natgillin/translations-raw huggingface dataset:
the products in the batch were manufactured in a manufacturing facility that has been certified as compliant by an equivalent regulatory authority;
združljivost naložbe z nacionalnimi politikami na področju industrije, gospodarstva in kulture, ob upoštevanju ciljev politike na področju industrije, gospodarstva in kulture, ki so jih izrazili vlada ali zakonodajalni organi province, na katero bo naložba po vsej verjetnosti pomembno vplivala; ter
the batch certificate is consistent with the Content of the Batch Certificate for Medicinal Products of the Internationally Harmonized Requirements for Batch Certification; and
prispevek naložbe k sposobnosti Kanade, da konkurira na svetovnih trgih.
the batch certificate is signed by the person responsible for releasing the batch for sale or supply.
Pri sprejemanju ugotovitve o neto koristih pristojni minister s posredovanjem direktorja za naložbe lahko pregleda načrte, v skladu s katerimi vložnik predstavi neto koristi predlagane pridobitve za Kanado.
Paragraph 1 does not affect a Party's right to conduct official batch release.
Vložnik lahko v zvezi s predlagano pridobitvijo, ki je predmet pregleda, pristojnemu ministru predloži tudi zaveze.
The person responsible for releasing the batch:
V primeru nezdružljivosti z vložnikovo zavezo lahko pristojni minister vloži zahtevek za sodno odločbo, s katero se naloži izpolnitev skladnosti, ali uporabi kakršno koli drugo pravno sredstvo v okviru Investment Canada Act.
of the finished medicinal product for sale or supply for manufacturing facilities in the European Union, must be a ‘qualified person’ as defined in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC; or
Subjekt, ki ni kanadski, in ustanovi ali pridobi kanadsko družbo, ki ni predmet pregleda, kakor je opisano zgoraj, mora obvestiti direktorja za naložbe.
for sale or supply of a drug for manufacturing facilities in Canada, is the person in charge of the quality control department as provided for by the Food and Drugs Regulations, C.R.C., c.
Pragi za pregled iz odstavkov 1 in 3 se ne uporabljajo za pridobitev družbe s področja kulture.
870, Part C, Division 2, section C.02.014.
Poleg tega je lahko posebna pridobitev ali ustanovitev nove družbe v okviru določenih vrst poslovnih dejavnosti v zvezi s kanadsko kulturno dediščino ali nacionalno identiteto, ki jih je treba priglasiti, predmet pregleda, če Governor in Council odobri pregled v javnem interesu.
On-site evaluation
Posredna „pridobitev nadzora“ nad kanadsko družbo, ki ni družba s področja kulture, s strani vlagatelja iz Evropske unije, ni predmet pregleda.
A Party has the right to conduct its own on-site evaluation of a manufacturing facility that has been certified as compliant by an equivalent regulatory authority of the other Party.
Ne glede na člen 8.5 (Operativne zahteve) lahko Kanada naloži izpolnitev zahteve ali izvajanje zaveze v povezavi z ustanavljanjem, pridobitvijo, širitvijo, izvajanjem, delovanjem ali upravljanjem kakršne koli naložbe s strani vlagatelja iz Evropske unije ali tretje države za prenos tehnologije, proizvodnega procesa ali drugega zaščitenega znanja na državljana ali družbo, povezano s prenosnikom, v Kanadi v zvezi s pregledom pridobitve naložbe v okviru Investment Canada Act.
A Party, prior to conducting an on-site evaluation under paragraph 1, shall notify the other Party in writing and inform that other Party of the scope of the on-site evaluation.
Razen za zahteve in zaveze v zvezi s prenosom tehnologije, kakor je navedeno v odstavku 10 tega pridržka, se člen 8.5 (Operativne zahteve) uporablja za zahteve in zaveze, ki so naložene v okviru Investment Canada Act.
The Party shall endeavour to notify the other Party in writing at least 30 days before a proposed on-site evaluation, but may provide less notice in urgent situations.
