qanastek/EMEA-V3 huggingface dataset:
13.6.2002 30.10.2002 OJ L 297, 31.10.2002
• 13.6.2002 • 30.10.2002 • OJ L 297, 31.10.2002
Omeprazole
• Omeprazole
12.4.2001 12.6.2002 120 days 306 days
• 12.4.2001 • 12.6.2002 • 120 days • 306 days
12.7.2002 30.10.2002 OJ L 297, 31.10.2002
• 12.7.2002 • 30.10.2002 • OJ L 297, 31.10.2002
Tulathromycin
• Tulathromycin
Bovine and swine
• Bovine and swine
9.8.2001 12.6.2002 120 days 187 days
• 9.8.2001 • 12.6.2002 • 120 days • 187 days
11.4.2002 10.7.2002 90 days 0
• 11.4.2002
1.8.2002
• 1.8.2002
Rabbits
• Rabbits
16.8.2002 13.11.2002 86 days 0
• 16.8.2002 • 13.11.2002 • 86 days •0
EMEA-Jahresbericht 2002 EMEA/MB/055/02/de/Endgültig Anhang 9 Gutachten des COMP zur Ausweisung von Arzneimitteln für seltene Leiden 2002
• • •
 EMEA 2003 Seite 76/90
EMEA Annual Report 2002
Positive COMP-Gutachten zur Ausweisung
Positive COMP designation opinions
Zusammenfassung der Anwendungsgebiete
Summary of indication
EMEA/COMP Einreichung Beginn Gutachten
EMEA/COMP • Submission • Start Date • Opinion • Active Time
Europäische Kommission Gutachten erhalten am
European Commission • Opinion received • Date of decision
4-(3,5-Bis(hdroxy-phenyl)-1,2,4) triazol-1-yl) benzoic acid (ICL670)
• 4-(3,5-Bis(hdroxy-phenyl) -1,2,4) triazol-1-yl) benzoic acid (ICL670)
10.10.2001 26.10.2001 23.1.2002 89 days
• 10.10.2001 • 26.10.2001 • 23.1.2002 • 89 days
31.1.2002 13.3.2002
• 31.1.2002 • 13.3.2002
Beclomethasone 17, 21- dipropionate
Beclomethasone 17, 21- dipropionate
Treatment of intestinal Graft- versus-Host Disease
Treatment of intestinal Graft- versus-Host Disease
11.7.2001 26.10.2001 23.1.2002 89 days
• 11.7.2001 • 26.10.2001 • 23.1.2002 • 89 days
14.11.2001 30.11.2001 23.1.2002 54 days
• 30.11.2001 • 23.1.2002 • 54 days
31.1.2002 13.3.2002
• 13.3.2002
GM-CSF receptor antagonist
GM-CSF receptor antagonist
15.11.2001 30.11.2001 23.1.2002 54 days
• 15.11.2001 • 30.11.2001 • 23.1.2002 • 54 days
31.1.2002 18.3.2002
• 31.1.2002 • 18.3.2002
31.1.2002 19.3.2002
• 31.1.2002 • 19.3.2002
3.9.2001 26.10.2001 23.1.2002 89 days
• 23.1.2002 • 89 days
31.1.2002 19.3.2002
•
3.9.2001 26.10.2001 23.1.2002 89 days
• 26.10.2001 • 23.1.2002 • 89 days
31.1.2002 19.3.2002
• 19.3.2002
TGF-ß2-specific phosphorothioate antisense oligodeoxynucleotide (Oncomun)
TGF-ß2-specific phosphorothioate
Treatment of high- grade glioma
• Treatment of high-grade glioma
14.11.2001 30.11.2001 23.1.2002 54 days
• 23.1.2002 • 54 days
31.1.2002 22.3.2002
•
Humanized anti-KSA monoclonal antibody – human interleukin-2-fusion protein (EMD 273066)
Humanized anti-KSA monoclonal antibody -
11.10.2001 26.10.2001 23.1.2002 89 days
• 23.1.2002 • 89 days
11.10.2001 26.10.2001 23.1.2002 89 days
• 11.10.2001 • 26.10.2001 • 23.1.2002 • 89 days
31.1.2002 22.3.2002
• 31.1.2002 • 22.3.2002
Pseudomonas exotoxin (domains II/III)-Interleukin 13 chimeric protein
• Pseudomonas exotoxin (domains II/III)-
16.1.2002 31.1.2002 26.3.2002 54 days
• 16.1.2002
28.3.2002 30.4.2002
• 28.3.2002
EMEA-Jahresbericht 2002 EMEA/MB/055/02/de/Endgültig
Interleukin 13 chimeric
 EMEA 2003 Seite 77/90
• 31.1.2002
INN des Arzneimittels
• 30.4.2002
Investor
protein
Zusammenfassung der Anwendungsgebiete
• 26.3.2002 • 54 days
EMEA/COMP Einreichung Beginn Gutachten Aktive Zeit
•
Bryostatin-1
Bryostatin-1
11.1.2002 31.1.2002 26.3.2002 54 days
• 31.1.2002 • 26.3.2002 • 54 days
28.3.2002 30.4.2002
• 30.4.2002
Recombinant human alpha-1 antitrypsin
Recombinant human alpha-1 antitrypsin
Treatment of emphysema secondary to congenital alpha-1
•
HemeBiotech A/S
• HemeBiotech A/S
12.12.2001 31.1.2002 30.4.2002 89 days
• 12.12.2001 • 31.1.2002 • 30.4.2002 • 89 days
6.5.2002 12.6.2002
• 6.5.2002 • 12.6.2002
15.11.2001 31.1.2002 30.4.2002 89 days
• 31.1.2002 • 30.4.2002 • 89 days
6.5.2002 12.6.2002
• 12.6.2002
14.1.2002 31.2.2002 30.4.2002 89 days
• 31.2.2002 • 30.4.2002 • 89 days
Carbamic acid, [[4-[[3-[[4-[1-(4- hydroxyphenyl)-1-methyl- ethyl]phenoxy]methyl]phenyl]m ethoxy]-phenyl]iminomethyl]-
Carbamic acid, [[4-[[3-[[4- [1-(4-hydroxyphenyl)-1-
07.2.2002 25.2.2002 22.5.2002
• 25.2.2002 • 22.5.2002
30.5.2002 26.6.2002
• 26.6.2002
,ethyl ester (Amelubant)
,ethyl ester (Amelubant)
4.4.2002 22.4.2002 27.6.2002 66 days
