natgillin/translations-raw huggingface dataset:
Since that level may vary from one Member State to another, Member States are to be allowed some discretion as regards the conditions for the supply on their territory of medicinal products to the public.
Sud je utvrdio i da su ljudsko zdravlje i život na prvom mjestu među dobrima i interesima koje štiti UFEU te da je na državama članicama da odrede razinu zaštite javnog zdravlja koju žele osigurati i način na koji tu razinu treba postići.
Member States should be able, therefore, to subject the supply of medicinal products offered for sale at a distance by means of information society services to conditions justified by the protection of public or animal health.
Budući da se ta razina može razlikovati od jedne do druge države članice, državama članicama treba bi dati određenu slobodu u pogledu uvjeta za opskrbu proizvoda javnosti na njihovom državnom području.
Such conditions should not unduly restrict the functioning of the internal market.
Stoga bi države članice trebale moći opskrbu proizvoda koji se nude na prodaju na daljinu putem usluga informacijskog društva podvrgnuti uvjetima koji su opravdani razlozima zaštite javnog zdravlja ili zdravlja životinja.
In that context, Member States should be able to subject the supply of veterinary medicinal products offered for retail to stricter conditions justified by the protection of public or animal health or of environment, provided that those conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market.
Takvi uvjeti ne bi smjeli neopravdano ograničavati funkcioniranje unutarnjeg tržišta.
In order to ensure high standards and safety of the veterinary medicinal products offered for sale at a distance, the public should be assisted in identifying websites which are legally offering such medicinal products.
U tom kontekstu, države članice trebale bi moći opskrbu veterinarsko-medicinskih proizvoda koji se nude u prometu na malo podvrgnuti strožim uvjetima koji su opravdani razlozima zaštite javnog zdravlja, zdravlja životinja ili okoliša, pod uvjetom da su ti uvjeti razmjerni riziku i da se njima neopravdano ne ograničava funkcioniranje unutarnjeg tržišta.
A common logo should be established, recognisable throughout the Union, while allowing for the identification of the Member State in which the person offering veterinary medicinal products for sale at a distance is established.
Kako bi se osigurali visoki standardi i neškodljivost veterinarsko-medicinskih proizvoda koji se nude na prodaju na daljinu, javnosti bi trebalo pomoći u prepoznavanju internetskih stranica koje zakonito nude takve proizvode.
The Commission should develop the design for such a common logo.
Trebalo bi utvrditi zajednički logotip prepoznatljiv u cijeloj Uniji, istodobno omogućujući utvrđivanje države članice u kojoj osoba koja nudi veterinarsko-medicinske proizvode na prodaju na daljinu ima poslovni nastan.
Websites offering veterinary medicinal products for sale at a distance to the public should be linked to the website of the competent authority concerned.
Komisija bi trebala izraditi dizajn za taj zajednički logotip.
The websites of the competent authorities of Member States, as well as that of the Agency, should give an explanation of the use of that common logo.
Internetske stranice na kojima se javnosti nude veterinarsko-medicinski proizvodi na prodaju na daljinu trebale bi biti povezane s internetskim stranicama dotičnog nadležnog tijela.
All those websites should be linked in order to provide comprehensive information to the public.
Na internetskim stranicama nadležnih tijela država članica, kao i na internetskim stranicama Agencije, trebalo bi se nalaziti objašnjenje upotrebe tog zajedničkog logotipa.
Collection systems for the disposal of waste veterinary medicinal products should continue to be in place in the Member States in order to control any risk that such products might raise with regard to the protection of human and animal health or the environment.
Sve te internetske stranice trebale bi biti povezane kako bi javnosti pružile sveobuhvatne informacije.
Advertising, even of medicinal products not subject to a veterinary prescription, could affect public and animal health and distort competition.
Sustavi za prikupljanje za zbrinjavanje otpadnih veterinarsko-medicinskih proizvoda trebali bi i dalje postojati u državama članicama radi kontrole rizika od takvih proizvoda za zdravlje ljudi i životinja ili okoliš.
Therefore, advertising of veterinary medicinal products should meet certain criteria.
Oglašavanje, čak i proizvoda koji se ne izdaju na veterinarski recept, moglo bi utjecati na javno zdravlje i zdravlje životinja te narušiti tržišno natjecanje.
