qanastek/ELRC-Medical-V2 huggingface dataset:
English: In another instance, a commercially available (via the internet) bacterial transformation kit was used to produce a Class 1 GMM.
Translation (en-da): I et andet tilfælde blev et kommercielt tilgængeligt (via internettet) bakterietransformationssæt anvendt til at fremstille en klasse 1-GMM.
English: Although there are significantly fewer class 3 and 4 activities being carried out, their number is increasing.
Translation (en-da): Selv om der udføres betydeligt færre klasse 3- og 4-aktiviteter, er deres antal stigende.
English: Others (Poland), allowed the Competent Authorities to decide whether a public consultation was needed on the basis of the Class of the activities.
Translation (en-da): Andre (Polen) lod det være op til de kompetente myndigheder at beslutte, hvorvidt der var behov for en offentlig høring på grundlag af klassen for aktiviteterne.
English: Finland also added that, as research groups may move from one institution to another, the need for new notifications of the new premises each time creates additional administrative work.
Translation (en-da): Finland tilføjede ligeledes, at eftersom forskergrupper flytter fra den ene institution til den anden, medfører behovet for nye anmeldelser for de nye lokaler hver gang yderligere administrativt arbejde.
English: In the Czech Republic and in Bulgaria, the inspections were carried out on the basis of annual schedule.
Translation (en-da): I Tjekkiet og i Bulgarien blev inspektionerne gennemført i henhold til en årsplan.
English: In the two Member States which received responses, the summaries of the comments were made available on the Competent Authorities' website.
Translation (en-da): I de to medlemsstater, der modtog svar, blev sammendrag af bemærkningerne stillet til rådighed på de kompetente myndigheders websted.
English: In Finland, the classification of viruses, cell cultures, and especially of pathogens, which have been attenuated, has also been problematic.
Translation (en-da): I Finland har klassificeringen af virus, cellekulturer og navnlig af patogener, der er blevet dæmpet, også været problematisk.
English: Neither the European Commission nor any person acting on its behalf is responsible for the content of this report and of any use made of the information contained in this report.
Translation (en-da): Hverken Europa-Kommissionen eller personer, der optræder på dennes vegne, kan gøres ansvarlige for indholdet af og anvendelsen af oplysningerne i denne rapport.
English: In Slovenia, delays occurred when the external experts (Scientific Committee) or another national body was involved in the processing of a notification.
Translation (en-da): I Slovenien opstod der forsinkelser, når de eksterne eksperter (den videnskabelige komité) eller en anden national instans var involveret i behandlingen af en anmeldelse.
English: Overview of activities and installations (reporting period 06.06.2009 - 05.06.2014)
Translation (en-da): Oversigt over aktiviteter og anlæg (rapporteringsperiode 6. juni 2009 - 5. juni 2014)
English: Although the internet was primarily used, other means of communication (seminars, meetings, brochures, etc.) were employed.
Translation (en-da): Selv om man især benyttede internettet, blev andre kommunikationsmetoder (seminarer, møder, brochurer osv.) også anvendt.
English: Moreover, it is not always possible to distinguish the amendments to earlier notifications from other types of subsequent contained use activities (continuation of activity or new activity).
Translation (en-da): Desuden er det ikke altid muligt at skelne ændringer af tidligere anmeldelser fra andre typer af efterfølgende indesluttede anvendelser (videreførelse af en aktivitet eller ny aktivitet).
English: Similarly, Spain, Sweden, and the United Kingdom, would like to simplify the procedures for Class 1 and 2 activities.
Translation (en-da): På samme måde ønsker Spanien, Sverige og Det Forenede Kongerige at forenkle procedurerne for klasse 1- og 2-aktiviteter.
English: They considered that the Union regulatory framework for the new techniques should be reviewed to clarify whether organisms obtained with these new techniques fall under the scope of the Directive.
Translation (en-da): De mente, at EU's lovgivningsramme for de nye teknikker bør revideres for at præcisere, hvorvidt organismer, der fremstilles med disse nye teknikker, hører under direktivets anvendelsesområde.
English: In Denmark, all activities were inspected upon notification of new premises or of changes in existing ones.
Translation (en-da): I Danmark blev alle aktiviteter inspiceret ved anmeldelse af nye lokaler eller ændringer af eksisterende lokaler.
English: The process of notification and approval is similar and timelines well respected.
Translation (en-da): Processen for anmeldelse og godkendelse er ensartet, og tidsfristerne overholdes.
