natgillin/translations-raw huggingface dataset:
the period of the protection of technical documentation as set out in Articles 39 and 40 of this Regulation has elapsed, or is due to elapse in less than two years;
Varstvo tehnične dokumentacije iz odstavka 1 (v nadaljnjem besedilu: varstvo tehnične dokumentacije) se uporablja tudi v državah članicah, v katerih zdravilo za uporabo v veterinarski medicini nima dovoljenja za promet ali ga nima več.
the applicants have obtained written agreement in the form of a letter of access with regard to that documentation.
Dovoljenje za promet ali sprememba pogojev dovoljenja za promet, ki se razlikuje od že izdanega dovoljenja za promet za istega imetnika samo po ciljni vrsti, jakosti, farmacevtski obliki, poteh uporabe ali predstavitvi, šteje za isto dovoljenje za promet kot že izdano dovoljenje za promet za istega imetnika za namene uporabe pravil o varstvu tehnične dokumentacije.
The protection of the technical documentation as set out to in paragraph 1 (‘the protection of technical documentation’) shall also apply in Member States where the veterinary medicinal product is not authorised or is no longer authorised.
Člen 39
A marketing authorisation or a variation to the terms of a marketing authorisation differing from the marketing authorisation previously granted to the same marketing authorisation holder only with regard to target species, strengths, pharmaceutical forms, administration routes or presentations shall be regarded as the same marketing authorisation as the one previously granted to the same marketing authorisation holder for the purpose of applying the rules of the protection of technical documentation.
Obdobja varstva tehnične dokumentacije
Article 39
Obdobje varstva tehnične dokumentacije je:
Periods of the protection of technical documentation
deset let za zdravila za uporabo v veterinarski medicini za govedo, ovce za proizvodnjo mesa, prašiče, piščance, pse in mačke;
The period of the protection of technical documentation shall be:
14 let za protimikrobna zdravila za uporabo v veterinarski medicini za govedo, ovce za proizvodnjo mesa, prašiče, piščance, pse in mačke, ki vsebujejo protimikrobno učinkovino, ki ni učinkovina v zdravilu za uporabo v veterinarski medicini, ki je imelo na datum predložitve vloge že izdano dovoljenje za promet v Uniji;
10 years for veterinary medicinal products for cattle, sheep for meat production, pigs, chickens, dogs and cats;
18 let za zdravila za uporabo v veterinarski medicini za čebele;
14 years for antimicrobial veterinary medicinal products for cattle, sheep for meat production, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;
14 let za zdravila za uporabo v veterinarski medicini za živalske vrste, ki niso navedene v točkah (a) in (c).
18 years for veterinary medicinal products for bees;
Varstvo tehnične dokumentacije se uporablja od dneva izdaje dovoljenja za promet z zdravilom za uporabo v veterinarski medicini v skladu s členom 5(1).
14 years for veterinary medicinal products for animal species other than those referred to in points (a) and (c).
Člen 40
The protection of technical documentation shall apply from the day when the marketing authorisation for the veterinary medicinal product was granted in accordance with Article 5(1).
Podaljšanje obdobja in dodatna obdobja varstva tehnične dokumentacije
Article 40
Kadar se prvo dovoljenje za promet izda za več kot eno živalsko vrsto iz točke (a) ali (b) člena 39(1) ali se v skladu s členom 67 odobri sprememba za razširitev dovoljenja za promet na še eno vrsto iz točke (a) ali (b) člena 39(1), se obdobje varstva iz člena 39 podaljša za eno leto za vsako dodatno ciljno vrsto, pod pogojem, da je vloga za spremembo predložena vsaj tri leta pred iztekom obdobja varstva iz točke (a) ali (b) člena 39(1).
Prolongation and additional periods of the protection of technical documentation
Kadar se prvo dovoljenje za promet izda za več kot eno živalsko vrsto iz točke (d) člena 39(1) ali se odobri sprememba v skladu s členom 67 za razširitev dovoljenja za promet na še eno živalsko vrsto iz točke (a) člena 39(1), se obdobje varstva iz člena 39 podaljša za štiri leta, pod pogojem, da je vloga za spremembo predložena vsaj tri leta pred iztekom obdobja varstva iz točke (d) člena 39(1).
Where the first marketing authorisation is granted for more than one animal species referred to in point (a) or (b) of Article 39(1) or a variation is approved in accordance with Article 67 extending the marketing authorisation to another species referred to in point (a) or (b) of Article 39(1), the period of the protection provided for in Article 39 shall be prolonged by one year for each additional target species, provided that, in the case of a variation, the application has been submitted at least three years before the expiration of the protection period laid down in point (a) or (b) of Article 39(1).
