natgillin/translations-raw huggingface dataset:
Ud over CPMP´s arbejdsgrupper afholdtes der en række møder i ad hoc- arbejdsgrupper i 1998:
In addition to the CPMP working parties a number of ad hoc working groups met in 1998.
ad hoc- ekspertgruppe vedrørende orale antikonceptionsmidler
Ad hoc expert group on oral contraceptives Chaired by Prof.
Bo Odlind for at drøfte kardiovaskulære risici i forbindelse med anvendelsen af disse præparater. ad hoc- arbejdsgruppe vedrørende blodpræparater
Bo Odlind, the group met once in 1998 to look at the cardiovascular risks associated with the use of these medicinal products.
Denne gruppe blev nedsat af CPMP i april 1998 med henblik på at undersøge virkningen af sikkerhedsaspekter i tilknytning til blodpræparater.
Ad hoc working group on blood products The group was created by the CPMP in April 1998 to address efficacy of safety aspects of blood products.
Gruppens mandat (CPMP/ 1489/ 98) og arbejdsprogram (CPMP/ BPWG/ 1488/ 98) blev vedtaget af CPMP i juli 1998.
The group’ s mandate (CPMP/ 1489/ 98) and work plan (CPMP/ BPWG/ 1488/ 98) were adopted by the CPMP in July 1998.
Dr Manfred Haase er formand for gruppen. ad hoc- ekspertgruppemøde om ajourføring af vejledning vedrørende produktresuméer
Dr Manfred Haase chairs the group.
Mary Teeling som koordinator for at udarbejde forslag til omformulering af de fleste afsnit og kvalitet og sikkerhed i produktresuméet.
Ad hoc expert group meeting on update of guidance on summary of product characteristics Coordinated by Dr Mary Teeling, this group met three times in 1998 to propose new wording for most sections of summary of product characteris- tics.
Gruppen samarbejdede med eksperter fra hver af CPMP- arbejdsgrupperne, EMEA´s ad hoc- gruppe vedrørende urtemedicin samt medlemmer af gruppen vedrørende kvalitetskontrol af dokumenter.
The group worked together with experts from each of the CPMP work- ing parties, the EMEA ad hoc group on herbal medicinal products and also members of the quality review of documents group.
2. 5
2.5.
EMEA´s ad hoc- arbejdsgruppe vedrørende urtemedicin
Ad hoc EMEA working group on herbal medicinal products
Konstantin Keller som formand mødtes EMEA´s arbejdsgruppe vedrørende urtemedicin to gange i 1998.
The ad hoc EMEA working group on herbal medicinal products met twice in 1998, chaired by Dr Konstantin Keller.
Foruden de af medlemsstaterne udnævnte medlemmer deltager også Europa- Parlamentets repræsentanter i bestyrelsen, Europa- Kommissionen og observatører fra Den Europæiske Farmakopé i gruppen.
In addition to members nominated by the Member States, the European Parliament representatives to the Management Board, the European Commission and observers from the European Pharmacopoeia also participate in the group.
Arbejdsgruppen vedrørende urtemedicin, der blev nedsat i 1997 på anmodning af Europa- Kommissionen, har grundlæggende til opgave så vidt muligt at forebygge voldgiftssager i forbindelse med proceduren for gensidig anerkendelse af disse lægemidler.
Created in 1997, at the request of the European Commission, the group operates to prevent arbitration arising from the mutual recognition procedure for these medicinal products.
På mødet i juli 1998 fortsatte gruppen sine drøftelser vedrørende vurderingen af videnskabelige monografier og fastsættelse af kriterier for vurdering af urtemedicins kvalitet, sikkerhed og virkninger.
During its July 1998 meeting the group continued its discussion on the global assessment of scientific monographs and on the definition of criteria to assess the quality, safety and efficacy of herbal medicinal products.
I december 1998 aflagde gruppen rapport om sine aktiviteter til bestyrelsen og Europa- Kommissionen.
