natgillin/translations-raw huggingface dataset:
EMEA/ CPMP/ BPWG/ 198/ 95 rev.
EMEA/CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/198/95 rev.
Note for guidance on the Clinical investigation of human plasma derived factor VIII and IX products
Core SPC for Human albumin Adopted October 2000 Note for guidance on the Clinical investigation of human plasma derived factor VIII and IX products Released for consultation June 2000
EMEA/ CPMP/ BPWG/ 1561/ 99
EMEA/ CPMP/ BPWG/1561/99
Ssendt til høring i juni 2000
Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Released for consultation June 2000
EMEA/ CPMP/ PhvWP/ BPWG / 2231/ 99
EMEA/ CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
Core SPC for Human albumin
Core SPC for Human albumin Released for consultation June 2000 Note for Guidance on the Clinical investigation of plasma derived antithrombin products Released for consultation December 2000
EMEA/ CPMP/ BPWG/ 2220/ 99
EMEA/ CPMP/BPWG/3226/99
Sendt til høring i december 2000
Core SPC for Human plasma derived antithrombin Released for consultation December 2000
Core SPC for Human plasma derived antithrombin
CPMP Efficacy Working Party Reference number
Sendt til høring i december 2000
Guidelines/Status
Referencenummer EMEA/ CPMP/ EWP/ 519/ 98
EMEA/ CPMP/ EWP/519/98
Status Vedtaget i februar 2000
Note for Guidance on clinical investigation of steroid contraceptives in woman Adopted February 2000
EMEA/ CPMP/ EWP/ 197/ 99
EMEA/ CPMP/ EWP/197/99
Vedtaget i februar 2000
Points to consider concerning Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells Adopted February 2000
EMEA/ CPMP/ EWP/ 570/ 98
EMEA/ CPMP/ EWP/570/98
Vedtaget i februar 2000
Points to consider on the clinical investigation of new medicinal products for treatment of acute coronary syndrome (ACS) without persistent ST-segment elevation Adopted February 2000
EMEA/ CPMP/ EWP/ 2922/ 99
EMEA/ CPMP/ EWP/2922/99
Vedtaget i februar 2000
Concept paper on the development of a CPMP Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma Adopted February 2000
EMEA/ CPMP/ EWP/ 2863/ 99
EMEA/ CPMP/ EWP/2863/99
Vedtaget i februar 2000
Concept paper on the development of a CPMP Points to Consider on biostatistical/methodological issues arising from CPMP discussions on licensing applications: adjustment for baseline covariates Adopted February 2000
EMEA/ CPMP/ EWP/ 707/ 98
EMEA/ CPMP/ EWP/707/98
Vedtaget i juni 2000
Points to consider on Clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk Adopted June 2000
EMEA/ CPMP/ EWP/ 612/ 00
EMEA/ CPMP/ EWP/612/00
Vedtaget i juni 2000
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adopted June 2000
EMEA/ CPMP/ EWP/ 2655/ 99
EMEA/ CPMP/ EWP/2655/99
Vedtaget i juli 2000
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Adopted July 2000
EMEA/ CPMP/ EWP/ 482/ 99
EMEA/ CPMP/ EWP/482/99
Vedtaget i juli 2000
Points to consider on switching between superiority and non-inferiority Adopted July 2000
EMEA/ CPMP/ EWP/ 1080/ 00
EMEA/ CPMP/ EWP/1080/00
Vedtaget i juli 2000
Concept paper on the Development of a CPMP Note for Guidance on Clinical investigation of medicinal products in the treatment of diabetes mellitus Adopted July 2000
EMEA/ CPMP/ EWP/ 565/ 98
EMEA/ CPMP/ EWP/565/98
Vedtaget i oktober 2000
Points to consider on Clinical investigation of medicinal products for treatment of Amyotrophic Lateral Sclerosis (ALS) Adopted October 2000
EMEA/ CPMP/ EWP/ 785/ 97
EMEA/CPMP/EWP/785/97
Vedtaget i november 2000
Concept paper on the Evaluation of drugs for the treatment of the irritable bowel syndrome Adopted November 2000
EMEA/ CPMP/ EWP/ 566/ 98 rev.