Za namene tega pridržka „subjekt, ki ni kanadski“ pomeni posameznika, vlado ali vladno agencijo ali entiteto, ki ni kanadska; „kanadski subjekt“ pa pomeni kanadskega državljana ali subjekt, ki je stalni rezident, vlado v Kanadi ali vladno agencijo ali entiteto pod kanadskim nadzorom, kot je opisano v okviru Investment Canada Act.
The other Party has the right to join the on-site evaluation conducted by the Party.
Pridržek I-C-2
Inspections and on-site evaluations at the request of a Party
Kakor so določeni v elementu Opis
At the request of a Party, the other Party shall inspect a facility involved in the manufacturing process of a medicinal product or drug that is being imported into the territory of the requesting Party in order to verify that the facility is in compliance with good manufacturing practices.
Kanada ali njena provinca ali ozemlje lahko v primeru prodaje ali odsvojitve svojih lastniških deležev ali sredstev v obstoječi vladni družbi ali entiteti uvede prepoved ali omejitve v zvezi z lastništvom takih lastniških deležev ali sredstev ter sposobnostjo lastnikov takih lastniških deležev ali sredstev, da nadzorujejo nastalo družbo prek vlagateljev iz Evropske unije ali tretje države ali njihovih naložb.
At the request of a Party, the other Party may conduct an on-site evaluation based on the assessment of data contained in a product submission dossier.
Kar zadeva tako prodajo ali drugo odsvojitev lahko Kanada ali njena provinca ali ozemlje sprejme ali ohranja ukrep v zvezi z državljanstvom oseb na višjih vodstvenih položajih ali članov upravnega odbora.
The Parties may exchange relevant product information with respect to a request to conduct an on-site evaluation in accordance with Article 14.
Za namene tega pridržka:
Safeguards
ukrep, ki je bil ohranjen ali sprejet po datumu začetka veljavnosti tega sporazuma, s katerim se v času prodaje ali druge odsvojitve prepove lastništvo lastniških deležev ali sredstev ali naloži omejitev v zvezi z njimi ali naloži zahteva za državljanstvo, opisana v tem pridržku, je obstoječ ukrep; ter
A Party has the right to conduct its own inspection of a manufacturing facility that has been certified as compliant by an equivalent regulatory authority of the other Party.
vladna družba pomeni družbo, ki je prek lastniške udeležbe v lasti ali pod nadzorom Kanade, njene province ali ozemlja, ter vključuje družbo, ki je bila ustanovljena po datumu začetka veljavnosti tega sporazuma izključno za namene prodaje ali odsvojitve lastniških deležev v obstoječi državni družbi ali vladni entiteti ali njunih sredstev.
Recourse to this right should be an exception from the normal practice of the Party.
Pridržek I-C-3
A Party, prior to conducting an inspection under paragraph 1, shall notify the other Party in writing and shall inform the other Party of the reasons for conducting its own inspection.
Družba lahko uvede omejitve na izdajo, prenos in lastništvo delnic v družbi, ustanovljeni na zvezni ravni.
The Party shall endeavour to notify the other Party in writing at least 30 days before a proposed inspection, but may provide less notice in urgent situations.
Cilj teh omejitev je omogočiti družbi, da izpolni zahteve v zvezi s kanadskim lastništvom ali nadzorom, ki so v skladu z nekaterimi zakoni določene v okviru Canada Business Corporations Regulations 2001, v sektorjih, kjer se kanadsko lastništvo ali nadzor zahtevata kot pogoj za pridobitev licenc, dovoljenj, nepovratnih sredstev, plačil ali drugih ugodnosti.
The other Party has the right to join the inspection conducted by the Party.
Da se ohrani določena stopnja kanadskega lastništva, lahko družba proda delnice delničarjev brez njihovega soglasja in kupi lastne delnice na odprtem trgu.
