natgillin/translations-raw huggingface dataset:
o predlogu Direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini, kar zadeva Komisiji podeljena izvedbena pooblastila
on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2006)0919 )
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2006)0919 )
– ob upoštevanju člena 251(2) in člena 95 Pogodbe o ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C6‑0030/2007 ),
– having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6‑0030/2007 ),
– ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane ( A6‑0277/2007 ),
– having regard to the report of the Committee on the Environment, Public Health and Food Safety ( A6‑0277/2007 ),
(4) Zlasti bi bilo treba Komisiji podeliti pooblastila za prilagoditev nekaterih določb in prilog, potrebnih za sprejem dogovorov, načel in smernic ter opredelitev zadevnih izvedbenih ukrepov.
(4) In particular, power should be conferred on the Commission to adapt certain provisions and annexes, to adopt arrangements and principles and guidelines, and to lay down specific conditions of application.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju ali črtanju nebistvenih določb Direktive 2001/83/ES ali dopolnitvi navedene direktive z dodajanjem novih nebistvenih določb, bi jih bilo treba sprejeti po regulativnem postopku s pregledom iz člena 5a Sklepa 1999/468/ES.
Since these measures are of general scope and are designed to amend/delete non-essential elements of Directive 2001/83/EC and/or to supplement this Directive by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(4) Zlasti bi bilo treba Komisiji podeliti pooblastila za prilagoditev nekaterih določb in prilog, potrebnih za sprejem dogovorov, načel in smernic , opredelitev zadevnih izvedbenih ukrepov ter za sprejetje seznama rastlinskih snovi ter končnih ukrepov o začasnem preklicu in ukinitvi dovoljenj za promet .
(4) In particular, power should be conferred on the Commission to adapt certain provisions and annexes, to adopt arrangements and principles and guidelines, to lay down specific conditions of application, and to adopt the list of herbal substances and the final measures in relation to suspension and revocation of marketing authorisations .
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju ali črtanju nebistvenih določb Direktive 2001/83/ES ali dopolnitvi navedene direktive z dodajanjem novih nebistvenih določb, bi jih bilo treba sprejeti po regulativnem postopku s pregledom iz člena 5a Sklepa 1999/468/ES.
Since these measures are of general scope and are designed to amend/delete non-essential elements of Directive 2001/83/EC and/or to supplement that Directive by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Člen 16 f, odstavek 1 (Direktiva 2001/83/ES)
Article 16 f, paragraph 1 (Directive 2001/83/EC)
Seznam pri vsaki rastlinski snovi navaja indikacijo, opredeljeno jakost in odmerjanje, način dajanja in druge informacije, potrebne za varno uporabo rastlinske snovi kot tradicionalnega zdravila."
This list shall contain, with regard to each herbal substance, the indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product.’
Člen 107, odstavek 2, pododstavek 4 (Direktiva 2001/83/ES)
Article 107, paragraph 2, subparagraph 4 (Directive 2001/83/EC)
(6a) V členu 107(2) se četrti pododstavek nadomesti z naslednjim:
(6a) The fourth subparagraph of Article 107(2) is replaced by the following:
"Končni ukrepi, namenjeni spremembi nebistvenih določb te direktive z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 121(2a).“
‘The final measures designed to amend non-essential elements of this Directive by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121(2a).’
ČLEN 1, TOČKA 9, TOČKA (B)
ARTICLE 1, POINT 9, POINT (B)
Člen 121, odstavek 4 (Direktiva 2001/83/ES)
Article 121, paragraph 4 (Directive 2001/83/EC)
(b) odstavek 4 se črta.
(b) Paragraph 4 is deleted.
Predlog Komisije, da se črta odstavek 4, temelji na sklepu 1999/468/ES, ki med drugim natančno določa pogoje za objavo in dostop do dokumentov institucij ter agencij in organov Unije.
La proposition de la Commission de supprimer le paragraphe 4 repose sur la décision 1999/468/CE qui précise entre autres les conditions de publication et d'accès aux documents des institutions et des agences et organes de l'Union.
Črtanje naj bi bilo potrebno zato, da se ta točka v zakonodaji Skupnosti ne bi ponavljala.
Cette suppression se justifierait par la nécessité de ne pas répéter ce point dans la législation communautaire.
Dostop do dokumentov pa je mogoč le na zahtevo, medtem ko je v skladu z odstavkom 4 objava poslovnika odbora obvezna.
