natgillin/translations-raw huggingface dataset:
Pripravljavec mnenja se zaveda, da so za zagotavljanje visokokakovostnih informacij brez oglasnih elementov nujni nadzorni sistemi, ki bodo zagotovili upoštevanje enotnih standardov kakovosti.
The author is aware that monitoring systems are required to safeguard compliance with harmonised quality standards and hence the provision of high-quality non-promotional information.
Iz tega razloga pozdravlja predlog Komisije, da se državam članicam zagotovi možnost izbire najprimernejših nadzornih mehanizmov in da bo kot temeljno pravilo določen nadzor v povezavi s širjenjem informacij, saj je to najučinkovitejše in še najmanj birokratično.
He therefore welcomes the Commission’s proposal that Member States should be free to choose the most appropriate monitoring mechanisms, the general rule being that monitoring should take place after the distribution of information since this is the most effective and least bureaucratic approach.
Pripravljavec mnenja ugotavlja zlasti, da je treba izboljšati financiranje agencije EMEA, kar bo obravnavano v okviru predlogov sprememb.
In particular, the author of the opinion identifies a need for improvement in relation to the funding of the European Medicines Agency (EMEA).
Izkušnje, pridobljene pri uporabi sedanjega pravnega okvira, so prav tako pokazale razlike v razlagi pravil Skupnosti v zvezi z oglaševanjem ter med nacionalnimi določbami o informacijah in nujno potrebo po pojasnitvi razlike med oglaševanjem in obveščanjem .
Experience gained from the application of the current legal framework has also shown disparities in the interpretation of the Community rules on advertising, and between national provisions on information , highlighting the urgent need for a more precise distinction between advertising and information .
(4) Direktiva 2001/83/ES določa, da morajo nacionalni pristojni organi držav članic nekatere vrste informacij nadzorovati, preden se začnejo širiti.
(4) Directive 2001/83/EC provides that certain types of information are subject to control by the Member States' national competent authorities prior to their dissemination.
To vključuje informacije o neintervencijskih znanstvenih študijah na podlagi poskusnega opazovanja ali spremljevalnih ukrepih za preprečevanje in zdravljenje ali informacije, ki zdravilo predstavljajo v okviru stanja, ki ga je treba preprečiti ali zdraviti.
This concerns information about non-interventional scientific studies based on experimental observation , or accompanying measures to prevention and medical treatment, or information which presents the medicinal product in the context of the condition to be prevented or treated.
V primeru zdravil za uporabo v humani medicini, odobrenih v skladu z naslovom II Uredbe (ES) št. 726/2004, mora Evropska agencija za zdravila (v nadaljnjem besedilu: Agencija) zagotoviti vnaprejšnje preverjanje nekaterih vrst informacij in nadzorovati ukrepe, ki jih bo proizvajalec sprejel po poročanju o neželenih učinkih, nato pa nemudoma posodobiti literaturo .
In the case of medicinal products for human use authorised pursuant to Title II of Regulation (EC) No 726/2004, provision should also be made for certain types of information to be subject to prior vetting by the European Medicines Agency (hereinafter referred to as the 'Agency') , and for the Agency to monitor the measures to be taken by the manufacturer following a report of adverse reactions, and the consequent immediate updating of the literature .
Upoštevati bi morali, da je treba po pripravljenih poročilih o neželenih učinkih po členih 24 do 26 uredbe pobližje spremljati nadaljnji razvoj v tem procesu, zlasti tako, da se upoštevajo rezultati znanstveno ovrednotenih izkušenj, ki so bile opažene pri uporabi zdravil.
It should be taken into account that, after the risk reports provided for in Articles 24 to 26 of the Regulation have been drawn up, further developments in the process need to be closely monitored, in particular by incorporating the result of the scientific appraisal of experience observed in the use of the medicinal products.
Člen 20b – odstavek 1
Article 20b – paragraph 1
Z odstopanjem od člena 100g(1) Direktive 2001/83/ES Agencija informacije v zvezi z zdravili iz člena 100b(d) navedene direktive preveri, preden se začnejo širiti.
By way of derogation from Article 100g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive shall be subject to vetting by the Agency prior to its dissemination.
Z odstopanjem od člena 100g(1) Direktive 2001/83/ES Agencija informacije v zvezi z zdravili iz člena 100b(d) navedene direktive preveri, preden se začnejo širiti , razen če so te informacije objavljene na spletnem mestu, katerega vsebino mora v skladu s členom 100h Direktive 2001/83/ES spremljati posamezna država članica.
