natgillin/translations-raw huggingface dataset:
• 19.09.2001
13. 07. 2001 30. 07. 2001 07. 09. 2001 40 days
• 25.05.2001
Celecoxib
• 25.07.2001
Pharmacia- Pfizer EEIG
• 11.06.2001 • 18.07.2001 • 54 days
Treatment of Familial Adenomatous Polyposis (FAP)
• 17.09.2001
04. 04. 2001 11. 06. 2001 07. 09. 2001 89 days
Deoxyribose phosphorothioate (5’- tct-ccc-agc-gtg-cgc-
Phenylephrine hydrochloride
• Voisin Consulting SARL
S. L. A Pharma (UK) Ltd
• 17.09.2001 • 20.11.2001
17. 09. 2001 20. 11. 2001
Indication
Thalidomide
• Idebenone
Pharmion Ltd
• Treatment of Friedreich’s ataxia
Treatment of multiple myeloma
• 30.07.2001 • 07.09.2001 • 40 days
Treatment of erythema nodosum leprosum (ENL) or type II lepra reactions
• 20.11.2001
13. 07. 2001 30. 07. 2001 07. 09. 2001 40 days
Treatment of Familial Adenomatous Polyposis (FAP)
Treatment of lupus nephritis
• 04.04.2001
25. 05. 2001 11. 06. 2001 07. 09. 2001 89 days
• 11.06.2001 • 07.09.2001 • 89 days
Treatment of multiple myeloma
Phenylephrine hydrochloride
Recombinant human monoclonal antibody to hsp90
• S.L.A Pharma (UK) Ltd
NeuTec Pharma plc
Thalidomide
Apomorphine
• Pharmion Ltd
Orion Corporation
•
11. 06. 2001 07. 09. 2001 89 days
•
05. 12. 2001
Treatment of erythema nodosum leprosum (ENL) or type II lepra
Treatment of severe myoclonic epilepsy in infancy
• 13.07.2001
04. 06. 2001 30. 07. 2001 07. 09. 2001 40 days
reactions
Indikation
• 30.07.2001 • 07.09.2001 • 40 days
EMEA/ COMP Validering Yttrande Aktiv tid Inaktiv tid
• 20.11.2001
PPD Global Ltd
• Abetimus sodium
Treatment of systemic sclerosis
Treatment of lupus nephritis
Denileukin diftitox (Onzar)
• 17.09.2001
Ligand Pharmaceuticals
• 11.06.2001 • 07.09.2001 • 89 days
Treatment of cutaneous T- cell Lymphoma
• 20.11.2001
12. 07. 2001 30. 07. 2001 26. 10. 2001 89 days
Deoxyribose phosphorothioate (5’-
Octovalent Pseudomonas aeruginosa O - polysaccharide- toxin A conjugate vaccine
• Voisin Consulting SARL
Orphan Europe SARL
• 17.09.2001
05. 11. 2001 11. 12. 2001
tct-ccc-agc-gtg-cgc-
Pharm Research Associates (UK) Ltd
• 30.07.2001
Treatment of short bowel syndrome
• 20.11.2001
09. 08. 2001 24. 08. 2001 26. 10. 2001 64 days
Recombinant human monoclonal antibody to hsp90
Iduronate- 2- sulfatase
• NeuTec Pharma plc
TKT UK Ltd
Treatment of off-periods in Parkinson’s disease not
Treatment of multiple myeloma
• 25.05.2001
23. 05. 2001
• 17.09.2001
17. 09. 2001
• 11.06.2001
30. 07. 2001 07. 09. 2001 40 days
• 05.12.2001
19. 12. 2001
treatment
♣
• Stiripentol
♣
• Laboratoires BIOCODEX
Treatment of acute lung injury
Treatment of severe myoclonic epilepsy in infancy
Treatment of diarrhoea associated with intestinal microsporidial infection
• 04.06.2001
29. 05. 2001 20. 09. 2001 21. 11. 2001 63 days
• 17.09.2001
♣
• 30.07.2001 • 07.09.2001 • 40 days
♣
• 05.12.2001
Treatment of acute lymphoblastic leukaemia
Halofuginone hydrobromide
♣
• PPD Global Ltd
♣
• 12.07.2001
28. 08. 2001 20. 09. 2001 21. 11. 2001 62 days
• 05.11.2001
♣
• 30.07.2001 • 26.10.2001 • 89 days
Treatment of high- grade glioma with subsequent use of ganciclovir sodium
• 11.12.2001
04. 09. 2001 20. 09. 2001 21. 11. 2001 62 days
Product INN
♣ Väntar på antagande av Europeiska kommissionens beslut Produkt INN
• Denileukin diftitox (Onzar)
♣
• Ligand Pharmaceuticals
♣
• Treatment of cutaneous T-cell Lymphoma
Treatment of myelodysplastic syndromes
• 05.11.2001 • 11.12.2001
05. 09. 2001 20. 09. 2001 21. 11. 2001 62 days
Octovalent Pseudomonas aeruginosa O- polysaccharide-toxin A conjugate vaccine
Treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis
•
06. 09. 2001 26. 10. 2001 18. 12. 2001 54 days
Orphan Europe SARL
Treatment of Familial Adenomatous Polyposis (FAP).