• 4.4.2002 • 22.4.2002 • 27.6.2002 • 66 days
3.7.2002 30.7.2002
• 3.7.2002 • 30.7.2002
Antisense NF-?Bp65 Oligonucletide (Kappaproct)
Antisense NF-KBp65 Oligonucletide (Kappaproct)
12.3.2002 25.3.2002 27.6.2002 94 days
• 12.3.2002 • 25.3.2002 • 27.6.2002 • 94 days
5.4.2002 22.4.2002 27.6.2002 66 days
• 5.4.2002 • 22.4.2002 • 27.6.2002 • 66 days
Myristolated-peptidyl- recombinant SCR1-3 of human complement receptor type I
Myristolated-peptidyl- recombinant SCR1-3 of human complement
8.3.2002 25.3.2002 27.6.2002 94 days
• 27.6.2002 • 94 days
3.7.2002 30.7.2002
•
6.3.2002 25.3.2002 27.6.2002 94 days
• 6.3.2002 • 25.3.2002 • 27.6.2002 • 94 days
Benzoic acid, sodium salt (Benzoate)
• Benzoic acid, sodium salt (Benzoate)
Ethicare GmbH
• Ethicare GmbH
Treatment of non- ketotic hyperglycinaemia
• Treatment of non-ketotic hyperglycinaemia
5.4.2002 17.6.2002 17.7.2002 30 days
• 5.4.2002 • 17.6.2002 • 17.7.2002 • 30 days
24.7.2002 11.9.2002
• 24.7.2002 • 11.9.2002
EMEA-Jahresbericht 2002 EMEA/MB/055/02/de/Endgültig
•
 EMEA 2003 Seite 78/90
Doxorubicin iron/carbon magnetically targeted
Zusammenfassung der Anwendungsgebiete
Interface International Consultancy Ltd
Europäische Kommission Gutachten erhalten am Datum der Entscheidung
Treatment of hepatocellular carcinoma
Doxorubicin iron/carbon magnetically targeted microparticles (MTC-DOX for Injection)
• 27.5.2002 • 17.6.2002
Interface International Consultancy Ltd
• 24.7.2002 • 11.9.2002
Treatment of hepatocellular carcinoma
microparticles (MTC- DOX for Injection)
27.5.2002 17.6.2002 17.7.2002 30 days
• 17.7.2002 • 30 days
24.7.2002 11.9.2002
•
Myristolated-peptidyl- recombinant Human CD59
Myristolated-peptidyl- recombinant Human CD59
5.4.2002 22.4.2002 17.7.2002 86 days
• 5.4.2002 • 22.4.2002 • 17.7.2002 • 86 days
AGEPS-EPHP Agence Générale des Équipements et Produits de Santé
AGEPS-EPHP Agence Générale des Équipements et Produits
5.4.2002 17.6.2002 17.7.2002 30 days
• 17.7.2002 • 30 days
24.7.2002 11.9.2002
(-)-17(cyclopropylmethyl)-1,14
(-)-17(cyclopropylmethyl)-1,14 ß-dihydroxy-4,5 alpha-epoxy- 6ß-[N-methyl-trans-3-(3-furyl) acrylamido] morphinan
•
5.4.2002 17.6.2002 01.8.2002
• 17.6.2002
5.8.2002 11.9.2002
• 11.9.2002
31.5.2002 17.6.2002 12.9.2002 87 days
• 17.6.2002 • 12.9.2002 • 87 days
23.9.2002 21.10.2002
• 21.10.2002
6.2.2002 17.6.2002 12.9.2002 87 days
• 6.2.2002 • 17.6.2002 • 12.9.2002 • 87 days
23.9.2002 21.10.2002
• 23.9.2002 • 21.10.2002
Recombinant glycoprotein gp350 of Epstein-Barr Virus (Henogen 350)
Recombinant glycoprotein gp350 of Epstein-Barr Virus (Henogen 350)
Prevention of post- transplantation lympho- proliferative
Prevention of post- transplantation lympho- proliferative disorders
Anti-CD 147 murine monoclonal IgM
Anti-CD 147 murine monoclonal IgM
2.8.2002 19.8.2002 09.10.2002 52 days
• 2.8.2002 • 19.8.2002 • 9.10.2002 • 52 days
16.10.2002 14.11.2002
• 16.10.2002 • 14.11.2002
29.7.2002 19.8.2002 9.10.2002 52 days
• 29.7.2002 • 19.8.2002 • 9.10.2002 • 52 days
16.10.2002 13.11.2002
• 16.10.2002 • 13.11.2002
Iodine 131 radiolabeled anti- nucleohistone H1 chimeric biotinylated monoclonal antibody
Iodine 131 radiolabeled anti-nucleohistone H1 chimeric biotinylated
26.7.2002 19.8.2002 9.10.2002
• 26.7.2002 • 19.8.2002
5-Aminolevulinic acid hydrochloride
• 5-Aminolevulinic acid hydrochloride
Intra-operative photodynamic diagnosis of residual glioma
• Intra-operative photodynamic diagnosis of residual glioma
26.7.2002 19.8.2002 9.10.2002 52 days
• 26.7.2002 • 19.8.2002 • 9.10.2002 • 52 days
Monoclonal antibody to human interleukin-6
Monoclonal antibody to human interleukin-6
Treatment of post- transplantation lymphoproliferative disorders
Treatment of post- transplantation lymphoproliferative disorders
5.9.2002 16.9.2002 15.11.2002 61 days
• 5.9.2002 • 16.9.2002 • 15.11.2002 • 61 days
20.11.2002 18.12.2002
• 20.11.2002 • 18.12.2002
 EMEA 2003 Seite 79/90
Recombinant inhibitor of human plasma
INN des Arzneimittels
•
Investor
Dyax s.a.
Zusammenfassung der Anwendungsgebiete
•
EMEA/COMP Einreichung Beginn Gutachten Aktive Zeit
Treatment of angioedema
Europäische Kommission Gutachten erhalten am Datum der Entscheidung
• 1.8.2002
Dyax s.a.