Or l'accès aux documents ne se fait que sur demande, alors que le paragraphe 4 rend obligatoire la publication du règlement intérieur du comité.
Po drugi strani pa ni razloga, da bi se v prihodnje objava poslovnika odbora, sprejeta ob reviziji zakonika Skupnosti o zdravilih za uporabo v humani medicini, zavračala, glede na to, da se je takrat sklep 1999/468/ES že uporabljal.
Par ailleurs, il n'y a aucune raison de refuser dorénavant cette publication du règlement intérieur du comité, acceptée lors de la révision du code communautaire relatif aux médicaments à usage humain, sachant qu'à cette date la décision 1999/468/CE était déjà d'application.
In pa, objava poslovnika je bila ena od točk splošnega sporazuma pri reviziji zakonika Skupnosti, še posebej v zvezi z večjo preglednostjo.
Enfin, cette publication du règlement intérieur était un point de l'accord général sur la révision du code communautaire, notamment en matière de renforcement de la transparence.
Pri prilagoditvi direktive o zakoniku Skupnosti o zdravilih za uporabo v humani medicini revidiranemu Sklepu 1999/468/EGS o postopkih komitologije se v celoti upošteva nedavno sprejeti regulativni postopek s pregledom.
The adjustment of the medicinal products for human use Directive to the revised Comitology Decision 1999/468/EEC shall take fully into account the newly introduced regulatory procedure with scrutiny.
Poročevalka meni, da je treba seznam rastlinskih snovi in končne ukrepe o začasnem preklicu in ukinitvi dovoljenj za promet sprejeti po novem regulativnem postopku s pregledom.
Your rapporteur is of the opinion that the list of herbal substances and the final measures in relation to suspension and revocation of marketing authorisations should be adopted under the new regulatory procedure with scrutiny.
Zakonik Skupnosti o zdravilih za uporabo v humani medicini (kar zadeva Komisiji podeljena izvedbena pooblastila)
Community code relating to medicinal products for human use (implementing powers conferred on the Commission)
o uporabi Direktive Sveta 2000/43/ES z dne 29. junija 2000 o izvajanju načela enakega obravnavanja oseb ne glede na raso ali narodnost
on the application of Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin
MANJŠINSKO MNENJE........................................................................................................16
MINORITY OPINION.............................................................................................................17
MNENJE Odbora za zaposlovanje in socialne zadeve ..................................17
OPINION of the Committee on Employment and Social Affairs ..............18
MNENJE Odbora za pravice žensk in enakost spolov ...................................23
OPINION of the Committee on Women's Rights and Gender Equality ...26
– ob upoštevanju poročila Odbora za državljanske svoboščine, pravosodje in notranje zadeve ter mnenj Odbora za pravice žensk in enakost spolov in Odbora za zaposlovanje in socialne zadeve ( A6-0278/2007 ),
– having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs and the opinions of the Committee on Women's Rights and Gender Equality and of the Committee on Employment and Social Affairs ( A6‑0278/2007 ),
Izvajanje direktive o rasni enakosti
Implementation of the Racial Equality Directive
A. ker je EU politični projekt, ki temelji na skupnih vrednotah, kot je varstvo človekovih pravic in temeljnih svoboščin, ki so navedene v členu 6 Pogodbe EU in Listini o temeljnih pravicah, ter spodbuja enakost in nediskriminacijo s politiko in zakonodajo tudi na podlagi člena 13 Pogodbe ES,
A. whereas the EU is a political project based on common values such as the protection of human rights and fundamental freedoms, as stated in Article 6 TEU and in the Charter of Fundamental Rights, and promotes equality and non-discrimination through its policies and laws, also on the basis of Article 13 TEC,
B. ker je pomembno, da politične izjave o boju proti diskriminaciji spremljata postopen razvoj ter dosledno in pravilno izvajanje politik in zakonov, predvsem direktiv za preprečevanje diskriminacije in projektov za spodbujanje enakosti, kot je evropsko leto enakih možnosti za vse,
B. whereas it is important that political declarations on the fight against discrimination are matched by the progressive development and full and correct implementation of policies and laws, and notably of the anti-discrimination directives and of the projects promoting equality, such as the European Year of Equal Opportunities for All,
