natgillin/translations-raw huggingface dataset:
Razširitev pojma „neželeni učinki“ na stranske učinke zaradi napak pri zdravilih ali uporabe, ki ni v skladu z odobrenim povzetkom glavnih značilnosti zdravila (vključno z nepravilno uporabo in zlorabo zdravil), omogoča celovitejši pregled nad stranskimi učinki, ki bi lahko škodili bolniku.
Extending the concept of ‘adverse reaction’ to include secondary effects resulting from a medication error or use that inconsistent with the authorised summary of the product’s characteristics (including misuse and abuse of the medicine) will make it possible to ascertain more comprehensively the secondary effects that may be harmful to patients.
Treba pa je jasno razločevati stranske učinke v običajnih pogojih uporabe zdravil od drugih stranskih učinkov.
But it is still important to make a clear distinction between secondary effects resulting from normal use and the others.
Člen 107a – odstavek 2 – pododstavek 1
Article 107a – paragraph 2 – subparagraph 1
Države članice v 15 dneh od prejema poročil iz odstavka 1 poročila elektronsko posredujejo v podatkovno bazo Eudravigilance ter pri tem navedejo, ali so se pojavili pri odmerkih, ki se običajno uporabljajo pri ljudeh za preprečevanje, diagnosticiranje ali zdravljenje bolezni ali za ponovno vzpostavitev, izboljšanje ali spremembo fiziološke funkcije, ali so se pojavili zaradi napake pri uporabi zdravila ali zaradi uporabe, ki ni v skladu z odobrenim povzetkom glavnih značilnosti zdravila .
Member States shall, within 15 days following the receipt of the reports referred to in paragraph 1, submit the reports electronically to the Eudravigilance database , specifying whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics .
Razširitev pojma „neželeni učinki“ na stranske učinke zaradi napak pri zdravilih ali uporabe, ki ni v skladu z odobrenim povzetkom glavnih značilnosti zdravila (vključno z nepravilno uporabo in zlorabo zdravil), omogoča celovitejši pregled nad stranskimi učinki, ki bi lahko škodili bolniku.
Extending the concept of ‘adverse reaction’ to include secondary effects resulting from a medication error or use that is inconsistent with the authorised summary of the product’s characteristics (including misuse and abuse of the medicine) will make it possible to ascertain more comprehensively the secondary effects that may be harmful to patients.
Treba pa je jasno razločevati stranske učinke v običajnih pogojih uporabe zdravil od drugih stranskih učinkov.
But it is still important to make a clear distinction between secondary effects resulting from normal use and those that do not.
Člen 107b – odstavek 3 – uvodni del
Article 107b – paragraph 3 – introductory part
Z odstopanjem od odstavka 1 tega člena morajo imetniki dovoljenja za promet z zdravilom iz členov 10, 10a ali 10c ter imetniki registracij zdravil iz člena 14 ali 16a redna poročila o varnosti zdravila za taka zdravila predložiti samo v naslednjih primerih:
By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c, and holders of registrations for medicinal products referred to in Articles 14 or 16a, shall be required to submit periodic safety update reports for such products only in the following cases:
Z odstopanjem od odstavka 1 tega člena morajo imetniki dovoljenja za promet z zdravilom iz členov 10, 10a ali 10c ter imetniki registracij zdravil iz člena 14 ali 16a redna poročila o varnosti zdravila za taka zdravila predložiti samo vsaka tri leta , razen v naslednjih primerih:
By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c, and holders of registrations for medicinal products referred to in Articles 14 or 16a, shall be required to submit periodic safety update reports for such products only every three years, save in the following cases:
Člen 107e– odstavek 3
Article 107e – paragraph 3
Svetovalni odbor za ocenjevanje tveganja farmakovigilance na naslednjem srečanju po koncu obdobja, ki ga ima imetnik dovoljenja za promet za predložitev pripomb iz odstavka 2, sprejme poročilo o oceni s spremembami ali brez njih, ob upoštevanju pripomb, predloženih v skladu z navedenim odstavkom .
At its next meeting following the end of the period for comments by the marketing authorisation holder referred to in paragraph 2, the Pharmacovigilance Risk Assessment Advisory Committee shall adopt the assessment report with or without changes , taking into account any comments submitted in accordance with that paragraph .
Svetovalni odbor za ocenjevanje tveganja farmakovigilance na naslednjem srečanju po koncu obdobja, ki ga ima imetnik dovoljenja za promet za predložitev pripomb iz odstavka 2, sprejme poročilo o oceni s spremembami ali brez njih.