Prevention of Pseudomonas aeruginosa infections in patients with cystic fibrosis
♣
• 20.07.2001 • 24.08.2001 • 26.10.2001 • 64 days
Treatment of high- grade dysplasia in Barrett’ s Esophagus
• 05.11.2001 • 11.12.2001
11. 10. 2001 26. 10. 2001 18. 12. 2001 54 days
•
Status Sändes ut på remiss i januari 2001
gly2-Recombinant human glucagon-like peptide
CPMP/ BWP/ 2490/ 00
•
Sändes ut på remiss i januari 2001
Pharm Research Associates (UK) Ltd
CPMP/ BWP/ 3088/ 99
•
Antogs i april 2001
Treatment of short bowel syndrome
1
• 09.08.2001 • 24.08.2001 • 26.10.2001 • 64 days
Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products
• Iduronate-2-sulfatase
Antogs av CPMP och CVMP i maj 2001
• TKT UK Ltd
CPMP/ BWP/ 3207/ 00
•
Antogs i september 2001
Treatment of Mucopolysaccharidosis type II
Referensnummer EMEA/ CPMP/ BPWG/ 283/ 00
• 05.09.2001
Status Sändes ut på remiss i mars 2001
• 05.11.2001
Sändes ut på remiss i december 2001
(Hunter Syndrome)
CPMP: arbetsgrupp för läkemedelseffekt
• 20.09.2001 • 26.10.2001 • 37 days
1
• 11.12.2001
Status Antogs i januari 2001
• Thalidomide
Antogs i mars 2001
• Kendle International Ltd
EMEA/ CPMP/ EWP/ 18/ 01
•
Antogs i mars 2001
Treatment of multiple myeloma
1
• 23.05.2001 • 30.07.2001 • 07.09.2001 • 40 days
Note for guidance on clinical investigation of medicinal products for the treatment and prevention of bipolar disorder
Treatment of acute lung injury
1
• 27.03.2001 • 24.08.2001 • 21.11.2001 • 90 days
Note for guidance on evaluation of anticancer medicinal products in man
•
Antogs i maj 2001
Treatment of diarrhoea associated with intestinal
EMEA/ CPMP/ EWP/ 1045/ 01
• 29.05.2001
Antogs i maj 2001
microsporidial infection
EMEA/ CPMP/ EWP/ 967/ 01
• 20.09.2001 • 21.11.2001 • 63 days
Concept paper on the development of a CPMP Note for guidance on the evaluation of medicinal products indicated for thrombolysis in acute myocardial infarction
Treatment of acute lymphoblastic leukaemia
EMEA/ CPMP/ EWP/ 512/ 01
• 09.08.2001
Antogs i maj 2001
• 24.08.2001 • 21.11.2001 • 90 days
EMEA/ CPMP/ EWP/ 788/ 01
•†
Concept paper on the development of a CPMP Note for Guidance on the evaluation of medicinal products for treatment of migraine
Treatment of systemic sclerosis
EMEA/ CPMP/ EWP/ 2330/ 99
• 28.08.2001 • 20.09.2001 • 21.11.2001 • 62 days
Points to consider on application with 1) meta - analyses and 2) one pivotal study
Treatment of high-grade glioma with subsequent use of
Points to consider on clinical investigation of medicinal products for the management of Crohn’ s disease
• 04.09.2001
Antogs i juni 2001
ganciclovir sodium
EMEA/ CPMP/ EWP/ PhVWP / 1417/ 01
• 20.09.2001 • 21.11.2001 • 62 days
Joint PhVWP/ EWP Concept paper on the development of a CPMP Note for Guidance on the use of medicinal products during pregnancy: need for post- marketing data
•
Antogs i juni 2001
Treatment of myelodysplastic syndromes
EMEA/ CPMP/ EWP/ 1343/ 01
• 05.09.2001
Antogs i juli 2001
• 20.09.2001 • 21.11.2001 • 62 days
CPMP/ EWP/ QWP/ 1401/ 98 rev.
