natgillin/translations-raw huggingface dataset:
* Answer all the questions on this form either by filling in the spaces provided or checking the appropriate answer
* Odgovorite na vsa vprašanja na tem obrazcu bodisi tako, da odgovore vpišete v za to predviden prostor, bodisi tako, da odkljukate ustrezni odgovor.
* Underline surname or family name
* Podčrtajte priimek.
* Address means complete mailing address
* Naslov pomeni popoln poštni naslov.
* All units Metric; Please specify if other units used
* Vse enote so metrične; navedite, če so uporabljene druge enote.
Cook Islands Fishing Vessel Licence Foreign Fishing Vessel License
Dovoljenje za ribiško plovilo Cookovih otokov Dovoljenje za tuje ribiško plovilo
(or ‘Local/Cook Islands Owned’ Fishing Vessel License (or Charter Fishing Vessel License)
(ali dovoljenje za „lokalno ribiško plovilo/ribiško plovilo v lasti Cookovih otokov“) (ali dovoljenje za zakupljeno ribiško plovilo)
Vessel Details
Podatki o plovilu
Country of Registration (Flag):
Država registracije (zastave):
International Radio Call Sign:
Mednarodni radijski klicni znak:
Flag State Registration Number:
Registracijska številka države zastave:
PREVIOUS VESSEL DETAILS (IF APPLICABLE)
PREJŠNJI PODATKI O PLOVILU (ČE JE USTREZNO)
Previous Name of Vessel:
Prejšnje ime plovila:
Last Country of Registration (Flag):
Zadnja država registracije (zastave):
Last Radio Call Sign:
Zadnji radijski klicni znak:
Last Flag State Registration Number:
Zadnja registracijska številka države zastave:
Year Change Occurred:
Leto spremembe:
VESSEL SPECIFICATIONS
SPECIFIKACIJE PLOVILA
Gross Registered Tonnage (GRT):
Bruto registrska tonaža (BRT):
Length Overall:
Skupna dolžina:
Country Built:
Država izdelave:
Year Built:
Leto izdelave:
Hull Material:
Material trupa:
Fibreglass
steklena vlakna
Steel
jeklo
Wood
les
Other — specify
drugo – navedite
Engine Make/Model:
Znamka/model motorja:
Total Engine Power:
Skupna moč motorja:
Total Fuel Carrying Capacity:
Skupna zmogljivost rezervoarja za gorivo:
Rated Speed (knots):
Nazivna hitrost (vozli):
Total Storage Capacity:
Skupna skladiščna zmogljivost:
Normal Crew Compliment:
Običajno število članov posadke:
Storage Methods:
Metode skladiščenja:
Brine
slanica
Freezer/Air Coils
zamrzovalnik/hladilna naprava (zrak)
Ice
led
Refrigerated Sea Water
globoko hlajena morska voda
Warning: It is an offence, punishable by a fine, to make a false, incomplete or misleading statement.
Opozorilo: Napačne, nepopolne ali zavajajoče navedbe pomenijo kaznivo dejanje, ki se kaznuje z globo.
A license will not be issued, or a license issued on the basis of this application is liable to cancellation, if any of the information given is false, incomplete or misleading.
Dovoljenje ne bo izdano oziroma se lahko dovoljenje, izdano na podlagi te vloge, prekliče, če so navedene informacije napačne, nepopolne ali zavajajoče.
VESSEL TYPE
TIP PLOVILA
Single Purse Seiner
Enojno plovilo z zaporno plavarico
Longliner
Plovilo za ribolov s parangalom
Fish Carrier
Plovilo za prevoz rib
Group Purse Seiner:
Plovilo z zaporno plavarico za skupinski ribolov
Pole and Line
Plovilo za ribolov z ribiško palico
Other — specify:
Drugo – navedite:
Mothership
Matična ladja
Trawler
Plovilo z vlečno mrežo
Net Boat
Plovilo za ribolov z mrežami
Troller
Plovilo za ribolov s panulo
Search Boat
Iskalni čoln
Bottom/Deep Sea Fishing
Plovilo za pridneni/globokomorski ribolov
VESSEL CHARTERER/OPERATOR/OWNER/MASTER/CAPTAIN
ZAKUPNIK/UPRAVLJAVEC/LASTNIK/POVELJNIK/KAPITAN PLOVILA
Charterer/Operator:
Zakupnik/upravljavec:
Owner:
Lastnik:
Master/Captain:
Poveljnik/kapitan:
Fishing Master:
Ribiški poveljnik:
Is the owner or charterer the subject of proceedings under the bankruptcy laws of any jurisdiction?
