FrancophonIA/ELRC3.0 huggingface dataset:
English: Variation and extension applications (Human medicines)
Slovenian: Vloge za spremembe in razširitve (Zdravila za uporabo v humani medicini)
English: Press officer
Slovenian: Tiskovni predstavnik
English: Direct telephone: (44-20) 75 23 71 08 E-mail: panos.tsintis@emea.europa.eu
Slovenian: Direktni telefon: (44-20) 75 23 71 08 E-naslov: panos.tsintis@emea.europa.eu
English: It will work with the Heads of Veterinary Medicines Agencies on availability and will provide support to the European Technology Platform for Global Animal Health,
Slovenian: Z vodji agencij za zdravila za uporabo v veterinarski medicini bo sodelovala na področju dostopnosti in zagotovila podporo evropski tehnološki platformi za globalno zdravje živali (European Technology Platform for Global Animal Health), katere namen je pospešiti razvoj novih proizvodov za zdravje živali, namenjenih velikim in majhnim trgom.
English: E-mail: silvia.domingo@emea.europa.eu
Slovenian: E-naslov: silvia.domingo@emea.europa.eu
English: Marijke KORTEWEG Direct telephone (44-20) 74 18 85 56 E-mail: iqmanagement@emea.europa.eu
Slovenian: Marijke KORTEWEG Direktni telefon: (44-20) 74 18 85 56 E-naslov: iqmanagement@emea.europa.eu
English: E-mail: europeanexperts@emea.europa.eu
Slovenian: E-naslov: europeanexperts@emea.europa.eu
English: Direct telephone: (44-20) 74 18 85 81 E-mail: fia.westerholm@emea.europa.eu
Slovenian: Direktni telefon: (44-20) 74 18 85 81 E-naslov: fia.westerholm@emea.europa.eu
English: 3.2 Certificates of medicinal products
Slovenian: 3.2 Potrdila za zdravila
English: E-mail: smeoffice@emea.europa.eu
Slovenian: E-naslov: smeoffice@emea.europa.eu
English: Fax: (44-20) 74 18 85 90 Out of hours telephone: (44-7880) 55 06 97
Slovenian: Faks: (44-20) 74 18 85 90 Telefon izven uradnih ur: (44-7880) 55 06 97
English: Document management and publishing Meeting management and conferences Project management
Slovenian: Upravljanje srečanj in konferenc
English: Direct telephone: (44-20) 74 18 85 75/86 43 Fax: (44-20) 75 23 70 40
Slovenian: Direktni telefon: (44-20) 74 18 85 75/86 43 Faks: (44-20) 75 23 70 40
English: Arbitration and Community referrals (Veterinary medicines)
Slovenian: Arbitraža in napotitve Skupnosti (zdravila za uporabo v veterinarski medicini)
English: EU contribution for IT Telematics strategy
Slovenian: Prispevek EU za telematsko strategijo IT Posebni prispevek EU za zdravila sirote Prispevek iz EGP
English: New applications for veterinary medicines
Slovenian: Nove vloge za zdravila za uporabo v veterinarski medicini
English: The European medicines network
Slovenian: Evropska mreža zdravil:
English: Safety of medicines for human and veterinary use
Slovenian: Varnost zdravil za uporabo v humani medicini in zdravil za uporabo v veterinarski medicini:
English: Medicines for human and veterinary use
Slovenian: Zdravila za uporabo v humani medicini in zdravila za uporabo v veterinarski medicini
English: PRE-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Patrick Le Courtois
Slovenian: VREDNOTENJE ZDRAVIL ZA UPORABO V HUMANI MEDICINI PRED IZDAJO DOVOLJENJA ZA PROMET Vdj Ptik L C ti
English: TOTAL EXPENDITURE
Slovenian: Odhodki za poslovanje
English: New MRL applications
Slovenian: Nove vloge MVO
English: Veterinary marketing authorisation procedures Safety of veterinary medicines
Slovenian: Varnost zdravil za uporabo v veterinarski medicini
English: The procedure started on 25 September 2014.
Slovenian: Postopek se je začel 25. septembra 2014.
English: These statements were carefully assessed.
Slovenian: Te izjave so bile podrobno obravnavane.