Two-way alert programme and information sharing
V okviru Canada Cooperatives Act je določeno, da se lahko uvedejo omejitve na izdajo ali prenos investicijskih delnic zadruge subjektom, ki niso rezidenti v Kanadi, in sicer se zadrugam tako omogoči izpolnitev zahtev za kanadsko lastništvo, da lahko pridobijo licenco za opravljanje dejavnosti, postanejo založnik kanadskega časopisa ali periodičnega tiska ali pridobijo investicijske delnice finančnega posrednika in v sektorjih, kjer je lastništvo ali nadzor zahtevan pogoj za pridobitev licenc, dovoljenj, nepovratnih sredstev, plačil in drugih ugodnosti.
A Party shall, pursuant to the two-way alert programme under the GMP Administrative Arrangement referred to in Article 15.3:
Za primere škodljivega vpliva lastništva investicijskih delnic ali nadzora nad njimi na sposobnost zadruge, da ohranja raven kanadskega lastništva ali nadzora, je v okviru Canada Cooperatives Actdoločena omejitev števila investicijskih delnic, ki so lahko v lasti, ali prepoved lastništva investicijskih delnic.
ensure that a restriction, suspension or withdrawal of a manufacturing authorisation that could affect the protection of public health is communicated from the relevant regulatory authority in its territory to the relevant regulatory authority in the territory of the other Party; and
Za namene tega pridržka kanadsko pomeni „kanadsko“, kakor je opredeljeno v okviru Canada Business Corporations Regulations 2001, ali v okviru Canada Cooperatives Regulations.
if relevant, proactively notify the other Party in writing of a confirmed report of a serious problem relating to a manufacturing facility in its territory, or as identified through an on-site evaluation or inspection in the territory of the other Party, including a problem related to quality defects, batch recalls, counterfeited or falsified medicinal products or drugs, or potential serious shortages.
Pridržek I-C-4
A Party shall, as part of the components of the information sharing process under the GMP Administrative Arrangement referred to in Article 15.3:
Posebni zakoni parlamenta, ki vključujejo specifične družbe
respond to a special request for information, including a reasonable request for an inspection report or an on-site evaluation report; and
V okviru Canada Business Corporations Act se za večino na zvezni ravni ustanovljenih družb zahteva, da je 25 odstotkov direktorjev kanadskih rezidentov, v primeru, da imajo take družbe manj kot štiri direktorje, pa mora biti vsaj eden od direktorjev kanadski rezident.
ensure that, at the request of the other Party or of an equivalent authority of the other Party, an equivalent authority within its territory provides relevant information.
Kakor je določeno v Canada Business Corporations Regulations 2001, morajo imeti družbe navadno večino direktorjev, ki so kanadski rezidenti, v naslednjih sektorjih: pridobivanje urana; knjižno založništvo ali distribucija; prodaja knjig, če prodaja knjig predstavlja glavno dejavnost družbe; in distribucija filmov ali videov.
A Party shall provide the other Party, through written notification, contact points for each equivalent authority in its territory.
Podobno se za družbe, za katere na podlagi akta parlamenta ali uredbe velja posamezno določena obveznost izpolnitve zahtev za minimalno kanadsko lastništvo, zahteva, da je večina direktorjev kanadskih rezidentov.
Equivalence of new regulatory authorities
Za namene Canada Business Corporations Act kanadski rezident pomeni posameznika, ki je kanadski državljan in običajno prebiva v Kanadi, ali kanadski državljan, ki običajno ne prebiva v Kanadi, pri čemer ta oseba spada v kategorijo, določeno v okviru Canada Business Corporations Regulations 2001, ali „stalnega rezidenta“, kakor je opredeljen v okviru Immigration and Refugee Protection Act, S.C.
A Party (‘requesting Party’) may request that a regulatory authority in its territory that is not recognised as equivalent to regulatory authorities in the other Party (‘evaluating Party’), be evaluated to determine whether it should be recognised as equivalent.
2001, p.
Upon receiving the request, the evaluating Party shall conduct an evaluation pursuant to the procedure for evaluating new regulatory authorities under the GMP Administrative Arrangement referred to in Article 15.3.