At its next meeting following the end of the period for comments by the marketing authorisation holder referred to in paragraph 2, the Pharmacovigilance Risk Assessment Advisory Committee shall adopt the assessment report with or without changes.
Navedeno poročilo o oceni se nemudoma javno objavi na evropskem spletnem portalu o varnosti zdravil.
That assessment report shall be made publicly accessible without delay by means of the European medicines safety web-portal.
Člen 107f
Article 107 f
Pristojni nacionalni organi po oceni rednih poročil o varnosti zdravila preučijo, ali so za zadevno zdravilo potrebni kakšni ukrepi glede pogojev dovoljenja za promet.
Following the assessment of periodic safety update reports, the national competent authorities shall consider whether any action concerning the terms of the marketing authorisation for the medicinal product concerned is necessary.
Pristojni nacionalni organi preučijo, ali so za zadevno zdravilo potrebni kakšni ukrepi glede pogojev dovoljenja za promet.
The national competent authorities shall consider whether any action concerning the terms of the marketing authorisation for the medicinal product concerned is necessary.
Če je to primerno, ohranijo, spremenijo, začasno prekličejo ali ukinejo dovoljenje za promet.
They shall maintain, vary , suspend or revoke the marketing authorisation as appropriate.
Če je to primerno, ohranijo, spremenijo, začasno prekličejo ali ukinejo dovoljenje za promet.
They shall maintain, modify , suspend or revoke the marketing authorisation as appropriate.
Njihove odločitve se nemudoma javno objavijo.
Their decisions shall be made publicly accessible without delay.
Če se dovoljenje za promet spremeni zaradi farmakovigilance, pristojni nacionalni organi ali zadevna država članica nemudoma objavijo posodobljeno poročilo o oceni zadevnega zdravila ali podrobno poročilo o spremembi.
Where a marketing authorisation is modified for reasons relating to pharmacovigilance, the national competent authorities or the reference Member State shall immediately publish an update of the assessment report of the medicinal product concerned or a detailed report about the modification.
Člen 107k – odstavek 2 – pododstavek 1
Article 107k – paragraph 2 – subparagraph 1
Svetovalni odbor za ocenjevanje razmerja med tveganjem in koristmi zdravil na področju farmakovigilance oceni zadevo, ki je bila predložena.
The Pharmacovigilance Risk -Benefit Balance Assessment Advisory Committee shall assess the matter which has been submitted.
Za namene navedene ocene lahko izvede javno obravnavo skupaj s predstavniki Odbora za zdravila za uporabo v humani medicini.
For the purposes of that assessment, it may hold a public hearing , together with representatives from the Committee for Medicinal Products for Human Use (CHMP) .
Agencija v posvetovanju z zainteresiranimi stranmi razvije smernice za organizacijo in izvajanje javnih obravnav.
The Agency, in consultation with stakeholders, shall develop guidelines for the organisation and conduct of public hearings .
Pri javni obravnavi je treba upoštevati tudi učinkovitost in koristi proizvoda ter predhodne ocene koristi in tveganja, ki jih opravi Odbor za zdravila ali skupina za usklajevanje v skladu s postopkom za izdajo dovoljenja za promet iz odstavka 107l.
The public hearing should also consider the effectiveness and benefits of the product as well as prior risk/benefit evaluations carried out by the CHMP or the coordination group under the procedure for granting marketing authorisation as described in Article 107l .
Javne obravnave, ki jih organizira ta odbor, so koristno orodje, če je organizacijo mogoče ustrezno opredeliti z upoštevanjem tveganj, pa tudi koristi, ki jih prinaša proizvod oz. proizvodi, da je razprava verodostojna in objektivna.
The organisation of public hearings by this committee is a useful tool, provided that the organization can be defined properly taking into account not only risks but also the benefits of the product (s) concerned in order to have a credible and objective discussion.
Namen tega je zlasti zaščititi dobro počutje bolnikov in oceniti odnos med tveganji in koristmi nekega zdravila ob upoštevanju razpoložljivih elementov.
This is primarily to safeguard the well being of the patient and assess the risks against the benefits of a medicinal product in view of all elements available
Člen 107k – odstavek 2 – pododstavek 4 a (novo)
Article 107k – paragraph 2 – subparagraph 4 a (new)
V primeru javne obravnave se po njej objavi predhodno poročilo.
In cases where a public hearing is held, a preliminary report shall be published following the hearing.
