other than seed, flour, groats, meal, pellets and grains
625000 ton/leto
625000 tonnes/year
Ječmen, razen semena, moke in peletov
Barley, other than seed, flour and pellets
325000 ton/leto
325000 tonnes/year
PRILOGA III
ANNEX III
PREFERENCIALNE CARINSKE DAJATVE, KI SE UPORABLJAJO ZA INDUSTRIJSKE IZDELKE IZ ČLENA 1(2)
PREFERENTIAL CUSTOMS DUTIES APPLIED FOR THE INDUSTRIAL PRODUCTS REFERRED TO IN ARTICLE 1(2)
Opis
Description
Uporabljene dajatve
Applied duties
POGLAVJE 31 – GNOJILA
CHAPTER 31 — FERTILISERS
Amonijev sulfat (razen v peletih ali podobnih oblikah ali pakiranjih do vključno 10 kg bruto mase)
Ammonium sulphate (excl. that in pellet or similar forms, or in packages with a gross weight not exceeding 10 kg)
Mešanice amonijevega nitrata s kalcijevim karbonatom ali drugimi anorganskimi negnojilnimi snovmi, pri katerih delež dušika ne presega 28 mas. % (razen v peletih ali podobnih oblikah ali pakiranjih do vključno 10 kg bruto mase)
Mixtures of ammonium nitrate with calcium carbonate or other inorganic non-fertilising substances, with a nitrogen content not exceeding 28 % by weight (excl. those in pellet or similar forms, or in packages with a gross weight not exceeding 10 kg)
Amonijev sulfat (razen v peletih ali podobnih oblikah ali pakiranjih do vključno 10 kg bruto mase)
Sodium nitrate (excl. that in pellet or similar forms, or in packages with a gross weight not exceeding 10 kg)
Mineralna ali kemična gnojila, ki vsebujejo dušik, fosfor in kalij, delež dušika pa presega 10 mas. % v suhem brezvodnem proizvodu (razen v tabletah ali podobnih oblikah ali pakiranjih do vključno 10 kg bruto mase)
Mineral or chemical fertilisers containing nitrogen, phosphorus and potassium, with a nitrogen content exceeding 10 % by weight on the dry anhydrous product (excl. those in tablets or similar forms, or in packages with a gross weight not exceeding 10 kg)
Mineralna ali kemična gnojila, ki vsebujejo nitrate in fosfate
Mineral or chemical fertilisers containing nitrates and phosphates
POGLAVJE 32 – EKSTRAKTI ZA STROJENJE ALI BARVANJE; TANINI IN NJIHOVI DERIVATI; BARVILA, PIGMENTI IN DRUGE BARVILNE SNOVI; BARVE IN LAKI; KITI IN DRUGE TESNILNE MASE; TISKARSKE BARVE IN ČRNILA
CHAPTER 32 — TANNING OR DYEING EXTRACTS; TANNINS AND THEIR DERIVATIVES; DYES, PIGMENTS AND OTHER COLOURING MATTER; PAINTS AND VARNISHES; PUTTY AND OTHER MASTICS; INKS
Pigmenti in preparati na osnovi titanovega dioksida, ki vsebujejo 80 mas. % ali več titanovega dioksida, računano na suho snov
Pigments and preparations based on titanium dioxide, containing 80 % or more by weight of titanium dioxide calculated on the dry matter
POGLAVJE 64 – OBUTEV, GAMAŠE IN PODOBNI IZDELKI; DELI TEH IZDELKOV
CHAPTER 64 — FOOTWEAR, GAITERS AND THE LIKE; PARTS OF SUCH ARTICLES
Obutev, ki pokriva gležnje, s podplati in zgornjim delom iz gume ali plastične mase
Footwear covering the ankle, with outer soles and uppers of rubber or plastics
Obutev s podplati iz gume ali plastične mase in zgornjim delom iz plastične mase, z notranjiki dolžine 24 cm ali več, za ženske
Footwear with outer soles of rubber or plastics and uppers of plastics, with insoles of a length of 24 cm or more, for women
Moška obutev s podplati iz gume, plastične mase ali umetnega usnja in zgornjim delom iz usnja (ne pokriva gležnjev), z notranjiki dolžine 24 cm ali več