EMEA/CPMP/EWP/566/98 rev.
1 EMEA/ MB/ 050/ 00
1
Vedtaget i november 2000
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders Adopted in November 2000
Årsberetning 2000
Points to consider on Clinical investigation of medicinal products for the management of Crohn's disease Released for consultation July 2000
Sendt til høring i juli 2000
85 EMEA General Report 2000
EMEA/ CPMP/ EPW/ 205/ 95 rev.
EMEA/CPMP/EPW/205/95 rev.
Note for Guidance on Evaluation of anticancer medicinal products in man
Note for Guidance on Evaluation of anticancer medicinal products in man Released for consultation July 2000 and extended in September 2000 for a further 2 months
EMEA/ CPMP/ EWP/ 560/ 98
EMEA/ CPMP/ EWP/560/98
Sendt til høring i oktober 2000
Points to consider on Clinical investigation of medicinal products in the treatment of acute stroke Released for consultation October 2000
EMEA/ CPMP/ EWP/ 2330/ 99
EMEA/ CPMP/ EWP/2330/99
Sendt til høring i oktober 2000
Points to consider on Validity and interpretation of meta-analyses, and one pivotal study Released for consultation October 2000
EMEA/ CPMP/ EWP/ 1119/ 98
EMEA/ CPMP/ EWP/1119/98
Sendt til høring i november 2000
Points to consider on the Evaluation of diagnostic agents Released for consultation November 2000
EMEA/ CPMP/ EWP/ 714/ 98
EMEA/ CPMP/ EWP/714/98
Sendt til høring i november 2000
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Released for consultation November 2000
EMEA/ CPMP/ EWP/ QWP / 1401/ 98
EMEA/ CPMP/EWP/QWP/ 1401/98
Sendt til høring i december 2000
Note for Guidance on the investigation of bioavailability and bioequivalence Released for consultation December 2000
EMEA/ CPMP/ EWP/ 2747/ 00
EMEA/CPMP/EWP/2747/00
Sendt til høring i december 2000
Note for Guidance on co-ordinating investigator signature of clinical study reports Released for consultation December 2000
CPMP- arbejdsgruppe vedrørende lægemiddelovervågning
CPMP Pharmacovigilance Working Party
Referencenummer EMEA/ CPMP/ PhVWP/ 2058/ 99
EMEA/CPMP/PhVWP/2058/99
Guidelines Joint Pilot Plan for the implementation of the electronic transmission of individual case safety reports between the EMEA, national competent authorities, and the Pharmaceutical Industry
Joint Pilot Plan for the implementation of the electronic transmission of individual case safety reports between the EMEA, national competent authorities, and the Pharmaceutical Industry Released for consultation May 2000
Status Sendt til høring i maj 2000
CPMP Safety Working Party
CPMP- arbejdsgruppe vedrørende sikkerhed
Guidelines/Status
Referencenummer EMEA/ CPMP/ SWP/ 2775/ 99
EMEA/ CPMP/ SWP/2775/99
Status Vedtaget i april 2000
CPMP Position paper on Selective Serotonin Uptake Inhibitors (SSRIs) and dependency/withdrawal reactions Adopted April 2000
EMEA/ CPMP/ SWP/ 1042/ 99
EMEA/ CPMP/ SWP/1042/99
Vedtaget i juli 2000
Note for Guidance on Repeated dose toxicity Adopted July 2000
EMEA/ CPMP/ SWP/ 2278/ 00
EMEA/ CPMP/ SWP/2278/00
Vedtaget i december 2000
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Adopted December 2000
EMEA/ CPMP/ SWP/ 4163/ 00
EMEA /CPMP/SWP/4163/00
Vedtaget i december 2000
Concept paper on the Development of a CPMP Points to consider on the need for reproduction toxicity studies in the development of human insulin analogues Adopted December 2000
EMEA/ CPMP/ SWP/ 2145/ 00 Draft 4
EMEA/CPMP/SWP/2145/00 Draft 4
Sendt til høring i september 2000
Note for Guidance on Non-clinical local tolerance testing of medicinal products Released for consultation September 2000
Guidelines Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species
EMEA Herbal Medicinal Products Working Party
Status Vedtaget af arbejdsgruppen i oktober 2000
Reference number
CPMP/ QWP/ 2819/ 00
Guidelines/Status
Note for guidance on quality of herbal medicinal products
EMEA/HMPWP/23/00
Sendt til høring i november 2000
Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species Adopted by the Working Party in October 2000
Sendt til høring i november 2000
CPMP/QWP/2819/00
Årsberetning 2000
Note for guidance on quality of herbal medicinal products Released for consultation November 2000
Side 90/ 93
CPMP/QWP/2820/00
herbal drugs, herbal drug preparations and herbal medicinal products
Note for guidance on specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products Released for consultation November 2000
EMEA/ MB/ 050/ 00 Årsberetning 2000 CVMP- arbejdsgruppe vedrørende virkninger
86 EMEA General Report 2000
Referencenummer Guidelines EMEA/ CVMP/ 133/ 99 Conduct of pharmacokinetic studies in animals
CVMP Efficacy Working Party Reference number EMEA/ CVMP/133/99
Status Vedtaget i marts 2000
Guidelines/Status Conduct of pharmacokinetic studies in animals Adopted March 2000
EMEA/ CVMP/ 344/ 99 Conduct of efficacy studies for intramammary products for use in cattle
EMEA/ CVMP/344/99
Vedtaget i marts 2000
Conduct of efficacy studies for intramammary products for use in cattle Adopted March 2000
EMEA/ CVMP/ 005/ 00
EMEA/ CVMP/005/00
Vedtaget i november 2000
Testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in cats and dogs Adopted November 2000
EMEA/ CVMP/ 016/ 00
EMEA/CVMP/016/00
Sendt til høring i januar 2000
The conduct of bioequivalence studies for veterinary medicinal products Released for consultation January 2000
CVMP/ VICH/ 546/ 00
CVMP/VICH/546/00
Efficacy of anthelmintics:
Efficacy of anthelmintics:
Sendt til høring i juli 2000
Specific recommendations for poultry Released for consultation July 2000
CVMP/ VICH/ 545/ 00
CVMP/VICH/545/00
Sendt til høring i juli 2000
Specific recommendations for feline Released for consultation July 2000
CVMP- arbejdsgruppe vedrørende immunologiske veterinærlægemidler
CVMP Immunologicals Working Party Reference number CVMP/IWP/52/97
Status Vedtaget i marts 2000
Guidelines/Status Requirements for combined veterinary vaccines Adopted March 2000
CVMP/ IWP/ 07/ 98
CVMP/IWP/07/98
Vedtaget i marts 2000
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use Adopted March 2000
EMEA/ CVMP/ 682/ 99
EMEA/ CVMP/682/99
Duration of protection achieved by veterinary vaccines
Duration of protection achieved by veterinary vaccines Adopted October 2000
Vedtaget i oktober 2000
Field trials with veterinary vaccines Released for consultation March 2000
EMEA/ CVMP/ 852/ 99 EMEA/ CVMP/ 743/ 00
EMEA/CVMP/743/00
Field trials with veterinary vaccines Requirements and controls applied to bovine serum (foetal or calf) used in the protection of immunological veterinary medicinal products
Requirements and controls applied to bovine serum (foetal or calf) used in the protection of immunological veterinary medicinal products Released for consultation October 2000
CVMP- arbejdsgruppe vedrørende lægemiddelovervågning
CVMP Pharmacovigilance Working Party
Referencenummer EMEA/ CVMP/ 044/ 99
Reference number EMEA/ CVMP/044/99
Guidelines Conduct of post- marketing surveillance studies of veterinary medicinal products
Guidelines/Status Conduct of post-marketing surveillance studies of veterinary medicinal products Adopted April 2000
Status Vedtaget i april 2000
Management of adverse event reports (AERs) Released for consultation July 2000
CVMP/ VICH/ 547/ 00
CVMP Safety Working Party
Management of adverse event reports (AERs)
linesStatus number
Sendt til høring i juli 2000
Reference
CVMP- arbejdsgruppe vedrørerende sikkerhed
Guidelines/Status
Referencenummer EMEA/ CVMP/ 276/ 99
EMEA/ CVMP/276/99
Status Vedtaget i marts 2000
Assessment of the effect of antimicrobial substances on dairy starter cultures Adopted March 2000
EMEA/ CVMP/ 473/ 98
EMEA/ CVMP/473/98
Vedtaget i marts 2000
Determination of withdrawal periods for milk Adopted March 2000
CVMP/ VICH/ 592/ 98
CVMP/ VICH/592/98
Environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1
Environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1 Adopted July 2000
Vedtaget i juli 2000
Risk analysis approach for residues of veterinary medicinal products in food of animal origin Released for consultation May 2000
EMEA/ CVMP/ 187/ 00
CVMP/VICH/526/00
Risk analysis approach for residues of veterinary medicinal products in food of animal origin
Safety studies for veterinary drug residues in human food:
Sendt til høring i maj 2000
Genotoxicity studies Released for consultation July 2000
CVMP/ VICH/ 526/ 00
CVMP/VICH/525/00
Safety studies for veterinary drug residues in human food:
Safety studies for veterinary drug residues in human food:
Sendt til høring i juli 2000
Reproduction studies Released for consultation July 2000
CVMP/ VICH/ 525/ 00
87 EMEA General Report 2000
Safety studies for veterinary drug residues in human food:
Joint CPMP/CVMP Quality Working Party
Sendt til høring i juli 2000
Reference number
Side 92/ 93
Guidelines/Status
Referencenummer Guidelines CPMP/ QWP/ 1676/ 00 Concept Paper on the Development of a CPMP/ CVMP Note for Guidance on Quality of Water for Pharmaceutical Use
CPMP/ QWP/1676/00
Status Vedtaget i juli 2000
Concept Paper on the Development of a CPMP/CVMP Note for Guidance on Quality of Water for Pharmaceutical Use Adopted July 2000
CPMP/ QWP/ 3015/ 99 CPMP/ QWP/ 1719/ 00
CPMP/ QWP/3015/99
Note for Guidance on Parametric Release Note for Guidance on Medicinal Gases – Pharmaceutical Information
Note for Guidance on Parametric Release Released for consultation March 2000
CPMP/ QWP/ 2845/ 00
CPMP/ QWP/1719/00
Sendt til høring i november 2000
Note for Guidance on Medicinal Gases – Pharmaceutical Information Released for consultation July 2000
CPMP/ QWP/ 2820/ 00 (CVMP/ 815/ 00)
CPMP/QWP/2845/00
Sendt til høring i november 2000
Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products Released for consultation November 2000
CPMP/ QWP/ 2819/ 00 (CVMP/ 814/ 00)
CPMP/QWP/2820/00 (CVMP/815/00)
Note for Guidance on Quality of Herbal Medicinal Products
Note for Guidance on Specifications:
Sendt til høring i november 2000
Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products Released for consultation November 2000
EMEA/ CVMP/ 065/ 99
CPMP/QWP/2819/00 (CVMP/814/00) EMEA/ CVMP/065/99
Annex to Guideline:
Note for Guidance on Quality of Herbal Medicinal Products Released for consultation November 2000 Annex to Guideline:
Development pharmaceutics for veterinary medicinal products:
Development pharmaceutics for veterinary medicinal products:
Vedtaget i februar 2000
Decision trees for the selection of sterilisation methods Adopted February 2000
EMEA/ CVMP/ 422/ 99
EMEA/ CVMP/422/99
Declaration of storage conditions for veterinary medicinal products in the product particulars
Declaration of storage conditions for veterinary medicinal products in the product particulars Adopted February 2000
Vedtaget i februar 2000
Stability testing of biotechnological/biological veterinary medicinal products Adopted June 2000
CVMP/ VICH/ 501/ 99
CVMP/ VICH/502/99
Vedtaget i juni 2000
Impurities: residual solvents Adopted June 2000
CVMP/ VICH/ 502/ 99 EMEA/ CVMP/ 198/ 99
EMEA/ CVMP/198/99
Impurities: residual solvents Maximum shelf- life for sterile medicinal products after first opening or following reconstitution
Maximum shelf-life for sterile medicinal products after first opening or following reconstitution Adopted July 2000
Vedtaget i juni 2000 Vedtaget i juli 2000
Good clinical practices Adopted July 2000
CVMP/ VICH/ 595/ 98 EMEA/ CVMP/ 846/ 99
EMEA/CVMP/846/99
Good clinical practices Stability testing of existing active substances and related finished products
Stability testing of existing active substances and related finished products Adopted November 2000
EMEA/ CVMP/ 816/ 00
EMEA/CVMP/816/00
Sendt til høring i november 2000
