natgillin/translations-raw huggingface dataset:
UVODNA IZJAVA 35 A (novo)
RECITAL 35 a (new)
(35a) Direktiva Sveta 76/769/EGS z dne 27. julija 1976o približevanju zakonov in drugih predpisov držav članic v zvezi z omejitvami pri trženju in uporabi nekaterih nevarnih snovi in pripravkov 1 prepoveduje trženje snovi za javno uporabo, ki so razvrščene kot kancerogene, mutagene ali strupene za razmnoževanje v skupino 1 ali 2, v skladu z Direktivo Sveta 67/548/EGS z dne 27. junija 1967 o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi 2 .
(35a) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations 1 prohibits the placing on the market for use by the general public of substances or preparations containing substances classified as carcinogenic, mutagenic or toxic for reproduction, category 1 or 2, pursuant to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances 2 .
1 UL L 262, 27.9.1976, str.
1 OJ L 262, 27.9.1976, p.
Direktiva, nazadnje spremenjene z Direktivo Evropskega parlamenta in Sveta 2005/90/ES (UL L 33, 4.2.2006, str.
Directive as last amended by Directive 2005/90/EC of the European Parliament and of the Council ( OJ L 33, 4.2.2006, p.
1 UL L 196, 16.8.1967, str.
2 OJ L 196, 16.8.1967, p.
Direktiva, nazadnje spremenjena z Direktivo 2004/73/ES (UL L 152, 30.4.2004, str.
Directive as last amended by Commission Directive 2004/73/EC (OJ L 152, 30.4.2004, p.
Novi predlog spremembe zaradi novega dejstva (člen 62 (2d)).
New amendment due to a new fact (Rule 62(2d)).
Nedavne raziskave so dokazale uporabo snovi, ki je kot pomožna snov strupena za razmnoževanje v več kot 100 zdravilih.
Recent research has revealed the use of a substance that is toxic to reproduction as an excipient in more than 100 medicinal products.
Zakonodaja skupnosti prepoveduje prodajo splošni javnosti snovi, ki so kancerogene, mutagene ali strupene za razmnoževanje..
Community law prohibits the sale to the general public of substances that are carcinogenic, mutagenic or toxic to reproduction.
Medtem, ko je bilo izvzetje iz te določbe za kozmetične proizvode odpravljeno, pa so zdravila še vedno izvzeta.
While an exemption from this provision for cosmetic products has been overcome, medicinal products are still exempted.
Uporaba takih snovi kot učinkovin je lahko upravičena, ni pa upravičena za pomožne snovi, če so na voljo druge možnosti.
While it may be justified to use such substances as active substances, there is no justification to do so for excipients, all the more that alternatives are available.
UVODNA IZJAVA 35 B (novo)
RECITAL 35 b (new)
(35b) Glede na posebna tveganja, ki jih lahko snovi, razvrščene kot kancerogene, mutagene ali strupene za razmnoževanje v skupino 1, 2 in 3 v skladu z Direktivo 67/548/EGS vsebujejo za zdravje ljudi, je njihova uporaba za zdravila kot sestavine pomožnih snovi ali sestavine zunanje zaščite prepovedana.
(35b) Given the special risks that substances classified as carcinogenic, mutagenic or toxic for reproduction, category 1, 2 and 3, pursuant to Directive 67/548/EEC may entail for human health, their use in medicinal products as constituents of excipients or as constituents of the outer covering should be prohibited.
Snov, ki je razvrščena v skupino 3, se lahko uporablja kot sestavina pomožnih snovi ali sestavina zunanje zaščite zdravil, če jo je ocenil odbor za zdravila za humano uporabo in ugotovil, da je sprejemljiva za uporabo za zdravila.
A substance classified in category 3 may be used as a constituent of excipients or as a constituent of the outer covering in medicinal products if the substance has been evaluated by the Committee for Medicinal Products for Human Use and found acceptable for use in medicinal products.
Uporaba kancerogenih, mutagenih snovi ali snovi, strupenih za razmnoževanje (CMR), za pomožne snovi je povzročila povečano izpostavljenost takim snovem.