Dokler lahko Agencija zagotovi funkcionalnost baze podatkov Eudravigilance, se vsa redna poročila o varnosti zdravila predložijo tudi pristojnim organom držav, v katerih je zdravilo odobreno.
Until the Agency can ensure the functionalities of the Eudravigilance database, all the periodic safety update reports shall also be submitted to the National Competent Authorities where the product is authorised.
Namestniki (člen 178(2)), navzoči pri končnem glasovanju
Substitute(s) under rule 187(2) present for the final vote
o predlogu uredbe Evropskega parlamenta in Sveta o spremembi Uredbe (ES) št. 1321/2004 o vzpostavitvi upravljavskih struktur Evropskega satelitskega radio-navigacijskega sistema
on the proposal for a regulation of the European Parliament and of the Council amending Council Regulation (EC) No 1321/2004 on the establishment of structures for the management of the European satellite radio‑navigation programmes
Poročevalec: Evžen Tošenovský
Rapporteur: Evžen Tošenovský
MNENJE Odbora za PRORAČUN .....................................................................................27
OPINION of the Committee on Budgets .................................................................29
o predlogu Uredbe Evropskega parlamenta in Sveta o spremembi Uredbe (ES) št. 1321/2004 o vzpostavitvi upravljavskih struktur Evropskega satelitskega radio-navigacijskega sistema
on the proposal for a regulation of the European Parliament and of the Council amending Council Regulation (EC) No 1321/2004 on the establishment of structures for the management of the European satellite radio‑navigation programmes
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2009)0139 ),
– having regard to the Commission proposal to Parliament and the Council ( COM(2009)0139 ),
– ob upoštevanju člena 251(2) in člena 156 Pogodbe ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C7-0103/2009 ),
– having regard to Article 251(2) and Article 156 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C7‑0103/2009 ),
– ob upoštevanju sporočila Komisije Evropskemu parlamentu in Svetu z naslovom „Posledice začetka veljavnosti Lizbonske pogodbe za še nedokončane medinstitucionalne postopke odločanja“ ( KOM(2009)0665 ),
- having regard to the Commission Communication to Parliament and the Council entitled 'Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures' ( COM(2009)0665 ),
– ob upoštevanju člena 172 Pogodbe o delovanju Evropske unije (PDEU),
- having regard to Article 172 of the Treaty of the Functioning of the European Union,
– ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora
- having regard to the opinion of the European Economic and Social Committee
– po posvetovanju z Odborom regij,
- after consulting the Committee of the Regions
– ob upoštevanju poročila Odbora za industrijo, raziskave in energetiko ter mnenja Odbora za proračun ( A7–0160/2010 ),
– having regard to the report of the Committee on Industry, Research and Energy and the opinion of the Committee on Budgets ( A7‑0160/2010 ),
* Politične spremembe: krepki ležeči tisk označuje novo ali spremenjeno besedilo, simbol ▌pa tiste dele besedila, ki so bili črtani. *
* Political amendments: new or replacement text is marked in bold italics and deletions are indicated by the symbol ▌. *
UREDBA EVROPSKEGA PARLAMENTA IN SVETA (EU) št. .../2010
REGULATION (EU) NO .../2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
ob upoštevanju PDEU in zlasti člena 172 Pogodbe,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 172 thereof,
Stališče Evropskega parlamenta z dne ...
Position of the European Parliament of ...
(1) Evropska satelitska radio-navigacijska politika se sedaj izvaja v okviru programov EGNOS in GALILEO.
(1) The European satellite radio-navigation policy is presently implemented through the EGNOS and Galileo programmes.
(1a) Z Uredbo Sveta (ES) št. 1321/2004 z dne 12. julija 2004 o vzpostavitvi upravljavskih struktur Evropskega satelitskega radionavigacijskega sistema
(1a) Council Regulation (EC) No 1321/2004 of 12 July 2004 on the establishment of structures for the management of the European satellite radio-navigation programmes
(3) V Uredbi (ES) št. 683/2008 Evropskega parlamenta in Sveta z dne 9. julija 2008 o nadaljevanju izvajanja evropskih satelitskih navigacijskih programov (EGNOS in Galileo)
(3) Regulation (EC) No 683/2008 of the European Parliament and of the Council of 9 July 2008 on the further implementation of the European satellite navigation programmes (EGNOS and Galileo)
V uredbi je predvideno načelo stroge razdelitve pristojnosti med Evropsko unijo, ki jo zastopa Komisija, Organom in Evropsko vesoljsko agencijo (v nadaljnjem besedilu: ESA), v njej se na Komisijo prenaša odgovornost za upravljanje programov in dodelijo naloge, ki so bile na začetku zaupane Organu.