Obdobje varstva tehnične dokumentacije prvega dovoljenja za promet, določeno v členu 39 in podaljšano za dodatna obdobja varstva zaradi sprememb ali novih dovoljenj, ki pripadajo istemu dovoljenju za promet, ni daljše od 18 let.
Where the first marketing authorisation is granted for more than one animal species referred to in point (d) of Article 39(1), or a variation is approved in accordance with Article 67 extending the marketing authorisation to another animal species not referred to in point (a) of Article 39(1), the period of the protection provided for in Article 39 shall be prolonged by four years, provided that, in the case of a variation, the application has been submitted at least three years before the expiration of the protection period laid down in point (d) of Article 39(1).
Kadar predlagatelj za pridobitev dovoljenja za promet z zdravilom za uporabo v veterinarski medicini ali za spremembo pogojev dovoljenja za promet predloži vlogo v skladu z Uredbo (ES) št. 470/2009 za določitev mejne vrednosti ostankov skupaj s testi varnosti in ostankov ter predkliničnimi študijami in kliničnimi preskušanji med postopkom obravnavanja vloge, se drugi predlagatelji ne sklicujejo na rezultate teh testov, študij in preskušanj za obdobje petih let od izdaje dovoljenja za promet, za katerega so bili izvedeni.
The period of the protection of technical documentation provided for in Article 39 of the first marketing authorisation, prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation, shall not exceed 18 years.
Prepoved glede uporabe teh rezultatov ne velja, če drugi predlagatelji pridobijo izjavo o dostopnosti podatkov v zvezi s temi testi, študijami in preskušanji.
Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of a marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with safety and residues tests and pre-clinical studies and clinical trials during the application procedure, other applicants shall not refer to results of those tests, studies and trials for a period of five years from the granting of the marketing authorisation for which they were carried out.
Če sprememba pogojev dovoljenja za promet z zdravilom, ki je bilo izdano v skladu s členom 67, zajema tudi spremembo farmacevtske oblike, poti uporabe ali odmerjanja zdravila, za katero je po oceni Agencije ali pristojnih organov iz člena 66 dokazano:
The prohibition on using those results shall not apply, insofar as the other applicants have obtained a letter of access with regard to those tests, studies and trials.
zmanjšanje mikrobne odpornosti ali odpornosti proti antiparazitikom ali
If a variation to the terms of the marketing authorisation approved in accordance with Article 67 involves a change to the pharmaceutical form, administration route or dosage, which is assessed by the Agency or the competent authorities referred to in Article 66 to have demonstrated:
izboljšanje razmerja med koristmi in tveganji pri zdravilu za uporabo v veterinarski medicini,
a reduction in the antimicrobial or antiparasitic resistance; or
potem za rezultate zadevnih predkliničnih študij ali kliničnih preskušanj velja štiriletno obdobje varstva podatkov.
an improvement of the benefit-risk balance of the veterinary medicinal product,
Prepoved glede uporabe teh rezultatov se ne uporablja, če drugi predlagatelji za te študije in preskušanja pridobijo izjavo o dostopnosti podatkov.
the results of the concerned pre-clinical studies or clinical trials shall benefit from four years protection.
Člen 41
The prohibition on using those results shall not apply, insofar as the other applicants have obtained a letter of access with regard to those studies and trials.
Pravice v zvezi s patenti
Article 41
Za izvajanje potrebnih testov, študij in preskušanj z namenom predložitve vloge za pridobitev dovoljenja za promet v skladu s členom 18 se ne šteje, da so v nasprotju s pravicami v zvezi s patenti ali dodatnimi varstvenimi certifikati za zdravila za uporabo v veterinarski medicini in zdravila za uporabo v humani medicini.
Patent-related rights
POGLAVJE III
Conducting the necessary tests, studies and trials with a view to applying for a marketing authorisation in accordance with Article 18 shall not be regarded as contrary to patent-related rights or to supplementary-protection certificates for veterinary medicinal products and medicinal products for human use.
POSTOPKI ZA DOVOLJENJA ZA PROMET
CHAPTER III
Dovoljenja za promet, veljavna po vsej Uniji (v nadaljnjem besedilu: centralizirana dovoljenja za promet)
PROCEDURES FOR MARKETING AUTHORISATIONS
Člen 42
Marketing authorisations valid throughout the Union (‘centralised marketing authorisations’)
Področje uporabe postopka za pridobitev centraliziranega dovoljenja za promet
Article 42
Centralizirana dovoljenja za promet so veljavna v vsej Uniji.