The use of CMR substances as excipients has led to very elevated exposure to such substances.
To je še posebej problematično za nosečnice, ker lahko poveča deformacije spolovil pri novorojenih dečkih.
This is particularly problematic for pregnant women, as it may contribute to the increase of genital malformations observed in new-born boys.
Prepovedati se mora uporaba snovi CMR (kancerogene, mutagene ali strupene za razmnoževanje) iz skupin 1 in 2 v pomožnih snoveh in zunanji zaščiti zdravil.
The use of CMR substances category 1 and 2 should be prohibited in excipients or in the outer covering of medicinal products.
Po analogiji s kozmetično zakonodajo so snovi CMR iz skupine 3 lahko dovoljene le, če so ocenjene kot varne (glej tudi obrazložitev k predlogu spremembe 6).
In analogy to the cosmetics legislation, CMR substances category 3 may only be allowed if they have been assessed to be safe (see also justification to amendment 6).
Za Odbor za pediatrijo se uporablja Uredba (ES) št. 726/2004, razen če ni s to uredbo določeno drugače.
Save where otherwise provided for in this Regulation, Regulation (EC) No 726/2004 shall apply to the Paediatric Committee.
Za Odbor za pediatrijo se uporablja Uredba (ES) št. 726/2004, razen če ni s to uredbo določeno drugače, vključno z določbami o neodvisnosti in nepristranskosti njegovih članov.
Save where otherwise provided for in this Regulation, Regulation (EC) No 726/2004 shall apply to the Paediatric Committee , including the provisions on the independence and impartiality of its members .
Pri pripravi mnenj si Odbor za pediatrijo po svojih najboljših močeh prizadeva doseči soglasje na znanstveni podlagi.
When preparing its opinions, the Paediatric Committee shall use its best endeavours to reach a scientific consensus.
Če takega soglasja ni mogoče doseči, Odbor za pediatrijo sprejme mnenje, ki predstavlja stališče večine članov.
If such a consensus cannot be reached, the Paediatric Committee shall adopt an opinion consisting of the position of the majority of the members.
V mnenju se navedejo različna stališča, vključno z njihovimi utemeljitvami.
The opinion shall mention the divergent positions, with the grounds on which they are based.
Mnenje se objavi.
The opinion shall be made public.
Deloma se ponovno vstavi predlog spremembe 22 iz prve obravnave, ki je bil sprejet 7. septembra 2005.
Partial reinstatement of amendment 22 from first reading, adopted on 7 September 2005.
Pomembno je zagotoviti objavo stališča Odbora za pediatrijo.
It is important to ensure that the position of the Paediatric Committee is made public.
ČLEN 16, ODSTAVEK 1
ARTICLE 16, PARAGRAPH 1
V primeru vlog iz členov 7 in 8 se načrt pediatričnih raziskav, če ni drugače določeno , predloži skupaj s prošnjo za soglasje najkasneje ob zaključku farmakokinetičnih študij pri odraslih, določenih v oddelku 5.2.3 dela I Priloge I k Direktivi 2001/83/ES, tako da je lahko mnenje o uporabi zadevnega zdravila pri pediatrični populaciji podano v času presoje dovoljenja za promet ali druge zadevne vloge.
In the case of the applications referred to in Articles 7 and 8, the paediatric investigation plan shall be submitted with a request for agreement, unless otherwise justified, not later than upon completion of the human pharmaco-kinetic studies in adults specified in Section 5.2.3 of Part I of Annex I to Directive 2001/83/EC, so as to ensure that an opinion on use in the paediatric population of the medicinal product concerned can be given at the time of the assessment of the marketing authorisation or other application concerned.
V primeru vlog za dovoljenje za promet iz členov 7 in 8 ali vlog za opustitev iz členov 11 in 12, se načrt pediatričnih raziskav ali vloge za opustitev , razen v ustrezno upravičenih primerih , predloži skupaj s prošnjo za soglasje najkasneje ob zaključku farmakokinetičnih študij pri odraslih, določenih v oddelku 5.2.3 dela I Priloge I k Direktivi 2001/83/ES, tako da je lahko mnenje o uporabi zadevnega zdravila pri pediatrični populaciji podano v času presoje dovoljenja za promet ali druge zadevne vloge.