Persons qualified to prescribe or supply veterinary medicinal products can properly evaluate the information available in advertising because of their knowledge, training and experience in animal health.
Stoga bi oglašavanje veterinarsko-medicinskih proizvoda trebalo udovoljavati određenim kriterijima.
The advertising of veterinary medicinal products to persons who cannot properly assess the risk associated with their use may lead to medicinal product misuse or overconsumption which is liable to harm public or animal health, or the environment.
Osobe kvalificirane za propisivanje ili opskrbu veterinarsko-medicinskih proizvoda mogu pravilno ocijeniti informacije dostupne iz oglašavanja zahvaljujući svojem znanju, izobrazbi i iskustvu u području zdravlja životinja.
However, in order to preserve the animal health status in their territory, Member States should be able under restricted conditions to allow advertising of immunological veterinary medicinal products also to professional animal keepers.
Oglašavanje veterinarsko-medicinskih proizvoda osobama koje ne mogu pravilno procijeniti rizik povezan s njihovom primjenom tih može dovesti do pogrešne ili pretjerane primjene proizvoda, što može nanijeti štetu javnom zdravlju, zdravlju životinja ili okolišu.
With regard to the advertising of veterinary medicinal products, Member States’ experience has shown that it is necessary to put emphasis on the distinction between feed and biocidal products, on the one hand, and veterinary medicinal products, on the other, because that distinction is often misrepresented in advertising.
Međutim, kako bi se očuvao status zdravlja životinja na njihovu državnom području, države članice trebale bi pod ograničenim uvjetima moći dopustiti oglašavanje imunoloških veterinarsko-medicinskih proizvoda i profesionalnim držateljima životinja.
The rules of advertisement in this Regulation are to be seen as specific rules that complement the general rules in Directive 2006/114/EC of the European Parliament and of the Council.
U pogledu oglašavanja veterinarsko-medicinskih proizvoda, iskustvo država članica pokazalo je da je potrebno staviti naglasak na razliku između hrane za životinje i biocidnih proizvoda, s jedne strane, i veterinarsko-medicinskih proizvoda, s druge strane, jer se ta razlika često pogrešno prikazuje u oglašavanju.
Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a veterinarian for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State.
Pravila oglašavanja u ovoj Uredbi smatraju se posebnim pravilima koja dopunjuju opća pravila iz Direktive 2006/114/EZ Europskog parlamenta i Vijeća.
The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for veterinarians to refuse to dispense the medicinal product stated in the prescription.
Ako su proizvodi odobreni unutar države članice i za njih je u toj državi članici veterinar izdao recept za pojedinačnu životinju ili skupinu životinja, u načelu bi trebala postojati mogućnost priznavanja takvih veterinarskih recepata i izdavanja proizvoda na njih u drugoj državi članici.
The implementation of the principle of recognition of veterinary prescriptions should be facilitated by the adoption of a model format for veterinary prescription, listing the essential information necessary to ensure the safe and efficacious use of the medicinal product.
Uklanjanje regulatornih i administrativnih prepreka za takvo priznavanje ne bi smjelo utjecati na profesionalnu ili etičku dužnost veterinara da odbiju izdati proizvod naveden na receptu.
Nothing should prevent Member States from having further elements in their veterinary prescriptions, as long as this does not prevent veterinary prescriptions from other Member States from being recognised.
Provedbu načela priznavanja veterinarskih recepata trebalo bi olakšati donošenjem standardnog obrasca veterinarskog recepta u kojem bi bile navedene bitne informacije potrebne da bi se osigurala neškodljiva i djelotvorna primjena proizvoda.
Information on veterinary medicinal products is essential in order to enable health professionals, authorities and companies make informed decisions.
Ništa ne bi smjelo sprečavati države članice da uključe dodatne elemente u svoje veterinarske recepte sve dok se time ne sprečava priznavanje veterinarskih recepata iz drugih država članica.
A key aspect is the creation of a Union database that should collate information on marketing authorisations granted in the Union.
Informacije o veterinarsko-medicinskim proizvodima bitne su kako bi zdravstveni radnici, tijela vlasti i trgovačka društva mogli donositi informirane odluke.
