natgillin/translations-raw huggingface dataset:
Rates of the refunds applicable from 5 June 2009 to certain milk products exported in the form of goods not covered by Annex I to the Treaty [1](EUR/100 kg)
Stopnje nadomestil od 5. junija 2009 za nekatere mlečne izdelke, izvožene kot blago, ki ni zajeto v Prilogi I k Pogodbi [1](EUR/100 kg)
Commission Regulation (EC) No 468/2009
Uredba Komisije (ES) št. 468/2009
This Regulation shall enter into force on 6 June 2009.
Ta uredba začne veljati 6. junija 2009.
Regulation (EC) No 469/2009 of the European Parliament and of the Council
Uredba (ES) št. 469/2009 Evropskega parlamenta in Sveta
concerning the supplementary protection certificate for medicinal products
o dodatnem varstvenem certifikatu za zdravila
Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products [3] has been substantially amended several times [4].
Uredba Sveta (EGS) št. 1768/92 z dne 18. junija 1992 o uvedbi dodatnega varstvenega certifikata za zdravila [3] je bila večkrat [4] bistveno spremenjena.
Pharmaceutical research plays a decisive role in the continuing improvement in public health.
Farmacevtske raziskave imajo pomembno vlogo v nadaljnjem izboljševanju javnega zdravja.
Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research.
Razvijanje zdravil, še posebej tistih, ki so plod dolgotrajnih in dragih raziskav, se v Skupnosti in Evropi ne bo nadaljevalo, če ni ustreznih predpisov, ki določajo zadostno varstvo, ki bi spodbudilo tako raziskovanje.
At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.
Doba med vložitvijo patentne prijave za novo zdravilo in dovoljenjem za dajanje tega zdravila v promet je trenutno tako dolga, da je doba dejanskega patentnega varstva prekratka, da bi omogočila povrnitev naložb v raziskave.
This situation leads to a lack of protection which penalises pharmaceutical research.
Tak položaj vodi k pomanjkanju ustreznega varstva, kar škoduje farmacevtskim raziskavam.
There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection.
Obstaja tveganje, da se bodo raziskovalni centri iz držav članic preselili v države, ki ponujajo boljše varstvo.
A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the functioning of the internal market.
Zagotoviti bi bilo treba enotno rešitev na ravni Skupnosti in s tem preprečiti heterogeni razvoj nacionalnih zakonodaj ustvarjajoč dodatna neskladja, ki bi verjetno ovirala prosti pretok zdravil v Skupnosti ter neposredno vplivala na delovanje notranjega trga.
Therefore, the provision of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary.
Zato je treba zagotoviti dodatni varstveni certifikat, ki ga pod enakimi pogoji podeli vsaka država članica na zahtevo imetnika nacionalnega ali evropskega patenta za zdravilo, za katero je bilo podeljeno dovoljenje za dajanje v promet.
A regulation is therefore the most appropriate legal instrument.
Posledično je uredba najustreznejši pravni instrument.
The duration of the protection granted by the certificate should be such as to provide adequate effective protection.
Trajanje varstva, ki ga zagotavlja certifikat, bi moralo biti tako, da bi omogočalo ustrezno dejansko varstvo.
For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.
V ta namen bi moralo biti imetniku patenta in certifikata omogočeno skupaj največ 15 let trajanja varstva od trenutka, ko je bila za zadevno zdravilo prvič izdano dovoljenje za dajanje v promet v Skupnosti.
All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account.
V tako kompleksnem in občutljivem sektorju, kakršen je farmacevtski, bi bilo vendarle treba upoštevati vse interese, vključno z interesi javnega zdravja.
For this purpose, the certificate cannot be granted for a period exceeding five years.
Zaradi tega certifikata ne bi smeli podeliti za obdobje, daljše od petih let.
The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product.
Nadalje bi moralo biti varstvo, ki ga omogoča certifikat, strogo omejeno na izdelek, za katerega je bilo izdano dovoljenje za dajanje v promet kot zdravilo.