Ali je lastnik ali zakupnik v postopku na podlagi stečajne zakonodaje katere koli jurisdikcije?
If ‘Yes’, please give details (attach details on a separate sheet).
Če je odgovor pritrdilen, navedite podrobnosti (priložite jih na posebnem listu).
Has the vessel ever been used in an offence against the Marine Resources Act?
Ali je bilo plovilo kadar koli uporabljeno v nasprotju z zakonom o morskih virih?
Does the vessel hold current fishing licenses elsewhere in the region?
Ali ima plovilo veljavna dovoljenja za ribolov drugje v regiji?
If ‘Yes’, please specify the licensing countr(y)(ies) and license number(s).
Če je odgovor pritrdilen, navedite države, ki so jih izdale, in številke dovoljenj.
Licence No.
Dovoljenje št.
Provide details of any joint ventures or other contractual arrangements with Government of the Cook Islands or any Cook Islands Nationals in connection with the proposed fishing operations such that;
Navedite podrobnosti o morebitnih skupnih podjetjih ali drugih pogodbenih dogovorih z vlado Cookovih otokov ali državljani Cookovih otokov v zvezi s predlaganimi ribolovnimi dejavnostmi, pri katerih:
the Companies shall supply a statement, setting out full details of the joint venture between the Companies, jointly or severally, relating to the Company's vessels (attach details);
podjetja skupaj ali posamično predložijo izjavo v zvezi s plovili podjetja, v kateri so navedene vse podrobnosti o skupnem podjetju med podjetji (priložite podrobnosti);
the Companies shall supply the Minister for Marine Resources with a business plan, showing full details of the proposed fishing, export and marketing operations of the Companies including projected costs and financial statements (attach details).
podjetja ministru za morske vire predložijo poslovni načrt, v katerem so navedene vse podrobnosti v zvezi s predlaganimi ribolovnimi, izvoznimi in trženjskimi dejavnostmi podjetij, vključno s predvidenimi stroški in računovodskimi izkazi (priložite podrobnosti).
Is there currently in force an access agreement between the Government of the Cook Islands and the Government of the Flag State of the vessel in respect of which this application is made or with an association representing foreign fishing vessel owners or charterers of which the owner or charterer of the vessel is a member?
Ali obstaja veljavni sporazum o dostopu med vlado Cookovih otokov in vlado države zastave plovila, za katero je ta vloga vložena, ali z združenjem, ki predstavlja lastnike ali zakupnike tujih ribiških plovil, katerega član je lastnik ali zakupnik plovila?
VESSEL INMARSAT ALC DETAILS
PODATKI O AVTOMATSKEM ODDAJNIKU LEGE INMARSAT NA PLOVILU
Is there a FFA VMS type approved ALC installed on the vessel?
Ali je na plovilu nameščen tip avtomatskega oddajnika lege v okviru sistema VMS, ki ga je odobrila agencija FFA?
If ‘Yes’, give details below.
Če je odgovor pritrdilen, spodaj navedite podrobnosti.
Inmarsat mobile unit number:
Številka mobilne enote Inmarsat:
Name of Installer:
Ime subjekta, ki je opravil namestitev:
Inmarsat unit serial number:
Serijska številka enote Inmarsat:
Contact Details:
Kontaktni podatki:
Make/Model:
Znamka/model:
Software Version:
Različica programske opreme:
APPLICANT DETAILS
PODATKI O VLOŽNIKU
Tick as appropriate:
Odkljukajte ustrezno:
Authorised Agent
Pooblaščeni zastopnik
Address:
Naslov:
Charterer/Operator
Zakupnik/upravljavec:
Owner
Lastnik
E-mail:
E-naslov:
APPLICANT DECLARATION
IZJAVA VLOŽNIKA
I hereby apply for a fishing vessel licence in respect of the (Cook Islands Fishing Vessel / Foreign Fishing Vessel) described above.
