natgillin/translations-raw huggingface dataset:
Where a certificate is granted for a product protected by a patent which, before 2 January 1993, had its term extended or for which such extension was applied for, under national law, the term of protection to be afforded under this certificate shall be reduced by the number of years by which the term of the patent exceeds 20 years.
Če je certifikat podeljen za izdelek, ki je varovan s patentom, katerega trajanje je bilo podaljšano po nacionalni patentni zakonodaji pred 2. januarjem 1993 ali pa je bila za tako podaljšanje vložena vloga, se trajanje varstva, ki ga omogoča ta certifikat, skrajša za število let, za katero trajanje patenta presega 20 let.
Expiry of the certificate
Prenehanje certifikata
The certificate shall lapse:
Certifikat preneha:
at the end of the period provided for in Article 13;
na koncu obdobja, določenega v členu 13;
if the certificate holder surrenders it;
če se mu imetnik odpove;
if the annual fee laid down in accordance with Article 12 is not paid in time;
če letna pristojbina, določena v skladu s členom 12, ni pravočasno plačana;
if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of the appropriate authorisation or authorisations to place on the market in accordance with Directive 2001/83/EC or Directive 2001/82/EC.
če in za tako dolgo, kolikor je bila izdelku, ki ga zajema certifikat, odvzeto dovoljenje za dajanje v promet v skladu z Direktivo 2001/83/ES ali Direktivo 2001/82/ES.
The authority referred to in Article 9(1) of this Regulation may decide on the lapse of the certificate either of its own motion or at the request of a third party.
Organ iz člena 9(1) te uredbe lahko odloči o prenehanju certifikata po uradni dolžnosti ali pa na zahtevo tretje stranke.
Invalidity of the certificate
Ničnost certifikata
The certificate shall be invalid if:
Certifikat je ničen, če:
it was granted contrary to the provisions of Article 3;
je bil podeljen v nasprotju z določbami člena 3;
the basic patent has lapsed before its lawful term expires;
je osnovni patent prenehal pred prenehanjem zakonitega trajanja;
the basic patent is revoked or limited to the extent that the product for which the certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation.
je osnovni patent razveljavljen ali toliko omejen, da izdelek, za katerega je bil podeljen certifikat, ne bi bil več varovan z zahtevki osnovnega patenta, ali če po prenehanju osnovnega patenta obstajajo razlogi za razveljavitev, ki bi utemeljili tako razveljavitev ali omejitev.
Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the body responsible under national law for the revocation of the corresponding basic patent.
Pri organu, ki je po nacionalni zakonodaji pristojen za ugotovitev ničnosti ustreznih osnovnih patentov, lahko vsakdo vloži vlogo ali tožbo za ugotovitev ničnosti certifikata.
Any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent.
Katera koli oseba lahko organu, ki je po nacionalni zakonodaji pristojen za preklic ustreznega osnovnega patenta, predloži prijavo za preklic podaljšanja veljavnosti.
Notification of lapse or invalidity
Obvestilo o prenehanju ali ničnosti
If the certificate lapses in accordance with point (b), (c) or (d) of Article 14, or is invalid in accordance with Article 15, notification thereof shall be published by the authority referred to in Article 9(1).
Če certifikat preneha v skladu s točkami (b), (c) ali (d) člena 14 ali je ničen v skladu s členom 15, organ iz člena 9(1) o tem objavi uradno obvestilo.
If the extension of the duration is revoked in accordance with Article 16, notification thereof shall be published by the authority referred to in Article 9(1).
Če je podaljšanje veljavnosti preklicano v skladu s členom 16, organ iz člena 9(1) o tem objavi uradno sporočilo.
The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Articles 15(2) and 16(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.
Proti odločitvam organa iz člena 9(1) ali organov iz členov 15(2) in 16(2), ki so bile sprejete na podlagi te uredbe, se lahko vložijo enake pritožbe, kot jih predvideva nacionalna zakonodaja za podobne odločitve, sprejete v zvezi z nacionalnimi patenti.
In the absence of procedural provisions in this Regulation, the procedural provisions applicable under national law to the corresponding basic patent shall apply to the certificate, unless the national law lays down special procedural provisions for certificates.