In December 1998, the group reported on its activities to the Management Board and to the European Commission.
Ad hoc- gruppens aktiviteter resulterede i følgende forslag:
The activities of the ad hoc group resulted in the following proposals:
EMEA/ adhocHMPWG /
EMEA/ adhocHMPWG/ -
Proposal for new guidance ‘
Proposal for new guidance'Fixed
Fixed
Released for consultation in
Sendt til høring i september 1998
36
33279/ 98
33279/ 98
combinations of herbal medicinal products with long- term marketing experience ’ – Guidance to facilitate mutual recognition and use on bibliographic data.
combinations of herbal medicinal products with long-term marketing experience '- Guidance to facilitate mutual recognition and use on bibliographic data
Sendt til høring i september 1998
September 1998
EMEA/ adhocHMPWG / 114/ 98
EMEA/ adhocHMPWG/ - 114/ 98
Good manufacturing practice:
Good manufacturing practice:
Comments and proposals for revision Proposals for revision of Note for Guidance “ Quality of Herbal Remedies ” Proposal for new guidance: “ Non- clinical testing of herbal drug preparations with long- term marketing experience ” Guidance to facilitate mutual recognition and use of bibliographic data
Comments and proposals for revision Proposals for revision of Note for guidance'Quality of herbal remedies'
Færdigbehandlet i september 1998 Færdigbehandlet i september 1998 Færdibehandlet i september 1998
Finalised in September 1998 Finalised in September 1998
Notice to Applicants Volume 2A and Volume 2B Parts IB1, IC2 and III – Comments and proposals for revision
Notice to applicants Volume 2A and Volume 2B Parts IB1, IC2 and III - Comments and proposals for revision
Færdigbehandlet i september 1998
Finalised in September 1998
Comments on Part 4 of Annex to Council Directive 75/ 318/ EEC of 20 May 1975 “ Clinical documentation ”
Comments on Part 4 of Annex to Council Directive 75/ 318/ EEC of 20 May 1975'Clinical documentation '
Proposal for a core- SPC for Valerianae radix
Proposal for a core-SPC for Valerianae radix
2. 6
2.6.
Gensidig anerkendelse af humanmedicinske lægemidler
Mutual recognition of medicinal products for human use
Gensidig anerkendelse eller den decentraliserede procedure er den anden del af det EF- godkendelsessystem, som er ved at blive etableret i Europa via et samarbejde mellem medlemsstaterne.
The mutual recognition or decentralised procedure is the second European Community licensing system that is being established in Europe with co-operation between the Member States.
Den gensidige anerkendelsesprocedure gjorde betydelige fremskridt i løbet af 1998.
The mutual recognition procedure has made considerable progress during 1998.
Proceduren fandt i 1998 anvendelse på følgende:
The use of the procedure in 1998 was:
Den gensidige anerkendelses - procedure
Mutual recognition procedure
I alt indgivet i 1998 *
Total submitted in 1998
Under vurdering i 1998 *
Under evaluation in 1998
Afsluttet med positivt resultat i 1998 *
Ended positively in 1998
Voldgifter i 1998 *
Arbitrations in 1998
Nye ansøgninger Type I- ændringer Type II- ændringer
New applications Type I variations Type II variations
183 482 344
183 482 344
30 152 147
30 152 147
179 327 204
179 327 204
1 -- 4
1 - 4
18. december 1998)
Figures at 18 December 1998
I 1998 er antallet af både indgivne og færdigbehandlede ansøgninger steget betydeligt i forhold til de 10 afsluttede procedurer i 1995, 84 i 1996 og 147 i 1997.
The number of applications both submitted and completed has risen during 1998, compared with 10 procedures completed in 1995, 84 in 1996 and 147 in 1997.
Et andet opmuntrende træk er det meget lave antal voldgiftssager.
The very low level of arbitrations is another encouraging feature.
I perioden januar- juni 1998 var dr.