That database should enhance overall transparency, streamline and facilitate the flow of information between authorities, and prevent multiple reporting requirements.
Ključan je aspekt stvaranje Unijine baze podataka u kojoj bi se trebale objedinjavati informacije o odobrenjima za stavljanje u promet izdanima u Uniji.
The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of this Regulation are effectively achieved across the Union.
Ta baza podataka trebala bi povećati ukupnu transparentnost, usmjeriti i olakšati protok informacija među nadležnim tijelima te spriječiti višestruke zahtjeve za izvješćivanje.
Therefore, the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products.
Kako bi se osiguralo učinkovito postizanje ciljeva ove Uredbe u cijeloj Uniji, od ključne je važnosti kontrolama provjeravati ispunjavanje pravnih zahtjeva.
In order to preserve the effectiveness of the inspections, the competent authorities should have the possibility to perform unannounced inspections.
Nadležna tijela država članica stoga bi trebala biti ovlaštena provoditi inspekcijske preglede u svim fazama proizvodnje, distribucije i primjene veterinarsko-medicinskih proizvoda.
The frequency of controls should be established by the competent authorities having regard to the risk and to the level of compliance expected in the different situations.
Kako bi se očuvala učinkovitost inspekcijskih pregleda, nadležna tijela trebala bi imati mogućnost provođenja nenajavljenih inspekcijskih pregleda.
That approach should allow those competent authorities to allocate resources where the risk is the highest.
Nadležna tijela trebala bi odrediti učestalost kontrola uzimajući u obzir rizik i razinu usklađenosti koja se očekuje u različitim situacijama.
In some cases, however, controls should be performed irrespective of the level of risk or expected non-compliance, for example prior to granting manufacturing authorisations.
Tim bi se pristupom trebalo omogućiti tim nadležnim tijelima da dodijele resurse tamo gdje je rizik najveći.
In certain cases, failures in Member States’ control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment.
Međutim, u nekim bi slučajevima kontrole trebalo provoditi neovisno o razini rizika ili očekivanoj neusklađenosti, na primjer prije davanja odobrenja za proizvodnju.
To ensure a harmonised approach to controls throughout the Union, the Commission should be able to carry out audits in the Member States to verify the functioning of national control systems.
U određenim slučajevima nedostaci u sustavima kontrola država članica mogu u značajnoj mjeri spriječiti ostvarenje ciljeva ove Uredbe te dovesti do pojave rizika za javno zdravlje i zdravlje životinja te okoliš.
Those audits should be carried out so as to avoid any unnecessary administrative burden and, as far as possible, be coordinated with Member States and with any other Commission audits to be carried out under Regulation (EU) 2017/625 of the European Parliament and of the Council.
Kako bi se osigurao usklađen pristup kontrolama u cijeloj Uniji, Komisija bi trebala moći provoditi revizije u državama članicama radi provjere funkcioniranja nacionalnih sustava kontrola.
In order to ensure transparency, impartiality and consistency in the level of enforcement activities by Member States, it is necessary for Member States to set up an appropriate framework for penalties with a view to imposing effective, proportionate and dissuasive penalties for non-compliance with this Regulation, as non-compliance can result in damage to public and animal health and the environment.
Te bi revizije trebalo provoditi tako da se izbjegne nepotrebno administrativno opterećenje i, koliko je to moguće, koordinirati s državama članicama i svim drugim revizijama koje Komisija provodi u skladu s Uredbom (EU) 2017/625 Europskog parlamenta i Vijeća.
Companies and authorities are frequently confronted with the need to distinguish between veterinary medicinal products, feed additives, biocidal products and other products.
Kako bi se osigurala transparentnost, nepristranost i dosljednost u aktivnostima izvršavanja država članica, potrebno je da države članice uspostave odgovarajući okvir za sankcije s ciljem određivanja učinkovitih, proporcionalnih i odvraćajućih sankcija za neusklađenost s ovom Uredbom jer neusklađenost može rezultirati štetom za javno zdravlje i zdravlje životinja te okoliš.