Kolikor ta uredba ne določa pravil postopka, veljajo za certifikat postopkovne določbe nacionalne zakonodaje za ustrezni osnovni patent, razen če nacionalna zakonodaja določa poseben postopek za certifikate.
Notwithstanding paragraph 1, the procedure for opposition to the granting of a certificate shall be excluded.
Ne glede na odstavek 1 postopek ugovora podelitvi certifikata ni mogoč.
Additional provisions relating to the enlargement of the Community
Dodatne določbe, ki se nanašajo na širitev Skupnosti
Without prejudice to the other provisions of this Regulation, the following provisions shall apply:
Naslednje določbe se uporabljajo brez poseganja v druge določbe te uredbe:
any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Bulgaria, provided that the application for a certificate was lodged within six months from 1 January 2007;
vsem zdravilom, ki so varovana z veljavnim osnovnim patentom in za katera je bilo prvo dovoljenje za dajanje v promet kot zdravila pridobljeno po 1. januarju 2000, se v Bolgariji sme podeliti certifikat, pod pogojem, da je prijava za pridobitev certifikata vložena v šestih mesecih od 1. januarja 2007;
any medicinal product protected by a valid basic patent in the Czech Republic and for which the first authorisation to place it on the market as a medicinal product was obtained:
vsem zdravilom, ki so v Češki republiki varovana z veljavnim osnovnim patentom in za katera je bilo prvo dovoljenje za dajanje v promet kot zdravila pridobljeno:
in the Czech Republic after 10 November 1999 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained;
v Češki republiki, po 10. novembru 1999, se sme podeliti certifikat, pod pogojem, da je bila prijava za certifikat vložena v šestih mesecih od dne pridobitve prvega dovoljenja za dajanje v promet;
in the Community not earlier than six months prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained;
v Skupnosti, največ šest mesecev pred 1. majem 2004, se sme podeliti certifikat, pod pogojem, da je bila prijava za certifikat vložena v šestih mesecih od dne pridobitve prvega dovoljenja za dajanje v promet;
any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Estonia prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or, in the case of those patents granted prior to 1 January 2000, within the six months provided for in the Patents Act of October 1999;
vsem zdravilom, ki so varovana z veljavnim osnovnim patentom in za katera je bila prvo dovoljenje za dajanje v promet kot zdravila pridobljeno v Estoniji pred 1. majem 2004, se sme podeliti certifikat, pod pogojem, da je bila prijava za certifikat vložena v šestih mesecih od dne pridobitve prvega dovoljenja za dajanje v promet, oziroma v primeru, da je bil patent podeljen pred 1. januarjem 2000, v roku šestih mesecev, kot ga določa Zakon o patentih iz oktobra 1999;
any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Cyprus prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; notwithstanding the above, where the market authorisation was obtained before the grant of the basic patent, the application for a certificate must be lodged within six months of the date on which the patent was granted;
vsem zdravilom, ki so varovana z veljavnim osnovnim patentom in za katera je bilo prvo dovoljenje za dajanje v promet kot zdravila pridobljeno na Cipru pred 1. majem 2004, se sme podeliti certifikat, pod pogojem, da je bila prijava za certifikat vložena v šestih mesecih od dne pridobitve prvega dovoljenja za dajanje v promet; ne glede na zgoraj navedeno, se mora prijava za certifikat vložiti v šestih mesecih od dne pridobitve patenta, če je bilo dovoljenje za dajanje v promet pridobljeno pred pridobitvijo osnovnega patenta;
any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Latvia prior to 1 May 2004 may be granted a certificate.
vsem zdravilom, ki so varovana z veljavnim osnovnim patentom in za katera je bilo prvo dovoljenje za dajanje v promet kot zdravila pridobljeno v Latviji pred 1. majem 2004, se sme podeliti certifikat.