English: The data manipulations took place between at least July 2008 and 2013.
Slovenian: Prirejanje podatkov je potekalo vsaj od julija 2008 do 2013.
English: The medicinal products concerned are listed in Annex I.
Slovenian: Zadevna zdravila so navedena v Prilogi I.
English: Therefore the information submitted at the stage of reexamination was taken into consideration in order to safeguard the right of defence of the company.
Slovenian: Zato so bile upoštevane informacije, predložene med ponovnim pregledom, da se zaščiti pravica družbe do obrambe.
English: Considerations to all products reviewed within the framework of this procedure
Slovenian: Opombe za vsa zdravila, pregledana v okviru tega postopka
English: Neo Balkanika (for Nebivolol);
Slovenian: Neo Balkanika (za nebivolol);
English: The CHMP therefore decided to extend the scope of the review by also including studies performed between 2004 and 2008.
Slovenian: Zato je sklenil, da obseg pregleda razširi tudi na študije, opravljene med letoma 2004 in 2008.
English: Discussions
Slovenian: Razprava
English: That being the case, volunteers would be unnecessarily exposed to a medicinal product without a clear need, which is not acceptable from an ethical point of view.
Slovenian: V tem primeru bi bili prostovoljci po nepotrebnem izpostavljeni zdravilu brez jasne potrebe, kar pa z etičnega vidika ni spremenljivo.
English: In addition, inspections by regulatory authorities follow a sampling process in which specific parts of a particular activity are looked at in detail to establish whether its conduct complied with all relevant guidelines and regulations.
Slovenian: Poleg tega pregledi, ki so jih opravili regulativni organi, sledijo postopku vzorčenja, pri katerem se podrobno preučijo posamezni deli določene dejavnosti, s čimer se ugotovi, ali te izpolnjujejo vse zadevne smernice in predpise.
English: This reference medicinal product has to be authorised in the EU under the EU procedures described in Article 6 and in accordance with the EU requirements defined in Article 8 of the said Directive.
Slovenian: To referenčno zdravilo mora biti odobreno v EU v okviru postopkov EU, opisanih v členu 6, in v skladu z zahtevami EU, opredeljenimi v členu 8 zadevne direktive.
English: It is recognised that alendronate occupies an important place in the treatment of post-menopausal osteoporosis.
Slovenian: Znano je, da ima alendronat pomembno vlogo pri zdravljenju pomenopavzne osteoporoze.
English: Category 2 medicinal products
Slovenian: Zdravila kategorije 2
English: Grounds for CHMP Opinion
Slovenian: Razlogi za mnenje odbora CHMP
English: As stated in Article 62(1) paragraph 4 of Regulation (EC) No 726/2004 and Article 32(4) paragraph 3 of Directive 2001/83/EC, “the re-examination procedure may deal only with the points of the opinion initially identified by the applicant/MAH and may be based only on the scientific data available when the Committee adopted the initial opinion.” Therefore these scientific data can not be considered during the re-examination procedure.
Slovenian: Kot je navedeno v četrtem odstavku člena 62(1) Uredbe (ES) št. 726/2004 in v tretjem odstavku člena 32(4) Direktive 2001/83/ES “lahko postopek ponovnega pregleda obravnava samo posamezne dele mnenja, ki jih je na začetku opredelil predlagatelj/imetnik dovoljenja za promet z zdravilom, in lahko temelji le na znanstvenih podatkih, ki so bili na voljo, ko je odbor sprejel prvotno mnenje.“ Teh znanstvenih podatkov zato ni mogoče obravnavati med postopkom ponovnega pregleda.
English: The European Commission initiated a referral under article 31 of Directive 2001/83/EC on 4 August 2014.
Slovenian: Evropska komisija je 4. avgusta 2014 sprožila napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES.
English: • Composition differences - the test product contains critical excipients that may affect the pharmacokinetics profile of the medicinal product (absorption).
Slovenian: • razlike v sestavi - testno zdravilo vsebuje kritične pomožne snovi, ki lahko vplivajo na farmakokinetični profil zdravila (absorpcijo).