The Mutual Recognition Facilitation Group (MRFG) continues to meet at the 37 EMEA every month on Monday of the CPMP week.
Christa Wirthumer- Hoche fra Østrig i perioden juli- december 1998.
The MRFG met under the chairmanship of Dr David Jefferys of the United Kingdom from January to June 1998 and Dr Christa Wirthumer-Hoche of Austria from July to December 1998.
MRFG og medlemsstaterne har været særdeles taknemmelige for den støtte, EMEA har ydet ved at stille mødelokaler til rådighed for MRFG og for gruppearbejdet.
The MRFG and the Member States were particularly grateful for the support of the EMEA in providing meeting rooms for the Group and for the break-out sessions.
EMEA har desuden stillet sit sekretariat til rådighed for MRFG.
The EMEA also provided the Secretariat to support the MRFG.
Kommissionens deltagelse i MRFG´s møder har også været værdifuld.
The participation of the Commission during the MRFG meetings was very valuable.
Observatører fra Island og Norge deltog i MRFG fra januar 1998 som forberedelse til deres fuldgyldige deltagelse i det gensidige anerkendelsessystem fra begyndelsen af 1999.
Observers from Iceland and Norway attended the MRFG from January 1998 in order to prepare for their full participation in the mutual recognition system from early in 1999.
For at undgå forsinkelser blev der pr.
During 1998, the MRFG concentrated upon improving the performance of the procedure.
1. maj 1998 indført en standardiseret valideringsprocedure for nye ansøgninger for en 6- måneders forsøgsperiode.
In order to avoid delays an automatic validation procedure for new application was introduced from 1 May 1998 for a six-month trial period.
Forsøget blev en succes og videreførtes som et integreret led i proceduren fra november, og sideløbende hermed blev der indført en standardiseret valideringsprocedure for alle type II- ændringer.
The great success of the trial meant that this was continued as an established part of the procedure from November and at the same time an automatic validation procedure was introduced to cover all type II variations.
Gruppen foretog en gennemgribende revision af håndteringen af gruppemøder og afklaringsfasen.
The group undertook a major review of the operation of break-out sessions and the clarification phase.
Dette spørgsmål blev drøftet på et uformelt møde i MRFG, der afholdtes i maj under det britiske formandskab.
This was discussed in depth at an informal meeting of the MRFG organised in May during the UK Presidency.
I forlængelse heraf blev “ Best Practice Guide ” ændret i juli 1998, således at fristen for indgivelse af kommentarer fra berørte medlemsstater er ændret fra 60 dage til 55 dage for at give mere tid til afklaringsfasen.
Following this, the Best Practice Guide was modified in July 1998 so that the deadline for comments from concerned Member States has been changed from day 60 to day 55 in order to increase the time for the clarification phase.
Der blev desuden foretaget ændringer af regelsættet vedrørende gruppemøder, og en række initiativer blev iværksat af medlemsstaterne til forbedring af denne del af proceduren.
Other changes were made to the break-out protocol document and a series of initiatives were put into place by the Member States to improve this part of the procedure.
Referencemedlemsstaterne tilrettelagde i alt 64 gruppemøder i 1998, som afholdtes i EMEA.
In 1998 a total of 64 break-out sessions were organised by reference Member States and held at the EMEA.
MRFG gennemgik regelsættet for håndtering af gruppemøder med henblik på at undersøge, hvorledes disse møder bedst udnyttes til afklaring af alvorlige betænkeligheder vedrørende eventuelle risici for folkesundheden.
The MRFG reviewed the protocol for the handling of break-out sessions in order to improve the outcome of these meetings for clarification of serious public health concerns.
Det skal bemærkes, at der i 1998 var 48 procent færre gruppemøder vedrørende nye ansøgninger end i perioden 1995- 1997.
It is important to mention that in 1998 there was a decrease of 48% in the number of break-out sessions for new applications compared to the period 1995 to 1997.