Men's footwear with outer soles of rubber, plastics or composition leather and uppers of leather (not covering the ankle), with insoles of a length of 24 cm or more
Obutev s podplati iz gume ali plastične mase ali umetnega usnja in zgornjim delom iz usnja, z notranjiki dolžine 24 cm ali več, za ženske
Footwear with outer soles of rubber, plastics or composition leather and uppers of leather, with insoles of a length of 24 cm or more, for women
POGLAVJE 74 – BAKER IN BAKRENI IZDELKI
CHAPTER 74 — COPPER AND ARTICLES THEREOF
Palice iz zlitine bakra in cinka (medenina)
Bars and rods, of copper-zinc base alloys (brass)
Žica iz rafiniranega bakra, z največjo dimenzijo prečnega prereza več kot 6 mm
Wire of refined copper, with a maximum cross-sectional dimension of more than 6 mm
POGLAVJE 76 – ALUMINIJ IN ALUMINIJASTI IZDELKI
CHAPTER 76 — ALUMINIUM AND ARTICLES THEREOF
Aluminij, nelegiran, surov
Aluminium, not alloyed, unwrought
Surove aluminijeve zlitine v obliki blokov ali drogov
Unwrought aluminium alloys in the form of slabs or billets
Surove aluminijeve zlitine (razen blokov in drogov)
Unwrought aluminium alloys (other than slabs and billets)
Votli profili iz aluminijevih zlitin
Hollow profiles of aluminium alloys
Polni profili iz aluminijevih zlitin
Solid profiles, of aluminium alloys
Izdelki iz aluminija, neliti
Articles of aluminium, uncast
POGLAVJE 85 – ELEKTRIČNI STROJI IN OPREMA TER NJIHOVI DELI; APARATI ZA SNEMANJE IN REPRODUKCIJO ZVOKA, APARATI ZA SNEMANJE IN REPRODUKCIJO TELEVIZIJSKE SLIKE IN ZVOKA, DELI IN PRIBOR ZA TE PROIZVODE
CHAPTER 85 — ELECTRICAL MACHINERY AND EQUIPMENT AND PARTS THEREOF; SOUND RECORDERS AND REPRODUCERS, TELEVISION IMAGE AND SOUND RECORDERS AND REPRODUCERS, AND PARTS AND ACCESSORIES OF SUCH ARTICLES
Video snemalne kamere, razen tistih, ki lahko snemajo samo zvok in slike, posnetih s televizijsko kamero
Video camera recorders other than those only able to record sound and images taken by the television camera
Video tunerji (razen elektronskih sestavov za vgradnjo v avtomatske stroje za obdelavo podatkov in naprave z mikroprocesorsko enoto, ki vsebujejo modem za dostop do interneta, imajo funkcijo za interaktivno izmenjavo informacij in lahko sprejemajo televizijske signale, to so TV-komunikatorji s komunikacijsko funkcijo)
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’)
Televizijski sprejemniki, ki imajo vgrajen radijski sprejemnik ali aparat za snemanje ali reprodukcijo slike ali ne, ki niso namenjeni za vgradnjo video prikazovalnika ali zaslona (razen video tunerjev in TV-komunikatorjev s komunikacijsko funkcijo)
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)
Televizijski sprejemniki, barvni, z zaslonom LCD
Reception apparatus for television, colour, with LCD screen
Izjava Komisije v zvezi s členom 3
Commission Statement related to Article 3
Komisija ugotavlja, da si bo, če ne bi bilo mogoče uveljaviti začasne opustitve preferencialne ureditve pred polno uporabo letnih ničnih tarifnih kvot za kmetijske proizvode, prizadevala predlagati znižanje ali začasno opustitev teh koncesij v naslednjih letih.
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.
Naslov IV Sporazuma o pridružitvi, ki se nanaša na trgovino in trgovinske zadeve, se začasno uporablja od 1. januarja 2016 [3].