It sets out the principle of the strict division of responsibilities between the European Union, represented by the Commission, the Authority and the European Space Agency (hereinafter referred to as "ESA"), granting the Commission responsibility for the management of the programmes and attributing to it the tasks originally assigned to the Authority.
Uredba prav tako predvideva, da Organ izpolnjuje dodeljene naloge ob priznavanju Komisije v vlogi upravnika programov in v skladu s smernicami, ki jih izda Komisija.
It also provides that the Authority, when accomplishing the tasks entrusted to it, will ensure that the Commission’s role as manager of the programmes is respected and that the Authority will act in accordance with guidelines issued by the Commission.
(3a) Poleg tega sta Evropski parlament in Svet v Uredbi (ES) št. 683/2008 povabila Komisijo, „naj izdela predlog za formalno uskladitev upravljavskih struktur programov, določenih z Uredbo (ES) št. 1321/2004, z novo vlogo Komisije in nadzornega organa“.
(3a) In Regulation (EC) No 683/2008 the European Parliament and the Council invited the Commission to put forward a proposal to align formally the management structures of the EGNOS and Galileo programmes as set out in Regulation (EC) No 1321/2004 with the new roles of the Commission and the Authority as set out in Regulation (EC) No 683/2008.
(5) ▌ Ta agencija se glede na svoje področje delovanja ne sme več imenovati „Evropski nadzorni organ za GNSS“, ampak „Agencija za evropski GNSS“ (v nadaljnjem besedilu: Agencija).
(5) ▌ In view of its reduced sphere of activity, the Authority should no longer be called the "European GNSS Supervisory Authority", but rather the " European GNSS Agency" (hereinafter "Agency").
Vendar pa mora Agencija zagotoviti nadaljevanje dejavnosti Organa, vključno glede pravic in obveznosti, osebja in veljavnosti vseh sprejetih sklepov.
However, the continuity of the activities of the Authority, including continuity as regards rights and obligations, staff and the validity of any decisions taken, should be ensured under the Agency.
(6) Tudi predmet Uredbe (ES) št. 1321/2004 je treba prilagoditi, da bo odražal dejstvo , da Agencija ne skrbi več za javne interese glede evropskih programov globalnega navigacijskega satelitskega sistema ( GNSS ) in da je regulativni organ za te programe
(6) The aims and objectives of Regulation (EC) No 1321/2004 should also be adjusted in order to reflect the fact that the Agency is no longer responsible for the management of public interests relating to Global Navigation Satellite Systems ( GNSS ) European programmes and for regulating such programmes.
(6a) Pravni status Agencije mora biti tak, da ji omogoča, da pri izvajanju svojih nalog deluje kot pravna oseba.
(6a) The legal status of the Agency should be such as to enable it to act as a legal person in the discharge of its tasks.
(7) Pomembno je prilagoditi tudi naloge Agencije in v zvezi s tem zagotoviti, da so njene naloge opredeljene v skladu s tistimi, določenimi v členu 16 Uredbe (ES) št. 683/2008 , vključno z možnostjo izpolnjevanja drugih nalog, ki ji jih lahko poveri Komisija, v podporo Komisiji pri izvajanju programov GNSS .
(7) It is also important to modify the tasks of the Agency, and, in this regard, to ensure that its tasks are defined in conformity with those set out in Article 16 of Regulation (EC) No 683/2008 , including the possibility for the Agency to accomplish other activities that may be entrusted to it by the Commission, in order to support the Commission in the implementation of the GNSS programmes.
V skladu s členom 54(2)(b) Uredbe Sveta (ES, Euratom) št. 1605/2002 z dne 25. junija 2002 o finančni uredbi, ki se uporablja za splošni proračun Evropskih skupnosti
In accordance with Article 54(2)(b) of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities
1. , bi takšne dejavnosti lahko vključevale recimo:
1. , such activities could for example include:
– spremljanje razvoja usklajevalnih in posvetovalnih postopkov na področju varnosti;
- following the development of coordination and consultation procedures on security-related matters;
– izvajanje vseh raziskovalnih dejavnosti, ki so koristne za razvoj in promocijo evropskih programov GNSS;
- carrying out research of benefit to the development and promotion of the European GNSS programmes;
– zagotavljanje podpore pri razvoju in izvajanju pilotnega projekta za javne regulirane storitve (projekt PRS).