Hyppigheden i enkeltstående medlemsstaters tilbagetrækning af ansøgninger i løbet af den gensidige anerkendelsesprocedure giver stadig anledning til bekymring, men også på dette område kan der noteres et fald i antallet af tilbagetrækninger på omkring 40 procent sammenlignet med overgangsperioden.
The frequency of withdrawals of applications from individual Member States during the mutual recognition procedure is still an issue of concern, but also this number of partial withdrawals decreased in 1998 by about 40% compared to the number during the transition period.
Version 3 af overvågningssystemet for den gensidige anerkendelsesprocedure “ EudraTrack ” har været fuldt funktionsdygtig fra den 1. november 1998.
Version 3 of the tracking system, ‘ EudraTrack’, for monitoring of the mutual recognition procedure became fully operational on 1 November 1998.
I årets løb fungerede et stigende antal medlemsstater som referencemedlemsstater, og næsten alle medlemsstater har nu påtaget sig denne vigtige rolle.
During the year an increasing number of Member States acted as reference Member State and nearly all Member States have now undertaken this important role.
Antal afsluttede procedurer, opgjort efter art er vist i nedenstående tabel:
The number of finalised procedures by type is given in the table:
Samlet antal afsluttede procedurer, opgjort efter art, i 1998 *
Total number of f inalised procedures by type in 1998*
Nyt aktivt stof Generiske præparater Udvidelser af produktserier
New active substances
35 45 26
26
19, 6 25, 1 14, 5
14.5
Faste kombinationspræparater
Fixed combinations
12, 3
12.3
håndkøbsmedicin Urtemedicin Andet
OTC
5 1 45
5
2, 8 0, 6 25, 1
1
* Tallet omfatter i alt 179 gentagne procedurer
* The number includes a total of 179 multiple procedures.
Med henblik på en mere detaljeret klassificering af produkterne er der siden november 1998 medtaget yderligere to kategorier, nemlig blodpræparater og vacciner.
In order to classify the products in a more detailed way two additional categories were identified, namely for blood products and vaccines since November 1998.
Det er opmuntrende, at proceduren for gensidig anerkendelse nu finder anvendelse på så bred en vifte af ansøgninger.
It is encouraging to see the wide range of applications now using the mutual recognition procedure.
I 1998 blev den årlige opdatering af influenzavacciner, der er tilladt via den gensidige anerkendelsesprocedure, for første gang afviklet efter den hurtige sporingsprocedure.
In 1998 there was for the first time the annual update of mutually recognised licenses of influenza vaccines via the fast track procedure.
At dømme ud fra denne første erfaring var proceduren yderst vellykket.
Based on the first experience this procedure proved to be very successful.
Den fungerede godt, for så vidt som tidsfristerne blev overholdt, og alle de krævede årlige ajourføringer blev gennemført tilfredsstillende.
It worked well taken into account the adherence to the agreed timetable in general, the final approval dates and the positive outcome of all requested annual updates.
Der blev i årets løb lagt vægt på at øge den gensidige anerkendelsesprocedures synlighed.
A major emphasis during the year was to increase the visibility of the mutual recognition procedure.
Udsendelsen af pressemeddelelser, der startede i juli 1997, er blevet en regelmæssigt tilbagevendende begivenhed, og der kan offentliggøres stadig flere statistiske oplysninger.
The press release instituted in July 1997 has become a regular feature with increased statistical information and increased feedback.
MRGF modtager på den måde også mere feedback, og det offentliggøres nu altsammen på MRFG´s Internet site (http: // heads. medagencies. org).
This is now published on the MRFG Internet site (http: / /heads. medagencies. org).
Det er
Additional statistical information and standard operating procedure are also published on the website along with a list of contact points.
© EMEA 1999
It is intended that a product index of mutual recognition procedures will be made available on the site early in 1999 and will be followed slightly later by the publication of summary of product characteristics of products which have been through mutual recognition.
hensigten at stille en fortegnelse over produkter, der er godkendt via gensidige anerkendelsesprocedurer, til rådighed på MRFG´s website i begyndelsen af 1999 og lidt senere at offentliggøre de tilsvarende produktresumeer.