• 20. 11.2002
1.8.2002 19.8.2002 15.11.2002 89 days
• 19.8.2002 • 15.11.2002 • 89 days
20.11.2002 18.12.2002
• 18.12.2002
27.6.2002 19.8.2002 15.11.2002 89 days
• 15.11.2002 • 89 days
20.11.2002 18.12.2002
•
3,4 diaminopyridine phosphate
3,4 diaminopyridine phosphate
Treatment of Lambert-Eaton myasthenic syndrome
Treatment of Lambert-Eaton myasthenic syndrome
29.8.2002 16.9.2002 15.11.2002 67 days
• 15.11.2002 • 67 days
28.8.2002 16.9.2002 13.12.2002 89 days
• 16.9.2002 • 13.12.2002 • 89 days
G17(9) gastrin-Diphtheria Toxoid Conjugate
G17(9) gastrin- Diphtheria Toxoid Conjugate
27.9.2002 14.10.2002 13.12.2002 61 days
• 27.9.2002 • 14.10.2002 • 13.12.2002 • 61 days
30.8.2002 16.9.2002 13.12.2002
• 30.8.2002
Negative COMP-Gutachten über Ausweisungen
Negative COMP designation opinions
EMEA/COMP Einreichung Beginn Gutachten Aktive Zeit
EMEA/COMP • Submission • Start Date • Opinion • Active Time
Europäische Kommission Gutachten erhalten am Datum der Entscheidung
European Commission • Opinion received • Date of decision
5.9.2001 20.9.2001 22.5.2002 244 days (including appeal)
• 5.9.2001 • 20.9.2001 • 22.5.2002 • 244 days (including appeal)
30.5.2002 26.7.2002
• 30.5.2002 • 26.7.2002
24.5.2002 17.6.2002 12.9.2002 88 days
• 24.5.2002 • 17.6.2002 • 12.9.2002 • 88 days
16.10.2002 18.12.2002
• 16.10.2002 • 18.12.2002
EMEA-Jahresbericht 2002 EMEA/MB/055/02/de/Endgültig Anhang 10 EMEA-Leitlinien und Arbeitsdokumente 2002
Annex 10 Guidelines and working documents in 2002
 EMEA 2003 Seite 80/90
CPMP Biotechnology Working Party
CPMP-Arbeitsgruppe Biotechnologie
Reference number
Dokumentennummer Titel des Dokuments
Document title
Stand
Status
Note for guidance on Cell Culture Inactivated Influenza Vaccines Annex to NfG on Harmonisation of requirements for Influenza Vaccines (CPMP/BWP/214/96)
Note for guidance on Cell Culture Inactivated Influenza Vaccines Annex to NfG on Harmonisation of requirements for Influenza Vaccines (CPMP/BWP/214/96)
Verabschiedet im Januar 2002
Adopted January 2002
EMEA/CPMP/571/02
EMEA /CPMP/571/02
Verabschiedet im Februar 2002
Adopted February 2002
CPMP/BWP/1793/01
CPMP/BWP/6622/02
Zur Stellungnahme freigegeben im April 2002
Adopted April 2002
CPMP/BWP/6622/02
CPMP/BWP/1412/02
Verabschiedet im April 2002
Adopted April 2002
CPMP/BWP/1412/02 CPMP/BWP/1571/02
CPMP/BWP/1571/02
Zur Stellungnahme freigegeben im Mai 2002
Adopted April 2002
CPMP/BWP/852/02
CPMP/BWP/852/02
Committee for Proprietary Medicinal Products (CPMP), Final EU recommendations for the influenza vaccine composition for the season 2002/2003
Committee for Proprietary Medicinal Products (CPMP), Final EU recommendations for the influenza vaccine composition for the season 2002/2003
Verabschiedet im Mai 2002
Adopted May 2002
CPMP/BWP/337/02
CPMP/BWP/337/02
CPMP/BWP/1818/02
CPMP/BWP/1818/02
CPMP Position Statement on Non-Remunerated and Remunerated Donors:
CPMP Position Statement on Non-Remunerated and Remunerated Donors:
Safety and Supply of Plasma- derived Medicinal Products
Safety and Supply of Plasma-derived Medicinal Products
CPMP/BWP/2758/02
EMEA/22314/02 rev.
EMEA/22314/02/Rev 1
1
Position Paper on Re-establishment of Working Seeds and Working Cell Banks using TSE compliant materials
Position Paper on Re-establishment of Working Seeds and Working Cell Banks using TSE compliant materials
Verabschiedet im Oktober 2002
Adopted October 2002
CPMP-Ad-hoc-Arbeitsgruppe Blutprodukte Dokumentennummer CPMP/BPWG/2220/99
CPMP/BPWG/2220/99
Titel des Dokuments Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products
Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products
Stand Verabschiedet im Januar 2002
Adopted January 2002
CPMP/BPWG/3226/99 CPMP/BPWG/283/00
CPMP/BPWG/3226/99
Core SPC for Human Plasma derived Antithrombin Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular use
Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular use
Verabschiedet im Januar 2002 Verabschiedet im Juli 2002
Adopted July 2002
CPMP/BPWG/282/00
CPMP/BPWG/282/00
Verabschiedet im Juli 2002
Adopted July 2002
CPMP-Arbeitsgruppe Wirksamkeit Dokumentennummer (CPMP/EWP/1412/01)
CPMP/EWP/1412/01
Titel des Dokuments Concept paper for the development of the revision of the CPMP Note for Guidance on evaluation of new anti- bacterial medicinal products (CPMP/EWP/558/95) and the CPMP Note for Guidance on the pharmacodynamic section of the SPC for anti-bacterial medicinal products (CPMP/EWP/520/96)
Concept paper for the development of the revision of the CPMP Note for Guidance on evaluation of new anti-bacterial medicinal products (CPMP/EWP/558/95) and the CPMP Note for Guidance on the pharmacodynamic section of the SPC for anti-bacterial medicinal products (CPMP/EWP/520/96)
(CPMP/EWP/226/02)
CPMP/EWP/226/02
Verabschiedet im März 2002
Adopted March 2002
(CPMP/EWP/225/02) EMEA-Jahresbericht 2002
Adopted March 2002
(CPMP/EWP/518/97 rev.
CPMP/EWP/518/97 rev.
(CPMP/EWP/714/98 rev.
CPMP/EWP/714/98 rev.
(CPMP/EWP/1080/00)
CPMP/EWP/1080/00
(CPMP/EWP/968/02)
CPMP/EWP/968/02
(CPMP/EWP/2455/02)
CPMP/EWP/2455/02
Concept paper on the development of a CPMP Points to consider on allergic rhino-conjuctivitis.
Concept paper on the development of a CPMP Points to consider on allergic rhino-conjuctivitis.
(CPMP/EWP/282/02)
CPMP/EWP/282/02
Position paper on the regulatory requirements for the authorisation of low-dose modified release ASA formulations in the secondary prevention of cardiovascular events.
Position paper on the regulatory requirements for the authorisation of low-dose modified release ASA formulations in the secondary prevention of cardiovascular events.
(CPMP/EWP/2454/02)
CPMP/EWP/2454/02
(CPMP/EWP/2339/02)
CPMP/EWP/2339/02
(CPMP/EWP/2459/02)
CPMP/EWP/2459/02
(CPMP/EWP/908/99)
CPMP/EWP/908/99
Verabschiedet im September 2002
Adopted September 2002
(CPMP/EWP/4279/02)
CPMP/EWP/4279/02
Verabschiedet im November 2002
Adopted November 2002
(CPMP/EWP/4280/02)
CPMP/EWP/4280/02
(CPMP/EWP/2922/01)
CPMP/EWP/2922/01
(CPMP/EWP/612/00 rev.
CPMP/EWP/612/00 rev.
1) (CPMP/EWP/4914/02)
1
Note for Guidance on clinical investigation of medicinal products for treatment of nociceptive pain Concept Paper on the Development of a CPMP Note for Guidance on Clinical investigation of medicinal products for the treatment of Generalised Anxiety Disorder
Note for Guidance on clinical investigation of medicinal products for treatment of nociceptive pain
Verabschiedet im November 2002 Verabschiedet im November 2002
Adopted November 2002
(CPMP/EWP/18/01)
CPMP/EWP/4914/02
Note for Guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence
Concept Paper on the Development of a CPMP Note for Guidance on Clinical investigation of medicinal products for the treatment of Generalised Anxiety Disorder
Verabschiedet im Dezember 2002
Adopted November 2002
(CPMP/EWP/967/01)
CPMP/EWP/18/01
Zur Stellungnahme freigegeben im November 2002
Note for Guidance on the clinical investigation of medicinal Adopted December 2002 products for the treatment of urinary incontinence
(CPMP/EWP/633/02)
CPMP/EWP/4151/00
Note for Guidance on the clinical development of medicinal products for the treatment of HIV infection.