Statistical principles for veterinary clinical trials Released for consultation November 2000
Ad hoc- arbejdsgrupper af
Ad hoc GMP Inspectors Working Group
GMP- tilsynsførende
Guidelines/Status
Referencenummer ENTR/ III/ 5717/ 99
ENTR/ III/5717/99
Guidelines Revised Version of Annex 14 - Manufacture of medicinal products derived from human blood or plasma to the EU Guide to Good Manufacturing Practice
Revised Version of Annex 14 - Manufacture of medicinal products derived from human blood or plasma to the EU Guide to Good Manufacturing Practice Finalised in February 2000
ENTR/ 6266/ 00
ENTR/6266/00
Færdiggjort i april 2000
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Finalised in April 2000
ENTR/ 6109/ 00
ENTR/6109/00
Draft Annex 6 to EU Guide to Good Manufacturing Practice on Medicinal Gases
Draft Annex 6 to EU Guide to Good Manufacturing Practice on Medicinal Gases Released for consultation March 2000
ENTR/ 6270/ 00
ENTR/6270/00
Draft Annex 17 to EU Guide to Good Manufacturing Practice on Parametric Release
Draft Annex 17 to EU Guide to Good Manufacturing Practice on Parametric Release Released for consultation April 2000
Side 93/ 93
88
Det Europæiske Agentur for Lægemiddelvurdering
The European Agency for the Evaluation of Medicinal Products
Syvende Årsberetning 2001
Seventh Annual Report 2001
Vedtaget af bestyrelsen den 18. december 2001 The annual report for 2001 is presented to the Management Board by the Executive Director in accordance with Article 55( 3) of Council Regulation (EEC) No 2309/ 93.
Adopted by the Management Board on 18 December 2001 The annual report for 2001 is presented to the Management Board by the Executive Director in accordance with Article 55(3) of Council Regulation (EEC) No 2309/ 93.
It is forwarded to the European Parliament, Council, Commission and Member States.
It is forwarded to the European Parliament, Council, Commission and Member States.
It is available on request in all the official EU languages.
It is available on request in all the official EU languages.
Previous annual reports and other reference documents are available from the EMEA web site at http: // www. emea. eu. int
Previous annual reports and other reference documents are available from the EMEA web site at http: / /www. emea. eu. int
This report covers activities of the EMEA in 2001.
This report covers activities of the EMEA in 2001.
Chapter 1 sets out the activities of the Management Board.
Chapter 1 sets out the activities of the Management Board.
It also covers the Agency’ s partnership with national competent authorities and European institutions, and other general aspects of the EMEA, including transparency and international activities.
It also covers the Agency’ s partnership with national competent authorities and European institutions, and other general aspects of the EMEA, including transparency and international activities.
The operational and technical work of the EMEA in 2001 is reported in Chapter 2 on human medicines, Chapter 3 on veterinary medicines and Chapter 4 on inspection activities.
The operational and technical work of the EMEA in 2001 is reported in Chapter 2 on human medicines, Chapter 3 on veterinary medicines and Chapter 4 on inspection activities.
Administration and other support activities are described in Chapter 5.
Administration and other support activities are described in Chapter 5.
The Report, in accordance with Article 15c( 1) of Council Directive 75/ 319/ EEC and Article 23c( 1) of Council Directive 81/ 851/ EEC, also summarises the operation of the decentralised (mutual recognition) procedure during 2001.
The Report, in accordance with Article 15c(1) of Council Directive 75/ 319/ EEC and Article 23c(1) of Council Directive 81/ 851/ EEC, also summarises the operation of the decentralised (mutual recognition) procedure during 2001.