English: In the Netherlands, only the notifier's name, the title of the project and the issuing date of the licence were published but members of the public could request access to an issued licence.
Translation (en-da): I Nederlandene offentliggjorde man kun anmelderens navn, projektets titel og tilladelsens udstedelsesdato, men offentligheden kunne anmode om adgang til en udstedt licens.
English: While the transformation kit is not sold in Belgium, its availability via the internet could potentially make the enforcement of the provisions of 2009/41/EC difficult.
Translation (en-da): Selv om transformationssættet ikke sælges i Belgien, kan dets tilgængelighed via internettet potentielt gøre det vanskeligt at håndhæve bestemmelserne i 2009/41/EF.
English: For Slovenia, the inclusion of safe organisms in Part C of the Annex II of Directive 2009/41/EC could contribute to the reduction of the number and size of notifications.
Translation (en-da): For Slovenien kan medtagelsen af sikre organismer i del C af bilag II til direktiv 2009/41/EF bidrage til at reducere anmeldelsernes antal og omfang.
English: The Netherlands also believed there is a need for simplification and harmonisation of disinfectants used as biocides in laboratories.
Translation (en-da): Nederlandene mente ligeledes, at der er behov for forenkling og harmonisering af desinfektionsmidler, der anvendes som biocider i laboratorier.
English: Belgium had difficulties interpreting the provisions of the Directive 2009/41/EC concerning commercial activities involving bacterial transformation.
Translation (en-da): Belgien havde problemer med at fortolke bestemmelserne i direktiv 2009/41/EF vedrørende kommercielle aktiviteter, der involverer bakteriel transformation.
English: The approaches of public consultations varied among the Member States.
Translation (en-da): Tilgangen til offentlige høringer varierede blandt medlemsstaterne.
English: Summary and Conclusions
Translation (en-da): Sammendrag og konklusioner
English: The following text summarises the information given by Member States under the headings provided and highlights similarities of and differences between the experiences of the Member States.
Translation (en-da): I den følgende tekst sammenfattes oplysningerne fra medlemsstaterne under de fastlagte overskrifter, og der sættes fokus på ligheder og forskelle mellem medlemsstaternes erfaringer.
English: Other Member States (Spain, United Kingdom) decide on a case by case basis whether a clinical trial is regarded as contained use or as a deliberate release.
Translation (en-da): Andre medlemsstater (Spanien, Det Forenede Kongerige) beslutter fra gang til gang, hvorvidt et klinisk forsøg betragtes som indesluttet anvendelse eller som forsætlig frigivelse.
English: In Hungary, a lot of consultations are necessary between the notifiers and the Competent Authority on the documentation and information requirements before the submission and/or after the submission of the notification.
Translation (en-da): I Ungarn er der behov for mange høringer mellem anmelderne og den kompetente myndighed om dokumentations- og informationskravene forud for og/eller efter indsendelsen af anmeldelsen.
English: The number of inspectors involved in GMM control also varied among Member States.
Translation (en-da): Antallet af inspektører, der beskæftiger sig med GMM-kontrol, varierede også blandt medlemsstaterne.
English: The information contained in this report is based on Member States individual reports and, therefore, does not represent the position of the European Commission.
Translation (en-da): Oplysningerne i denne rapport er baseret på medlemsstaternes individuelle rapporter og er derfor ikke udtryk for Europa-Kommissionens holdning.
English: The Netherlands reported a number of specific technical issues including differences in the (strict) GMO-regulations and the less strict regulation of wild type pathogens (Netherlands).
Translation (en-da): Nederlandene rapporterede om en række specifikke tekniske problemer, herunder forskelle i de (strenge) GMO-bestemmelser og de mindre strenge bestemmelser for vilde patogener (Nederlandene).
English: Accidents
Translation (en-da): uheld
English: Accidents in the reporting Member States were few and minor in significance in terms of human health and the environment.
Translation (en-da): Uheldene i de rapporterende medlemsstater var få og af begrænset betydning for menneskers sundhed og miljøet.
English: Three Member States (Estonia, Lithuania, and Malta) considered that specific training programmes for inspectors and joint inspections with other Member States would improve the inspection process.
Translation (en-da): Tre medlemsstater (Estland, Litauen og Malta) fandt, at specifikke uddannelsesprogrammer for inspektører og fælles inspektioner med andre medlemsstater ville forbedre inspektionsprocessen.
English: In the Brussels-Capital Region some problems were encountered in the notification process due to the Brussels legislation which has set up numerous different procedures regarding the class of risk (8 in total).