C. ker letno poročilo Evropskega centra za spremljanje rasizma in ksenofobije za leto 2006 potrjuje, da je diskriminacija v državah članicah še vedno resen problem;
C. whereas the 2006 annual report of the European Monitoring Centre for Racism and Xenophobia confirms that discrimination remains a serious problem in the Member States,
D. ker nedavna raziskava Eurobarometra
D. whereas a recent Eurobarometer survey
http://ec.europa.eu/public_opinion/archives/ebs/ebs_263_sum_en.pdf. kaže, da 64 % državljanov v 25 državah članicah, vključenih v raziskavo, meni, da je diskriminacija na podlagi narodnostne pripadnosti še vedno razširjena;
http://ec.europa.eu/public_opinion/archives/ebs/ebs_263_sum_en.pdf shows that 64% of citizens in 25 Member States surveyed think discrimination based on ethnic origin is still widespread,
E. ker je sprejetje Direktive Sveta 2000/43/ES z dne 29. junija 2000 o izvajanju načela enakega obravnavanja oseb ne glede na raso ali narodnost
E. whereas the adoption of Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin
22. pomemben korak k izboljšanju ravni varstva žrtev diskriminacije na podlagi rase ali narodnosti ter k zagotavljanju boljših možnosti glede odškodnin,
22. may be seen as a major step in raising the level of protection for victims of discrimination based on racial or ethnic origin and in giving them better possibilities of redress,
F. ker je določba o dokaznem bremenu ključni vidik direktive, saj prispeva k učinkovitemu uveljavljanju varstva, ki ga zagotavlja;
F. whereas the burden of proof provision is a key aspect of the Directive because it contributes to an effective enforcement of the protection which it provides,
G. ker sodna praksa na področju dokaznega bremena kaže, da med državami članicami še vedno obstajajo bistvene razlike v zvezi s tem, kaj je sprejeto kot dokaz prima facie tožnikov; ker je zato treba države članice spodbujati, da v zvezi s tem izmenjajo mnenja, da bi ugotovile, ali je mogoče sodne postopke uskladiti,
G. whereas the case-law on the burden of proof shows that there are still considerable divergences between Member States as to what is accepted as prima facie evidence by plaintiffs; whereas Member States should therefore be encouraged to exchange views on this subject, with a view to seeing whether it is possible to bring judicial procedures into line with one another,
H. ker bi k učinkovitemu izvajanju načela enakosti pripomoglo, če bi se pravila o dokaznem bremenu v civilnih in administrativnih zadevah razširila na sodne določbe proti viktimizaciji,
H. whereas the effective implementation of the principle of equality would be helped if the rules on the burden of proof in civil and administrative cases were extended to judicial provisions against victimisation,
Organi za enako obravnavo
Equality bodies
I. ker imajo zdaj skoraj vse države članice organe za spodbujanje enakosti ali so naloge, ki jih izvajajo takšni organi, dodelile obstoječim organom;
I. whereas almost all Member States now have equality bodies or have allocated the functions to be carried out by such bodies to existing bodies,
J. ker je treba vse države članice spodbujati, naj sprejmejo izredno pozitiven ukrep, s katerim bodo razširile področje pristojnosti organov za spodbujanje enakosti in tako zajele tudi diskriminacijo na podlagi drugih razlogov, ne le rase ali narodnosti,
J. whereas all Member States should be encouraged to take the extremely positive step of broadening the remit of their equality bodies to cover discrimination on grounds other than race or ethnic origin,
K. ker morajo imeti organi za spodbujanje enakosti ustrezne vire, tako kadrovske kot finančne,
K. whereas equality bodies should have adequate resources in terms of both personnel and financing,
L. ker morajo biti organi za spodbujanje enakosti sposobni delovati neodvisno od vlade in bi jih morali tudi tako obravnavati, t.j. da niso del vlade,
L. whereas equality bodies should be able to function independently of government and should be perceived as functioning independently, i. e. not forming part of government,
M. ker v številnih državah članicah število zabeleženih pritožb kljub obstoju specializiranih organov za boj proti diskriminaciji in za spodbujanje enake obravnave ostaja nizko,
M. whereas, despite the existence of specialised anti-discrimination and equality bodies, the number of registered complaints remains low in a number of Member States,
N. ker organi za spodbujanje enakosti v praksi le malo zadev predložijo sodiščem, razlog za to pa je pomanjkanje finančnih in človeških virov; ker so pogosto nevladne organizacije tiste, ki žrtvam diskriminacije zagotavljajo celovito pomoč pri ukrepanju,