In order to avoid inconsistencies in the treatment of such products, to increase legal certainty, and to facilitate the decision-making process by Member States, a coordination group of Member States should be established, and among other tasks it should provide on a case-by-case basis a recommendation as to whether a product falls within the definition of a veterinary medicinal product.
Trgovačka društva i tijela vlasti često se suočavaju s potrebom razlikovanja između veterinarsko-medicinskih proizvoda, dodataka hrani za životinje, biocidnih proizvoda i drugih proizvoda.
In order to ensure legal certainty, the Commission may decide whether a specific product is a veterinary medicinal product.
Kako bi se izbjegle nedosljednosti u postupanju s takvim proizvodima, povećala pravna sigurnost i državama članicama olakšalo donošenje odluka, trebalo bi osnovati koordinacijsku skupinu država članica koja bi između ostalih zadaća trebala davati preporuke u pojedinom slučaju o tome je li neki proizvod obuhvaćen definicijom veterinarsko-medicinskog proizvoda.
Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of those products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for package leaflets for certain homeopathic veterinary medicinal products which are placed on the market without indications.
Kako bi se osigurala pravna sigurnost, Komisija može odlučiti je li određeni proizvod veterinarsko-medicinski proizvod.
The quality aspect of homeopathic medicinal products is independent of their use, so no specific provisions should apply to such products with regard to the necessary quality requirements and rules.
S obzirom na posebne značajke homeopatskih veterinarsko-medicinskih proizvoda, posebno sastojaka tih proizvoda, poželjno je uspostaviti poseban pojednostavnjeni postupak registracije te predvidjeti posebne odredbe o uputama o proizvodu za određene homeopatske veterinarsko-medicinske proizvode koji se stavljaju u promet bez indikacija.
Moreover, while the use of homeopathic veterinary medicinal products authorised under this Regulation is regulated in the same way as other authorised veterinary medicinal products, it does not regulate the use of registered homeopathic veterinary medicinal products.
Kakvoća homeopatskih proizvoda neovisna je o njihovoj primjeni pa se stoga na takve proizvode ne bi trebale primjenjivati posebne odredbe u odnosu na zahtjeve i pravila u pogledu potrebne kakvoće.
The use of such registered homeopathic veterinary medicinal products is therefore subject to national law which is also the case as regards homeopathic medicinal products registered in accordance with Directive 2001/83/EC of the European Parliament and of the Council.
Povrh toga, iako je primjena homeopatskih veterinarsko-medicinskih proizvoda odobrenih na temelju ove Uredbe uređena na isti način kao i primjena drugih odobrenih veterinarsko-medicinskih proizvoda, njome se ne uređuje primjena registriranih homeopatskih veterinarsko-medicinskih proizvoda.
In order to protect public and animal health and the environment, the activities, services and tasks attributed to the Agency in this Regulation should be adequately funded.
Primjena takvih registriranih homeopatskih veterinarsko-medicinskih proizvoda stoga podliježe nacionalnom pravu, kao i u slučaju homeopatskih lijekova registriranih u skladu s Direktivom 2001/83/EZ Europskog parlamenta i Vijeća.
Those activities, services and tasks should be funded through fees charged by the Agency to undertakings.
Kako bi se zaštitilo javno zdravlje i zdravlje životinja te okoliš, trebalo bi na odgovarajući način financirati aktivnosti, usluge i zadaće koje se ovom Uredbom dodjeljuju Agenciji.
Those fees, however, should not affect the right of Member States to charge fees for activities and tasks carried out at national level.
Te aktivnosti, usluge i zadaće trebalo bi financirati putem naknada koje Agencija naplaćuje poduzećima.
It is generally accepted that the existing requirements regarding the technical documentation on the quality, safety and efficacy of veterinary medicinal products presented when applying for a marketing authorisation in Annex I to Directive 2001/82/EC as last amended by Commission Directive 2009/9/EC work sufficiently well in practice.
Navedene naknade, međutim, ne bi smjele utjecati na pravo država članica da naplaćuju naknade za aktivnosti i zadaće koje se izvršavaju na nacionalnoj razini.
There is no urgent need, therefore, to substantially change those requirements.