27, razen stalnih rezidentov, ki so v Kanadi običajno prebivali več kot eno leto, potem ko so postali upravičeni, da lahko zaprosijo za kanadsko državljanstvo.
The evaluating Party shall evaluate the new regulatory authority by applying the components of a GMP compliance programme under the Administrative Arrangement referred to in Article 15.3.
V primeru holdinške družbe mora biti ne več kot ena tretjina direktorjev kanadskih rezidentov, če dobiček holdinške družbe in njenih hčerinskih družb v Kanadi znaša manj kot pet odstotkov bruto dobička holdinške družbe in njenih hčerinskih podjetij.
The components of a GMP compliance programme must include such elements as legislative and regulatory requirements, inspections standards, surveillance systems and a quality management system.
V okviru Canada Cooperatives Act se zahteva, da sta vsaj dve tretjini direktorjev med člani zadruge.
If, upon completion of its evaluation, the evaluating Party determines that the new regulatory authority is equivalent, it shall notify the requesting Party in writing that it recognises the new regulatory authority as equivalent.
Vsaj 25 odstotkov direktorjev zadruge mora biti rezidentov v Kanadi; če ima zadruga samo tri direktorje, mora biti vsaj eden od njih rezident v Kanadi.
If, upon completion of its evaluation, the evaluating Party determines that the new regulatory authority is not equivalent, the evaluating Party shall provide to the requesting Party a written justification demonstrating that it has well-founded reasons for not recognising that the new regulatory authority is equivalent.
Za namene Canada Cooperatives Act je kanadski rezident opredeljen v okviru Canada Cooperatives Regulations kot posameznik, ki je kanadski državljan in običajno prebiva v Kanadi; kanadski državljan, ki običajno ne prebiva v Kanadi in spada v kategorijo, določeno v okviru Canada Cooperatives Regulations,ali „stalni rezident“, kakor je opredeljen v okviru Immigration and Refugee Protection Act, razen stalnega rezidenta, ki je običajno prebival v Kanadi več kot eno leto, potem ko je postal upravičen, da lahko zaprosi za kanadsko državljanstvo.
At the request of the requesting Party, the Joint Sectoral Group on Pharmaceuticals (‘Joint Sectoral Group’) referred to in Article 15 shall consider the evaluating Party's refusal to recognise the new regulatory authority as equivalent, and may provide recommendations to assist both Parties to resolve the matter.
Pridržek I-C-5
If, upon completion of its evaluation, the evaluating Party determines that the new regulatory authority is only equivalent for a more limited scope than that proposed by the requesting Party, the evaluating Party shall provide to the requesting Party a written justification demonstrating that it has well-founded reasons to determine that the new regulatory authority is only equivalent for the more limited scope.
Foreign Ownership of Land Regulationstemelji na Citizenship Actin Agricultural and Recreational Land Ownership Act,R.S.A.
At the request of the requesting Party, the Joint Sectoral Group shall consider the evaluating Party's refusal to recognise the new regulatory authority as equivalent, and may provide recommendations to assist both Parties to resolve the matter.
V provinci Alberti ima lahko subjekt, ki ni upravičenec, ali družba v tuji lasti ali pod tujim nadzorom delež samo pri ozemlju, ki je pod nadzorom in vključuje največ dve zemljišči, ki obsegata vsega skupaj največ 20 akrov.
A regulatory authority recognised as equivalent under the Agreement on Mutual Recognition Between the European Community and Canada, done at London on 14 May 1998, is recognised as equivalent under this Agreement from its entry into force.
subjekt, ki ni upravičenec, pomeni:
Equivalence maintenance programme
fizično osebo, ki ni kanadski državljan ali stalni rezident;
The Joint Sectoral Group shall develop an equivalence maintenance programme under the GMP Administrative Arrangement referred to in Article 15.3 to maintain the equivalence of the regulatory authorities.
tujo vlado ali tujo vladno agencijo; ali
The Parties shall act in accordance with this programme when deciding whether to change the equivalence status of a regulatory authority.