N. whereas in practice equality bodies unfortunately bring only a small number of cases before the courts, owing to a lack of financial and human resources; whereas it is often NGOs that provide victims of discrimination with end-to-end assistance in taking action,
O. ker je usposabljanje javnih uradnikov za namene direktive bistveno zaradi njihove odgovornosti pri izvajanju,
O. whereas the training of public officials on the aims of the Directive is vital because of their responsibility for implementing it,
P. ker ločevanje med diskriminacijo na podlagi rase ali narodnosti ter diskriminacijo na podlagi vere, mnenja ali narodnosti ni vedno mogoče,
P. whereas it is not always possible to distinguish between discrimination on the ground of racial or ethnic origin and discrimination on the ground of religion, opinion or nationality,
Q. ker ni vedno enostavno določiti, ali diskriminacija temelji na spolu, etnični pripadnosti, rasi, socialnih pogojih, spolni usmerjenosti ali drugih dejavnikih,
Q. whereas it is not always easy to determine whether discrimination is based on gender, ethnicity, race, social conditions, sexual orientation or other factors,
Razširjanje informacij in ozaveščanje
Dissemination of information and awareness-raising
R. ker nedavna raziskava Eurobarometra potrjuje, da je ozaveščenost o obstoju protidiskriminacijske zakonodaje v EU precej majhna, in v povprečju le tretjina državljanov EU navaja, da pozna svoje pravice, če postanejo žrtve diskriminacije ali nadlegovanja,
R. whereas the recent Eurobarometer survey confirms that awareness of the existence of anti-discrimination legislation in the EU is quite low and that on average only one third of EU citizens claim to know their rights should they be victims of discrimination or harassment,
S. ker so nekatere države članice kljub temu sprejele številne pobude glede obveščanja/ozaveščanja (spletne strani, kampanje, televizijski in časopisni oglasi),
S. whereas, however, some Member States have taken a wide range of information/awareness-raising initiatives (websites, campaigns, television spots, newspaper advertisements);
T. ker so nekatere države članice sprejele pomembne pobude in so v nacionalno zakonodajo vključile obveznost, da morajo delodajalci svoje zaposlene obveščati o zakonodaji na področju diskriminacije,
T. whereas some Member States have taken the important initiative of incorporating in their national law an obligation on employers to inform their employees of discrimination laws,
U. ker so nekateri specializirani organi v državah članicah vzpostavili odprte telefonske linije, ki zagotavljajo informacije in pomoč žrtvam diskriminacije,
U. whereas some specialised bodies in the Member States have established hotlines providing information and support to victims of discrimination,
V. ker so bile dejavnosti obveščanja/ozaveščanja v več državah članicah izvedene pomanjkljivo , v nekaterih državah jih sploh ni bilo,
V. whereas there are also a number of Member States that implemented rather limited information/awareness-raising activities and in some countries no awareness-raising campaigns were reported,
W. ker si morajo zlasti v okviru evropskega leta enakih možnosti institucije EU in države članice resnično prizadevati, da državljane obveščajo o njihovih pravicah, in ker morajo zagotoviti, da se bodo ukrepi, ki so se začeli izvajati leta 2007, nadaljevali tudi leta 2008, ki je evropsko leto medkulturnega dialoga,
W. whereas especially in the context of the European Year for Equal Opportunities, both the EU institutions and the Member States should make substantial efforts to inform citizens of their rights, and whereas the latter should ensure that the measures initiated in 2007 continue into 2008, the European Year for Intercultural Dialogue,
Zbiranje podatkov
Data collection
X. ker je zbiranje podatkov bistveno v boju proti diskriminaciji in so lahko etnično ločeni statistični podatki bistveni za prikazovanje posredne diskriminacije, politiko obveščanja in razvijanje strategij pozitivnih ukrepov, pri čemer pa se pojavljajo številna etična in pravna vprašanja,
X. whereas data collection is essential in the fight against discrimination, and ethnically disaggregated statistical data can be essential for demonstrating indirect discrimination, informing policy and developing positive action strategies, but at the same time raises several ethical and legal questions,
Y. ker takšno zbiranje podatkov ne sme kršiti človekove zasebnosti z razkrivanjem posameznih identitet ali biti podlaga za etnično ali rasno profiliranje,