In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 May 2004;
V primeru, da se je rok iz člena 7(1) že iztekel, je mogoče podati prijavo za pridobitev certifikata v roku šestih mesecev od 1. maja 2004;
any medicinal product protected by a valid basic patent applied for after 1 February 1994 and for which the first authorisation to place it on the market as a medicinal product was obtained in Lithuania prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from 1 May 2004;
vsem zdravilom, ki so varovana z veljavnim osnovnim patentom, prijavljenim po 1. februarju 1994, in za katera je bilo prvo dovoljenje za dajanje v promet kot zdravila pridobljeno v Litvi pred 1. majem 2004, se sme podeliti certifikat, pod pogojem, da je prijava za pridobitev certifikata vložena v šestih mesecih od 1. maja 2004;
any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Hungary, provided that the application for a certificate was lodged within six months from 1 May 2004;
vsem zdravilom, ki so varovana z veljavnim osnovnim patentom in za katere je bilo prvo dovoljenje za dajanje v promet kot zdravila pridobljeno na Madžarskem po 1. januarju 2000, se sme podeliti certifikat, pod pogojem, da je prijava za pridobitev certifikata vložena v šestih mesecih od 1. maja 2004;
any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Malta prior to 1 May 2004 may be granted a certificate.
vsem zdravilom, ki so varovana z veljavnim osnovnim patentom in za katera je bilo prvo dovoljenje za dajanje v promet kot zdravila pridobljeno na Malti pred 1. majem 2004, se sme podeliti certifikat.
any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Poland, provided that the application for a certificate was lodged within six months starting no later than 1 May 2004;
vsem zdravilom, ki so varovana z veljavnim osnovnim patentom in za katere je bilo prvo dovoljenje za dajanje v promet kot zdravila pridobljeno na Poljskem po 1. januarju 2000, se sme podeliti certifikat, pod pogojem, da je prijava za pridobitev certifikata vložena v šestih mesecih od 1. maja 2004;
any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Romania.
vsem zdravilom, ki so varovana z veljavnim osnovnim patentom in za katera je bilo prvo dovoljenje za dajanje v promet kot zdravila pridobljeno po 1. januarju 2000, se v Romuniji sme podeliti certifikat.
In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 January 2007;
V primeru, da je rok iz člena 7(1) že potekel, je mogoče podati prijavo za pridobitev certifikata v roku šestih mesecev od 1. januarja 2007;
any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovenia prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from 1 May 2004, including in cases where the period provided for in Article 7(1) has expired;
vsem zdravilom, ki so varovana z veljavnim osnovnim patentom in za katera je bilo prvo dovoljenje za dajanje v promet kot zdravila pridobljeno v Sloveniji pred 1. majem 2004, se sme podeliti certifikat, pod pogojem, da je prijava za pridobitev certifikata vložena v šestih mesecih od 1. maja 2004, vključno s primeri, v katerih je rok iz člena 7(1) že potekel;
any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovakia after 1 January 2000 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or within six months of 1 July 2002 if the market authorisation was obtained before that date.
vsem zdravilom, ki so varovana z veljavnim osnovnim patentom in za katera je bilo prvo dovoljenje za dajanje v promet kot zdravila pridobljeno na Slovaškem pred 1. januarjem 2000, se sme podeliti certifikat, pod pogojem, da je bila prijava za certifikat vložena v šestih mesecih od dne, ko je bilo pridobljeno prvo dovoljenje za dajanje v promet, oziroma v šestih mesecih od 1. julija 2002, če je bilo dovoljenje za dajanje v promet pridobljeno pred tem datumom.
This Regulation shall not apply to certificates granted in accordance with the national legislation of a Member State before 2 January 1993 or to applications for a certificate filed in accordance with that legislation before 2 July 1992.
Ta uredba se ne uporablja za certifikate, podeljene v skladu z nacionalno zakonodajo države članice pred 2. januarjem 1993, ali za prijave za certifikate, ki so bile vložene v skladu z nacionalno zakonodajo pred 2. julijem 1992.
With regard to Austria, Finland and Sweden, this Regulation shall not apply to certificates granted in accordance with their national legislation before 1 January 1995.
V primeru Avstrije, Finske in Švedske se ta uredba ne uporablja za certifikate, izdane skladno z njihovo nacionalno zakonodajo pred 1. januarjem 1995.
This Regulation shall apply to supplementary protection certificates granted in accordance with the national legislation of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Malta, Poland, Slovenia and Slovakia prior to 1 May 2004 and the national legislation of Romania prior to 1 January 2007.