- providing support in the development and implementation of the Public Regulated Service (PRS) pilot project. .
(7a) Na svojem področju, v okviru ciljev in pri opravljanju nalog, Agencija upošteva zlasti določbe , ki se uporabljajo za institucije Unije.
(7a) Within its scope, its objectives and in the performance of its tasks, the Agency should comply in particular with the provisions applicable to Union institutions.
(7b) Prav tako bi morala Komisija v okviru vmesnega pregleda programa Galileo, predvidenega v letu 2010, kakor določa člen 22 Uredbe (ES) št. 683/2008, obravnavati vprašanje upravljanja programa v fazi delovanja in uporabe ter vprašanje, kakšno vlogo bo v tej zvezi imela Agencija.
(7b) The Commission should, in the context of its mid-term review of the Galileo programme foreseen for 2010 as referred to in Article 22 of Regulation (EC) No 683/2008, also address the issue of the governance of the programme in the operating and exploitation phase and the role of the Agency in this context.
(8) Da bi odražale naslov te uredbe ▌in ime Agencije ▌, je treba spremeniti vse določbe Uredbe (ES) št. 683/2008 , ki omenjajo prejšnja naslov in ime.
(8) In order to reflect the ▌title of this Regulation ▌and the new name of the Agency , all provisions of Regulation (EC) No 683/2008 citing the previous name of the Agency should be amended .
(9a) Da bi bilo zagotavljanje izpolnjevanja nalog Agencije učinkovito, naj bodo države članice in Komisija zastopane v upravnem svetu, ki so mu poverjene pristojnosti, potrebne za določanje proračuna, preverjanje njegovega izvrševanja, sprejemanje finančnih pravil, določanje preglednih delovnih postopkov pri odločanju Agencije, odobritev njegovega programa dela ter imenovanje izvršilnega direktorja.
(9a) In order to ensure effectively the accomplishment of the tasks of the Agency, the Member States and the Commission should be represented on an Administrative Board entrusted with the necessary powers to establish the budget, verify its execution, adopt the appropriate financial rules, establish transparent working procedure for decision making by the Agency, approve its work programme and appoint the Executive Director.
(9b) Prav tako je primerno vključiti opazovalca Evropskega parlamenta v upravni svet Agencije ▌kot člana brez glasovalne pravice , saj je bila v Uredbi (ES) št. 683/2008 poudarjena koristnost tesnega sodelovanja med Evropskim parlamentom, Svetom in Komisijo. ▌
(9b) It is also appropriate to include a representative of the European Parliament in the Agency’s Administrative Board as a non-voting member , in view of the fact that Regulation (EC) No 683/2008 highlighted the usefulness of close cooperation between the European Parliament, the Council and the Commission. ▌
(10) Da bi se zagotovilo, da bi Agencija izpolnjevala svoje naloge ob priznavanju Komisije v vlogi upravnika programov in v skladu s smernicami, ki jih izda Komisija, je pomembno izrecno določiti, da mora Agencijo upravljati njen izvršilni direktor pod nadzorom upravnega sveta in v skladu s smernicami, ki jih za Agencijo izda Komisija .
(10) In order to ensure that the Agency accomplishes its tasks whilst respecting the Commission’s role as manager of the programmes and in accordance with guidelines issued by the Commission, it is also important ▌to state explicitly that the Agency should be managed by an Executive Director under the supervision of the Administrative Board, in accordance with the guidelines provided to the Agency by the Commission .
Enako pomembno je določiti, da bi morala imeti Komisija v upravnem svetu Agencije pet predstavnikov in da sklepi v zvezi z omejenim številom nalog sveta ne bi smeli biti sprejeti brez privolitve predstavnikov Komisije.
It is equally important to specify that the Commission should have five representatives on the Agency’s Administrative Board and that decisions regarding a limited number of tasks of the Board should not be adopted without the assent of the representatives of the Commission .
(10a) Da bi Agencija delovala nemoteno, je treba njegovega izvršilnega direktorja imenovati na podlagi zaslug in z dokazili izkazanih upravnih in vodstvenih sposobnosti; ustrezno mora biti usposobljen in izkušen, svoje naloge pa mora opravljati popolnoma neodvisno ter, kar zadeva organizacijo notranjega delovanja Agencije, prožno.
(10a) The smooth functioning of the Agency requires that its Executive Director be appointed on the grounds of merit and documented administrative and managerial skills, as well as relevant competence and experience, and that he/she performs his/her duties with complete independence and flexibility as to the organisation of the internal functioning of the Agency.