•†
1
•† •†
Note for guidance on the investigation of bioavailability and bioequivalence
• Treatment of glioma
Antogs i juli 2001
EMEA Annual Report 2001
EMEA/ CPMP/ EWP/ 561/ 98
EMEA/COMP • Validation • Opinion • Active time • Clock stop
Note for guidance on clinical investigation of medicinal products for the treatment of multiple sclerosis
• 06.09.2001
Antogs i juli 2001
•†
EMEA/ CPMP/ EWP/ 1533/ 01
(including colonisation) in cystic
Concept paper on the development of an addendum on acute cardiac failure to the CPMP Note for Guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure
• 26.10.2001
Antogs i juli 2001
• 18.12.2001 • 54 days
EMEA/ CPMP/ EWP/ 560/ 98
•† •†
Points to consider on Clinical investigation of medicinal products for the treatment of acute stroke
Treatment of Familial Adenomatous Polyposis (FAP)
Note for guidance on co- ordinating investigator signature of clinical study reports
• 09.08.2001
Antogs i oktober 2001
• 26.10.2001 • 18.12.2001 • 54 days
EMEA/ CPMP/ EWP/ 2991/ 01 draft 2
•†
Concept paper on the development of an addendum on the clinical requirements of modified release medicinal products submitted as a line- extension of an existing marketing authorisation to the CPMP Note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation) (CPMP/ EWP/ 280/ 96)
•
Antogs i november 2001
Treatment of high-grade dysplasia in Barrett’s Esophagus
Points to consider on the evaluation of diagnostic agents
• 11.10.2001
Antogs i november 2001
Annex 10 Guidelines and working documents in 2001
EMEA/ CPMP/ EWP/ 1776/ 99 EMEA/ CPMP/ 602/ 95 rev.
Points to consider on missing data
Points to consider on missing data Points to consider on the assessment of anti- HIV medicinal products
Adopted November 2001
Antogs i november 2001 Antogs i november 2001
CPMP/EWP/1776/99 draft 5
CPMP/ EWP/ 1776/ 99 draft 5 CPMP/ EWP/ 908/ 99
Points to consider on missing data
Points to consider on missing data Points to consider on multiplicity issues in clinical trials
Released for consultation January 2001
Sändes ut på remiss i januari 2001 Sändes ut på remiss i juli 2001
Released for consultation December 2001
Sändes ut på remiss i december 2001
Released for consultation May 2001
Sändes ut på remiss i maj 2001
Released for consultation April 2001
Sändes ut på remiss i april 2001
Released for consultation July 2001
Sändes ut på remiss i juli 2001
Released for consultation November 2001
Sändes ut på remiss i november 2001
Released for consultation November 2001 EMEA Annual Report 2001 63
Sändes ut på remiss i november 2001
CPMP Pharmacovigilance Working Party
CPMP: s arbetsgrupp för biverkningsbevakning
CPMP/PhVWP/1618/01
Referensnummer CPMP/ PhVWP/ 1618/ 01
Position paper on compliance with pharmacovigilance regulatory obligations
Dokumenttitel Position paper on compliance with pharmacovigilance regulatory obligations
Adopted November 2001
Status Antogs i november 2001
CPMP/EWP/PhVWP/1417/01
CPMP/ EWP/ PhVWP/ 1417/ 0 1
Adopted June 2001
Antogs i juni 2001
Published by the European Commission in December 2001 in volume 9 of the 2001 edition of the Rules governing medicinal products in the European Union
Offentliggjordes av Europeiska kommissionen i december 2001 i volym 9 av 2001 års upplaga av Rules governing medicinal products in the European Union
Notice to marketing authorisation holders - pharmacovigilance guidlines
Notice to marketing authorisation holders – pharmacovigilance guidlines
CPMP Safety Working Party
CPMP: s arbetsgrupp för läkemedelssäkerhet
CPMP/SWP/2145/00
Referensnummer CPMP/ SWP/ 2145/ 00
Update of Note for guidance on non-clinical local tolerance testing of medicinal products
Dokumenttitel Update of Note for guidance on non- clinical local tolerance testing of medicinal products
Adopted March 2001
Status Antogs i mars 2001
Adopted November 2001
Antogs i november 2001
Released for consultation January 2001
Sändes ut på remiss i januari January 2001
Released for consultation January 2001
Sändes ut på remiss i januari 2001
Released for consultation March 2001
CPMP/ SWP/ 398/ 01 CPMP/ SWP/ 2600/ 01
Points to consider document on the need for reproduction studies in the development of insulin analogues