Z vlogo zaprošam za izdajo dovoljenja za (ribiško plovilo Cookovih otokov/tuje ribiško plovilo), opisano zgoraj.
I declare that the above information is true, complete and correct.
Izjavljam, da so zgornji podatki resnični, popolni in pravilni.
I understand I am required to report immediately to the Secretary of Marine Resources any changes to the information given on this form within seven (7) days and further understand that failure to do so may render me liable to prosecution.
Seznanjen sem z dejstvom, da moram sekretarju za morske vire nemudoma v sedmih (7) dneh sporočiti vse spremembe podatkov, navedenih na tem obrazcu, in da sem lahko zaradi neupoštevanja te obveznosti kazensko preganjan.
Applicant
Vložnik
Attachments Checklist
Kontrolni seznam prilog
Attach the following documentation to your application:
Vlogi priložite naslednjo dokumentacijo:
· Cook Islands Shipping Registration Certificate
· potrdilo Cookovih otokov o registraciji plovila;
· FFA Certificate of Registration
· potrdilo o vpisu v register agencije FFA;
· Demise Charter Agreement / Fishing Charter Agreement
· pogodbo o zakupu ladje brez posadke/pogodbo o zakupu plovila za ribolov;
· Recent Photograph of the vessel and markings and identification (port and starboard shots of the whole vessel and a stern shot — not older than six months)
· novejšo fotografijo plovila ter oznak in identifikacije (posnetki levega in desnega boka celotnega plovila ter posnetek krme – ki niso starejši od šestih mesecev);
· Certified Schematic and Stowage Plans (a.k.a.
· potrjene shematske načrte in natovorne načrte (splošni načrt plovila);
General Arrangements Plan)
· seznam posadke in podatke o posadki;
· Crew list and details
· kopije vseh drugih dovoljenj za ribolov, trenutno veljavnih na drugem območju.
· Copies of any other fishing license/permit currently valid in another zone
Ta vloga se pošlje sekretarju na ministrstvu za morske vire na spodaj navedeni naslov, zanjo pa se plača predpisana pristojbina za vlogo.
This application is to be forwarded to the Secretary, Ministry of Marine Resources at the address shown below and is to be accompanied by the prescribed application fee.
Sekretar
The Secretary
Ministrstvo za morske vire P.O.
Ministry of Marine Resources
Box 85
P.O. Box 85
Telefon: +682 28721
Telephone: (682) 28721
Faks: +682 29721
Fax: (682) 29721
Dodatek 3
Appendix 3
Dodatek 4
Appendix 4
Predloge oblike poročil
Communication Format Reports Templates
Poročilo o vstopu (COE) [1]
Entry Report (COE) [1]
Vsebina
Content
Prenos
Transmission
Poročilo namenjeno
Destination of message
Koda za ukrepanje
Action code
Ime plovila
Position of entry
DD/MM/LLLL – UU.MM Količina (Mt) rib na krovu po vrstah:
Date and Time (UTC) of entry
Rumenoplavuti tun (YFT)
DD/MM/YYYY — HH:MM
Veleoki tun (BET)
Quantity (Mt) of fish on board per specie:
Črtasti tun (SKJ)
Yellowfin (YFT)
Drugo (navedite)
Bigeye Tuna (BET)
Poročilo o izstopu (COX) [2]
Skipjack (SKJ)
Zemljepisna širina/dolžina
Others (Specify)
Oblika poročila o ulovu (CAT) po vstopu na ribolovna območja v ribolovnih vodah Cookovih otokov [3]
Position of exit
Vsa poročila se pošljejo pristojnemu organu prek naslednjih kontaktnih podatkov:
Date and Time (UTC) of exit
E-naslov: a.jones@mmr.gov.ck
Date and Time (UTC) of report
Poslano štiriindvajset (24) ur pred vstopom na ribolovna območja v ribolovnih vodah Cookovih otokov.