Points to consider on the requirements for clinical Release for consultation January 2002 documentation for metered dose inhalers (MDI) EMEA Annual Report 2002 65
Zur Stellungnahme freigegeben im Juli 2002
Reference number
(CPMP/EWP/788/01)
CPMP/EWP/49/01
Zur Stellungnahme freigegeben im September 2002
Released for consultation February 2002
(CPMP/EWP/596/02)
CPMP/EWP/785/97
Zur Stellungnahme freigegeben im September 2002
Released for consultation April 2002
(CPMP/EWP/1343/01 rev.
CPMP/EWP/556/95 rev.
1) (CPMP/EWP/556/95 rev.
1
Points to consider on the evaluation of new anti-fungal agents for invasive fungal infections.
Points to consider on the evaluation of new anti-fungal agents for invasive fungal infections
EMEA-Jahresbericht 2002 EMEA/MB/055/02/de/Endgültig Dokumentennummer Titel des Dokuments
Release for consultation July 2002
(CPMP/EWP/785/97)
CPMP/EWP/633/02
Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome.
Note for Guidance on the clinical development of medicinal products for the treatment of HIV infection
Zur Stellungnahme freigegeben im April 2002
Released for consultation July 2002
(CPMP/EWP/49/01)
CPMP/EWP/788/01
Appendix to the NfG on the Clinical investigation of medicinal products in the treatment of schizophrenia (CPMP/EWP/559/95) – methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia.
Note for Guidance on clinical investigation of medicinal products for the treatment of migraine
Zur Stellungnahme freigegeben im Februar 2002
Released for consultation September 2002
(CPMP/EWP/4151/00)
CPMP/EWP/596/02
Points to consider on the requirements for clinical documentation for metered dose inhalers (MDI)
Note for Guidance on evaluation of anticancer medicinal Released for consultation products in man (CPMP/EWP/205/95 rev.
Zur Konsultation freigegeben im Januar 2002
Points to consider on the clinical development of Released for consultation fibrinolytic medicinal products in the treatment of November 2002 patients with ST segment elevation acute myocardial infarction (STEMI)
CPMP-Arbeitsgruppe Pharmakovigilanz Dokumentennummer CPMP/PhVWP/4838/02
CPMP/PhVWP/4838/02
Titel des Dokuments Concept Paper on Conduct of Pharmacovigilance For Medicines Used by Children
Concept Paper on Conduct of Pharmacovigilance For Medicines Used by Children
Stand Verabschiedet im Oktober 2002
Adopted October 2002
CPMP/1199/02
CPMP/1199/02
Zur Stellungnahme freigegeben im November 2002
Released for consultation November 2002
CPMP/ICH4679/02
CPMP/ICH/4679/02
Übertragung durch CPMP an Interessengruppen bei ICH Stufe 3 im September 2002
Transmission by CPMP to Interested Parties at ICH step 3 in September 2002
CPMP-Arbeitsgruppe Sicherheit Dokumentennummer CPMP/SWP/2600/01
CPMP/SWP/2600/01
Titel des Dokuments Points to consider on the need for assessment of reproductive toxicity of human insulin analogues
Points to consider on the need for assessment of reproductive toxicity of human insulin analogues
Stand Verabschiedet im März 2002
Adopted March 2002
CPMP/SWP/668/02
CPMP/SWP/668/02
Concept paper on the development of a CPMP position paper on the non-clinical safety studies to support low dose clinical screening studies in humans
Concept paper on the development of a CPMP position paper on the non-clinical safety studies to support low dose clinical screening studies in humans
CPMP/SWP/2599/02
CPMP/SWP/398/01
Position Paper on the Non-clinical safety studies to support clinical trials with a single low dose of a compound
Note for Guidance on photosafety testing
Zur Konsultation freigegeben im Juni 2002
Adopted June 2002
CPMP/SWP/2592/02
CPMP/SWP/2592/02
Verabschiedet im Juni 2002
Adopted June 2002
CPMP/SWP/2877/00 rev.
CPMP/SWP/2877/00 rev.
CPMP/3097/02
CPMP/3097/02
Note for Guidance on Comparability of Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance:
Note for Guidance on Comparability of Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance:
Annex on Non-Clinical and Clinical Considerations
Annex on Non-Clinical and Clinical Considerations
Zur Stellungnahme freigegeben im Juli 2002
Released for consultation July 2002
CPMP/SWP/799/95
CPMP/SWP/799/95
Note for Guidance on the Non-Clinical Documentation of Medicinal Products with Well-Established Use
Note for Guidance on the Non-Clinical Documentation of Medicinal Products with Well-Established Use
CPMP/SWP/5199/02
CPMP/SWP/5199/02
Zur Stellungnahme freigegeben im Dezember 2002
Released for consultation December 2002
EMEA-Arbeitsgruppe Pflanzliche Arzneimittel Dokumentennummer EMEA/HMPWP/41/01
EMEA Herbal Medicinal Products Working Party
Titel des Dokuments SOP:
EMEA/HMPWP/41/01
Recording of core data for herbal drugs/herbal drug preparations (*)
Recording of core data for herbal drugs/herbal drug preparations (*)
Stand Im Mai 2002 veröffentlicht
Published May 2002
EMEA/HMPWP/18123/0 0
EMEA/HMPWP/18123/00
Im Mai 2002 veröffentlicht
Published May 2002
EMEA/HMPWP/31/99 Rev 3
3
EMEA/HMPWP/13/00
EMEA/HMPWP/13/00
Proposal for a core-data for Plantaginis psyllium (Psyllium seed) (*)
Proposal for a core-data for Plantaginis psyllium (Psyllium seed) (*)
Zur Konsultation freigegeben Juli 2002
Released for consultation July 2002
EMEA/HMPWP/14/00 EMEA-Jahresbericht 2002
EMEA Annual Report 2002
Proposal for a core-data for Plantaginis ovatae semen
Reference number
Zur Konsultation freigegeben  EMEA 2003
EMEA/ HMPWP/14/00
EMEA/MB/055/02/de/Endgültig Dokumentennummer Titel des Dokuments (Ispaghula seed) (*)
Proposal for a core-data for Plantaginis ovatae semen (Ispaghula seed) (*)
Stand Juli 2002
Released for consultation July 2002
EMEA/HMPWP/15/00
EMEA/HMPWP/15/00
Final draft Proposal for a core-data for Plantaginis ovatae testa (Ispaghula husk) (*)
Final draft Proposal for a core-data for Plantaginis ovatae testa (Ispaghula husk) (*)
EMEA/HMPWP/17/00
EMEA/HMPWP/17/00
Proposal for a core-data for Calendula flos (Calendulae flower) (*)
Proposal for a core-data for Calendula flos (Calendulae flower) (*)
EMEA/HMPWP/18/00
EMEA /HMPWP/18/00
Proposal for a core-data for Passiflora herba (Passion flower) (*)
Proposal for a core-data for Passiflora herba (Passion flower) (*)
EMEA/HMPWP/19/00
EMEA/HMPWP/19/00
Proposal for a core-data for Melissae folium (Melissa leaf) (*)
Proposal for a core-data for Melissae folium (Melissa leaf) (*)
EMEA/HMPWP/20/00
EMEA/HMPWP/20/00
Proposal for a core-data for Lupuli flos (Hop strobile) (*)
Proposal for a core-data for Lupuli flos (Hop strobile) (*)
EMEA/HMPWP/21/00
EMEA/HMPWP/21/00
Proposal for a core-data for Harpagophyti radix (Devil’ s Claw root) (*)
Proposal for a core-data for Harpagophyti radix (Devil's Claw root) (*)
EMEA/HMPWP/1417/02 Proposal for a core-data for Menthae piperitae aetheroleum (Peppermint oil) (*) EMEA/HMPWP/1418/02 Proposal for a core-data for Menthae piperitae folium (Peppermint leaf) (*) EMEA/HMPWP/1416/02 Proposal for a core-data for Urticae folium (Nettle leaf) (*)
Proposal for a core-data for Menthae piperitae aetheroleum (Peppermint oil) (*)
Zur Konsultation freigegeben Dezember 2002 Zur Konsultation freigegeben Dezember 2002 Zur Konsultation freigegeben Dezember 2002
Released for consultation December 2002
Diese Dokumente werden zum Zweck der Transparenz freigegeben und haben keine rechtliche Kraft in Bezug auf die Richtlinie 2001/83/EG.