Translation (en-da): I regionen Bruxelles-Capitale var man stødt på visse problemer med anmeldelsesprocessen på grund af lovgivningen i Bruxelles, som har opstillet talrige forskellige procedurer vedrørende risikoklassen (otte i alt).
English: In Hungary, the notifications published on the internet contain a summary of the risk assessment available at the Secretariat of Gene Technology Advisory Board.
Translation (en-da): I Ungarn indeholder de anmeldelser, der offentliggøres på internettet, et resumé af den risikovurdering, der ligger hos sekretariatet for rådgivningspanelet for genteknologi.
English: In Germany, there are two genetic engineering facilities where large animals can be disposed of with the help of a digester (alkaline hydrolysis).
Translation (en-da): I Tyskland findes der to genmodificeringsanlæg, hvor større dyr kan bortskaffes ved hjælp af et nedbrydningsanlæg (alkalisk hydrolyse).
English: According to its national report, there were no GMMs contained use activities in Romania during the reporting period.
Translation (en-da): Ifølge landerapporten fra Rumænien blev der ikke gennemført nogen GMM-aktiviteter med indesluttet anvendelse i rapporteringsperioden.
English: In terms of public consultation and information, almost all reporting Member States have implemented provisions for conducting public consultations, and for informing the public on the outcome of their activities under the Directive.
Translation (en-da): Med hensyn til offentlig høring og information har næsten alle rapporterende medlemsstater indført bestemmelser for afholdelse af offentlige høringer og informering af offentligheden om resultaterne af deres aktiviteter i henhold til direktivet.
English: Activities were also carried out in hospitals, public institutions, education (universities) or in detection laboratories.
Translation (en-da): Der blev ligeledes udført aktiviteter på hospitaler, offentlige institutioner, læreanstalter (universiteter) eller på sporingslaboratorier.
English: Spain and France also pointed to the burden of the large number of inspections required in order to enforce the provisions of Directive 2009/41/EC.
Translation (en-da): Spanien og Frankrig påpegede ligeledes byrden ved det store antal inspektioner, der kræves for at håndhæve bestemmelserne i direktiv 2009/41/EF.
English: In some instances, Member States required the most stringent waste management treatment for all classes of GMMs.
Translation (en-da): I nogle tilfælde krævede medlemsstaterne, at den strengeste affaldshåndtering skulle anvendes for alle GMM-klasser.
English: In Spain, the waste inactivation is optional for class 1 and obligatory for class 2, 3 and 4 but the Competent Authority recommends operators to inactivate the GMOs in all cases.
Translation (en-da): I Spanien er deaktiveringen af affaldet valgfri for klasse 1 og obligatorisk for klasse 2, 3 og 4, men den kompetente myndighed anbefaler operatørerne at deaktivere GMO'erne i alle tilfælde.
English: Inspections are conducted systematically and on an ad hoc basis in all premises or in specific class (classes 3 and 4) activities using specialised staff.
Translation (en-da): Inspektionerne gennemføres systematisk og på ad hoc-basis på alle anlæg eller ved aktiviteter i specifikke klasser (klasse 3 og 4) ved hjælp af specialiseret personale.
English: The Czech Republic is currently amending its legislation which requires a new notification in each case of contained use even for Class 1 activities.
Translation (en-da): Tjekkiet er i øjeblikket i færd med at ændre sin lovgivning, som kræver en ny anmeldelse for hvert tilfælde af indesluttet anvendelse, selv for klasse 1-aktiviteter.
English: Ireland and Denmark considered that there is a need for deregulation of Class 1 GMMs as the requirements under Annex II, Part B of the Directive is considered to be rather heavy given the 'non harmful' status of Class 1 GMMs.
Translation (en-da): Irland og Danmark mente, at der er behov for deregulering af klasse 1-GMM'er, idet kravene i bilag II, del B, i direktivet anses for at være ret strenge i lyset af, at klasse 1-GMM'er betragtes som "ikkeskadelige".
English: The notifier does not always know when an activity is considered to be a subsequent contained use of the same containment class, especially in cases when the authorised activity is modified.
Translation (en-da): Anmelderen er ikke altid klar over, hvornår en aktivitet betragtes som en efterfølgende indesluttet anvendelse af den samme indeslutningsklasse, navnlig i tilfælde, hvor den godkendte aktivitet ændres.
English: Affected personnel were given prophylactic treatment and/or vaccination, and were monitored to ensure full recovery (in the cases of accidental sticking with needles).