Number of sets made since last report
Poslano štiriindvajset (24) ur pred izstopom z ribolovnih območij v ribolovnih vodah Cookovih otokov.
All reports shall be transmitted to the competent authority through the following contacts:
Tedensko po vstopu na ribolovna območja v ribolovnih vodah Cookovih otokov.
E-mail: a.jones@mmr.gov.ck
1049 Bruselj
Fax: (+682) 29721
B-1049 Bruselj
Sent twenty four (24) hours before entering fishing areas within the fishery waters of the Cook Islands.
Subdirección General de Control e Inspección – Secretaria General de Pesca
Sent twenty four (24) hours before exiting fishing areas within the fishery waters of the Cook Islands.
Cookovi otoki
Weekly after entering fishing areas within the fishery waters of the Cook Islands.
Položaj ob izstopu
1049 Brussels
Mednarodni radijski klicni znak (IRCS)
B-1049 Bruxelles
Mednarodni radijski klicni znak (IRCS)
Subdirección General de Control e Inspección — Secretaria General de Pesca
Mednarodni radijski klicni znak (IRCS)
in the form of an Exchange of Diplomatic Notes with Japan in accordance with Article 15(3)(b) of the Agreement on Mutual Recognition (MRA) in order to amend Part B of the Sectoral Annex on Good Manufacturing Practice (GMP) for medicinal products
v obliki izmenjave diplomatskih not z Japonsko v skladu s členom 15(3)(b) Sporazuma o vzajemnem priznavanju za spremembo dela B Sektorske priloge o dobri proizvodni praksi (DPP) za zdravila
LETTER FROM JAPAN
DOPIS JAPONSKE
Brussels, April 22, 2016
Bruselj, 22. aprila 2016
Sir,
Spoštovani generalni direktor,
I have the honour to propose, on behalf of the Government of Japan, that Sections I and II of Part B of the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products of the Agreement on Mutual Recognition between Japan and the European Community, done at Brussels on April 4, 2001 (hereinafter referred to as the ‘Agreement’) be replaced by the Sections I and II of Part B attached to this Note, in accordance with subparagraph 3(b) of Article 15 of the Agreement.
V čast mi je, da lahko v imenu japonske vlade predlagam, da se oddelka I in II dela B Sektorske priloge o dobri proizvodni praksi (DPP) za zdravila k Sporazumu o vzajemnem priznavanju med Evropsko skupnostjo in Japonsko, sprejetim 4. aprila 2001 v Bruslju (v nadaljnjem besedilu: Sporazum), nadomestita z oddelkoma I in II dela B, priloženega k tej noti v skladu s členom 15(3)(b) Sporazuma.
I have further the honour to propose that, if the above proposal is acceptable to the European Union, it is suggested that this Note and your reply to that effect shall be regarded as constituting an agreement between the Government of Japan and the European Union on this matter which shall enter into force on the date of your reply.
Če je zgoraj navedeni predlog za Evropsko unijo sprejemljiv, mi je v čast tudi predlagati, da se ta nota in Vaš odgovor nanjo štejeta za sporazum med japonsko vlado in Evropsko unijo o tej zadevi, ki začne veljati na dan Vašega odgovora.
I avail myself of this opportunity to extend to you the assurance of my high consideration.
Ob tej priložnosti Vas prosim, da sprejmete izraz mojega globokega spoštovanja.
Ambassador Extraordinary and Plenipotentiary of Japan to the European Union
Veleposlanik in stalni predstavnik Japonske pri Evropski uniji
Director-General
Generalni direktor
LETTER FROM THE EUROPEAN UNION
DOPIS EVROPSKE UNIJE
I have the honour to acknowledge the receipt of Your Excellency's Note of today's date, which reads as follows.