Scope of the centralised marketing authorisation procedure
Postopek za pridobitev centraliziranega dovoljenja za promet se uporablja za naslednja zdravila za uporabo v veterinarski medicini:
Centralised marketing authorisations shall be valid throughout the Union.
zdravila za uporabo v veterinarski medicini, razvita po enem od naslednjih biotehnoloških postopkov:
Centralised marketing authorisation procedure shall apply in respect of the following veterinary medicinal products:
tehnologija rekombinantne DNK;
veterinary medicinal products developed by means of one of the following biotechnological processes:
kontrolirana ekspresija genov, ki kodirajo biološko aktivne proteine v prokariontih in evkariontih, vključno s transformiranimi celicami sesalcev;
recombinant DNA technology;
metode hibridomov in monoklonskih protiteles;
controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells;
zdravila za uporabo v veterinarski medicini, ki so namenjena zlasti uporabi kot sredstva za povečanje proizvodnosti, da se spodbudi rast zdravljenih živali ali poveča donosnost zdravljenih živali;
hybridoma and monoclonal antibody methods;
zdravila za uporabo v veterinarski medicini, ki vsebujejo učinkovino, ki na datum predložitve vloge nima dovoljenja kot zdravilo za uporabo v veterinarski medicini znotraj Unije;
veterinary medicinal products intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals;
biološka zdravila za uporabo v veterinarski medicini, ki vsebujejo inženirsko obdelana alogenska tkiva ali celice ali so iz njih sestavljena;
veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application;
zdravila za uporabo v veterinarski medicini za nove terapije.
biological veterinary medicinal products which contain or consist of engineered allogeneic tissues or cells;
Točki (d) in (e) odstavka 2 se ne uporabljata za zdravila za uporabo v veterinarski medicini, ki jih sestavljajo izključno krvne komponente.
novel therapy veterinary medicinal products.
Za zdravila za uporabo v veterinarski medicini, razen tistih iz odstavka 2, se lahko izda centralizirano dovoljenje za promet, če zanje znotraj Unije ni bilo izdano nobeno drugo dovoljenje za promet.
Points (d) and (e) of paragraph 2 shall not apply to veterinary medicinal products consisting exclusively of blood components.
Člen 43
For veterinary medicinal products other than those referred to in paragraph 2, a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the Union.
Vloga za centralizirano dovoljenje za promet
Article 43
Vloga za centralizirano dovoljenje za promet se predloži Agenciji.
Application for centralised marketing authorisation
Vlogi se priloži pristojbina, ki se Agenciji plača za pregled vloge.
An application for a centralised marketing authorisation shall be submitted to the Agency.
V vlogi za centralizirano dovoljenje za promet z zdravilom za uporabo v veterinarski medicini je navedeno eno samo ime za zdravilo za uporabo v veterinarski medicini, ki se bo uporabljalo po vsej Uniji.
The application shall be accompanied by the fee payable to the Agency for the examination of the application.
Člen 44
The application for a centralised marketing authorisation of a veterinary medicinal product shall state a single name for the veterinary medicinal product to be used throughout the Union.
Postopek za pridobitev centraliziranega dovoljenja za promet
Article 44
Agencija vlogo iz člena 43 oceni.
Procedure for centralised marketing authorisation
Kot rezultat ocene Agencija pripravi mnenje, v katerem so navedene informacije iz člena 33.
The Agency shall assess the application referred to in Article 43.
Agencija mnenje iz odstavka 1 izda v 210 dneh od prejema veljavne vloge.
The Agency shall prepare, as an outcome of the assessment, an opinion containing the information referred to in Article 33.
Kadar je potrebno posebno strokovno znanje, se lahko rok izjemoma podaljša za največ 90 dni.
The Agency shall issue the opinion referred to in paragraph 1 within 210 days of receipt of a valid application.
Ko je predložena vloga za pridobitev dovoljenja za promet z zdravili za uporabo v veterinarski medicini, ki so bistvenega pomena zlasti s stališča zdravja živali in terapevtskih inovacij, lahko predlagatelj zahteva pospešen postopek ocene.
Exceptionally, where a particular expertise is required, the time limit may be extended by a maximum of 90 days.