English: Annex II Scientific conclusions and grounds for the recommendations for maintenance and suspension of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za priporočila za ohranitev ali začasni umik dovoljenj za promet z zdravilom
English: Category 1 medicinal products
Slovenian: Zdravila kategorije 1
English: Genericon Pharma Austria (for Nebivolol).
Slovenian: Genericon Pharma Austria (za nebivolol).
English: The grounds submitted were taken into consideration and assessed by the CHMP.
Slovenian: Odbor CHMP je predložene razloge upošteval in ocenil.
English: • Absorption through the oral cavity for an orodispersible formulation cannot be excluded
Slovenian: • pri orodisperzibilnih formulacijah ni mogoče izključiti absorpcije prek ustne votline;
English: Nor does it allow for the findings of a previous inspection to be ignored.
Slovenian: Uspešen izid prav tako ne omogoča, da bi prezrli ugotovitve preteklih pregledov.
English: However the CHMP is of the view that the findings by ANSM in 2014 were serious in terms of the impact on the integrity of the studies.
Slovenian: Odbor CHMP kljub temu meni, da so bile ugotovitve agencije ANSM leta 2014 resne kar zadeva vpliv na neoporečnost študij.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for medicinal products concerned by the GVK Bio procedure;
Slovenian: • odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki jih zadeva postopek v zvezi z družbo GVK Bio;
English: For the above reasons, the lack of proof of bioequivalence can not be substituted by post marketing experience data.
Slovenian: Zaradi zgornjih razlogov pomanjkanja dokaza o biološki enakovrednosti ni mogoče nadomestiti s podatki iz izkušenj v obdobju trženja.
English: These data manipulations cast doubts on the authenticity of all other clinical records of these nine clinical trials.
Slovenian: Zaradi tega prirejanja podatkov se pojavlja dvom o pristnosti druge klinične dokumentacije iz teh devetih kliničnih preskušanj.
English: This period of deferral shall not exceed twenty-four months from the Commission Decision.
Slovenian: Ta odlog je mogoč za največ 24 mesecev od sklepa Komisije.
English: This means that a successful outcome in a particular inspection cannot be taken as a guarantee that all processes are properly run and GCP compliant.
Slovenian: To pomeni, da uspešnega izida določenega pregleda ni mogoče upoštevati kot jamstvo, da vsi postopki potekajo pravilno in v skladu z dobro klinično prakso.
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP recommends:
Slovenian: odbor CHMP zato v skladu s členoma 31 in 32 Direktive 2001/83/ES priporoča naslednje:
English: The French Agency on medicinal products (ANSM) conducted an inspection on 19-23 May 2014 (inspection reference GCP-141001-FR) at GVK Biosciences Private Limited, Swarna Jayanthi commercial complex, Ameerpet, Hyderabad 500 038, India.
Slovenian: Francoska agencija za zdravila (ANSM) je med 19. in 23. majem 2014 izvedla inšpekcijski pregled (referenca pregleda: GCP-141001-FR) na lokaciji družbe GVK Biosciences Private Limited, Swarna Jayanthi commercial complex, Ameerpet, Hyderabad 500 038, Indija.
English: The clinical phase was conducted at GVK Bio; the bioanalytical, pharmacokinetic and statistical phases of the study were carried out by another CRO.
Slovenian: Klinična faza je bila izvedena na lokaciji družbe GVK Bio; bioanalitične, farmakokinetične in statistične faze študije je izvedla druga pogodbena raziskovalna organizacija.
English: Importance of alendronate therapy for patients: The MAHs argue on the importance of the alendronate therapy for patients and continuous availability of the medicine to safeguard public health.
Slovenian: Pomen zdravljenja z alendronatom za bolnike: Imetniki dovoljenj za promet z zdravilom poudarjajo pomen zdravljenja z alendronatom za bolnike in stalno razpoložljivost zdravila za varovanje javnega zdravja.
English: • Re-examination request for Nebivolol Genericon Pharma Austria
Slovenian: • Zahteva za ponovni pregled za zdravilo Nebivolol družbe Genericon Pharma Austria
English: The information was noted, but as no data of this bioequivalence study have been submitted within the article 31 procedure, it was not considered in the review.