Translation (en-da): De berørte medarbejdere modtog profylaktisk behandling og/eller vaccination og blev overvåget for at sikre fuldstændig helbredelse (i tilfælde af nålestik ved et uheld).
English: Directive 2009/41/EC on the contained use of genetically modified micro-organisms (GMMs) requires the Commission to publish every three year a summary report on Member States experience with that Directive, based on individual reports to be sent by the Member States to the Commission.
Translation (en-da): I direktiv 2009/41/EF om indesluttet anvendelse af genetisk modificerede mikroorganismer (GMM) kræves det, at Kommissionen hvert tredje år offentliggør en sammenfattende rapport om medlemsstaternes erfaring med direktivet baseret på individuelle rapporter, som medlemsstaterne indsender til Kommissionen.
English: On the same subject, Finland, the Netherlands, and the United Kingdom would like to see that the definitions in the Directive be reviewed to take into account new techniques or technological advances.
Translation (en-da): I samme forbindelse ønsker Finland, Nederlandene og Det Forenede Kongerige, at definitionerne i direktivet revideres for at tage højde for nye teknikker eller teknologiske fremskridt.
English: Within the framework of Directive 2009/41/EC, the premises for contained use activities must be notified to the national competent authorities when they are to be used for the first time.
Translation (en-da): Inden for rammerne af direktiv 2009/41/EF skal lokalerne til aktiviteter med indesluttet anvendelse anmeldes til de nationale kompetente myndigheder, inden de tages i brug første gang.
English: In some Member States inspections were conducted by specialised inspectors from the Competent Authority, while in others inspections were carried out at the request of the Competent Authorities by specialised inspectors from other ministries or services.
Translation (en-da): I nogle medlemsstater blev inspektionerne gennemført af specialiserede inspektører fra den kompetente myndighed, mens inspektionerne i andre blev foretaget af specialiserede inspektører fra andre ministerier eller tjenester på anmodning af de kompetente myndigheder.
English: In Austria, there are special legal national provisions for applications concerning gene therapy in clinical trials.
Translation (en-da): I Østrig har man specifikke nationale juridiske bestemmelser for anvendelser vedrørende genterapi ved kliniske forsøg.
English: Public consultation and information
Translation (en-da): Offentlig høring og information
English: Some Member States had electronic registers (databases) for applications submitted under Directive 2009/41/EC.
Translation (en-da): Nogle medlemsstater havde elektroniske registre (databaser) for ansøgninger indgivet i henhold til direktiv 2009/41/EF.
English: Directive 2009/41/EC is a recast of Directive 90/219/EEC amended by Directive 98/81/EC.
Translation (en-da): Direktiv 2009/41/EF er en omarbejdning af direktiv 90/219/EØF som ændret ved direktiv 98/81/EF.
English: Slovakia reported 3 accidents caused by fire in different facilities including the Institute of Virology (class 1 and 2 GMOs), the Institute of Neuroimmunology (class 1 and 2 GMOs), and the Slovak University of Technology (class 1 GMOs).
Translation (en-da): Slovakiet indberettede tre uheld, der skyldtes brand i forskellige faciliteter, bl.a. instituttet for virologi (GMO'er i klasse 1 og 2), instituttet for neuroimmunologi (GMO'er i klasse 1 og 2) og det slovakiske teknologiske universitet (GMO'er i klasse 1).
English: Following this notification subsequent class 1 contained use may proceed without further notification, whereas higher containment class levels require additional specific notification.
Translation (en-da): Efter denne anmeldelse kan efterfølgende indesluttet anvendelse i klasse 1 indledes uden yderligere anmeldelse, mens indesluttet anvendelse i højere klasser kræver en specifik anmeldelse.
English: Another reported issue was the potential borderline situation between contained use and deliberate release in clinical trials with GM-viruses in which it cannot be excluded that patients' or experimental animals' excretions may contain the tested viruses.
Translation (en-da): Et andet indberettet problem var den potentielle afgrænsning af indesluttet anvendelse og forsætlig frigivelse ved kliniske forsøg med genmodificerede virus, hvor man ikke kan udelukke, at ekskreter fra patienter eller forsøgsdyr kan indeholde de testede virus.
English: Most Member States use autoclave or chemical treatment to dispose of GMM waste, and/or incinerate GM plants and animals.
Translation (en-da): De fleste medlemsstater anvender autoklaver eller kemisk behandling til at bortskaffe GMM-affald og/eller forbrænding af genmodificerede planter og dyr.