Zahteva se ustrezno utemelji.
When an application is submitted for a marketing authorisation in respect of veterinary medicinal products of major interest, particularly from the point of view of animal health and therapeutic innovation, the applicant may request an accelerated assessment procedure.
Če Agencija zahtevo sprejme, se rok 210 dni skrajša na 150 dni.
The request shall be duly substantiated.
Agencija mnenje pošlje predlagatelju.
If the Agency accepts the request, the time limit of 210 days shall be reduced to 150 days.
Predlagatelj lahko Agenciji v 15 dneh od prejema mnenja pošlje pisno obvestilo, da želi ponoven pregled mnenja.
The Agency shall forward the opinion to the applicant.
V tem primeru se uporablja člen 45.
Within 15 days of receipt of the opinion, the applicant may provide written notice to the Agency that he or she wishes to request a re-examination of the opinion.
Kadar predlagatelj ne predloži pisnega obvestila v skladu z odstavkom 4, Agencija svoje mnenje brez nepotrebnega odlašanja pošlje Komisiji.
In such a case, Article 45 shall apply.
Komisija lahko od Agencije zahteva pojasnila v zvezi z vsebino mnenja, Agencija pa v tem primeru v 90 dneh zagotovi odgovor na to zahtevo.
Where the applicant has not provided written notice in accordance with paragraph 4, the Agency shall, without undue delay, forward its opinion to the Commission.
Predlagatelj Agenciji v skladu s členom 7 priskrbi potrebne prevode povzetka glavnih značilnosti zdravila, navodil za uporabo in označevanja, in sicer v roku, ki ga določi Agencija, vendar najpozneje na datum, ko se v skladu z odstavkom 8 tega člena pristojnim organom posreduje osnutek sklepa.
The Commission may request clarifications from the Agency as regards the content of the opinion, in which case the Agency shall provide a response to this request within 90 days.
Komisija v 15 dneh od prejema mnenja Agencije pripravi osnutek sklepa, ki se sprejme v zvezi z vlogo.
The applicant shall submit to the Agency the necessary translations of the summary of product characteristics, package leaflet and labelling in accordance with Article 7, within the time limit set by the Agency, but at the latest on the date that the draft decision is forwarded to the competent authorities in accordance with paragraph 8 of this Article.
Kadar osnutek sklepa določa izdajo dovoljenja za promet, ta vključuje tudi mnenje Agencije, pripravljeno v skladu z odstavkom 1.
Within 15 days of receipt of the opinion of the Agency, the Commission shall prepare a draft decision to be taken in respect of the application.
Kadar osnutek sklepa ni v skladu z mnenjem Agencije, Komisija priloži podrobno razlago razlogov za razlike.
Where a draft decision envisages granting of a marketing authorisation, it shall include the opinion of the Agency prepared in accordance with paragraph 1.
Komisija osnutek sklepa pošlje pristojnim organom držav članic in predlagatelju.
Where the draft decision is not in accordance with the opinion of the Agency, the Commission shall annex a detailed explanation of the reasons for the differences.
Komisija z izvedbenimi akti sprejme sklep o izdaji ali zavrnitvi centraliziranega dovoljenja za promet v skladu s tem oddelkom ter na podlagi mnenja Agencije.
The Commission shall forward the draft decision to the competent authorities of Member States and to the applicant.
Agencija svoje mnenje objavi, potem ko izbriše vse poslovno zaupne informacije.
The Commission shall, by means of implementing acts, take a decision to grant or refuse a centralised marketing authorisation in accordance with this Section and on the basis of the opinion of the Agency.
Člen 45
The Agency shall make its opinion publicly available, after deleting any commercially confidential information.
Ponoven pregled mnenja Agencije
Article 45
Kadar predlagatelj v skladu s členom 44(4) zahteva ponoven pregled mnenja Agencije, Agenciji v 60 dneh po prejemu mnenja pošlje podrobne razloge za tako zahtevo.
Re-examination of the opinion of the Agency
Agencija v 90 dneh po prejemu podrobnih razlogov za zahtevo ponovno pregleda svoje mnenje.
Where the applicant requests a re-examination of the opinion of the Agency in accordance with Article 44(4), that applicant shall forward to the Agency detailed grounds for such request within 60 days of receipt of the opinion.
Mnenju priloži sklepne ugotovitve in razloge zanje, oboje pa je sestavni del mnenja.
Within 90 days of receipt of the detailed grounds for the request, the Agency shall re-examine its opinion.