Slovenian: Informacije so bile zabeležene, ker pa v okviru postopka po členu 31 niso bili predloženi nobeni podatki o tej študiji biološke enakovrednosti, študija v tem pregledu ni bila upoštevana.
English: • The Committee reviewed all available data and information provided by the MAHs, as well as information provided by GVK Bio;
Slovenian: • odbor je pregledal vse razpoložljive podatke in informacije, ki so jih zagotovili imetniki dovoljenj za promet z zdravilom, ter informacije, ki jih je zagotovila družba GVK Bio;
English: The MAH did not exercise the right to submit the above mentioned scientific data for assessment before the adoption of the initial opinion.
Slovenian: Pri tem ni uveljavljal pravice do predložitve zgoraj navedenih znanstvenih podatkov za oceno pred sprejetjem prvotnega mnenja.
English: For generic products authorised under Article 10(1) of Directive 2001/83/EC, establishment of bioequivalence vis-à-vis a reference medicinal product is a pre-requisite.
Slovenian: Za generična zdravila, odobrena v skladu s členom 10(1) Direktive 2001/83/ES, je določitev biološke enakovrednosti z referenčnim zdravilom predpogoj.
English: Post-marketing experience: The MAH argues on the long term post marketing experience of almost seven years for Alendronic acid containing formulations.
Slovenian: Izkušnje v obdobju trženja: Imetnik dovoljenja za promet z zdravilom izpostavlja dolgoročne izkušnje iz obdobja trženja skoraj sedmih let za formulacije, ki vsebujejo alendronsko kislino.
English: Finally, it is noted that bioequivalence for a generic product should be proven in line with the criteria as outlined in article 10 of Directive 2001/83/EC and the Guideline on the investigation of bioequivalence.
Slovenian: Nazadnje je bilo ugotovljeno, da bi bilo treba biološko enakovrednost za generično zdravilo dokazati v skladu z merili, opredeljenimi v členu 10 Direktive 2001/83/ES, in Smernicami o raziskavah biološke enakovrednosti.
English: • Request for re-examination for Alendronate:
Slovenian: • Zahteva za ponovni pregled za alendronat
English: Ranbaxy, Basics GmbH, Takeda Belgium, Pensa Pharma and Labesfal Genéricos (for Alendronate);
Slovenian: Ranbaxy, Basics GmbH, Takeda Belgium, Pensa Pharma in Labesfal Genéricos (za alendronat);
English: Dr. Reddy's Laboratories (UK) Ltd and betapharm Arzneimittel GmbH (for Dipyridamole and Levetiracetam);
Slovenian: Dr. Reddy's Laboratories (UK) Ltd in betapharm Arzneimittel GmbH (za dipiridamol in levetiracetam);
English: However, prescription of the suspended MAs can be reported to another generic or the innovator brand.
Slovenian: Vendar se lahko o predpisovanju začasno umaknjenih dovoljenj za promet z zdravilom poroča pri drugi znamki generičnih ali inovatorskih zdravil.
English: The MAHs argue that this generalisation can only be justified if evidence is provided that individual audits were not conducted to the appropriate standard, and that no such evidence has been provided.
Slovenian: Imetniki dovoljenj za promet z zdravilom trdijo, da je ta posplošitev upravičena le, če se predložijo dokazi, da posamezne revizije niso bile opravljene po ustreznem standardu, kar pa ni bilo storjeno.
English: However, in light of the nature, the severity and the extent of the GCP findings identified in the ANSM's inspection in May 2014, these arguments do not demonstrate that the said studies can be relied upon.
Slovenian: Vendar ob upoštevanju značaja, resnosti in obsega ugotovitev v zvezi z dobro klinično prakso, opredeljenih v okviru inšpekcijskega pregleda agencije ANSM maja 2014, te utemeljitve ne dokazujejo, da se je na zadevne študije mogoče zanesti.
English: Following submission of MAHs' responses, and whilst due consideration was given to every MAHs' replies, the arguments and data provided were classified into three categories.
Slovenian: Potem ko so imetniki dovoljenj za promet z zdravili predložili odgovore in so se ustrezno upoštevali odgovori vsakega od imetnikov dovoljenj, so bile predložene utemeljitve in dokazi razvrščeni v tri kategorije.