Provision should be made for appropriate limitation of the duration of the certificate in the special case where a patent term has already been extended under a specific national law,
Določiti bi bilo treba ustrezno omejitev trajanja certifikata v posebnih primerih, kadar je bil patentni rok že podaljšan v skladu z določeno nacionalno zakonodajo –
‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
„zdravilo“ pomeni katero koli snov ali kombinacijo snovi za zdravljenje ali preprečevanje bolezni pri ljudeh ali živalih, in katero koli snov ali kombinacijo snovi, ki jo je mogoče dati ljudem ali živalim za medicinsko diagnosticiranje ali obnavljanje, izboljševanje ali spreminjanje fizioloških funkcij pri ljudeh ali živalih;
‘product’ means the active ingredient or combination of active ingredients of a medicinal product;
„izdelek“ pomeni učinkovino ali kombinacijo učinkovin zdravila;
‘basic patent’ means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;
„osnovni patent“ pomeni patent, ki varuje izdelek kot tak, postopek pridobivanja izdelka ali uporabo izdelka, in ga je imetnik določil za postopek pridobivanja certifikata;
‘certificate’ means the supplementary protection certificate;
„certifikat“ pomeni dodatni varstveni certifikat;
‘application for an extension of the duration’ means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use [5].
„prijava za podaljšanje veljavnosti“ pomeni prijavo za podaljšanje veljavnosti certifikata v skladu s členom 13(3) te uredbe in členom 36 Uredbe (ES) št. 1901/2006 Evropskega parlamenta in Sveta z dne 12. decembra 2006 o zdravilih za pediatrično uporabo [5].
Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in 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 [6] or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products [7] may, under the terms and conditions provided for in this Regulation, be the subject of a certificate.Article 3
Za vsak izdelek, ki je varovan s patentom na ozemlju države članice in je pred trženjem kot zdravilo predmet upravnega postopka odobritve, kakor je določeno v Direktivi 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [6] ali Direktivi 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini [7] se lahko zahteva certifikat po določbah in pogojih, določenih v tej uredbi.Člen 3
Conditions for obtaining a certificate
Pogoji za pridobitev certifikata
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
Certifikat se podeli, če je v državi članici, v kateri je vložena prijava iz člena 7, na dan vložitve:
the product is protected by a basic patent in force;
izdelek varovan z veljavnim osnovnim patentom;
a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
že bilo izdano veljavno dovoljenje za dajanje izdelka v promet kot zdravila, v skladu z Direktivo 2001/83/ES ali Direktivo 2001/82/ES, kakor je ustrezno;
the product has not already been the subject of a certificate;
za izdelek še ni bil podeljen certifikat;
the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.
dovoljenje iz točke (b) prvo dovoljenje za dajanje izdelka v promet kot zdravila.
Subject matter of protection
Predmet varstva
Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.
V okviru varstva, podeljenega z osnovnim patentom, se varstvo, ki ga podeljuje certifikat, razširi samo na izdelek, ki ga zajema dovoljenje za dajanje ustreznega zdravila v promet, in sicer za kakršno koli uporabo izdelka kot zdravila, ki je odobren pred prenehanjem certifikata.
Effects of the certificate
Učinki certifikata
Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.
Ob upoštevanju člena 4 podeljuje certifikat enake pravice kot osnovni patent in zanj veljajo iste omejitve in obveznosti.
Entitlement to the certificate
Upravičenost do certifikata
The certificate shall be granted to the holder of the basic patent or his successor in title.
Certifikat se podeli imetniku osnovnega patenta ali njegovemu pravnemu nasledniku.
Application for a certificate
Prijava za certifikat
The application for a certificate shall be lodged within six months of the date on which the authorisation referred to in Article 3(b) to place the product on the market as a medicinal product was granted.
Prijava za certifikat se vloži v šestih mesecih od datuma izdaje dovoljenja iz točke (b) člena 3 za dajanje izdelka v promet kot zdravila.
Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within six months of the date on which the patent is granted.
Če je dovoljenje za dajanje v promet izdano pred podelitvijo osnovnega patenta, se ne glede na odstavek 1 prijava za certifikat vloži v šestih mesecih od datuma podelitve patenta.
The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Article 8(1)(d) or Article 8(2), respectively, are fulfilled.
Prijava za podaljšanje veljavnosti certifikata se lahko predloži skupaj s prijavo za izdajo certifikata ali ko je prijava za izdajo certifikata v postopku in so izpolnjeni ustrezni pogoji iz točke (d) člena 8(1) ali iz člena 8(2).
Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate.
Ne glede na odstavek 4 se pet let po začetku veljavnosti Uredbe (ES) št. 1901/2006 prijava za podaljšanje veljavnosti že izdanega certifikata vloži najpozneje šest mesecev pred iztekom veljavnosti certifikata.