English: Most activities were related to research but several served commercial purposes such as the manufacture of diagnostics, veterinary and medicinal products.
Translation (en-da): De fleste aktiviteter vedrørte forskning, men adskillige tjente kommercielle formål såsom fremstilling af diagnostiske, veterinærmedicinske og medicinske produkter.
English: When delays occurred, they were mostly due to requests for additional information, lack of clarity on the notification submission requirements on the part of applicants, the involvement of more than one national body in the approval process, and delays in the delivery of the opinion by the scientific advisory body responsible for the assessment of the notifications.
Translation (en-da): Når der forekommer forsinkelser, skyldes de oftest anmodninger om yderligere oplysninger, manglende klarhed om kravene til indgivelse af anmeldelser hos ansøgerne, inddragelse af mere end én national instans i godkendelsesprocessen og forsinkelser i afgivelsen af udtalelsen fra den videnskabelige rådgivende instans, der er ansvarlig for at vurdere anmeldelserne.
English: In one instance, a GMM falling within the scope of 2009/41/EC was produced using techniques (self-cloning) which do not fall under the scope of Directive 2009/41/EC.
Translation (en-da): I et tilfælde fremstillede man en GMM, der falder inden for rammerne af 2009/41/EF, ved hjælp af teknikker (selvkloning), der ikke hører under anvendelsesområdet for direktiv 2009/41/EF.
English: Fewer class 3 and 4 activities were being carried out.
Translation (en-da): Der blev udført færre aktiviteter i klasse 3 og 4.
English: In Austria, the Netherlands, and Finland, there is one waste treatment facility dedicated to GM waste inactivation, otherwise the operators inactivate it themselves.
Translation (en-da): I Østrig, Nederlandene og Finland findes der ét affaldsbehandlingsanlæg udelukkende til deaktivering af genmodificeret affald, og ellers deaktiverer operatørerne det selv.
English: Belgium, Finland, Slovenia, the United Kingdom and Sweden pointed out that the large number of notifications, the high information requirements for each notification, the detailed reporting system, and the complexity of the different procedures can result in a heavy administrative burden for both authorities and notifiers.
Translation (en-da): Belgien, Finland, Slovenien, Det Forenede Kongerige og Sverige påpegede, at det store antal anmeldelser, de høje informationskrav til de enkelte anmeldelser, det detaljerede rapporteringssystem og kompleksiteten af de forskellige procedurer kan medføre en stor administrativ byrde for både myndigheder og anmeldere.
English: The Danish authorities informed the Commission that this procedure is about to change to allow Class 1 GMM work to start based on the notification alone with inspections following after the start of operations.
Translation (en-da): De danske myndigheder informerede Kommissionen om, at denne procedure snart vil blive ændret for at gøre det muligt at påbegynde arbejde med GMM i klasse 1 alene baseret på anmeldelsen, mens inspektionerne foretages, efter at operationerne er indledt.
English: Of the eight accidents reported, six involved class 2 GMMs, and two involved class 3 GMMs.
Translation (en-da): Ud af de otte indberettede uheld omfattede seks GMM'er i klasse 3, mens to involverede GMM'er i klasse 3.
English: In their reports, several Member States, stressed that the problems mentioned above and the actual administration of the process (number of notifications, processing of notifications and approval, inspections, etc.) result in a significant administrative burden which merits examination with the view to harmonise and simplify to the extent possible.
Translation (en-da): I deres rapporter understregede adskillige medlemsstater, at ovennævnte problemer og den faktiske forvaltning af processen (antal anmeldelser, behandling af anmeldelser og godkendelse, inspektioner osv.) medfører en betydelig administrativ byrde, der fortjener at blive undersøgt med henblik på harmonisering og forenkling i videst mulig udstrækning.
English: Lithuania, Estonia, and Malta would welcome more exchanges on experiences and training among Member States.
Translation (en-da): Litauen, Estland og Malta ville sætte pris på mere udveksling af erfaringer og uddannelse mellem medlemsstaterne.
English: Inspection and enforcement issues
Translation (en-da): inspektions- og håndhævelsesspørgsmål
English: Member States applied the Directive in a similar fashion in terms of administration, handling of the notifications, inspections, waste disposal and public consultation and information.
Translation (en-da): Medlemsstaterne anvender direktivet ensartet med hensyn til administration, håndtering af anmeldelser, inspektioner, bortskaffelse af affald samt offentlig høring og information.