družbo, ustanovljeno v državi, ki ni Kanada; ter
If the equivalence status of a regulatory authority changes, a Party may re-evaluate that regulatory authority.
ozemlje pod nadzorom pomeni ozemlje v Alberti, vendar ne vključuje:
Any re-evaluation must be undertaken pursuant to the procedure set out in Article 12.
ozemlja Krone, ki je zajeto v njenih pravicah do province Alberte;
The scope of re-evaluation shall be limited to the elements that caused the change of the equivalence status.
ozemlja znotraj mest, krajev, novih krajev, vasi ali počitniških naselij; ter
The Parties shall exchange all the necessary information to ensure that both Parties remain confident that equivalent regulatory authorities are in fact equivalent.
rudnikov ali mineralov.
A Party shall inform the other Party before adopting changes to its technical guidance or regulations relating to good manufacturing practices.
Pridržek I-C-6
A Party shall inform the other Party of any new technical guidance, inspection procedures or regulations relating to good manufacturing practices.
1985, p.
A Party shall not publicly disclose non-public and confidential technical, commercial or scientific information, including trade secrets and proprietary information that it has received from the other Party.
35 (4th Supp.)
A Party may disclose the information referred to in paragraph 1 if it deems such disclosure necessary to protect public health and safety.
1986, p.
The Joint Sectoral Group, established under Article 26.2.1(a) (Specialised committees), is composed of representatives from both Parties.
Za nekatere družbe se omejitve uporabljajo za posamezne delničarje, medtem ko se za druge družbe omejitve lahko uporabljajo za celoto.
The Joint Sectoral Group shall establish its composition and determine its rules and procedures.
Če obstajajo omejitve glede deleža, ki ga ima lahko v lasti posamezni kanadski vlagatelj, se te omejitve uporabljajo tudi za nerezidente.
The Joint Sectoral Group shall conclude a GMP Administrative Arrangement to facilitate the effective implementation of this Protocol.
Omejitve so naslednje:
The GMP Administrative Arrangement shall include:
Air Canada: 25 odstotkov v celoti;
the terms of references of the Joint Sectoral Group;
Cameco Limited (prej Eldorado Nuclear Limited): 15 odstotkov na fizično osebo, ki ni rezident, 25 odstotkov v celoti;
the two-way alert programme;
Nordion International Inc.: 25 odstotkov v celoti;
the list of contact points responsible for matters arising under this Protocol;
Theratronics International Limited: 49 odstotkov v celoti; ter
the components of the information sharing process;
Canadian Arsenals Limited: 25 odstotkov v celoti.
the components of a good manufacturing practices compliance programme;
Za namene tega pridržka nerezidenti vključujejo:
the procedure for evaluating new regulatory authorities; and
fizično osebo, ki ni kanadski državljan in običajno ne prebiva v Kanadi;
the equivalence maintenance programme.
družbo, ki je bila ustanovljena, oblikovana ali drugače organizirana zunaj Kanade;
The Joint Sectoral Group may modify the GMP Administrative Arrangement if it considers it necessary.
vlado tuje države ali politično enoto vlade tuje države ali osebo, ki je pooblaščena, da opravlja funkcijo ali dolžnost v imenu take vlade;
At the request of the Parties, the Joint Sectoral Group shall review the Annexes to this Protocol, and shall develop recommendations for amendments to these Annexes for consideration by the CETA Joint Committee.
družbo, ki je pod neposrednim ali posrednim nadzorom osebe ali entitete iz pododstavkov (a) do (c);
Pursuant to paragraph 5, the Joint Sectoral Group shall review the operational scope of medicinal products or drugs under paragraph 2 of Annex 1, with a view to including those medicinal products or drugs listed in paragraph 1 of Annex 1.
trust;
The Parties shall establish the GMP Administrative Arrangement upon entry into force of the Agreement.
ki ga je ustanovila oseba ali entiteta iz pododstavkov (b) do (d) in ni trust za upravljanje pokojninskega sklada v korist fizičnih oseb, od katerih je večina rezidentov v Kanadi; ali
This Arrangement is not subject to the provisions of Chapter Twenty-Nine (Dispute Settlement).
v katerem ima oseba ali entiteta iz pododstavkov (a) do (d) več kot 50 odstotkov upravičenega deleža; ter
For the purposes of this Article, a fee includes a cost-recovery measure such as a user fee, a regulatory charge or an amount set under a contract.
družbo, ki je pod neposrednim ali posrednim nadzorom trusta iz pododstavka (e).