Note for guidance on photosafety testing Points to consider document on the need for reproduction studies in the development of insulin analogues
Released for consultation September 2001
Sändes ut på remiss i mars 2001 Sändes ut på remiss i september 2001
EMEA Herbal Medicinal Products Working Party
EMEA: s arbetsgrupp för naturläkemedel
Reference number
Referensnummer EMEA/ 18123/ 00
Compilation of general quality questions answered by the Herbal Medicinal Products Working Party
Dokumenttitel Compilation of general quality questions answered by the Herbal Medicinal Products Working Party
Endorsed in March 2001
Status Godkändes i mars 2001
CVMP Efficacy Working Party
CVMP: s arbetsgrupp för läkemedelseffekt
EMEA/CVMP/016/00
Referensnummer EMEA/ CVMP/ 016/ 00
Conduct of bioequivalance studies for veterinary medicinal products
Dokumenttitel Conduct of bioequivalance studies for veterinary medicinal products
Adopted January 2001
Status Antogs i januari 2001
Adopted February 2001
Antogs i februari 2001
Adopted July 2001
Antogs i juli 2001
Adopted December 2001
Antogs i december 2001
Adopted December 2001 EMEA Annual Report 2001
Antogs i december 2001 Sändes ut på remiss i mars 2001
Released for consultation October 2001
Sändes ut på remiss i oktober 2001
CVMP Immunologicals Working Party
CVMP: s arbetsgrupp för immunologiska läkemedel
Field trials with veterinary vaccines
Referensnummer EMEA/ CVMP/ 852/ 99 EMEA/ CVMP/ 743/ 00
Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products
Dokumenttitel Field trials with veterinary vaccines Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products
Adopted October 2001
Status Antogs i oktober 2001 Antogs i oktober 2001
Released for consultation February 2001
Sändes ut på remiss i februari 2001
CVMP/VICH/095/01
CVMP/ VICH/ 095/ 01 CVMP/ VICH/ 096/ 01
Testing of residual formaldehyde
Testing of residual formaldehyde Biologicals:
Released for consultation July 2001
Sändes ut på remiss i februari 2001 Sändes ut på remiss i juli 2001
CVMP Pharmacovigilance Working Party
CVMP: s arbetsgrupp för biverkningsbevakning
CVMP/VICH/646/01
Referensnummer CVMP/ VICH/ 646/ 01
Pharmacovigilance of veterinary medicinal products:
Dokumenttitel Pharmacovigilance of veterinary medicinal products:
Released for consultation July 2001
Status Sändes ut på remiss i juli 2001
CVMP Safety Working Party
CVMP: arbetsgrupp för läkemedelssäkerhet
EMEA/CVMP/187/00
Referensnummer EMEA/ CVMP/ 187/ 00
Risk analysis approach for residues of veterinary medicinal products in food of animal origin
Dokumenttitel Risk analysis approach for residues of veterinary medicinal products in food of animal origin
CVMP/VICH/525/00
CVMP/ VICH/ 525/ 00
Joint CPMP/CVMP Quality Working Party
CPMP: s och CVMP: s gemensamma arbetsgrupp för kvalitetsfrågor
EMEA/CVMP/598/99
Referensnummer EMEA/ CVMP/ 598/ 99 EMEA/ CVMP/ 271/ 01
Process validation
Dokumenttitel Process validation Limitations to the use of ethylene oxide in the manufacture of medicinal products
Adopted February 2001
Status Antogs i februari 2001 Antogs i april
Adopted
Antogs i maj 2001 Antogs i juli 2001 Antogs i juli 2001
Released for consultation February 2001
EMEA/ CVMP/ 115/ 01 EMEA/ CVMP/ 115/ 01 EMEA/ CVMP/ 424/ 01
In-use stability testing of veterinary medicinal products
Quality of water for pharmaceutical use Quality of water for pharmaceutical use In- use stability testing of veterinary medicinal products
Released for consultation May 2001
Antogs i november 2001 Sändes ut på remiss i februari 2001 Sändes ut på remiss i maj 2001
Committee for Orphan Medicinal Products
Kommittén för särläkemedel
Reference number
Referensnummer EMEA/ 14220/ 00
Procedure for orphan medicinal product designation - general principles
Dokumenttitel Procedure for orphan medicinal product designation – general principles
Revised January 2001
Status Reviderad i januari 2001
Finalised February 2001
Klar i februari 2001
Released for consultation September 2001
Sändes ut på remiss i september 2001
Annex 11 EMEA contact points
Bilaga 11 EMEA: s kontaktpunkter
Pharmacovigilance and product defect reporting
Biverkningar och produktdefekter
The constant monitoring of the safety of medicines after authorisation (‘pharmacovigilance’) is an important part of the work of the national competent authorities and EMEA.