Agencija Komisiji in predlagatelju pošlje mnenje v 15 dneh po njegovem ponovnem pregledu.
The conclusions reached and the reasons for those conclusions shall be annexed to its opinion and shall form an integral part thereof.
Po izvedenem postopku iz odstavka 3 tega člena se uporablja člen 44(6) do (10).
Within 15 days of the re-examination of its opinion, the Agency shall forward its opinion to the Commission and the applicant.
Dovoljenja za promet, veljavna v eni sami državi članici (v nadaljnjem besedilu: nacionalna dovoljenja za promet)
Subsequent to the procedure set out in paragraph 3 of this Article, Article 44(6) to (10) shall apply.
Člen 46
Marketing authorisations valid in a single Member State (‘national marketing authorisations’)
Področje uporabe nacionalnega dovoljenja za promet
Article 46
Vloga za nacionalno dovoljenje za promet se predloži pristojnemu organu v državi članici, za katero se zahteva dovoljenje.
Scope of national marketing authorisation
Pristojni organ izda nacionalno dovoljenje za promet v skladu s tem oddelkom in veljavnimi nacionalnimi določbami.
An application for a national marketing authorisation shall be submitted to the competent authority in the Member State for which the authorisation is applied.
Nacionalno dovoljenje za promet velja samo v državi članici pristojnega organa, ki ga je izdal.
The competent authority shall grant a national marketing authorisation in accordance with this Section and applicable national provisions.
Nacionalna dovoljenja za promet se ne izdajo za zdravila za uporabo v veterinarski medicini, ki spadajo v področje uporabe člena 42(2) ali za katera je bilo že izdano nacionalno dovoljenje ali za katera vloga za pridobitev nacionalnega dovoljenja za promet čaka na odobritev v drugi državi članici v času predložitve vloge.
A national marketing authorisation shall be valid only in the Member State of the competent authority which granted it.
Člen 47
National marketing authorisations shall not be granted in respect of veterinary medicinal products which fall within the scope of Article 42(2), or for which a national marketing authorisation has been granted, or for which an application for a national marketing authorisation is pending in another Member State at the time of the application.
Postopek za nacionalno dovoljenje za promet
Article 47
Postopek za izdajo ali zavrnitev nacionalnega dovoljenja za promet z zdravilom za uporabo v veterinarski medicini se zaključi v 210 dneh od predložitve veljavne vloge.
Procedure for national marketing authorisation
Pristojni organ pripravi poročilo o oceni, v katerem so navedene informacije iz člena 33.
The procedure for granting or refusing a national marketing authorisation for a veterinary medicinal product shall be completed within a maximum of 210 days of the submission of the valid application.
Pristojni organ poročilo o oceni po izbrisu vseh poslovno zaupnih informacij objavi.
The competent authority shall prepare an assessment report containing the information referred to in Article 33.
Dovoljenja za promet, veljavna v več državah članicah (v nadaljnjem besedilu: decentralizirana dovoljenja za promet)
The competent authority shall make the assessment report publicly available, after deleting any commercially confidential information.
Člen 48
Marketing authorisations valid in several Member States (‘decentralised marketing authorisations’)
Področje uporabe decentraliziranega dovoljenja za promet
Article 48
Decentralizirana dovoljenja za promet v skladu s tem oddelkom izdajo pristojni organi v državah članicah, v katerih jih želijo predlagatelji pridobiti (v nadaljnjem besedilu: zadevne države članice).
Scope of decentralised marketing authorisation
Taka decentralizirana dovoljenja za promet so veljavna v teh državah članicah.
Decentralised marketing authorisations shall be granted by the competent authorities in the Member States in which the applicant seeks to obtain a marketing authorisation (‘Member States concerned’) in accordance with this Section.
Decentralizirana dovoljenja za promet se ne odobrijo za zdravila za uporabo v veterinarski medicini, za katera je bilo v času predložitve vloge za decentralizirano dovoljenje za promet že izdano nacionalno dovoljenje za promet ali se vloga za dovoljenje za promet še obravnava ali ki spadajo v področje uporabe člena 42(2).
Such decentralised marketing authorisations shall be valid in those Member States.
Člen 49
Decentralised marketing authorisations shall not be granted in respect of veterinary medicinal products for which a national marketing authorisation has been granted, or for which an application for a marketing authorisation is pending at the time of the application for a decentralised marketing authorisation, or which fall within the scope of Article 42(2).
Postopek za pridobitev decentraliziranega dovoljenja za promet