Title IV of the Association Agreement, which relates to trade and trade-related matters, has been applied provisionally since 1 January 2016 [3].
V uvodnih izjavah Sporazuma o pridružitvi sta pogodbenici izrazili željo, da medsebojne odnose okrepita in razširita na ambiciozen in inovativen način.
In the preamble to the Association Agreement, the Parties thereto expressed their desire to strengthen and widen relations in an ambitious and innovative way.
KN 2016
Council Implementing Regulation (EU) 2017/1568
Izvedbena uredba Sveta (EU) 2017/1568
implementing Regulation (EU) 2017/1509 concerning restrictive measures against the Democratic People's Republic of Korea
o izvajanju Uredbe (EU) 2017/1509 o omejevalnih ukrepih proti Demokratični ljudski republiki Koreji
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,
ob upoštevanju Uredbe Sveta (EU) 2017/1509 z dne 30. avgusta 2017 o omejevalnih ukrepih proti Demokratični ljudski republiki Koreji in razveljavitvi Uredbe (ES) št. 329/2007 [1] ter zlasti člena 47(1) Uredbe,
On 30 August 2017, the Council adopted Regulation (EU) 2017/1509.
Svet je 30. avgusta 2017 sprejel Uredbo (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.
Varnostni svet Združenih narodov je 11. septembra 2017 sprejel Resolucijo 2375 (2017), s katero je eno osebo in tri subjekte dodal na seznam oseb in subjektov, za katere veljajo omejevalni ukrepi.
Annex XIII to Regulation (EU) 2017/1509 should therefore be amended accordingly,
Prilogo XIII k Uredbi (EU) 2017/1509 bi bilo treba zato ustrezno spremeniti –
HAS ADOPTED THIS REGULTION:
SPREJEL NASLEDNJO UREDBO:
Annex XIII to Regulation (EU) 2017/1509 shall be amended as set out in the Annex to this Regulation.
Priloga XIII k Uredbi (EU) 2017/1509 se spremeni, kot je določeno v Prilogi k tej uredbi.
OJ L 224, 31.8.2017, p.
UL L 224, 31.8.2017, str.
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.
Spodaj navedene osebe in subjekti se dodajo na seznam oseb in subjektov, za katere veljajo omejevalni ukrepi iz Priloge XIII k Uredbi (EU) 2017/1509.
YOB: 1950
Leto rojstva: 1950
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.
Član osrednje vojaške komisije Delavske stranke Koreje, ki je pristojna za oblikovanje in izvajanje vojaške politike Delavske stranke Koreje, ki poveljuje vojaškim silam DLRK in jih nadzira ter sodeluje pri usmerjanju vojaške obrambne industrije te države.
Central Military Commission of the Worker's Party of Korea (CMC)
Osrednja vojaška komisija Delavske stranke Koreje
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.
Osrednja vojaška komisija je pristojna za oblikovanje in izvajanje vojaške politike Delavske stranke Koreje, poveljuje vojaškim silam DLRK in jih nadzira ter usmerja vojaško obrambno industrijo te države v sodelovanju s komisijo za državne zadeve.
Organization and Guidance Department (OGD)
Oddelek za organizacijo in usmerjevanje
DPRK
DLRK
The Organization and Guidance Department is a very powerful body of the Worker's Party of Korea.
Oddelek za organizacijo in usmerjevanje je zelo vpliven organ Delavske stranke Koreje.
It directs key personnel appointments for the Workers' Party of Korea, the DPRK's military, and the DPRK's government administration.
Nadzoruje ključna imenovanja osebja Delavske stranke Koreje, vojaških sil DLRK in vladne administracije DLRK.
It also purports to control the political affairs of all of the DPRK and is instrumental in implementing the DPRK's censorship policies.
Poleg tega si prizadeva nadzirati politične zadeve celotne DLRK in ima aktivno vlogo pri izvajanju politike cenzure DLRK.
Propaganda and Agitation Department (PAD)
Oddelek za propagando in agitacijo
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.