Proposals are currently under discussion to increase transparency in the mutual recognition system and the possible development of mutual recognition public assessment reports.
I september 1998 var Det Forenede Kongerige vært for en workshop om gennemsigtighed i forbindelse med den gensidige anerkendelsesprocedure.
Following the release of the ‘ Commission communication on the Community marketing authorisation procedures for medicinal products’ (OJ C 229, 22.7.1998, p.
Forslag herom er i øjeblikket under behandling tillige med forslag om offentlige evalueringsrapporter.
4) the Group had in-depth discussions on the document in order to clarify the situation and created several standard operating procedures, which are available on the MRFG website for information.
I forlængelse af offentliggørelsen af “ Kommissionens meddelelse om fællesskabsprocedurer for markedsføringstilladelser for lægemidler ” (EFT C 229 af 22. 7. 1998, s. 4) drøftede gruppen, hvad der kunne gøres for at skabe større klarhed, og den udarbejdede forskellige operationelle standardprocedurer, som kan ses på MRFG´s website.
The close cooperation between all the stakeholders in the system provides an encouraging platform for the rapid expansion in the number of procedures, which can be expected over the next years.
Der er stadig væsentlige spørgsmål, der skal løses i forbindelse med den gensidige anerkendelsesprocedure, men der er gjort gode fremskridt i 1998.
Unit for the Evaluation of Medicinal Products for Veterinary Use 3.2.
Det tætte samarbejde mellem alle deltagerne i systemet er et lovende udgangspunkt for den forventede hastige stigning i antallet af procedurer i de kommende år.
Establishment of maxi- mum residue limits 3.1.
EMEA/ MB/ 040/ 98 EMEA ’ årsberetning for 1998
Unit for the Evaluation of Medicinal Products for Veterinary Use
VETERINÆRLÆGEMIDLER
CVMP working parties
3. 1
3.5.
Afdelingen for vurdering af veterinærlægemidler
Mutual recognition of veterinary medicinal products
Afdelingen havde et travlt år med at varetage sine to hovedfunktioner: fastsættelse af maksimalgrænseværdier (MRL) for stoffer anvendt i lægemidler til dyr, som er bestemt til levnedsmiddelproduktion, og behandling af centraliserede ansøgninger om godkendelse af nye veterinærlægemidler.
The Unit had a busy year working to fulfil its two major functions: the establishment of maximum residue limits (MRLs) for substances used in medicines for food-producing animals, and progressing centralised applications for new veterinary medicinal products.
Kornelia Grein som sektionsledere.
The structure of the Unit remained stable with Dr Peter Jones as Head of Unit and the Heads of Sector, Dr Jill Ashley-Smith and Dr Kornelia Grein.
Med sigte på at overholde fristen (1. januar 2000) for afslutningen af MRL- procedurerne for stoffer, der er markedsført inden den 1. januar 1992 (de såkaldte “ gamle stoffer ”) opfyldte arbejdsgruppen vedrørende sikkerhed i forbindelse med restkoncentrationer, med støtte fra den berørte sektion under ledelse af Kornelia Grein og hendes stab, de fastsatte mål for 1998.
Working towards the deadline of 1 January 2000 to set MRLs for all substances on the market before 1 January 1992 (so-called ‘ old substances’), the Safety 41 of Residues Working Party, supported by the sector concerned headed by Kornelia Grein and her staff, has met the goals for setting MRLs for old substances in 1998.
Der er dog stadig meget, der skal nås inden den fastsatte deadline.
There however remains a considerable amount of work to complete before the deadline.
Der er gjort en kraftig indsats for at styrke industriens tillid til den centraliserede procedure.
Significant efforts have been made in meeting the target of increasing industry’ s confidence in the centralised system in the veterinary sector.