A Party shall have the right to determine a fee applicable to manufacturing facilities in its territory, including fees related to issuing certificates of GMP compliance and fees related to inspections or on-site evaluations.
Pridržek I-C-7
The fees charged to a manufacturing facility in case of an inspection or on-site evaluation conducted by a Party at the request of the other Party must be consistent with paragraph 2.
Čezmejna trgovina s storitvami
MEDICINAL PRODUCTS OR DRUGS
Samo fizična oseba, ki običajno prebiva v Kanadi, družba z glavnim sedežem v Kanadi ali podružnica tuje družbe v Kanadi lahko vložijo vlogo in pridobijo uvozno ali izvozno dovoljenje ali certifikat za tranzitno dovoljenje za blago ali povezano storitev, ki sta predmet nadzora v okviru Export and Import Permits Act.
Scope of medicinal products or drugs
Pridržek I-C-8
human pharmaceuticals including prescription and non-prescription medicinal products or drugs and medicinal gases;
Naložbe in čezmejna trgovina s storitvami
human biologicals including immunologicals, stable medicinal products derived from human blood or human plasma, and biotherapeutics;
Kanada si pridržuje pravico, da ohrani ukrep v zvezi z zagotavljanjem storitev socialnega varstva, ki niso zajete s pridržkom II-C-9, kar zadeva storitve socialnega varstva.
veterinary pharmaceuticals, including prescription and non-prescription medicinal products or drugs, and pre-mixes for the preparation of veterinary medicated feeds;
Pridržek I-C-9
veterinary biologicals;
Komunikacijske storitve
if appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products;
Telekomunikacijska prenosna omrežja in storitve
active pharmaceutical ingredients;
Radiokomunikacije
intermediate products and bulk pharmaceuticals (for example, bulk tablets);
Tuje naložbe v ponudnike telekomunikacijskih storitev z lastno infrastrukturo so omejene na največji skupni seštevek 46,7 odstotkov glasovalnega deleža, ki temelji na 20 odstotkih neposrednih naložb in 33,3 odstotka posrednih naložb.
products intended for use in clinical trials or investigational medicinal products; and
Ponudniki telekomunikacijskih storitev z lastno infrastrukturo morajo biti dejansko pod nadzorom kanadskih subjektov.
advanced therapy medicinal products.
Vsaj 80 odstotkov članov upravnega odbora ponudnikov telekomunikacijskih storitev z lastno infrastrukturo mora biti kanadskih.
Operational scope of medicinal products or drugs
Ne glede na zgoraj opisane omejitve velja naslednje:
Further to paragraph 1, the GMP requirements and compliance programmes of both Parties are equivalent for the following medicinal products or drugs:
tuje naložbe lahko znašajo do 100 odstotkov za ponudnike, ki izvajajo operacije v okviru mednarodne licence za podvodni kabel;
human biologicals including immunologicals and biotherapeutics;
za zagotovitev storitev v Kanadi lahko kanadski ponudnik storitev uporabi mobilne satelitske sisteme tujega ponudnika storitev;
intermediate products and bulk pharmaceuticals;
fiksni satelitski sistemi tujega ponudnika storitev se lahko uporabijo za zagotovitev storitev med točkami v Kanadi in vsemi točkami zunaj Kanade;
products intended for use in clinical trials or investigational medicinal products; manufactured by the manufacturers holding a manufacturing authorisation or establishment licence; and
tuje naložbe lahko znašajo do 100 odstotkov za ponudnike, ki izvajajo operacije v okviru dovoljenja v povezavi s satelitom; ter