English: For the purpose of this report, GVK Biosciences Private Limited/Clinogent will be hereafter referred to as ‘GVK Bio'.
Slovenian: Za namene tega poročila se za družbo GVK Biosciences Private Limited/Clinogent v nadaljevanju uporablja ime GVK Bio.
English: Finally, The CHMP determined that GVK Bio did not provide evidence to demonstrate that the problem was confined to a specific time period or specific clinical trials or specific individuals and clinical activities.
Slovenian: Nazadnje je odbor CHMP ugotovil, da družba GVK Bio ni predložila dokaza, da je bila težava omejena na določeno časovno obdobje ali določena klinična preskušanja ali določene posameznike in klinične dejavnosti.
English: • Re-examination request for Levetiracetam and Dipyridamole:
Slovenian: • Ponovni pregled zahteve za levetiracetam in dipiridamol
English: The Committee therefore recommends that these marketing authorisations (Annex IB) should be suspended unless the medicinal product is considered critical by the relevant national competent authorities.
Slovenian: Odbor zato priporoča, da se ta dovoljenja za promet z zdravilom (Priloga IB) začasno umaknejo, razen v primeru, da je zadevno zdravilo po mnenju ustreznega nacionalnega pristojnega organa kritičnega pomena.
English: Neo-Balkanika submitted the bioequivalence study (PK-05-035) which had already been submitted during the referral procedure in support of marketing authorisations for Nebivolol 5 mg tablets, with the same qualitative and quantitative composition and same manufacturers.
Slovenian: Družba Neo Balkanika je predložila študijo biološke enakovrednosti (PK-05-035), ki je že bila predložena med napotitvenim postopkom v podporo dovoljenjem za promet z zdravilom Nebivolol 5 mg tablete z enako kakovostno in količinsko sestavo in enakimi proizvajalci.
English: According to article 10 of Directive 2001/83/EC, the bioequivalence vis-à-vis an EU reference medicinal product needs to be established and therefore the abovementioned studies can not be considered fulfilling the criteria of article 10.
Slovenian: V skladu s členom 10 Direktive 2001/83/ES je treba ugotoviti biološko enakovrednost z referenčnim zdravilom, odobrenim v EU, zato se za zgoraj navedene študije ne more šteti, da izpolnjujejo merila iz člena 10.
English: Heumann Pharma GmbH & co. Generica KG, and Torrent Pharma GmbH / Torrent Pharma SRL (for Irbesartan/hydrochlorothiazide and Irbesartan);
Slovenian: Heumann Pharma GmbH & co. Generica KG in Torrent Pharma GmbH/Torrent Pharma SRL (za irbesartan hidroklorotiazid in irbesartan);
English: In the light of these uncertainties and consequent potential efficacy, safety and tolerability concerns, the benefit-risk balance of the concerned medicinal products is not positive.
Slovenian: Ob upoštevanju teh negotovosti in posledičnih morebitnih pomislekov glede učinkovitosti, varnosti in prenašanja razmerje med tveganji in koristmi zadevnih zdravil ni pozitivno.
English: The following findings were reported in the French inspection report dated 02 July 2014, to which GVK Bio have responded on 18 July 2014 and in the final inspection report, which was issued on 21 July 2014: data manipulations of electrocardiograms (ECGs) were detected in each and every one of the 9 trials inspected by the ANSM.
Slovenian: V poročilu francoske agencije o inšpekcijskem pregledu z dne 2. julija 2014, na katerega se je družba GVK Bio odzvala 18. julija 2014, in v končnem poročilu o inšpekcijskem pregledu, ki je bilo izdano 21. julija 2014, so bile navedene naslednje ugotovitve: v vseh devetih preskušanjih, ki jih je pregledala agencija ANSM, je bilo ugotovljeno prirejanje podatkov o elektrokardiogramih (EKG).
English: Having taken into account the ANSM's inspection report, the available data and all arguments presented in the MAHs' replies, the CHMP concluded in its plenary meeting on January 2015 that in the absence of demonstration of bioequivalence to an EU Reference Medicinal Product, the efficacy, safety and tolerability of the concerned medicinal product cannot be established.