In the case of the applications for marketing authorisation referred to in Articles 7 and 8 or the applications for waiver referred to in Articles 11 and 12 , the paediatric investigation plan or the application for waiver shall be submitted with a request for agreement, except in duly justified cases , not later than upon completion of the human pharmaco-kinetic studies in adults specified in Section 5.2.3 of Part I of Annex I to Directive 2001/83/EC, so as to ensure that an opinion on use in the paediatric population of the medicinal product concerned can be given at the time of the assessment of the marketing authorisation or other application concerned.
Namen predloga spremembe je, da se odobritve dovoljenja za promet za zdravilo, namenjeno odraslemu, ne odloži ter da se upošteva pomen posebnih pediatričnih raziskav, ki jih bo moral vlagatelj opraviti.
The purpose of the amendment is to ensure that marketing authorisations for medicinal products for adults are not delayed while at the same time taking due account of the importance of the specific paediatric studies which applicants will be obliged to conduct.
ČLEN 25, ODSTAVEK 3
ARTICLE 25, PARAGRAPH 3
Odbor za pediatrijo v 30-ih dneh od prejema zahteve za ponovni pregled iz odstavka 2, potem ko imenuje novega poročevalca, izda novo mnenje, s katerim potrdi ali spremeni svoje predhodno mnenje.
Within 30 days following receipt of a request for re-examination pursuant to paragraph 2, the Paediatric Committee, having appointed a new rapporteur, shall issue a new opinion confirming or revising its previous opinion.
Mnenje se ustrezno utemelji in novemu mnenju, ki je dokončno, se priloži obrazložitev sprejete odločitve.
The opinion shall be duly reasoned and a statement of reasons for the conclusion reached shall be annexed to the new opinion, which shall become definitive.
Poročevalec mora imeti možnost neposrednega zaslišanja vlagatelja.
The rapporteur shall be able to question the applicant directly.
Tudi vlagatelj lahko predlaga zaslišanje.
The applicant may also offer to be questioned.
Poročevalec takoj pisno obvesti Odbor za pediatrijo o podrobnostih stikov z vlagateljem.
The rapporteur shall inform the Paediatric Committee without delay in writing about details of contacts with the applicant.
Poročevalec deluje kot predstavnik Odbora in ga obvešča o stikih z vlagateljem.
The rapporteur shall act as representative of the Committee and keep it informed about contacts with the applicant.
(Ponovno se vstavi predlog spremembe 41, sprejet v prvi obravnavi 7. septembra 2005).
(Reinstates amendment 41 adopted at first reading on 7 September 2005.)
ČLEN 34, ODSTAVEK 1, UVODNI DEL
ARTICLE 34, PARAGRAPH 1, INTRODUCTORY PART
Poleg običajnih zahtev za spremljanje zdravila po začetku trženja vlagatelj podrobno določi ukrepe, s katerimi se zagotovi spremljanje učinkovitosti in morebitnih neželenih učinkov pri pediatrični uporabi zdravila v naslednjih primerih vlog:
In the following cases, the applicant shall detail , in addition to the normal requirements for post marketing monitoring, the measures to ensure the follow-up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product:
Vlagatelj podrobno določi ukrepe, s katerimi se zagotovi spremljanje učinkovitosti in morebitnih neželenih učinkov pri pediatrični uporabi zdravila v naslednjih primerih vlog:
In the following cases, the applicant shall detail the measures to ensure the follow-up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product:
V okviru 'boljše pravne ureditve' se je treba sklicevati na že sprejeta načela v drugih zakonodajah, ki morajo veljati za obstoječo uredbo, zlasti glede farmakovigilance.
Within the ‘better regulation’ context, reference should be made to principles already adopted in other legislation which must apply under this Regulation, notably as regards pharmacovigilance.