Jill Ashley- Smith og hendes stab har da også i årets løb behandlet væsentligt flere ansøgninger end det i arbejdsprogrammet for 1998- 99 anslåede antal.
The efforts of Jill Ashley-Smith and her staff have seen a very significant increase in the number of centralised applications exceeding that forecast in the work programme for 1998-99.
Den øgede bevidsthed om risikoen for at udvikle resistens over for antimikrobielle stoffer som følge af brugen af antibiotika i humanmedicinske lægemidler har CVMP nedsat en ekspertgruppe, som gør gode fremskridt med vurderingen af de potentielle risici, der er forbundet med anvendelsen af disse produkter i veterinærlægemidler – en rapport herom forventes at foreligge i midten af 1999.
Its working group of experts continues to make progress in evaluating the potential risks associated with the use of these products in veterinary medicine – a report is expected to be available by the middle of 1999.
På baggrund af den stigende bekymring over manglende adgang til lægemidler til specielle indikationer for visse arter, navnlig mindre dyrearter, er der nedsat en ad hoc- gruppe af udvalgsmedlemmer, der skal undersøge, hvorledes dette problem kan løses.
In addition the growing concerns about the lack of available medicines for particular indications in certain species, especially minor species, has necessitated the creation of an ad hoc group of committee members to look at new ideas for addressing the problem.
Som led i VICH- initiativet har afdelingen i sin egenskab af europæisk koordinator fortsat deltaget aktivt i arbejdet med at fremme harmoniseringen af tekniske krav til registrering af veterinærlægemidler mellem EU, Japan og USA.
Within the VICH initiative, the Unit in its role of European Coordinator has continued to participate actively in progressing the harmonisation of testing requirements for registration of veterinary medicines amongst the major parties:
Side 39
EU, Japan and USA.
3. 2
3.2.
CVMP´s kerneaktiviteter
Operation of the CVMP
© EMEA 1999
Details of membership are given in Annex 3.
Prof.
Professor Reinhard Kroker was re-elected chairman of the CVMP and Mr Cyril O’ Sullivan was re-elected vice-chairman for the period 1998 to 2000.
2309/ 93, der giver mulighed for, at nye stoffer bestemt for kæledyr såvel som nye stoffer til dyr, der anvendes til levnedsmiddelproduktion, kan gøres til genstand for en fællesskabsgodkendelse.
Authorisations under the centralised procedure Reinhard Kroker A significant development in 1998 has been the change to Part B of the Annex to Council Regulation (EEC) No 2309/ 93 allowing applications to be lodged under the centralised system for new molecules intended to be used for companion (i. e. non-food-producing) animals as well as for food-producing animals.
Som forudset i arbejdsprogrammet for 1998- 99 har dette positive skridt medført en stigning i antallet af ansøgninger efter den centraliserede procedure på veterinærlægemiddelområdet.
As forecast in the 1998-99 work programme this positive step has already contributed to an increase in the number of centralised applications in the veterinary sector.
Industriens øgede tillid til det centraliserede system gav sig udtryk i en stigning i antallet af ansøgninger indgivet til agenturet i 1998.
Industry showed its confidence in the centralised system in 1998 with an increase
Der blev indgivet i alt 14 ansøgninger, hvilket var 55 procent mere end det i arbejdsprogrammet anslåede antal.
A total of 14 applications were made, a 55% rise over the number forecast for this year.
Det skal her bemærkes, at mange af ansøgningerne er indgivet af virksomheder, som tidligere har valgt den centraliserede procedure, hvilket kan tages som udtryk for, at de er tilfredse med EMEA´s og CVMP´s rolle.
It is also worth noting that many of the applications are from companies who have already selected the centralised route for a previous submission and are expressing their satisfaction with the role played by the EMEA and CVMP.
2309/ 93.
applications and optional applications for innovative medicines where the applicant had a choice of procedure under Part B of the Annex to Council Regulation (EEC) No 2309/ 93.