Den löpande övervakningen av läkemedels säkerhet efter det att de godkänts för försäljning (” biverk - ningsbevakning ”) är en viktig del av det arbete som utförs av de behöriga nationella myndigheterna och EMEA.
The EMEA receives safety reports from within the EU and outside concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
EMEA får in säkerhetsrapporter från EU- länderna och andra länder om centralt godkända läkemedel och samordnar den verksamhet som rör läkemedels säkerhet och kvalitet.
For matters relating to pharmacovigilance for medicinal products for human use:
Frågor rörande biverkningsbevakning avseende humanläkemedel
Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel.wathion@emea.eu.int
Noël WATHION Tfn direkt (44- 20) 74 18 85 92 E- post: noel. wathion@ emea. eu. int
For matters relating to pharmacovigilance for medicinal products for veterinary use:
Frågor rörande biverkningsbevakning avseende veterinärmedicinska läkemedel
Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara.freischem@emea.eu.int For product defect and other quality-related matters:
Barbara FREISCHEM Tfn direkt (44- 20) 74 18 85 81 E- post: barbara. freischem@ emea. eu. int
Amanda BOSWORTH
Produktdefekter och andra kvalitetsfrågor
Francisco PEÑARANDA FERNANDEZ Fax number for defective product rapid alerts:
Francisco PEÑARANDA FERNANDEZ Faxnummer för snabblarm om defekta produkter:
(44-20) 74 18 85 90 E-mail: francisco.penaranda@emea.eu.int
(44- 20) 74 18 85 90 E- post: francisco. penaranda@ emea. eu. int
Direct telephone (44-20) 74 18 84 08 E-mail: amanda.bosworth@emea.eu.int European experts lists
Jonna SUNELL- HUET Tfn direkt (44- 20) 74 18 84 65 E- post: certificate@ emea. eu. int
The list of European experts is available for examination on
Dokumentservice
Certificates of a medicinal product The EMEA issues certificates of a medicinal product in
EMEA har nu publicerat ett stort antal dokument, bl. a. pressmeddelanden, allmän information, årsrapporter och arbetsprogram.
request at the EMEA offices.
Distribution sker elektroniskt eller i pappersform.
Requests may be made either in writing to the EMEA or sent to the following e-mail addresses:
Mer information kan erhållas från adressen ovan eller från
conformity with the arrangements laid down by the World Health Organisation.
Iro MAVROPOULOS Tfn direkt (44- 20) 74 18 85 82 E- post: subscriptions@ emea. eu. int
These certify the marketing authorisation and good manufacturing status of medicinal products in the EU
Informationspaket kan rekvireras från
Human medicines’ experts list: human_experts@emea.eu.int Veterinary medicines’ experts list: vet_experts@emea.eu.int
Amanda BOSWORTH Tfn direkt (44- 20) 74 18 84 08 E- post: amanda. bosworth@ emea. eu. int
and are intended for use in support of marketing authorisation applications in and export to non-EU countries.
Förteckningarna över europeiska experter kan på begäran studeras vid EMEA: s kontor.