Y. whereas such data collection must not infringe personal privacy by revealing individual identities or serve as a basis for ethnic or racial profiling,
Pravna sredstva
Legal redress
Z. ker alternativni postopki reševanja sporov ne smejo vnaprej zagotavljati dostopa do sodišč,
Z. whereas alternative dispute resolution procedures should not pre-empt access to the courts,
Za. ker številne žrtve diskriminacije pritožbe na sodišče ne vložijo zaradi različnih razlogov, tudi stroškov in strahu pred maščevanjem,
Za. whereas a large number of victims of discrimination do not lodge a complaint with the courts for various reasons, including cost and fear of reprisals,
Zb. ker se lahko cilji boja proti diskriminaciji dosežejo le, če se pravni ukrepi kombinirajo s pozitivnimi ukrepi na ravni EU in držav članic,
Zb. whereas the goals of the fight against discrimination can be reached only if the legal measures are combined with positive actions on the level of the EU and the Member States;
Zc. ker ima Agencija Evropske unije za temeljne pravice nalogo, da zbira in analizira pomembne, zanesljive in primerljive informacije ter podatke v zvezi s temeljnimi pravicami,
Zc. whereas the European Union Agency for Fundamental Rights has the task of collecting and analysing relevant, reliable, comparable information and data relating to fundamental rights,
3. pozdravlja sporočilo Komisije o izvajanju Direktive 2000/43/ES z 29. junija 2000 o izvajanju načela enakega obravnavanja oseb ne glede na raso ali narodnost, katere cilj je vzpostavitev okvira za boj proti diskriminaciji na podlagi rase ali etničnega porekla ( KOM(2006)0643 ), da se zagotovi okrepitev načel enakosti pred zakonom, enakih možnosti in enakega obravnavanja v državah članicah ob doslednem spoštovanju načela subsidiarnosti in v skladu z različnimi nacionalnimi tradicijami in postopki; kljub upoštevanju pregleda izvrševanja direktive iz poročila Komisije, ugotavlja, da bi bilo koristno, če bi bil dan na razpolago podroben opis načina, kako se določbe Direktive 2000/43/ES vključujejo v nacionalno pravo, kot je to določeno v sami direktivi; nadalje ugotavlja, da se je Komisija zavezala ne le, da bo zbrala podrobne podatke, temveč tudi, da bo o tem poročala Parlamentu in Svetu, in da je Parlament v svoji resoluciji s14. junija 2006 o nediskriminaciji in enakih možnostih za vse – okvirna strategija
Welcomes the Commission Communication on the application of Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin ( COM(2006)0643 ), which seeks to establish a framework to combat discrimination based on racial or ethnic origin in order to ensure that the principle of equality before the law, equal opportunities and equal treatment is consolidated in the Member States, whilst fully complying with the principle of subsidiarity and respecting the various national traditions and procedures; while appreciating the overview of the implementation of the Directive contained in the Commission Communication, notes that it would also have been useful to have been provided with a detailed description of the way in which the provisions of Directive 2000/43/EC have been incorporated into national law, as specified in the Directive itself; further notes that the Commission undertook not only to collect detailed information, but to report on it to Parliament and the Council and that Parliament, in its resolution of 14 June 2006 on non-discrimination and equal opportunities for all – a framework strategy
Sprejeta besedila, P6_TA(2006)0261 . pozval Komisijo, naj nemudoma oceni kakovost in vsebino zakonov, s katerimi se izvajajo protidiskriminacijske direktive;
T exts Adopted , P6_TA (2006)0261. , asked the Commission to 'examine as to matter of urgency the quality and content of the laws implementing the anti‑discrimination directives';
6. izraža zadovoljstvo, ker je večina držav članic sprejela ukrepe za izvajanje direktive, vendar z razočaranjem ugotavlja, da so le nekatere ustrezno v celoti prenesle vse njene določbe;
Notes with satisfaction that most Member States have taken action in order to implement the Directive, but is disappointed that only a few have adequately transposed all of its provisions fully;
8. poziva zlasti k natančnemu nadzoru nad uporabo določbe o deloma obrnjenem dokaznem bremenu, ki je zlasti učinkovita v sporih, povezanih z zaposlovanjem;
Calls, in particular, for strict monitoring of the application of the rule on the partial reversal of the burden of proof, which is particularly effective in the case of employment-related disputes;