„V čast mi je, da lahko v imenu japonske vlade predlagam, da se oddelka I in II dela B Sektorske priloge o dobri proizvodni praksi (DPP) za zdravila k Sporazumu o vzajemnem priznavanju med Evropsko skupnostjo in Japonsko, sprejetim 4. aprila 2001 v Bruslju (v nadaljnjem besedilu: Sporazum), nadomestita z oddelkoma I in II dela B, priloženega k tej noti v skladu s členom 15(3)(b) Sporazuma.
‘I have the honour to propose, on behalf of the Government of Japan, that Sections I and II of Part B of the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products of the Agreement on Mutual Recognition between Japan and the European Community, done at Brussels on April 4, 2001 (hereinafter referred to as the “Agreement”) be replaced by the Sections I and II of Part B attached to this Note, in accordance with subparagraph 3(b) of Article 15 of the Agreement.
Če je zgoraj navedeni predlog za Evropsko unijo sprejemljiv, mi je v čast tudi predlagati, da se ta nota in Vaš odgovor nanjo štejeta za sporazum med japonsko vlado in Evropsko unijo o tej zadevi, ki začne veljati na dan Vašega odgovora.“
I have further the honour to propose that, if the above proposal is acceptable to the European Union, it is suggested that this Note and your reply to that effect shall be regarded as constituting an agreement between the Government of Japan and the European Union on this matter which shall enter into force on the date of your reply.’
V imenu Evropske unije mi je v čast obvestiti Vašo ekscelenco, da Evropska unija sprejme zgoraj navedeni predlog japonske vlade in potrjuje, da se nota Vaše ekscelence šteje za sporazum med Evropsko unijo in japonsko vlado o tej zadevi, ki začne veljati na dan tega odgovora.
I have the honour to inform Your Excellency, on behalf of the European Union, that the European Union accepts the above proposal of the Government of Japan and to confirm that Your Excellency's Note and this reply shall be regarded as constituting an agreement between the European Union and the Government of Japan on this matter which shall enter into force on the date of this reply.
Ob tej priložnosti Vas prosim, da sprejmete izraz mojega globokega spoštovanja.
I avail myself of this opportunity to extend to Your Excellency the assurance of my highest consideration.
Njegova ekscelenca
Mr Keiichi Katakami
PRILOGA
ANNEX
DEL B
PART B
Oddelek I
Section I
Veljavni zakoni, predpisi in upravne določbe o zdravilih, zahtevah DPP za zdravila, preverjanju in potrjevanju
The applicable laws, regulations and administrative provisions stipulating medicinal products, GMP requirements for medicinal products, verification and confirmation
Evropska unija
European Union
Japonska
Japan
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, 28.11.2001, str. 67) in njene spremembe
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. 67) and amendments thereto
Direktiva 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi (UL L 121, 1.5.2001, str. 34) in njene spremembe
Directive 2001/20/EC of the European Parliament and of the Council 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. 34) and amendments thereto
Direktiva Komisije 2005/28/ES z dne 8. aprila 2005 o načelih in podrobnih smernicah za dobro klinično prakso v zvezi z zdravili v preskušanju za humano uporabo ter o zahtevah za pridobitev dovoljenja za proizvodnjo ali uvoz takšnih izdelkov (UL L 91, 9.4.2005, str. 13) in njene spremembe
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. 13) and amendments thereto
Uredba (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 (UL L 158, 27.5.2014, str. 1) in njene spremembe
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. 1)and amendments thereto
Direktiva Komisije 2003/94/ES z dne 8. oktobra 2003 o določitvi načel in smernic dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini in zdravili za uporabo v humani medicini v preskušanju (UL L 262, 14.10.2003, str. 22) in njene spremembe
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. 22) and amendments thereto