Oddelek za propagando in agitacijo ima popoln nadzor nad mediji, ki jih uporablja kot orodje za nadzor javnosti v imenu vodstva DLRK.
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 dopolnitvi Uredbe (EU) št. 536/2014 Evropskega parlamenta in Sveta z določitvijo načel in smernic dobre proizvodne prakse za zdravila za uporabo v humani medicini v preskušanju ter ureditvijo poteka pregledov
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,
ob upoštevanju Uredbe (EU) št. 536/2014 Evropskega parlamenta in Sveta z dne 16. aprila 2014 o kliničnem preskušanju zdravil za uporabo v humani medicini in razveljavitvi Direktive 2001/20/ES [1] ter zlasti člena 63(1) Uredbe,
The good manufacturing practice for investigational medicinal products for human use ensures that there is consistency between batches of the same investigational medicinal product used in the same or different clinical trials, and that changes during the development of an investigational medicinal product are adequately documented and justified.
Z dobro proizvodno prakso za zdravila za uporabo v humani medicini v preskušanju se zagotovi, da so serije istega zdravila v preskušanju, ki se uporabljajo pri istem ali drugem kliničnem preskušanju, skladne ter da so spremembe med razvojem zdravila v preskušanju ustrezno dokumentirane in utemeljene.
The manufacturing of investigational medicinal products presents additional challenges comparing to the manufacturing of authorised medicinal products because there are no fixed routines, there is a variety of clinical trial designs and consequently packaging designs.
Proizvodnja zdravil v preskušanju prinaša v primerjavi s proizvodnjo odobrenih zdravil dodatne izzive, saj ustaljenih postopkov ni, obstajajo pa različne zasnove kliničnih preskušanj in posledično različne zasnove ovojnin.
Those challenges are due to the need, often, of randomisation and to disguise the identity of the investigational medicinal products for the purpose of clinical trial (blinding).
Ti izzivi so pogosto posledica potrebe po naključnosti in po prikritju identitete zdravil v preskušanju za namen kliničnega preskušanja (zakrivanje).
The toxicity, potency and sensitising potential of investigational medicinal products for human use may not be fully understood at the time of the trial, and the need to minimise all risks of cross-contamination is therefore of even greater importance than for authorised medicinal products.
Ker toksičnost, potentnost in potencial za senzibilizacijo zdravil za uporabo v humani medicini v preskušanju v času preskušanja niso vedno popolnoma jasni, je zmanjšanje kakršnega koli tveganja za navzkrižno kontaminacijo še pomembnejše kot pri odobrenih zdravilih.
Because of this complexity, the manufacturing operations should be subject to a highly effective pharmaceutical quality system.
Zaradi tolikšne kompleksnosti bi morali biti proizvodni postopki predmet visokoučinkovitega sistema farmacevtske kakovosti.
Good manufacturing practice as regards both medicinal products authorised to be placed on the market and investigational medicinal products are based on the same principles.
Dobra proizvodna praksa za zdravila, za katera je bilo izdano dovoljenje za promet z zdravilom, in zdravila v preskušanju temelji na istih načelih.
The same manufacturing sites will often manufacture both investigational and medicinal products authorised to be placed on the market.
Zdravila v preskušanju in zdravila, za katera je bilo izdano dovoljenje za promet z zdravilom, se pogosto proizvajajo v istem proizvodnem obratu.
For that reason the principles and guidelines of good manufacturing practice for investigational medicinal products for human use should be aligned as much as possible with those applicable to medicinal products for human use.
Zato bi morala biti načela in smernice dobre proizvodne prakse za zdravila za uporabo v humani medicini v preskušanju v največji možni meri usklajena z načeli in smernicami, ki se uporabljajo za zdravila za uporabo v humani medicini.
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.
V skladu s členom 61(5) Uredbe (EU) št. 536/2014 dovoljenje iz člena 61(1) navedene uredbe za nekatere postopke ni potrebno.
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.
V skladu s členom 63(2) Uredbe (EU) št. 536/2014 se dobra proizvodna praksa za zdravila v preskušanju ne uporablja za navedene postopke.