Proposal for a core-data for Menthae piperitae folium (Peppermint leaf) (*)
Arbeitsgruppe Wissenschaftliche Beratung Dokumentennummer EMEA/H/238/02
Released for consultation December 2002
Titel des Dokuments EMEA guidance for companies requesting protocol assistance regarding scientific issues
Proposal for a core-data for Urticae folium (Nettle leaf) (*)
Stand Veröffentlicht im Februar 2002
Released for consultation December 2002
Prüfgremium für erfundene Namen Dokumentennummer CPMP/328/98, rev.
These documents are released for the purpose of transparency and have no legal force with respect to Directive 2001/83/EC.
3
Status
Titel des Dokuments Guideline on the acceptability of Invented Names For Human Medicinal Products Processed Through The Centralised Procedure
EMEA guidance for companies requesting protocol assistance regarding scientific issues
Stand Verabschiedet im Januar 2002
Published February 2002
CVMP-Arbeitsgruppe Wirksamkeit Dokumentennummer EMEA/CVMP/1166/02
3 68 EMEA Annual Report 2002
Titel des Dokuments Standard statements for the SPC of certain classes/types of veterinary medicinal products
Guideline on the acceptability of Invented Names For Human Medicinal Products Processed Through The Centralised Procedure
Stand Zur Stellungnahme freigegeben im Dezember 2002
Adopted January 2002
Verabschiedet im Dezember 2002
Adopted December 2002
CVMP-Arbeitsgruppe Immunologische Tierarzneimittel Dokumentennummer CVMP/VICH/095/01 CVMP/VICH/096/01 EMEA/CVMP/552/02
Standard statements for the SPC of certain classes/ types of veterinary medicinal products
Titel des Dokuments Biologicals:
CVMP Immunologicals Working Party
EMEA-Jahresbericht 2002 EMEA/MB/055/02/de/Endgültig Dokumentennummer Titel des Dokuments
Adopted May 2002
Stand
CVMP/VICH/463/02
 EMEA 2003 Seite 84/90
EMEA/CVMP/552/02
EMEA/CVMP/550/02
EMEA/CVMP/550/02
Zur Konsultation freigegeben im Juni 2002
Released for consultation June 2002
CVMP/VICH/463/02
EMEA/CVMP/695/01
Zur Stellungnahme freigegeben im Mai 2002
Adopted February 2002
CVMP allgemein Dokumentennummer EMEA/CVMP/695/01 EMEA/CVMP/328/98 – Revision 2
EMEA/CVMP/328/98 – Revision 2
Titel des Dokuments Processing of renewals in the centralised procedure Acceptability of invented names for veterinary medicinal products processed through the centralised procedure
Acceptability of invented names for veterinary medicinal products processed through the centralised procedure
Stand Verabschiedet im Februar 2002 Verabschiedet im März 2002
Adopted March 2002
CVMP-Arbeitsgruppe Sicherheit Dokumentennummer EMEA/CVMP/234/01
EMEA/CVMP/234/01
Titel des Dokuments Safety evaluation of antimicrobial substances regarding the effects on human gut flora
Safety evaluation of antimicrobial substances regarding the effects on human gut flora
Pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial Veterinary Medicinal Products
Pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
CVMP/VICH/484/02
CVMP/VICH/484/02
Repeat-dose (90 days) toxicity testing
Repeat-dose (90 days) toxicity testing
CVMP/VICH/485/02
CVMP/VICH/485/02
CVMP/VICH/486/02
CVMP/VICH/486/02
Zur Stellungnahme freigegeben im Mai 2002
Released for consultation May 2002
Repeat-dose (90days) toxicity testing
Repeat-dose (90 days) toxicity testing
Zur Stellungnahme freigegeben im Mai 2002
Adopted January 2002
Gemeinsame CPMP/CVMP-Arbeitsgruppe Qualität Dokumentennummer CPMP/QWP/1719/00 CPMP/ICH/2737/99 CPMP/ICH/142/95
CPMP/ICH/2737/99 CPMP/ICH/142/95
Titel des Dokuments Medicinal gases – pharmaceutical documentation ICH Q3A – Impurities testing:
ICH Q3A – Impurities testing:
Stand Verabschiedet im Januar 2002 Verabschiedet im Februar 2002
Adopted February 2002
CPMP/ICH/4104/00
CPMP/ICH/4104/00
CVMP/424/02
CVMP/424/02
In-use stability testing of Veterinary medicinal products (excluding immunological Veterinary medicinal products)
In-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)
CPMP/ICH/420/02
EMEA/CVMP/424/01
ICH Q1E Evaluation of stability data
In-use stability testing of veterinary medicinal products
Zur Stellungnahme freigegeben im Februar 2002
Adopted February 2002
CPMP/ICH/421/02
CPMP/QWP/2845/00
ICH Q1F Stability data package for registration in climatic zones III and IV
Requirements for pharmaceutical documentation for pressurised metered dose inhalation products
Zur Stellungnahme freigegeben im Februar 2002
Adopted March 2002
CPMP/QWP/2845/00
CPMP/ICH/1507/02
Requirements for pharmaceutical documentation for pressurised metered dose inhalation products
ICH Q3C (M) Maintenance document for guidance on impurities
Verabschiedet im März 2002
Adopted April 2002
EMEA/CVMP/422/99
CPMP/QWP/158/01
Declaration of storage conditions for Veterinary medicinal products and active substances – Revision
Quality of water for pharmaceutical use
Zur Stellungnahme freigegeben im März 2002
Adopted May 2002
ICH Q3C (M) Maintenance document for guidance on impurities
EMEA/CVMP/115/01 – Revision Quality of water for pharmaceutical use
Verabschiedet im April 2002
Adopted May 2002
ICH Q3C (M) Maintenance document for guidance on impurities:
CPMP/ICH/1940/00 ICH Q3C (M) Maintenance document for guidance on impurities:
CPMP/ICH/4680/02
EMEA/CVMP/1055/02 70 EMEA Annual Report 2002
ICH M4Q Questions and Answers / Location issues for common technical documents for the registration of pharmaceuticals for human use
Concept paper for the development of guideline on quality aspects of pharmaceutical veterinary medicines administered via drinking water
Zur Stellungnahme freigegeben im September 2002
Adopted November 2002
EMEA/CVMP/1055/02
Reference number
Concept paper for the development of guideline on quality aspects of pharmaceutical veterinary medicines administered via drinking water
Stability testing: stability testing of existing active substances and related finished products
Verabschiedet im November 2002
Adopted December 2002
CPMP/QWP/122/02 CPMP/QWP/556/96 EMEA/CVMP/424/01 EMEA/CVMP/115/01 – Revision
CPMP/QWP/122/02 CPMP/QWP/556/96
Stability testing: stability testing of existing active substances and related finished products In-use stability testing of Veterinary medicinal products Quality of water for pharmaceutical use
Stability testing: stability testing of existing active substances and related finished products – Revision
Verabschiedet im Dezember 2002 Verabschiedet im Februar 2002 Verabschiedet im Mai 2002
Released for consultation February 2002
EMEA/CVMP/422/99 – Revision
European Drug Master File – Revision
Declaration of storage conditions for pharmaceutical Veterinary medicinal products in the product particulars and active substances.