New e- mail addresses for the EMEA staff members were introduced with effect from 1 November 2001 with the introduction of the ‘ emea. eu. int ’ domain for e - mail:
New e-mail addresses for the EMEA staff members were introduced with effect from 1 November 2001 with the introduction of the ‘ emea. eu. int ’ domain for e- mail:
firstname. familyname@ emea. eudra. org becomes: firstname. familyname@ emea. eu. int
firstname. familyname@emea. eudra. org becomes: firstname. familyname@emea. eu. int
The general e- mail address for the EMEA becomes mail@ emea. eu. int and other functional e- mail addresses will change in the same way, e. g. certificate@ emea. eu. int
The general e-mail address for the EMEA becomes mail@emea. eu. int and other functional e-mail addresses will change in the same way, e. g. certificate@emea. eu. int
The ‘ emea. eudra. org ’ e- mail address format will continue to be recognised until 1 October 2002.
The ‘ emea. eudra. org’ e-mail address format will continue to be recognised until 1 October 2002.
This change of domain follows on from the change of the Agency’ s web site to www. emea. eu. int at the beginning of 2001 and is part of the alignment of the EMEA with other European Union institutions and bodies.
This change of domain follows on from the change of the Agency’ s web site to www. emea. eu. int at the beginning of 2001 and is part of the alignment of the EMEA with other European Union institutions and bodies.
The European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom Tel:
The European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom Tel:
(44- 20) 74 18 84 00 Fax:
(44-20) 74 18 84 00 Fax:
(44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int Internet: http: // www. emea. eu. int
(44-20) 74 18 84 16 E-mail: mail@emea. eu. int Internet: http: / /www. emea. eu. int
A great deal of additional information on the European Union is available on the Internet.
A great deal of additional information on the European Union is available on the Internet.
It can be accessed through the Europa server (http: // europa. eu. int)
It can be accessed through the Europa server (http: / /europa. eu. int)
© EMEA 2002
© EMEA 2002
Designed and printed in England by The Colour Works Printing Co.
Designed and printed in England by The Colour Works Printing Co.
The European Agency for the Evaluation of Medicinal Products
Foreword by the Chairman of the Management Board
EMEA/ MB/ 052/ 01- DA
3
SYVENDE ÅRSBERETNING OM AKTIVITETERNE I DET DET EUROPÆISKE AGENTUR FOR LÆGEMIDDELVURDERING
Chapter 3 Veterinary Medicines 3.1 Initial evaluation
2001
23 24
Vedtaget af bestyrelsen den 18. december 2001
Introduction by the Executive Director
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
3.2 Establishment of maximum residue limits for old substances
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int Indholdsfortegnelse FORORD VED BESTYRELSESFORMANDEN INDLEDNING VED DEN ADMINISTRERENDE DIREKTØR EMEA' S STRUKTUR
Structure of the EMEA
5 6 7
5
KAPITEL 1 EMEA I DET EUROPÆISKE SYSTEM 1. 1 Bestyrelsen 1. 2 Kompetente nationale myndigheder 1. 3 Gennemsigtighed og dialog om forskriftsmæssigt grundlag 1. 4 Revision af EMEA' s gebyrer
3.3 Post-authorisation activities 3.4 Pharmacovigilance and maintenance activities
8 8 9 9 9
26 26
1. 5 Revision af det europæiske system for markedsføringstilladelser 1. 6 Kvalitetsstyring 1. 7 Internationale partnere 1. 8 Det Europæiske Direktorat for Lægemiddelkvalitet 1. 9 Finanskontrol
Chapter 1 EMEA in the European System
10 10 11 12 12
Scientific advice
KAPITEL 2 HUMANMEDICINSKE LÆGEMIDLER 2. 1 Indledende evaluering 2. 2 Aktiviteter efter godkendelse 2. 3 Lægemiddelovervågning og ajourføringsaktiviteter 2. 4 Videnskabelig rådgivning 2. 5 Voldgifter og henvisninger af sager til Fællesskabet 2. 6 Særlige tjenester 2. 7 Internationale aktiviteter 2. 8 Lægemidler til sjældne sygdomme 2. 9 Arbejdsgrupper og ad hoc- grupper 2. 10 Gruppen for fremme af gensidig anerkendelse
3.8
13 15 17 18 19 21 22 22 23 25 28
International activities