ČLEN 34, ODSTAVEK 2, PODODSTAVEK 1
ARTICLE 34, PARAGRAPH 2, SUBPARAGRAPH 1
Če obstaja poseben razlog za zaskrbljenost, lahko pristojni organ kot pogoj za izdajo dovoljenja za promet zahteva, da se vzpostavi sistem obvladovanja tveganja ali da se izvedejo določene študije po začetku trženja, ki se predložijo v pregled.
Where there is particular cause for concern, the competent authority may require, as a condition for granting marketing authorisation, that a risk management system be set up or that specific post-marketing studies be performed and submitted for review .
Sistem obvladovanja tveganja obsega sklop dejavnosti farmakovigilance in intervencij, namenjenih identifikaciji, opisu, preprečevanju ali zmanjševanju tveganj, povezanih z zdravili, vključno z oceno učinkovitosti teh intervencij.
The risk management system shall comprise a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions.
Za odobritev dovoljenja za promet zdravil s pediatrično indikacijo mora vlagatelj vzpostaviti sistem obvladovanja tveganja.
Granting marketing authorisation for a paediatric indication shall be subject to the setting-up of a risk management system by the firm concerned.
Pristojni organ lahko zahteva, da se, če je potrebno, izvedejo specifične študije.
If necessary, the competent authority may also require specific studies to be performed.
Povzetek predloga spremembe 47, sprejetega v prvi obravnavi 7. septembra 2005.
Reinstatement of Amendment 47 adopted at first reading on 7 September 2005.
Samodejno je treba vzpostavljati sistem oblvadovanja tveganja za zdravila s pediatrično indikacijo.
A risk management system should be set up systematically for medicinal products with a paediatric indication.
ČLEN 34, ODSTAVEK 2 A (novo)
ARTICLE 34, PARAGRAPH 2 a (new)
Poleg določb iz 1. in 2. odstavka, je treba pri dovoljenjih za promet zdravil s pediatrično indikacijo upoštevati tudi določbe o farmakovigilenci, navedene v Uredbi (ES) št. 726/2004 in Direktivi 2001/83/ES.
In addition to the provisions contained in paragraphs 1 and 2, the provisions on pharmacovigilance as laid down in Regulation (EC) No 726/2004 and in Directive 2001/83/EC must apply to marketing authorisations for medicinal products which include a paediatric indication.
Če se uporabijo postopki, določeni v Direktivi 2001/83/ES, se šestmesečno podaljšanje obdobja iz odstavka 1 odobri samo, če je zdravilo odobreno v vseh državah članicah.
Where the procedures laid down in Directive 2001/83/EC have been used, the six‑month extension of the period referred to in paragraph 1 shall be granted only if the product is authorised in all Member States.
Če se uporabijo postopki, določeni v Direktivi 2001/83/ES, se šestmesečno podaljšanje obdobja iz odstavka 1 odobri samo, če je zdravilo dobilo dovoljenje za promet v vseh državah članicah.
Where the procedures laid down in Directive 2001/83/EC have been used, the six‑month extension of the period referred to in paragraph 1 shall be granted only if the product has received a marketing authorisation in all Member States.
ČLEN 43, ODSTAVEK 1, ALINEA 2
ARTICLE 43, PARAGRAPH 1, SUBPARAGRAPH 2
Agencija najkasneje do ….*** objavi seznam, ki ga redno posodablja.
By …. * * * , the Agency shall make the inventory public and shall update it regularly.
Agencija ne prej kot drugo leto in najpozneje do ….*** objavi seznam, ki ga redno posodablja.
The Agency shall make the inventory public in the second year at the earliest and not later than …. * * * and shall update it regularly.
ČLEN 45, ODSTAVEK 3 A (novo)
ARTICLE 45, PARAGRAPH 3 a (new)
V posvetovanju z agencijo Komisija pripravi smernice za določitev ocenjevalnih meril za pomen študij za namene uporabe odstavka 3.
In consultation with the Agency, the Commission shall draw up guidelines to establish assessment criteria for the significance of studies for the purposes of applying paragraph 3.