Content of the application for a certificate
Vsebina prijave za certifikat
The application for a certificate shall contain:
Prijava za certifikat vsebuje:
a request for the grant of a certificate, stating in particular:
zahtevo za podelitev certifikata, ki vsebuje zlasti:
the name and address of the applicant;
ime in naslov prijavitelja;
if he has appointed a representative, the name and address of the representative;
če je imenoval zastopnika, ime in naslov zastopnika;
the number of the basic patent and the title of the invention;
številko osnovnega patenta in naziv izuma;
the number and date of the first authorisation to place the product on the market, as referred to in Article 3(b) and, if this authorisation is not the first authorisation for placing the product on the market in the Community, the number and date of that authorisation;
številko in datum prvega dovoljenja za dajanje izdelka v promet iz točke (b) člena 3, in, če to ni prvo dovoljenje za dajanje v promet v Skupnosti, številko in datum prvega dovoljenja;
a copy of the authorisation to place the product on the market, as referred to in Article 3(b), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC or Article 14 of Directive 2001/82/EC;
kopijo dovoljenja za dajanje v promet iz točke (b) člena 3, v kateri je izdelek opredeljen in ki vsebuje zlasti številko in datum dovoljenja ter povzetek značilnosti izdelka, naštetih v členu 11 Direktive 2001/83/ES ali v členu 14 Direktive 2001/82/ES;
if the authorisation referred to in point (b) is not the first authorisation for placing the product on the market as a medicinal product in the Community, information regarding the identity of the product thus authorised and the legal provision under which the authorisation procedure took place, together with a copy of the notice publishing the authorisation in the appropriate official publication;
če dovoljenje iz točke (b) ni prvo dovoljenje za dajanje izdelka v promet kot zdravila v Skupnosti, informacije o istovetnosti odobrenega izdelka in o pravnem predpisu, po katerem je bil opravljen postopek izdaje dovoljenja, skupaj s kopijo uradnega obvestila o dovoljenju, kot je izšlo v ustrezni uradni publikaciji;
where the application for a certificate includes a request for an extension of the duration:
če prijava za certifikat vključuje zahtevo za podaljšanje veljavnosti:
where necessary, in addition to the copy of the authorisation to place the product on the market as referred to in point (b), proof of possession of authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006.
kadar je potrebno, poleg kopije dovoljenja za dajanje v promet iz točke (b), dokazilo, da ima dovoljenje za dajanje v promet v vseh drugih državah članicah, kakor določa člen 36(3) Uredbe (ES) št. 1901/2006.
Where an application for a certificate is pending, an application for an extended duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) of this Article and a reference to the application for a certificate already filed.
Kadar je prijava za certifikat v postopku, prijava za podaljšanje veljavnosti v skladu s členom 7(3) vsebuje podatke iz točke (d) odstavka 1 tega člena in sklicevanje na prijavo za certifikat, ki je bila že vložena.
The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1(d) and a copy of the certificate already granted.
Prijava za podaljšanje veljavnosti že izdanega certifikata vsebuje podrobnosti iz točke (d) odstavka 1 in kopijo certifikata, ki je bil že izdan.
Member States may provide that a fee is to be payable upon application for a certificate and upon application for the extension of the duration of a certificate.
Države članice lahko določijo plačilo pristojbine ob vložitvi prijave za izdajo certifikata in ob vložitvi prijave za podaljšanje veljavnosti certifikata.
Lodging of an application for a certificate
Vložitev prijave za certifikat
The application for a certificate shall be lodged with the competent industrial property office of the Member State which granted the basic patent or on whose behalf it was granted and in which the authorisation referred to in Article 3(b) to place the product on the market was obtained, unless the Member State designates another authority for the purpose.
Prijava za certifikat se vloži pri pristojnem uradu za industrijsko lastnino v državi članici, ki je podelila osnovni patent ali v katere imenu je bil patent podeljen in v kateri je bilo izdano dovoljenje za dajanje v promet iz točke (b) člena 3, razen če država članica za ta namen določi drug organ.
The application for an extension of the duration of a certificate shall be lodged with the competent authority of the Member State concerned.
Prijava za podaljšanje veljavnosti certifikata se vloži pri pristojnem organu zadevne države članice.
Notification of the application for a certificate shall be published by the authority referred to in paragraph 1.
Organ iz odstavka 1 objavi obvestilo o vložitvi prijave za certifikat.
The notification shall contain at least the following information:
Obvestilo vsebuje vsaj naslednje podatke:
the number of the basic patent;
številko osnovnega patenta;
the title of the invention;
naziv izuma;
the number and date of the authorisation to place the product on the market, referred to in Article 3(b), and the product identified in that authorisation;
številko in datum dovoljenja za dajanje v promet iz točke (b) člena 3, in izdelek, opredeljen v tem dovoljenju;
where relevant, the number and date of the first authorisation to place the product on the market in the Community;
kadar je ustrezno, številko in datum prvega dovoljenja za dajanje v promet v Skupnosti;
where applicable, an indication that the application includes an application for an extension of the duration.
kadar je potrebno, navedbo, da prijava vključuje prijavo za podaljšanje veljavnosti.