Inspectors’ experts list: inspectors_experts@emea.eu.int
human_ experts@ emea. eu. int
For enquiries concerning certificates for centrally authorised medicines for human or veterinary use
Experter - veterinärmedicinska läkemedel
Press officer
Experter - inspektioner
Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65 E-mail: certificate@emea.eu.int
inspectors_ experts@ emea. eu. int
Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin.harvey@emea.eu.int
Martin HARVEY Tfn direkt (44- 20) 74 18 84 27 E- post: martin. harvey@ emea. eu. int
The European Agency for the Evaluation of Medicinal Products
Europeiska läkemedelsmyndigheten
Eighth Annual Report 2002
Åttonde allmänna rapporten 2002
(44-20) 74 18 84 00 Fax:
Antagen av styrelsen den 19 december 2002 The European Agency for the Evaluation of Medicinal Products
ISBN 92-9155-036-1
EMEA/ MB/ 055/ 02/ sv/ Final
EMEA Annual Report 2002
Åttonde allmänna rapporten om verksamheten vid Europeiska läkemedelsmyndigheten 2002
Foreword by the Chairman of the Management Board Introduction by the Executive Director
Antagen av styrelsen den 19 december 2002
Chapter 4 Inspections 4.1 Coordination of inspections for centralised
7 Westferry Circus, Canary Wharf, London, E14 4HB, Förenade kungariket Tfn (44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- post: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2003 Reproduction and/ or distribution of this document is authorised for non- commercial purposes only provided the EMEA is acknowledged Innehåll
procedures 4.2 Implementation of the clinical trials directive
FÖRORD AV STYRELSENS ORDFÖRANDE.................................................................................................................
1.3 Review of the European marketing authorisation
INLEDNING AV VERKSTÄLLANDE DIREKTÖREN......................................................................................................
Revision of EMEA fees Transparency Interested parties International partners Quality management
EMEA: S STRUKTUR................................................................................................................................................
5.1 Implementation of the EU telematics strategy 5.2 Project management 5.3 Meeting management and conferences 5.4 Document management and publishing
KAPITEL 1 EMEA: S ROLL I DET EUROPEISKA SYSTEMET.......................................................................................
37
1. 1 1. 2
1.10 Financial control
Styrelsen Nationella behöriga myndigheter
9
9 9
Personnel and budget Infrastructure services
1. 3 1. 4 1. 5 1. 6 1. 7 1. 8 1. 9
Chapter 2 Medicines for Human Use 2.1 Initial evaluation
Översyn av det europeiska systemet för beviljande av godkännanden för försäljning Översynen av EMEA: s avgifter Öppenhet Berörda parter Internationella partner Kvalitetsstyrning Europarådets avdelning för läkemedelskvalitet (EDQM)
10 11
10 10 11 11 12 13 13
Accounting
1. 10 Ekonomistyrning
38
14
Post-authorisation activities Pharmacovigilance and maintenance activities Scientific advice and protocol assistance
KAPITEL 2 HUMANLÄKEMEDEL...........................................................................................................................
13 14 15
15
2.6
2. 1
Parallel distribution
Initial utvärdering
3 Members of the Committee for Veterinary Medicinal Products
35
43
3. 1 3. 2 3. 3 3. 4 3. 5 3. 6 3. 7 3. 8
2.7
Initial utvärdering Fastställande av högsta tillåtna restmängder för gamla substanser Verksamheter efter godkännande för försäljning Biverkningsbevakning och uppföljning Vetenskaplig rådgivning Skiljedomsärenden och hänskjutna gemenskapsärenden Arbetsgrupper och ad hoc- grupper Gruppen för underlättande av ömsesidigt erkännande av veterinärmedicinska läkemedel
Orphan medicinal products
37 38 40 41 42 42 42 44
18
EMEA 2003 Sida 2/ 88
4 Members of the Committee for Orphan
KAPITEL 4.............................................................................................................................................................
20
45
Medicinal Products
INSPEKTIONER.......................................................................................................................................................
2.10 Mutual recognition facilitation group
4. 1 4. 2 4. 3 4. 4 4. 5
22
Samordning av inspektioner inom det centraliserade förfarandet Genomförandet av direktivet om kliniska prövningar Avtal om ömsesidigt erkännande Läkemedelscertifikat Provtagning och provning
Chapter 3 Veterinary Medicines 3.1 Initial evaluation
46 47 48 49 49
24 25
50
6 7 8
5. 1 5. 2 5. 3 5. 4
EMEA budget summaries 2001-2003 CPMP opinions in 2002 on medicinal products for human use CVMP opinions in 2002 on medicinal products
Genomförandet av EU: s telematikstrategi Projektledning Möten och konferenser Hantering och publicering av dokument
49 50
50 51 52 53
3.2 Establishment of maximum residue limits for old substances
KAPITEL 6 ADMINISTRATION...............................................................................................................................
26
54
9
6. 1 6. 2 6. 3
for veterinary use COMP opinions in 2002 on designation of
Personal och budget Infrastrukturtjänster Redovisning
54
54 55 56
27
BILAGOR...............................................................................................................................................................