Slovenian: Ob upoštevanju poročila agencije ANSM o inšpekcijskem pregledu, razpoložljivih podatkov in vseh utemeljitev, ki so jih imetniki dovoljenj za promet z zdravilom podali v svojih odgovorih, je odbor CHMP na svojem plenarnem zasedanju januarja 2015 zaključil, da ob odsotnosti dokazov o biološki enakovrednosti z referenčnim zdravilom, odobrenim v EU, učinkovitosti, varnosti in prenašanja zadevnega zdravila ni mogoče ugotoviti.
English: According to the MAH, this is only mentioned in the Guideline on the Investigation of Bioequivalence.
Slovenian: Po mnenju imetnika dovoljenja za promet z zdravilom je to navedeno samo v Smernicah o raziskavah biološke enakovrednosti.
English: Based on the same argumentation as described above for Irbesartan, the MAH claims that the data obtained in the AU study are still applicable for the EU.
Slovenian: Na podlagi enakih utemeljitev, kot so opisani zgoraj za zdravilo Irbesartan, imetnik dovoljenja za promet z zdravilom trdi, da podatki, pridobljeni v avstralski študiji, še vedno veljajo za EU.
English: Further to the assessment, the CHMP noted that medicinal products containing Pravastatin were to be excluded of this procedure as out of the scope of the procedure.
Slovenian: Nadalje je odbor CHMP opozoril, da bi bilo treba zdravila, ki vsebujejo pravastatin, izključiti iz tega postopka, saj ne spadajo v njegov obseg.
English: However, the CHMP is of the opinion that the absence of the identification of any pharmacovigilance signals does not provide sufficient reassurance because it is not established that the pharmacovigilance activities may be designed to detect such a signal.
Slovenian: Vendar meni, da dejstvo, da farmakovigilančni signali niso bili ugotovljeni, ne zagotavlja zadostne gotovosti, saj ni ugotovljeno, da so farmakovigilančne dejavnosti zasnovane na način, ki omogoča zaznavanje tovrstnih znakov.
English: The MAH claimed that it had not received the official notification of the inclusion of the product in the Article 31 Referral procedure.
Slovenian: Imetnik dovoljenja za promet z zdravilom je trdil, da ni prejel uradnega obvestila o vključitvi zdravila v napotitveni postopek po členu 31.
English: The CHMP was asked to assess the potential impact of the findings on the benefit risk balance of products authorised on the basis of studies with clinical activities performed at the inspection site.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je bil naprošen, da oceni morebitni učinek ugotovitev na razmerje med tveganji in koristmi zdravil, odobrenih na podlagi študij, pri katerih so klinične dejavnosti potekale na pregledani lokaciji.
English: Submission of new scientific data: The MAHs informed the CHMP that they have initiated activities for a new bioequivalence study.
Slovenian: Predložitev novih znanstvenih podatkov: Imetniki dovoljenj za promet z zdravilom so odbor CHMP obvestili, da so začeli dejavnosti za izvedbo nove študije biološke enakovrednosti.
English: The CHMP therefore confirms that it cannot be ruled out beyond reasonable doubt that critical GCP violations at the site have not affected the integrity of the scientific data of other bioequivalence studies conducted at the site, and that the studies therefore remain unreliable.
Slovenian: Odbor CHMP zato potrjuje, da ni mogoče brez vsakega dvoma izključiti, da kritične kršitve dobre klinične prakse na zadevni lokaciji niso vplivale na neoporečnost znanstvenih podatkov drugih študij biološke enakovrednosti, opravljenih na lokaciji, in da študije zato ostajajo nezanesljive.
English: During September 2014 CHMP plenary meeting, the CHMP adopted a LoQ to the CRO to clarify whether the findings should be confined to the period 2008-2014, to specific clinical trials and/or specific clinical activities at the Hyderabad site.
Slovenian: Na plenarnem zasedanju odbora CHMP septembra 2014 je Odbor sprejel seznam vprašanj za pogodbeno raziskovalno organizacijo, da bi pojasnili, ali bi morali ugotovitve omejiti na obdobje 2008-2014, na določena klinična preskušanja in/ali določene klinične dejavnosti na lokaciji v Hyderabadu.