Delegirana uredba Komisije (EU) št. 1252/2014 z dne 28. maja 2014 o dopolnitvi Direktive 2001/83/ES Evropskega parlamenta in Sveta v zvezi z načeli in smernicami dobre proizvodne prakse za zdravilne učinkovine zdravil za uporabo v humani medicini (UL L 337, 25.11.2014, str. 1) in njene spremembe
Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (OJ L 337, 25.11.2014, p. 1) and amendments thereto
Zadnji različici Smernic za dobro proizvodno prakso, ki so del zvezka 4 Pravil, ki urejajo zdravila v Evropski uniji, in Zbirke postopkov Evropske unije o pregledih in izmenjavi informacij
Current versions of the Guide to good manufacturing practices contained in volume IV of Rules governing medicinal products in the European Union and Compilation of the European Union Procedures on Inspections and exchange of Information
Zakon o zagotavljanju kakovosti, učinkovitosti in varnosti izdelkov, vključno z zdravili in medicinskimi pripomočki (Zakon št. 145, 1960) in njegove spremembe
The Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Law No 145, 1960) and amendments thereto
Odredba kabineta o Zakonu o zagotavljanju kakovosti, učinkovitosti in varnosti izdelkov, vključno z zdravili in medicinskimi pripomočki (Odredba kabineta št. 11, 1961) in njene spremembe
Cabinet Order of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Cabinet Order No 11, 1961) and amendments thereto
Odlok o Zakonu o zagotavljanju kakovosti, učinkovitosti in varnosti izdelkov, vključno z zdravili in medicinskimi pripomočki (Odlok Ministrstva za zdravje in socialno varstvo št. 1, 1961) in njegove spremembe
Ordinance of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Ordinance of the Ministry of Health and Welfare No 1, 1961) and amendments thereto
Zdravila, ki jih je določil minister za zdravje, delo in socialno varstvo v skladu z določbami pododstavkov 6 in 7 člena 20-1 Odredbe kabineta o Zakonu o zagotavljanju kakovosti, učinkovitosti in varnosti izdelkov, vključno z zdravili in medicinskimi pripomočki in v skladu z določbami pododstavkov 6 in 7 člena 96 Odloka o Zakonu o zagotavljanju kakovosti, učinkovitosti in varnosti izdelkov, vključno z zdravili in medicinskimi pripomočki (Obvestilo Ministrstva za zdravje, delo in socialno varstvo št. 431) in njegove spremembe
Pharmaceuticals Designated by the Minister for Health, Labour and Welfare under the provisions of subparagraphs 6 and 7 of Article 20-1 of the Cabinet Order of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, and under the provisions of subparagraphs 6 and 7 of Article 96 of Ordinance of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Notice of Ministry of Health, Labour and Welfare No 431, 2004) and amendments thereto
Odlok o objektih in opremi za lekarne itn.
Ordinance for Facilities and Equipments for Pharmacies etc.
(Odlok Ministrstva za zdravje in socialno varstvo št. 2, 1961) in njegove spremembe
(Ordinance of the Ministry of Health and Welfare No 2, 1961) and amendments thereto
Ministrski odlok za standard o nadzoru proizvodnje in nadzoru kakovosti za zdravila in neprava zdravila (Odlok Ministrstva za zdravje, delo in socialno varstvo št. 179, 2004) in njegove spremembe
Ministerial Ordinance for the Standard of Manufacturing Control and Quality Control for Drugs and Quasi Drugs (Ordinance of the Ministry of Health, Labour and Welfare No 179, 2004) and amendments thereto
Oddelek II
Section II
Pristojni organi
Competent authorities
Pristojni organi Evropske unije so naslednji organi držav članic Evropske unije ali organi, ki jih nasledijo:
Competent Authorities of the European Union are the following authorities of the Member States of the European Union or authorities succeeding them:
Avstrija
Belgium
Bolgarija
Bulgaria
Hrvaška
Croatia
Ciper
Státní ústav pro kontrolu léčiv (SÚKL)
Estonija
Denmark
Finska
Estonia
Francija
Finland
Nemčija
France
Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel (samo biološka zdravila)
Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel (biologicals only)
Madžarska
Greece
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet(OGYÉI)
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI)
Italija
Malta
Portugalska
Netherlands
Romunija
Poland
Slovaška
Romania
Španija
Slovenia
Združeno kraljestvo
Spain
Evropska agencija za zdravila