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.
Da bi proizvajalec lahko ravnal v skladu z dobro proizvodno prakso za zdravila v preskušanju, morata proizvajalec in sponzor medsebojno sodelovati.
Likewise, for the sponsor to comply with the requirements of Regulation (EU) No 536/2014 cooperation with the manufacturer is necessary.
To sodelovanje je prav tako pomembno za sponzorja, da lahko ravna v skladu z zahtevami iz Uredbe (EU) št. 536/2014.
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.
Če sta proizvajalec in sponzor različni pravni osebi, bi morale biti obveznosti proizvajalca do sponzorja in obratno določene v dvostranskem tehničnem sporazumu.
Such an agreement should provide for the sharing of inspection reports and exchange of information on quality issues.
Takšen sporazum bi moral določati izmenjavo poročil o pregledih in informacij o vprašanjih, povezanih s kakovostjo.
Investigational medicinal products imported into the Union should be manufactured by applying quality standards at least equivalent to those in the Union.
Pri proizvodnji zdravil v preskušanju, uvoženih v Unijo, bi se morali uporabljati standardi kakovosti, ki so vsaj enakovredni standardom v Uniji.
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.
Zato bi moral biti v Unijo dovoljen samo uvoz zdravil, ki jih proizvede proizvajalec iz tretje države, ki ima za to pravico ali dovoljenje v skladu z zakoni države, kjer se nahaja.
All manufacturers should operate an effective quality assurance system of their manufacturing or import operations.
Vsi proizvajalci bi morali uporabljati učinkovit sistem zagotavljanja kakovosti svojih proizvodnih ali uvoznih postopkov.
Such a system in order to be effective requires the implementation of a pharmaceutical quality system.
Da bi bil takšen sistem učinkovit, je treba upoštevati sistem farmacevtske kakovosti.
Good documentation constitutes an essential part of a quality assurance system.
Dobra dokumentacija je bistveni del sistema zagotavljanja kakovosti.
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.
Dokumentacijski sistem proizvajalcev omogoča sledljivost proizvodnje vsake serije in sledenje spremembam, ki so bile uvedene med razvojem zdravila v preskušanju.
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.
Načela in smernice dobre proizvodne prakse za zdravila v preskušanju je treba opredeliti v zvezi z upravljanjem kakovosti, osebjem, prostori, opremo, dokumentacijo, proizvodnjo, kontrolo kakovosti, delom zunanjih izvajalcev, pritožbami in odpoklicem zdravil ter notranjim nadzorom.
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.
Treba je zahtevati dokument s specifikacijami zdravila, ki združuje in vsebuje vse bistvene referenčne dokumente, s čimer se zagotovi, da so zdravila v preskušanju proizvedena v skladu z dobro proizvodno prakso za zdravila v preskušanju in dovoljenjem za klinično preskušanje.
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.
Zaradi posebnih lastnosti zdravil za napredno zdravljenje v preskušanju bi bilo treba s pomočjo pristopa, ki temelji na tveganju, za ta zdravila prilagoditi določbe o dobri proizvodni praksi.
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.
V primeru zdravil za napredno zdravljenje, ki so v prometu v Uniji, takšno prilagoditev omogoča člen 5 Uredbe (ES) št. 1394/2007 Evropskega parlamenta in Sveta [2].
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.
V smernicah Komisije iz člena 5 Uredbe (ES) št. 1394/2007 bi morale biti določene tudi zahteve glede dobre proizvodne prakse, ki se uporablja za zdravila za napredno zdravljenje v preskušanju.
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.
Za zagotovitev skladnosti z načeli in smernicami dobre proizvodne prakse za zdravila v preskušanju bi bilo treba sprejeti določbe o pregledih, ki jih izvajajo pristojni organi držav članic.
Member States should not be obliged to inspect third country manufacturers of investigational medicinal products routinely.
Države članice ne bi smele biti obvezane rutinsko izvajati pregledov proizvajalcev zdravil v preskušanju iz tretjih držav.