By way of derogation from Article 100g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive shall be subject to vetting by the Agency prior to its dissemination , unless this information is given on an internet website where responsibility for monitoring the content disseminated rests with a Member State in accordance with Article 100h of Directive 2001/83/EC .
Zagotovitev skladnosti z določbami člena 100h Direktive 2001/83/ES.
Consistency with the provisions of Article 100h of Directive 2001/83EC.
Člen 20b – odstavek 3
Article 20b – paragraph 3
Agencija lahko na podlagi razlogov, povezanih z neizpolnjevanjem določb naslova VIIIa Direktive 2001/83/ES, predloženim informacijam ali delom teh informacij ugovarja v 120 dneh po prejemu obvestila , pri čemer mora svojo odločitev ustrezno utemeljiti .
The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC , stating the grounds for its decision, within 120 days after receipt of the notification.
Utemeljitev Evropske agencije za zdravila bo omogočila večjo preglednost in učinkovitost postopka oblikovanja informacij.
Requiring the European Medicines Agency to state the grounds for its decision will make the process of drawing up information more transparent and efficient.
Podaljšanje roka za tiho strinjanje z informacijami s 60 na 120 dni bo agenciji omogočilo boljše pogoje, da se jasno izreče.
Extending the time-limit for the tacit acceptance of the information from 60 to 120 days will better enable the Agency to give clear reasons for its decisions.
Člen 20b – odstavek 3 a (novo)
Article 20b – paragraph 3 a (new)
Če Agencija ugovarja predloženim informacijam, imetnik dovoljenja za promet pa meni, da je ugovor neutemeljen, mu Agencija na zahtevo dovoli nadaljnjo pojasnitev, pisno ali kot ustno predstavitev, slednjo pa je treba pripraviti v 30 delovnih dneh po tem, ko Agencija prejme tovrstno zahtevo.
If the Agency objects to the submitted information and the marketing authorisation holder believes that the objections are not justified, the Agency shall allow the marketing authorisation holder, upon request, to make further representations, in writing and/or by way of an oral hearing to be held within 30 working days of receipt by the Agency of such a request.
Agencija odgovori imetniku dovoljenja za promet v 30 delovnih dneh.
The Agency shall communicate its response to the marketing authorisation holder within 30 working days.
Namen predloga spremembe je zagotoviti večjo učinkovitost in preglednost procesa.
This amendment aims to ensure greater efficiency and transparency in the process.
Člen 57 – odstavek 1 – točka l
Article 57 – paragraph 1 – point l
(1a) V členu 57(1) se drugi pododstavek, točka (l), nadomesti z naslednjim:
(1a) In Article 57(1), second subparagraph, point (l) shall be replaced by the following:
(l) ustvarjanje baze podatkov o zdravilih, ki naj bo dostopna javnosti, v vseh uradnih jezikih EU , zagotavljanje njenega posodabljanja in upravljanja neodvisno od poslovnih interesov farmacevtskih podjetij; baza podatkov olajša iskanje podatkov že odobrenih zdravil za navodila za uporabo; vključuje skupino podatkov o zdravilih, odobrenih za zdravljenje otrok; podatki za javnost se oblikujejo v primernem in razumljivem jeziku in so namenjeni nestrokovni javnosti ;
(l) creating a database on medicinal products, to be accessible to the general public, in all the official languages of the EU, and ensuring that it is updated, and managed independently of the commercial interests of pharmaceutical companies ; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner , designed for the non-expert public ;
Okrepitev vloge, ki jo ima agencija na področju obveščanja javnosti o zdravilih, ki se izdajajo na zdravniški recept, je nujna za kakovostne informacije, dostopne vsem državljanom pod enakimi pogoji.
Strengthening the agency’s role with regard to information for the public on medicinal products for which a medical prescription is required is crucial in order to ensure that all citizens have equal access to high-quality information.
(2a) V členu 57 se odstavek 2 nadomesti z:
(2a) In Article 57, paragraph 2 shall be replaced by the following:
Baza podatkov se razvija v stopnjah: prednost dobijo zdravila, odobrena po tej uredbi, in tista, ki so odobrena po poglavju 4 naslova III Direktive 2001/83/ES in Direktive 2001/82/ES.
The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and of Directive 2001/82/EC respectively.