Released for consultation February 2002
Annex to note for guidance on stability testing of new active substances and medicinal products.
ICH Q1E Evaluation of stability data
Annex to note for guidance on stability testing of existing active substances and related finished products.
ICH Q1F Stability data package for registration in climatic zones III and IV
Zur Stellungnahme freigegeben im März 2002
Released for consultation February 2002
EMEA/CVMP/134/02
EMEA/CVMP/134/02
Zur Stellungnahme freigegeben im Februar 2002
Released for consultation February 2002
EMEA/CVMP/680/02
EMEA/CVMP/680/02
Quality of modified release dosage forms for veterinary use
Quality of modified release dosage forms for veterinary use Released for consultation July 2002
Zur Stellungnahme freigegeben im Juli 2002
Released for consultation September 2002
Ausschuss für Arzneimittel für seltene Leiden Dokumentennummer ENTR/6283/00
Committee for Orphan Medicinal Products
Titel des Dokuments Guideline on the format and content of applications for designation as Arzneimittel für seltene Leiden
Points to consider on the calculation and reporting of the prevalence of a condition for orphan designation
Stand Oktober 2002
Adopted March 2002
COMP/436/01
COMP/189/01
EMEA/14222/00
EMEA/14222/00
Revision 2, Oktober 2002
Revision 2, October 2002
EMEA/4795/00
ENTR/6283/00
General information for sponsors of Arzneimittel für seltene Leiden
Guideline on the format and content of applications for designation as orphan medicinal products
Revision 1, Oktober 2002
Revision 1, October 2002
COMP/189/01
EMEA/4795/00
Note for guidance on the format and content of the annual report on the state of development of an Arzneimittel für seltene Leiden
General information for sponsors of orphan medicinal products
Verabschiedet im April 2002
Revision 1, October 2002
 EMEA 2003 Seite 86/90
EMEA Annual Report 2002
Verfahren beim CPMP
71
Art der Befassung Datum des CPMP-Gutachtens
Annex 11 Arbitration and Community referrals overview 2002
Schiedsverfahren nach Artikel 29 (2)
Referrals made to the CPMP Type of referral Article 29 (2) Referrals
April 2002 Juni 2002
Date of CPMP opinion April 2002 June 2002 Ongoing Ongoing
Isotretinoin Clostridium botulinum type A neutoxin
International non-proprietary name (INN) Dacarbazine Alteplase Isotretinoin Clostridium botulinum type A neutoxin
Schiedsverfahren nach Artikel 7 (5)
Article 7 (5) Referrals
Norditropin Genotropin Salmeterol/fluticasone proprionate
Ongoing Ongoing Ongoing Withdrawn by the company Ongoing Ongoing Ongoing Ongoing Ongoing
Schiedsverfahren nach Artikel 30
Article 30 Referrals
September 2002 Januar 2002 Mai 2002 April 2002 Februar 2002
September 2002 January 2002 May 2002 April 2002 February 2002
Fluoxetine Fluvoxamine Captopril Captopril/hydrochlorothiazide Midazolam
Fluoxetine Fluvoxamine Captopril Captopril/hydrochlorothiazide Midazolam
2002 (Berufung durch Firma)
September 2002 (company appealed) Enalapril
Juni 2002 Juli 2002
June 2002 July 2002 Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing
Calcium folinate Ranitidine Isotretinoin Lisinopril Calcium 500/1000 Calcium 500 + Vitamin D 400 IU Calcium 500 + Vitamin D 200 IU Pravastatin Simvastatin
Domperidone Clozapine Calcium folinate Ranitidine Isotretinoin Lisinopril Calcium 500/1000 Calcium 500 + Vitamin D 400 IU Calcium 500 + Vitamin D 200 IU Pravastatin Simvastatin
nach Artikel 31
Article 31 Referrals
Laufendes Verfahren Juni 2002 Laufendes Verfahren
November 2002 October 2002 (company appealed) Ongoing June 2002 Ongoing Ongoing Ongoing
Schiedsverfahren Befassung nach Artikel 36
Article 36 Referrals
März 2002 Juli 2002 Oktober 2002
March 2002 July 2002 October 2002
Cerivastatin Bupropion Felodipine
Cerivastatin Bupropion Felodipine
Datum des CVMP- Gutachtens
Referrals made to the CVMP
Internationaler Freiname (INN)
Community harmonisation and pharmacovigilance referrals
Schiedsverfahren nach Artikel 33 der Richtlinie
Type of referral Article 33 Directive 2001/82/EC
Juni 2002 Juni 2002
Date of CVMP opinion June 2002 June 2002 Ongoing
2001/82/EG
Article 20 Council Regulation 81/851 (EEC) now Article 35 Directive 2001/82/EC 72 EMEA Annual Report 2002
Dezember 2002
December 2002 (under appeal)
 EMEA 2003 Seite 88/90
Annex 12 EMEA contact points
Pharmakovigilanz und Meldung von Produktmängeln
Pharmacovigilance and product defect reporting
Panos TSINTIS Durchwahl (44-20) 75 23 71 08 E-Mail: panos.tsintis@emea.eu.int
Documentation services A wide range of documents has now been published by the
Die EMEA stellt Arzneimittelbescheinigungen gemäß den Bestimmungen der Weltgesundheitsorganisation aus.
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.
Diese attestieren die Zulassung sowie den Status der Guten Herstellungspraxis von Arzneimitteln in der EU und sind als Unterstützung für Anträge auf Genehmigung für das Inverkehrbringen bzw. den Export in Nicht-EU Länder bestimmt.
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.