Opće je prihvaćeno da u praksi dovoljno dobro funkcioniraju postojeći zahtjevi u pogledu tehničke dokumentacije o kakvoći, neškodljivosti i djelotvornosti veterinarsko-medicinskih proizvoda koja se iznosi prilikom podnošenja zahtjeva za izdavanje odobrenja za stavljanje u promet iz Priloga I. Direktivi 2001/82/EZ, kako je zadnje izmijenjena Direktivom Komisije 2009/9/EZ.
However, there is a need to adjust those requirements in order to respond to the identified discrepancies with the international scientific progress or latest developments, including guidance from VICH, WHO, the Organisation for Economic Cooperation and Development (OECD) standards, and taking into account also the need to develop specific requirements for novel therapy veterinary medicinal products while avoiding major overhaul of the current provisions, in particular not altering their structure.
Stoga ne postoji hitna potreba za bitnu izmjenu tih zahtjeva.
In order to, inter alia, adapt this Regulation to the scientific developments of the sector, to exercise the supervisory powers of the Commission effectively, and to introduce harmonised standards within the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of establishing the criteria for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans; establishing the requirements for collection of data as regards the antimicrobial medicinal products, rules on the methods of collection and quality assurance; establishing the rules to ensure the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed; providing details on content and format of the information as regards equine species in the single lifetime identification document; amending the rules on withdrawal period in the light of new scientific evidence; providing the necessary detailed rules on the application, by operators in third countries, of the provisions on the prohibition of the use of antimicrobial medicinal products in animals for the purpose of promoting growth or increase yield and the prohibition of the use of designated antimicrobials; laying down the procedure for the imposition of fines or periodic penalty payments as well as the conditions and methods for their collection; and amending Annex II in order to (i) adapt the requirements regarding the technical documentation on the quality, safety and efficacy of veterinary medicinal products to technical and scientific progress and (ii) achieve a sufficient level of detail that ensures legal certainty and harmonisation as well as any necessary updating.
Međutim, potrebno je prilagoditi te zahtjeve kako bi se odgovorilo na utvrđene neusklađenosti s međunarodnim znanstvenim napretkom ili najnovijim kretanjima, uključujući smjernice VICH-a, SZO-a i standarde Organizacije za gospodarsku suradnju i razvoj (OECD) te uzimajući u obzir i potrebu za razvojem posebnih zahtjeva za veterinarsko-medicinske proizvode namijenjene novim terapijama, uz izbjegavanje većih izmjena postojećih odredaba, a osobito ne mijenjajući njihovu strukturu.
Since the objectives of this Regulation, namely to establish rules on veterinary medicinal products ensuring the protection of human and animal health and the environment as well as the functioning of the internal market, cannot be sufficiently achieved by the Member States, but can rather, by reason of its effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
S obzirom na to da ciljeve ove Uredbe, to jest utvrđivanje pravila o veterinarsko-medicinskim proizvodima kojima se osigurava zaštita zdravlja ljudi i životinja i okoliša te funkcioniranje unutarnjeg tržišta, ne mogu dostatno ostvariti države članice, nego se zbog njihovih učinaka oni na bolji način mogu ostvariti na razini Unije, Unija može donijeti mjere u skladu s načelom supsidijarnosti utvrđenim u članku 5.
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,
Ugovora o Europskoj uniji.
HAVE ADOPTED THIS REGULATION:
U skladu s načelom proporcionalnosti utvrđenim u tom članku, ova Uredba ne prelazi ono što je potrebno za ostvarivanje tih ciljeva,
This Regulation lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products.
Predmet
Article 2
Ovom se Uredbom utvrđuju pravila za stavljanje u promet, proizvodnju, uvoz, izvoz, opskrbu, distribuciju, farmakovigilanciju, kontrolu i primjenu veterinarsko-medicinskih proizvoda.
This Regulation shall apply to veterinary medicinal products prepared industrially or by a method involving an industrial process and intended to be placed on the market.
Područje primjene
In addition to the products referred to in paragraph 1 of this Article, Articles 94 and 95 shall also apply to active substances used as starting materials in veterinary medicinal products.
Ova se Uredba primjenjuje na veterinarsko-medicinske proizvode koji su pripremljeni industrijski ili metodom koja uključuje neki industrijski proces i namijenjeni su stavljanju u promet.