Uporaba te baze podatkov se dejavno spodbuja med evropskimi državljani.
This database shall be actively promoted to European citizens.
Informacije, ki jih posredujejo imetniki dovoljenja za dajanje v promet in jih odobrijo nacionalni organi, morajo ti organi poslati agenciji, ta pa jih mora vključiti v svojo bazo podatkov, dostopno javnosti.
The information submitted by holders of marketing authorisation and approved by the national authorities shall be sent to the Agency by those authorities and included in its database available to the public.
Baza podatkov bi morala za javnost pomeniti prvovrsten vir objektivnih informacij.
The database should be publicly accessible as a prime source of objective information.
António Fernando Correia De Campos, Rachida Dati, Ilda Figueiredo, Andrzej Grzyb, Jolanta Emilia Hibner, Oriol Junqueras Vies, Ivajlo Kalfin (Ivailo Kalfin), Marian-Jean Marinescu, Vladko Todorov Panajotov (Vladko Todorov Panayotov), Silvia-Adriana Ţicău, Hermann Winkler
António Fernando Correia De Campos, Rachida Dati, Ilda Figueiredo, Andrzej Grzyb, Jolanta Emilia Hibner, Oriol Junqueras Vies, Ivailo Kalfin, Marian-Jean Marinescu, Vladko Todorov Panayotov, Silvia-Adriana Ţicău, Hermann Winkler
o predlogu uredbe Evropskega parlamenta in Sveta o spremembi Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila v zvezi z informacijami za širšo javnost o zdravilih na recept za uporabo v humani medicini
on the proposal for a regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Pripravljavec mnenja: António Fernando Correia De Campos
Rapporteur: António Correia de Campos
Namen predlagane uredbe o spremembi Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila v zvezi z informacijami za širšo javnost o zdravilih na recept za uporabo v humani medicini je, da bi zagotovili jasen okvir za informiranje potrošnikov o zdravilih, ki se izdajajo samo na recept, in s tem pri njih spodbujali bolj obveščeno izbiro.
The proposal for a regulation amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency aims to provide a clear framework for information on prescription-only medicines to consumers with a view to promoting more informed consumer choices.
Informacije za paciente morajo upoštevati tri poglavitna načela:
Information for patients must comply with three key criteria:
· Predlagana uredba uvaja pravno strukturo, ki omogoča farmacevtski industriji dajanje informacij na voljo potrošnikom.
· The proposed regulation introduces a legal structure allowing the pharmaceutical industry to make information available to consumers.
Pri tem se zastavlja vprašanje, kakšno vlogo bi morala industrija imeti pri zagotavljanju informacij o zdravilih, ki se izdajajo samo na recept, neposredno potrošnikom.
The question that arises is to ascertain what role the pharmaceutical industry should play in providing information on prescription-only medicinal products direct to patients.
· Razlika med informiranjem in oglaševanjem ni jasna.
· The distinction between information and advertising is not clear.
Potrošniki potrebujejo razumljive, visokokakovostne vire informacij s področja zdravja (zlasti na internetu), da bodo lahko pretehtali svoje možnosti in se obveščeno odločili.
Consumers require comprehensible, high-quality sources of information in the field of health (particularly on the Internet) so that they can assess their options and take an informed decision;
· Regulativni agenciji je treba dati dovolj časa za preverbo kakovosti in neodvisnosti informacij, ki jih priskrbijo farmacevtske družbe.
· The regulatory agency must be given sufficient time to check the quality and independence of the information to be provided by pharmaceutical companies;
(1) Komisija je 20. decembra 2007 Evropskemu parlamentu in Svetu predložila Sporočilo o „poročilu o obstoječi praksi glede zagotavljanja informacij o zdravilih bolnikom“.
(1) On 20 December 2007, the Commission submitted a Communication to the European Parliament and the Council concerning the "Report on current practices with regard to the provision of information to patients on medicinal products" .
Če Agencija ne ugovarja v 60 dneh, se informacije štejejo za sprejete in se lahko objavijo.
If the Agency does not object within 60 days , the information shall be deemed accepted and may be published.
Če Agencija ne ugovarja v 120 dneh, se informacije štejejo za sprejete in se lahko objavijo.
If the Agency does not object within 120 days , the information shall be deemed accepted and may be published.