The notification shall additionally contain an indication of the application for an extended duration of the certificate.
Obvestilo dodatno vsebuje navedbo o prijavi za podaljšanje veljavnosti certifikata.
Grant of the certificate or rejection of the application for a certificate
Podelitev certifikata ali zavrnitev prijave za certifikat
Where the application for a certificate and the product to which it relates meet the conditions laid down in this Regulation, the authority referred to in Article 9(1) shall grant the certificate.
Če vloga za certifikat in izdelek, na katerega se nanaša, izpolnjujeta pogoje te uredbe, organ iz člena 9(1) podeli certifikat.
The authority referred to in Article 9(1) shall, subject to paragraph 3, reject the application for a certificate if the application or the product to which it relates does not meet the conditions laid down in this Regulation.
Organ iz člena 9(1), ob upoštevanju odstavka 3, zavrne prijavo za certifikat, če prijava ali izdelek, na katerega se nanaša, ne izpolnjuje pogojev te uredbe.
Where the application for a certificate does not meet the conditions laid down in Article 8, the authority referred to in Article 9(1) shall ask the applicant to rectify the irregularity, or to settle the fee, within a stated time.
Če prijava za certifikat ne izpolnjuje pogojev iz člena 8, organ iz člena 9(1) od prijavitelja zahteva, da odpravi nepravilnost ali poravna pristojbino v določenem roku.
If the irregularity is not rectified or the fee is not settled under paragraph 3 within the stated time, the authority shall reject the application.
Če nepravilnost ni odpravljena ali pristojbina ni poravnana v določenem roku, kot določa odstavek 3, organ zavrne prijavo.
Member States may provide that the authority referred to in Article 9(1) is to grant certificates without verifying that the conditions laid down in Article 3(c) and (d) are met.
Države članice lahko določijo, da sme organ iz člena 9(1) izdati certifikate brez preverjanja, ali so izpolnjeni pogoji, določeni v točkah (c) in (d) člena 3.
Paragraphs 1 to 4 shall apply mutatis mutandis to the application for an extension of the duration.
Odstavki 1 do 4 se smiselno uporabljajo za prijavo za podaljšanje veljavnosti certifikata.
Notification of the fact that a certificate has been granted shall be published by the authority referred to in Article 9(1).
Uradno obvestilo o tem, da je bil certifikat podeljen, objavi organ iz člena 9(1).
the name and address of the holder of the certificate;
ime in naslov imetnika certifikata;
the number and date of the authorisation to place the product on the market referred to in Article 3(b) and the product identified in that authorisation;
številko in datum dovoljenja za dajanje v promet iz točke (b) člena 3, in izdelek, opredeljen v tem dovoljenju;
the duration of the certificate.
trajanje certifikata.
Notification of the fact that the application for a certificate has been rejected shall be published by the authority referred to in Article 9(1).
Uradno obvestilo o tem, da je bila prijava za certifikat zavrnjena, objavi organ iz člena 9(1).
The notification shall contain at least the information listed in Article 9(2).
Obvestilo vsebuje vsaj podatke, naštete v členu 9(2).
Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate has been granted or of the fact that the application for an extension has been rejected.
Odstavka 1 in 2 se uporabljata za uradno obvestilo o tem, da je podaljšanje veljavnosti certifikata odobreno, ali o tem, da je bila prijava za takšno podaljšanje zavrnjena.
Annual fees
Letne pristojbine
Member States may require that the certificate be subject to the payment of annual fees.
Države članice lahko zahtevajo, da je za certifikat treba plačati letne pristojbine.
Duration of the certificate
Trajanje certifikata
The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years.
Certifikat začne veljati s koncem zakonitega trajanja osnovnega patenta za obdobje, ki je enako obdobju, ki je poteklo med datumom, ko je bila vložena prijava za osnovni patent, in datumom prvega dovoljenja za dajanje v promet v Skupnosti, skrajšano za dobo petih let.
Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.
Ne glede na odstavek 1 certifikat ne sme trajati dlje kot pet let od datuma začetka veljavnosti.
In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.
V tem primeru se obdobje, določeno v odstavku 1 tega člena, lahko podaljša samo enkrat.