V zvezi s tem mora Komisija, na podlagi strokovnega znanja in izkušenj, odločiti, katere študije so potrebne in/ali ustrezne.
In this context, it is for the Commission to decide, based on the Agency’s scientific expertise, which studies are considered necessary and/or relevant.
ČLEN 52, TOČKA 2
ARTICLE 52, POINT 2
Člen 7, odstavek 4a (novo) (Uredba (EGS) št. 1768/92)
Article 7, paragraph 4 a (new) (Regulation (EEC) No 1768/92)
Ne glede na odstavek 4 se pet let po začetku veljavnosti Uredbe (ES) št. …/…*[uredba o pediatriji] prijava za podaljšanje veljavnosti že izdanega certifikata vloži najpozneje šest mesecev pred iztekom veljavnosti certifikata.
Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No .../...*[paediatric regulation], 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.
*UL: vstavi številko te uredbe.
* Note to OJ: please insert number of this Regulation.
Uvedba prehodne klavzule je pomembna, če obstajajo zdravila, ki jim poteče certifikat, vendar so lahko pomembna za pediatrično populacijo.
The introduction of this transitional clause is important in so far as there are currently medicinal products whose certificate is due to expire but which may be important for the paediatric population.
ČLEN 54, TOČKA 1 A (novo)
ARTICLE 54, POINT 1 a (new)
Člen 117, odstavek 1, točka (d a) (novo) (Direktiva 2001/83/ES)
Article 117, paragraph 1, point (d a) (new) (Directive 2001/83/EC)
1a.V členu 117(1) Direktive 2001/83/EGS se doda naslednji odstavek:
1a) In Article 117(1) of Directive 2001/83/EC, the following point shall be added:
"(da) zdravilo vsebuje snovi, ki so kancerogene, strupene ali mutagene za razmnoževanje, kot so navedene v Prilogi I Direktive Sveta 67/584/EGS , kot sestavine pomožnih snovi ali sestavine zunanje zaščite.
‘(da) it contains substances that are carcinogenic, mutagenic or toxic to reproduction as listed in Annex I to Council Directive 67/548/EEC 1 as constituents of excipients or as constituents of the outer covering.
1 UL L 196, 16.8.1967, str.
1 OJ L 196, 16.8.1967, p.
Direktiva, nazadnje spremenjena z Direktivo Komisije 2004/73/ES (UL L 152, 30.4.2004, str.
Directive as last amended by Commission Directive 2004/73/EC (OJ L 152, 30.4.2004, p.
Zdravila, ki vsebujejo snovi CMR v pomožni snovi ali zunanji zaščiti, bi morala biti umaknjena s trga.
Medicinal products containing CMR substances in excipients or in outer covering should be withdrawn from the market.
Za isto zdravljenje so na voljo druga zdravila.
Alternative medicinal products for the same treatment are available.
Proizvajalci bi lahko zaprosili za spremembo dovoljenja, da bi lahko nadaljevali s prodajo spremenjenega zdravila, ki ne vsebuje snovi CMR v pomožni snovi in zunanji zaščiti.
Manufacturers could then apply to vary the authorisation so as to continue to sell a varied medicinal product that does not contain CMR substances in excipients and outer covering.
ČLEN 54, TOČKA 1 B (novo)
ARTICLE 54, POINT 1 b (new)
Priloga I, točka 3.2.2.4 (a) (Direktiva 2001/83/ES)
Annex 1, point 3.2.2.4 (a) (Directive 2001/83/EC)
"Snovi, ki so razvrščene kot kancerogene, mutagene ali strupene za razmnoževanje v skupino 1, 2 in 3 v skladu z Direktivo 67/548/EGS 1 , se ne sme uporabljati za sestavine pomožnih snovi ali zunanje zaščite zdravil.
‘Substances classified as carcinogenic, mutagenic or toxic for reproduction, category 1, 2 and 3, pursuant to Directive 67/548/EEC 1 must not be used as constituents of excipients or constituents of the outer covering of medicinal products.
V bodoče se je nujno treba izogibati uporabi snovi CMR za pomožne snovi ali za zunanjo zaščito.