Člen 20 b – odstavek 3 a (novo)
Article 20b – paragraph 3a (new)
Če Agencija ugovarja predloženim informacijam, vlagatelj pa meni, da ugovor ni utemeljen, mu Agencija na zahtevo omogoči, da podpre svoje argumente pisno ali ustno na predstavitvi, in sicer v 30 delovnih dneh po prejetju njegovega zahtevka.
If the Agency raises objections to the information submitted and the applicant takes the view that those objections are not justified, the Agency shall give the applicant, on his or her request, an opportunity to support his or her arguments in writing or at an oral hearing within 30 working days of the Agency's receipt of the request.
Agencija svoj odgovor utemelji v 30 dneh po prejetju utemeljene vlagateljeve izjave.
The Agency shall justify its reply within 30 working days of receipt of the applicant's reasoned statement.
Za večjo preglednost procesa se obema stranema omogoči, da svojo zadevo predstavita in utemeljita.
To make the process more transparent by giving both sides the opportunity to put their case.
„ (l) ustvarjanje baze podatkov o zdravilih, ki naj bo dostopna javnosti, v vseh uradnih jezikih EU, zagotavljanje njenega posodabljanja in upravljanja neodvisno od poslovnih interesov farmacevtskih podjetij ; baza podatkov olajša iskanje podatkov že odobrenih zdravil za navodila za uporabo; vključuje skupino podatkov o zdravilih, odobrenih za zdravljenje otrok; podatki za javnost se oblikujejo v primernem in razumljivem jeziku in so namenjeni nestrokovni javnosti ;“
" (l) creating a database on medicinal products, to be accessible to the general public, in all official languages of the EU, and ensuring that it is updated, and managed independently of the commercial interests of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner designed for the non-expert public ; "
(2a) Člen 57 (2) se nadomesti z naslednjim:
(2a) Article 57(2) is replaced by the following:
Baza podatkov se bo širila, da bo vključevala vsa zdravila, dana v promet znotraj Skupnosti.
The database shall [...] be extended to include any medicinal product placed on the market within the Community.
Uporaba te baze podatkov se dejavno oglašuje med evropskimi državljani.
The database shall be actively publicised to European citizens.
Informacije, ki jih posredujejo imetniki dovoljenj za dajanje v promet in jih odobrijo nacionalni organi, morajo ti organi poslati Agenciji, ta pa jih mora vključiti v svojo bazo podatkov, dostopno javnosti.“
The information submitted by holders of marketing authorisations and approved by the national authorities shall be sent to the Agency and included in its database available to the public."
V ta name države članice, Komisija in tudi agencija EMEA proaktivno delujejo za zagotovitev, da se bo učinkovito uporabljala.
To this end, the Member States , the Commission and the EMEA itself should be proactive in order to ensure that it is used effectively.
Cristian Silviu Buşoi, Lara Comi, Anna Maria Corazza Bildt, António Fernando Correia De Campos, Jürgen Creutzmann, Christian Engström, Evelyne Gebhardt, Louis Grech, Małgorzata Handzlik, Malcolm Harbour, Philippe Juvin, Sandra Kalniete, Alan Kelly, Eija-Riitta Korhola, Edvard Kožušník, Kurt Lechner, Toine Manders, Mitro Repo, Robert Rochefort, Zuzana Roithová, Heide Rühle, Andreas Schwab, Róża grofica Von Thun Und Hohenstein, Kiriakos Triantafilidis (Kyriacos Triantaphyllides), Bernadette Vergnaud, Barbara Weiler
Cristian Silviu Buşoi, Lara Comi, Anna Maria Corazza Bildt, António Fernando Correia De Campos, Jürgen Creutzmann, Christian Engström, Evelyne Gebhardt, Louis Grech, Małgorzata Handzlik, Malcolm Harbour, Philippe Juvin, Sandra Kalniete, Alan Kelly, Eija-Riitta Korhola, Edvard Kožušník, Kurt Lechner, Toine Manders, Mitro Repo, Robert Rochefort, Zuzana Roithová, Heide Rühle, Andreas Schwab, Róża Gräfin Von Thun Und Hohenstein, Kyriacos Triantaphyllides, Bernadette Vergnaud, Barbara Weiler
Informacije o zdravilih na recept (spremeba Uredbe (ES) št. 726/2004)
Information on medicinal products subject to medical prescription (amendment of Regulation (EC) No 726/2004)