Jonna SUNELL-HUET Durchwahl (44-20) 74 18 84 65 E-Mail: certificate@emea.eu.int
For matters relating to pharmacovigilance for medicinal products for human use:
Pressemitteilungen, allgemeine Informationen, Jahresberichte und Arbeitsprogramme.
EMEA, including press releases, general information documents, annual reports and work programmes.
Diese und weitere Dokumente sind im Internet (http://www.emea.eu.int) sowie unter folgender Anschrift erhältlich:
These and other documents are available either on the Internet at http://www.emea.eu.int or by writing to:
Weitere Informationen erhalten Sie unter obiger obiger Anschrift sowie per
Panos TSINTIS Direct telephone (44-20) 75 23 71 08 E-mail: panos.tsintis@emea.eu.int
E-Mail: emearequests@emea.eu.int Fax:
E-mail: emearequests@emea.eu.int Fax:
(44-20) 74 18 86 70
(44-20) 74 18 86 70
Anfragen nach allgemeinem Informationsmaterial sind Amanda BOSWORTH sind zu richten an
For matters relating to pharmacovigilance for medicinal products for veterinary use:
Durchwahl (44-20) 74 18 84 08 E-Mail: amanda.bosworth@emea.eu.int
Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda.bosworth@emea.eu.int
EMEA-Jahresbericht 2002 EMEA/MB/055/02/de/Endgültig Europäische Sachverständigenliste
(44-20) 74 18 85 90 Approximately 3 000 are used by the EMEA in its scientific Out of hours telephone:
 EMEA 2003 Seite 89/90
(44-7880) 55 06 97 evaluation work.
Von der EMEA werden ca.
Requests should be sent in writing to the EMEA or to:
3 000 bei der wissenschaftlichen Beurteilung in Anspruch genommen.
Certificates of a medicinal product E-mail: europeanexperts@emea.eu.int
Anfragen sollten schriftlich an die EMEA oder an geschickt werden
The EMEA issues certificates of a medicinal product in
E-Mail: europeanexperts@emea.eu.int
These certify the marketing authorisation
Integriertes Qualitätsmanagement
Integrated quality management
IQM-Berater
For enquiries concerning certificates for centrally authorised medicines for human or veterinary use:
Marijke KORTEWEG Durchwahl (44-20) 74 18 85 56 E-Mail: iqmanagement@emea.eu.int
IQM adviser Marijke KORTEWEG Direct telephone (44-20) 74 18 85 56 E-mail: iqmanagement@emea.eu.int
Pressebeauftragter
E-mail: certificate@emea.eu.int
Martin HARVEY ALLCHURCH Durchwahl (44-20) 74 18 84 27 E-Mail: martin.harvey-allchurch@emea.eu.int
Press officer Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: martin.harvey-allchurch@emea.eu.int
DIE EUROPÄISCHE AGENTUR FÜR DIE BEURTEILUNG VON ARZNEIMITTELN
THE EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS
ZWEITER ALLGEMEINER TÄTIGKEITSBERICHT 1996 ZWEITER ALLGEMEINER TÄTIGKEITSBERICHT DER EUROPÄISCHEN AGENTUR FÜR DIE BEURTEILUNG VON ARZNEIMITTELN 3 1996
SECOND GENERAL REPORT 1996 European Agency for the Evaluation of Medicinal Products
Verabschiedet vom Verwaltungsrat am 4.
Second General Report 1996
Dezember 1996
Adopted by the Management Board on 4 December 1996
European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard:
European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard:
(+44-171) 418 8590 E-Mail: mail@emea.eudra.org Internet: http://www.eudra.org/emea.html Inhaltsverzeichnis
(+44-171) 418 8416 E-Mail: mail@emea. eudra. org Internet: http: / /www. eudra. org/ emea. html Contents
Vorwort des Vorsitzenden des Verwaltungsrates
Foreword from the Chairman of the Management Board
Einleitung durch den Verwaltungsdirektor
Introduction by the Executive Director
1.1 1.2 1.3 1.4
1.1 1.2 1.3 1.4
Die Agentur im Jahr 1996 - erstes volles Tätigkeitsjahr Führung der Geschäfte der Agentur Personal und Verwaltung Internationale Aktivitäten Beziehungen zu interessierten Kreisen
EMEA in 1996 - first full year of operation Managing the business of the Agency Personnel and administration International activities Relations with interested parties
Humanarzneimittel
Medicinal Products for Human Use
Vorwort des Vorsitzenden des Ausschusses für Arzneispezialitäten 4
Preface by the Chairman of the Committee for Proprietary Medicinal Products 4 2.1 Unit for the Evaluation of Medicinal Products for Human Use 2.2 Operation of the centralised procedure 2.3 Other CPMP core activities 2.4 Mutual recognition and other Community referrals 2.5 CPMP Working Parties and ad hoc Groups
Tierarzneimittel
Medicinal Products for Veterinary Use
Referat für die Bewertung von Tierarzneimitteln Tätigkeit des Ausschusses für Tierarzneimittel Festsetzung von maximalen Rückstandsgrenzwerten Gegenseitige Anerkennung Arbeitsgruppen des Ausschusses für Tierarzneimittel
Preface by the Chairman of the Committee for Veterinary Medicinal Products 3.1 Unit for the Evaluation of Medicinal Products for Veterinary Use 3.2 Operation of the Committee for Veterinary Medicinal Products 3.3 Establishment of maximum residue limits 3.4 Mutual recognition 3.5 CVMP Working Parties
4.1 4.2
4.1 4.2
Aktivitäten der technischen Koordinierung Einrichtung des technischen Koordinierungsreferates Koordinierung von Inspektionen und Qualitätssicherung von Human- und Tierarzneimitteln
Technical Co-ordination Activities Setting-up the Technical Co-ordination Unit Co-ordination of inspections and quality of human & veterinary medicinal products
4.3 4.4 4.5
4.3 4.4 4.5
Dokumentation und Archivierung Konferenz- und Sprachendienste Informationstechnik
Documentation and archiving Conference and linguistic support Information technology
Europäisches Technisches Büro für Arzneimittel
European Technical Office for Medicinal Products
1 Mitglieder des Verwaltungsrates 2 Mitglieder des Ausschusses für Arzneispezialitäten 3 Mitglieder des Ausschusses für Tierarzneimittel 4 Organigramm des Sekretariats der Agentur 5 Haushalt 1994-1996 der Agentur 6 Gutachten des Ausschusses für Arzneispezialitäten über Humanarzneimittel im Jahr 1996 7 Gutachten des Ausschusses für Tierarzneimittel über Tierarzneimittel im Jahr 1996 8 Die Regelung der Arzneimittel in der Europäischen Union
Annexes 1 Membership of Management Board 2 Membership of Committee for Proprietary Medicinal Products 3 Membership of Committee for Veterinary Medicinal Products 4 Organigram of the EMEA Secretariat 5 EMEA Budget 1994-1996 6 CPMP Opinions in 1996 on Medicinal Products for Human Use 7 CVMP Opinions in 1996 on Medicinal Products for Veterinary Use 8 Rules Governing Medicinal Products in the European Community
5 In diesem Dokument verwendete Abkürzungen:
5 Abbreviations used in this document
UAW
ADR BEUC
Unerwünschte Arzneimittelwirkung
Adverse drug reaction Bureau Européen des Unions de Consommateurs
FEDESA
FEDESA GMP
Fédération Européenne de la Santé Animale
Fédération Européenne de la Santé Animale Good Manufacturing Practice
BEUC
CPMP
Bureau Européen des Unions de Consommateurs
Committee for Proprietary Medicinal Products
GMP ICH
ICH
Gute Herstellungspraxis Internationale Konferenz zur Harmonisierung der
International Conference for Harmonisation of Technical Requirements