It is necessary to avoid that CMR substances are used as excipients or in outer coverings in the future.
Pri nadzoru pomožnih snovi je zato treba podrobno opredeliti, da se teh snovi ne sme uporabljat (glej tudi obrazložitvi predlogov sprememb 6 in 7).
It therefore needs to be specified in the control of excipients that such substances must not be used (see also justifications to amendments 6 and 7).
S to uredbo bodo končno na voljo posebna, otrokom namenjena zdravila.
Thanks to this Regulation, medicinal products specifically intended for paediatric use will finally be able to be made available to children.
Pogosto se za otroke uporabljajo ista zdravila kot za odrasle paciente, le da je odmerek manjši.
In many cases, the medicines used for children are the same as those prescribed for adults.
Poskrbeti moramo, da se bo ta akt Skupnosti lahko čim prej uporabljal.
We must therefore seek to ensure that this Community act is able to be implemented as soon as possible.
Poročevalka z določenim zadovoljstvom sprejema skupno stališče, ki po eni strani povzema številne predloge sprememb Parlamenta in po drugi sprejema posebne pobude za evropske raziskave.
Your rapporteur welcomes, with some satisfaction, the common position, which both incorporates many of Parliament’s amendments and accepts the introduction of specific incentives for European research.
Poročevalka zato želi vnesti nekaj sprememb v skupno stališče, da bo uredba bolj pragmatična.
However, your rapporteur wishes to make some adjustments to the common position to make the regulations more pragmatic.
Da ne bi prišlo do prekrivanje uredb, se je potrebno na področju farmakovigilance in v zvezi z neodvisnostjo članov Odbora za pediatrijo, sklicevati na že sprejete direktive in uredbe.
In the area of pharmacovigilance and as regards the independence of members of the Paediatric Committee, reference should be made to directives and regulations already adopted in order to avoid overlapping of regulatory texts.
Razvoj proizvodov, namenjenih otrokom, ne sme ovirati razvoja zdravil za odrasle.
The development of medicinal products intended for children must not be allowed to hamper the development of medicinal products for adults.
Poročevalka tudi predlaga uvedbo ustrezno utemeljenega odstopanja v nekaterih primerih.
Your rapporteur is therefore proposing the introduction in certain cases of a duly justified derogation.
To bo omogočalo, da iz znanstvenih razlogov ne bo obvezna hkratna predstavitev rezultatov pediatričnih raziskav in rezultatov, namenjenih odraslim.
This will make it possible, on scientific grounds, for the requirement for the results of the paediatric studies to be submitted at the same time as those of the studies in adults not to apply.
Prav tako je potrebno uvesti prehodno klavzulo v členu 52.
It is also necessary to introduce a transitional clause under Article 52.
Uvedba slednje je pomembna, če obstajajo zdravila, ki jim poteče certifikat, vendar so lahko pomembna za pediatrično populacijo.
The introduction of such a clause is important in so far as there are currently medicinal products whose certificate is due to expire but which may be important for the paediatric population.
Če bi bili že sedaj preveč restriktivni, bi lahko ovirali razvoj novih terapij.
Being too restrictive at this stage would risk blocking the development of new treatments.
Prehodna klavzula ne bo oškodovala generične proizvodnje, ki bo lahko imela koristi od tako razvitih novih zdravil.
This transitional clause will not penalise the generics industry, which will be able to benefit from new medicinal products developed in this way.
Kot zadnje, uredba ima svojo pravno podlago v členu 95 Pogodbe ES in ni verjetno, da bi Svet to referenco črtal.
Finally, this Regulation derives its legal basis from Article 95 of the EC Treaty, and it seems inconceivable that the Council should be proposing to delete this reference.
Z uvedbo tega akta Skupnosti bo Evropska unija dobila učinkovito sredstvo za pomoč pri razvoju pediatričnih zdravil in za odpravo glavne pomanjkljivosti, ki jo še vedno poznamo v sistemu javnega zdravstva.
With the introduction of this Community act, the European Union will have effective means of promoting the development of medicinal products for paediatric use and closing this current major gap in the area of public health.