János Áder, Kriton Arsenis, Pilar Ayuso, Paolo Bartolozzi, Sergio Berlato, Milan Cabrnoch, Martin Callanan, Nessa Childers, Chris Davies, Bairbre de Brún, Anne Delvaux, Bas Eickhout, Edite Estrela, Elisabetta Gardini, Julie Girling, Nick Griffin, Françoise Grossetête, Satu Hassi, Jolanta Emilia Hibner, Dan Jørgensen, Karin Kadenbach, Christa Klaß, Holger Krahmer, Jo Leinen, Corinne Lepage, Peter Liese, Radvilė Morkūnaitė-Mikulėnienė, Gilles Pargneaux, Antonija Prvanova (Antonyia Parvanova), Andres Perello Rodriguez, Sirpa Pietikäinen, Mario Pirillo, Pavel Poc, Frédérique Ries, Oreste Rossi, Dagmar Roth-Behrendt, Daciana Octavia Sârbu, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Bogusław Sonik, Catherine Soullie, Salvatore Tatarella, Anja Weisgerber, Sabine Wils, Marina Yannakoudakis
János Áder, Kriton Arsenis, Pilar Ayuso, Paolo Bartolozzi, Sergio Berlato, Milan Cabrnoch, Martin Callanan, Nessa Childers, Chris Davies, Bairbre de Brún, Anne Delvaux, Bas Eickhout, Edite Estrela, Elisabetta Gardini, Julie Girling, Nick Griffin, Françoise Grossetête, Satu Hassi, Jolanta Emilia Hibner, Dan Jørgensen, Karin Kadenbach, Christa Klaß, Holger Krahmer, Jo Leinen, Corinne Lepage, Peter Liese, Radvilė Morkūnaitė-Mikulėnienė, Gilles Pargneaux, Antonyia Parvanova, Andres Perello Rodriguez, Sirpa Pietikäinen, Mario Pirillo, Pavel Poc, Frédérique Ries, Oreste Rossi, Dagmar Roth-Behrendt, Daciana Octavia Sârbu, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Bogusław Sonik, Catherine Soullie, Salvatore Tatarella, Anja Weisgerber, Sabine Wils, Marina Yannakoudakis
o predlogu direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini v zvezi z informacijami za širšo javnost o zdravilih na recept
on the proposal for a directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use
MNENJE Odbora za industrijo, raziskave in energetiko .............................57
OPINION of the Committee on Industry, Research and Energy ...............61
MNENJE Odbora za notranji trg in varstvo potrošnikov .........................82
OPINION of the Committee on the Internal Market and Consumer Protection 88
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2008)0663 ),
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2008)0663 ),
– ob upoštevanju člena 251(2) in člena 95 Pogodbe ES, na podlagi katerih je Komisija Parlamentu podala predlog (C7 ‑ 0156/2008),
– having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6‑0516/2008 ),
– ob upoštevanju sporočila Komisije Evropskemu parlamentu in Svetu z naslovom „Posledice uveljavitve Lizbonske pogodbe za še nedokončane medinstitucionalne postopke odločanja“ ( KOM(2009)0665 ),
– having regard to the communication from the Commission to the European Parliament and the Council entitled: 'Consequences of the entry into force of the Treaty of Lisbon for ongoing interistitutional decision-making procedures' (COM)2009)0665),
– ob upoštevanju členov 294(3), 114 in 168(4)(c) Pogodbe o delovanju EU,
– having regard to Article 294(3), Article 114 and Article 168(4)c) of the Treaty on the functioning of the EU,
– ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora
– having regard to the opinion of 10 June 2009 of the European Economic and Social Committee
19. z dne 10. junija 2009 ter Odbora regij
19. and the opinion of 7 October 2009 of the Committee of the Regions
UL C z dne 7. oktobra 2009,
OJ C ,
– ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane in mnenj Odbora za industrijo, raziskave in energetiko ter Odbora za notranji trg in varstvo potrošnikov ( A7‑0029/2010 ),
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection ( A7-0290/2010 ),
(2) Na področju informacij Direktiva 2001/83/ES določa podrobne predpise o dokumentih, ki jih je treba priložiti dovoljenju za promet in so namenjeni obveščanju: povzetek značilnosti zdravila (ki se posreduje zdravstvenim delavcem) in navodila za uporabo (vstavljena v embalažo zdravila, ko se to posreduje bolniku).
(2) In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to health-care professionals) and the package leaflet (inserted in the product's packaging when it is dispensed to the patient).