Ta uredba se uporablja za dodatne varstvene certifikate, pridobljene v skladu z nacionalno zakonodajo Češke republike, Estonije, Cipra, Latvije, Litve, Malte, Poljske, Slovenije in Slovaške pred 1. majem 2004 ter nacionalno zakonodajo Romunije pred 1. januarjem 2007.
Regulation (EEC) No 1768/92, as amended by the acts listed in Annex I, is repealed.
Uredba (EGS) št. 1768/92, kakor je bila spremenjena z akti iz Priloge I, se razveljavi.
References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.
Sklicevanja na razveljavljeno uredbo se upoštevajo kot sklicevanja na to uredbo in se berejo v skladu s korelacijsko tabelo iz Priloge II.
Opinion of the European Parliament of 21 October 2008 (not yet published in the Official Journal) and Council Decision of 6 April 2009.
Mnenje Evropskega parlamenta z dne 21. oktobra 2008 (še ni objavljeno v Uradnem listu) in Sklep Sveta z dne 6. aprila 2009.
REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS
RAZVELJAVLJENA UREDBA S SEZNAMOM NJENIH ZAPOREDNIH SPREMEMB
Council Regulation (EEC) No 1768/92
Uredba Sveta (EGS) št. 1768/92
(OJ L 182, 2.7.1992, p. 1)
(UL L 182, 2.7.1992, str. 1)
Annex I, point XI.F.I, of the 1994 Act of Accession
Priloga I, točka XI.F.I, k Aktu o pristopu iz leta 1994
(OJ C 241, 29.8.1994, p. 233)
(UL C 241, 29.8.1994, str. 233)
Annex II, point 4.C.II, of the 2003 Act of Accession
Priloga II, točka 4.C.II, k Aktu o pristopu iz leta 2003
Annex III, point 1.II, of the 2005 Act of Accession
Priloga III, točka 1.II, k Aktu o pristopu iz leta 2005
(OJ L 157, 21.6.2005, p. 56)
(UL L 157, 21.6.2005, str. 56)
(OJ L 378, 27.12.2006, p. 1)
(UL L 378, 27.12.2006, str. 1)
Only Article 52
Samo člen 52
Regulation (EEC) No 1768/92
Uredba (EGS) št. 1768/92
Recital 1
Uvodna izjava 1
Recital 2
Uvodna izjava 2
Recital 3
Uvodna izjava 3
Recital 4
Uvodna izjava 4
Recital 5
Uvodna izjava 5
Recital 6
Uvodna izjava 6
Recital 7
Uvodna izjava 7
Recital 10
Uvodna izjava 10
Recital 11
Uvodna izjava 11
Recital 12
Uvodna izjava 12
Recital 13
Uvodna izjava 13
Article 3, point (b), first sentence
Člen 3, točka (b), prvi stavek
Article 3, point (b), second sentence
Člen 3, točka (b), drugi stavek
Article 3, points (c) and (d)
Člen 3, točki (c) in (d)
Article 8(1a)
Člen 8(1a)
Article 8(1b)
Člen 8(1b)
Articles 16, 17 and 18
Členi 16, 17 in 18
Articles 17, 18 and 19
Členi 17, 18 in 19
Article 19a, introductory wording
Člen 19a, uvodno besedilo
Article 20, introductory wording
Člen 20, uvodno besedilo
Article 19a, point (a), points (i) and (ii)
Člen 19a, točka (a), točki (i) in (ii)
Article 20, point (b), introductory wording, points (i) and (ii)
Člen 20, točka (b), uvodno besedilo, točki (i) in (ii)
Article 19a, point (b)
Člen 19a, točka (b)
Article 20, point (c)
Člen 20, točka (c)
Article 19a, point (c)
Člen 19a, točka (c)
Article 20, point (d)
Člen 20, točka (d)
Article 19a, point (d)
Člen 19a, točka (d)
Article 20, point (e)
Člen 20, točka (e)
Article 19a, point (e)
Člen 19a, točka (e)
Article 20, point (f)
Člen 20, točka (f)
Article 19a, point (f)
Člen 19a, točka (f)
Article 20, point (g)
Člen 20, točka (g)
Article 19a, point (g)
Člen 19a, točka (g)
Article 20, point (h)
Člen 20, točka (h)
Article 19a, point (h)
Člen 19a, točka (h)
Article 20, point (i)
Člen 20, točka (i)
Article 19a, point (i)
Člen 19a, točka (i)
Article 20, point (k)
Člen 20, točka (k)
Article 19a, point (j)
Člen 19a, točka (j)
Article 20, point (l)
Člen 20, točka (l)
Article 19a, point (k)
Člen 19a, točka (k)
Article 20, point (a)
Člen 20, točka (a)
Article 19a, point (l)
Člen 19a, točka (l)
Article 20, point (j)
Člen 20, točka (j)
Regulation (EC) No 470/2009 of the European Parliament and of the Council
Uredba (ES) št. 470/2009 Evropskega parlamenta in Sveta
laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council
o določitvi postopkov Skupnosti za določitev mejnih vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora in razveljavitvi Uredbe Sveta (EGS) št. 2377/90 in spremembi Direktive 2001/82/ES Evropskega parlamenta in Sveta ter Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
Having regard to the Treaty establishing the European Community, and in particular Article 37 and Article 152(4)(b) thereof,
ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti ter zlasti členov 37 in 152(4)(b) Pogodbe,
Having regard to the opinion of the European Economic and Social Committee [1],
ob upoštevanju mnenja Evropskega ekonomsko-socialnega odborae [1],
As a result of scientific and technical progress it is possible to detect the presence of residues of veterinary medicinal products in foodstuffs at ever lower levels.
Zaradi znanstvenega in tehničnega napredka je mogoče dokazati prisotnost vedno nižjih vrednosti ostankov zdravil za uporabo v veterinarski medicini v živilih.
In order to protect public health, maximum residue limits should be established in accordance with generally recognised principles of safety assessment, taking into account toxicological risks, environmental contamination, as well as the microbiological and pharmacological effects of residues.
Zaradi varovanja zdravja ljudi bi bilo treba v skladu s splošno priznanimi načeli presoje varnosti določiti najvišje mejne vrednosti ostankov ob upoštevanju toksikološkega tveganja, okoljske onesnaženosti ter mikrobiološke in farmakološke učinke ostankov.
Account should also be taken of other scientific assessments of the safety of substances concerned which may have been undertaken by international organisations or scientific bodies established within the Community.
Upoštevati bi bilo treba tudi druge morebitne znanstvene ocene varnosti zadevnih snovi, ki so jih opravile mednarodne organizacije ali znanstveni organi, ustanovljeni v Skupnosti.
This Regulation directly concerns public health and is relevant to the functioning of the internal market in products of animal origin included in Annex I to the Treaty.
Ta uredba neposredno zadeva varovanje zdravja ljudi in je pomembna za delovanje notranjega trga s proizvodi živalskega izvora, ki so navedeni v Prilogi I Pogodbe.
It is therefore necessary to establish maximum residue limits for pharmacologically active substances in respect of various foodstuffs of animal origin, including meat, fish, milk, eggs and honey.
Zato bi bilo treba določiti najvišje mejne vrednosti ostankov farmakološko aktivnih snovi za različna živila živalskega izvora, vključno z mesom, ribami, mlekom, jajci in medom.
Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin [3] introduced Community procedures to evaluate the safety of residues of pharmacologically active substances in accordance with human food safety requirements.
Z Uredbo Sveta (EGS) št. 2377/90 z dne 26. junija 1990 o določitvi postopka Skupnosti za določanje najvišjih mejnih vrednosti ostankov zdravil za uporabo v veterinarski medicini v živilih živalskega izvora [3] so bili uvedeni postopki Skupnosti za oceno varnosti ostankov farmakološko aktivnih snovi v skladu z zahtevami glede varnosti živil, namenjenih prehrani ljudi.
A pharmacologically active substance may be used in food-producing animals only if evaluated favourably.
Farmakološko aktivna snov se lahko uporablja pri živalih, namenjenih za proizvodnjo hrane samo, če je bila pozitivno ocenjena.
Maximum residue limits are established for such substances where they are considered necessary for the protection of human health.
Najvišje mejne vrednosti ostankov za take snovi se določijo, če se to zdi potrebno zaradi varovanja zdravja ljudi.