Ausschuß für Tierarzneimittel
Committee for Veterinary Medicinal Products
Zulassung von Humanarzneimitteln
for Registration of Pharmaceuticals for Human Use
ECU
ECU EEA
Europäische Währungseinheit
European Currency Unit European Economic Area
Europäischen Kommission
European Commission Joint Research Centre
EFPIA
EFPIA
European Federation of Pharmaceutical
European Federation of Pharmaceutical
Maximaler Rückstandsgrenzwert
Maximum Residue Limit
Industries’ Associations
Industries’ Associations
Standardarbeitsanweisung
Standard Operating Procedure
EMEA
EMEA
Europäische Agentur für die Beurteilung von
Evaluation of Medicinal Products
SPC
SPC
Zusammenfassung der Produktmerkmale
Summary of Product Characteristics
Arzneimitteln Europäischer öffentlicher Bewertungsbericht
European Public Assessment Report
VICH
VICH
Internationale Konferenz zur Harmonisierung der Technischen
International Conference for Harmonisation of Technical Requirements
ETOMEP EU
ETOMEP
Europäisches Technisches Büro für Arzneimittel Europäische Union
European Technical Office for Medicinal Products
Anforderungen an die Zulassung von Tierarzneimitteln
for Registration of Pharmaceuticals for Veterinary Use
Vorwort von Strachan Heppell Vorsitzender des Verwaltungsrates
Foreword from Strachan Heppell Chairman of the Management Board
Ich freue mich, den Allgemeinen Tätigkeitsbericht für das Jahr 1996 der Europäischen Agentur für die Beurteilung von Arzneimitteln vorlegen zu dürfen.
I have pleasure in presenting the General Report for 1996 on the activities of the European Agency for the Evaluation of Medicinal Products.
Fortschritt des europäischen Zulassungssystems
Progress of the European registration system
Das europäische System zur Bewertung, Zulassung und Überwachung von Arzneimitteln ist seit zwei Jahren in Kraft.
The European system for the evaluation, authorisation and supervision of medicinal products has been in operation for two years.
In dieser Zeit hat es sich als effizientes und wirksames Mittel der Regelung etabliert und ist auf dem besten Wege, seinen Platz als eines der weltweit führenden Regulierungssysteme für Arzneimittel einzunehmen.
In that time it has established itself as an efficient and effective means of regulation and it has started to take its place as one of the world’ s leading regulatory systems for medicinal products.
Verständlicherweise bestanden zunächst erhebliche Bedenken bezüglich der Funktionsfähigkeit des Systems.
Understandably, at the start there was considerable apprehension about how the system would work.
Dies galt insbesondere für das zentrale Verfahren, dem als völlig neues Verfahren seine Bewährungsprobe noch bevorstand.
This was particularly so with the centralised procedure which was seen as new and untested.
Es gab aber auch 6 Bedenken bezüglich der gegenseitigen Anerkennung im Rahmen des dezentralisierten Verfahrens, insbesondere Befürchtungen, daß das Verfahren dadurch lahmgelegt werden könnte, daß ursprüngliche Bewertungen in Frage gestellt werden.
But there was also concern about mutual recognition 6 in the decentralised procedure, where there were fears that the procedure would be crippled by challenges to the original assessment.
Diese Befürchtungen haben sich nicht bewahrheitet.
These fears did not materialise.
Das zentrale Verfahren, für das die Agentur zuständig ist, hat sich zur Zufriedenheit seiner Kunden entwickelt.
The centralised procedure, which is the responsibility of the Agency, has delivered a service which its customers have found satisfactory.
Die gegenseitige Anerkennung, die den nationalen Aufsichtsbehörden obliegt, lief anfangs nur langsam an, hat sich aber seither immer besser etabliert.
Mutual recognition, which is the responsibility of national regulatory authorities, got off to a rather slower start but has established itself progressively since then.
Insgesamt war die Reaktion auf das System positiv.
Overall, the response to the system has been positive.
Ich selbst habe dies bei einem Besuchsprogramm in den Mitgliedstaaten festgestellt, im Rahmen dessen ich den Fortschritt des Systems sowohl mit den nationalen Aufsichtsbehörden als auch mit der pharmazeutischen Industrie eingehend erörtern konnte.
I have seen this for myself during a programme of visits to Member States where I have discussed progress in detail with both national regulatory authorities and the pharmaceutical industry.
Beschäftigte im Gesundheitswesen oder Verbraucher, teilnahmen.
The positive response has been equally evident in a variety of conferences and meetings involving those with a major interest in the system, including health care professions and consumer groups.
Oktober 1996 in Canary Wharf einberufen wurde.
In particular, this was the clear outcome of an audit of the system convened at Canary Wharf on 21 October 1996 by Dr Martin Bangemann, Member of the Commission responsible for the pharmaceutical industry.
Lehren aus den bisherigen Erfahrungen:
Lessons learned: devolution and partnership
Der Verwaltungsrat hat eine Reihe von Lehren aus den ersten beiden Jahren seit Bestehen des Systems gezogen.
The Board has learned a number of lessons from the system ’ s first two years.
Des weiteren ist sich der Verwaltungsrat der Bedeutung guter Kommunikationssysteme bewußt geworden und ist zu der Überzeugung gelangt, daß Zielvorgaben und Leistungsindikatoren sowie eine Leistungstransparenz notwendig sind.
It has seen the importance of identifying and focusing on core responsibilities; recognised the value of good communication systems; and become convinced of the need for performance goals and indicators and for transparency about that performance.
Es war eine herausragende Erkenntnis, daß die Übertragung von Kompetenzen und die Partnerschaft für den Erfolg des Systems entscheidend sind.
One lesson in particular has stood out - that devolution and partnership are critical to the success of the system.
Das übergreifende Wesen des Systems geht aus diesem Bericht hervor.
The devolved nature of the system is made clear in this report.
Dabei ist von großem Vorteil, daß es Erfahrungswissen und Sachverstand aus der gesamten EU nutzt und nicht versucht, diese Ressourcen an einem Ort zu konzentrieren.
Its great value is that it makes such good use of experience and expertise across the whole of the EU, rather than trying to concentrate those skills in one place.
Darin kommt der Geist der Subsidiarität zum Ausdruck.
In so doing, it reflects the spirit of subsidiarity.
Um ein solches System erfolgreich zu betreiben, müssen sich alle Beteiligten gegenseitig als Partner wahrnehmen, die die gemeinsame Verantwortung für den Erfolg des Unternehmens tragen.
To operate such a system successfully requires all concerned to see themselves as partners with a shared responsibility to ensure that the enterprise is successful.