qanastek/EMEA-V3 huggingface dataset:
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Verabschiedet im April 2000
EMEA/COMP - Submission - Validation - Opinion - Active time
Report of the EMEA Expert Workshop on human TSEs and plasma- derived medicinal products, 15-16 Mai 2000 Verabschiedet im Juli 2000
Commission - Opinion received - Date of Designation
EMEA/CPMP/BWP/3326/99
Somatropin
EMEA/CPMP/BWP/3354/99 Draft Note
Ares-Serono (Europe) Ltd
for Guidance on the production and quality control of animal
AIDS-wasting
immunoglobulins and immunosera for human use Zur Stellungnahme freigegeben im Januar 2000
- 28.04.2000 - 15.06.2000 - 11.07.2000 - 27 days
EMEA/CPMP/BWP/3 207/00
- 17.07.2000 - 08.08.2000
EMEA/CPMP/BWP/1143/00
Alpha - Galactosidase A
EMEA/CPMP/BWP/269/95 rev.
TKT Europe- 5S AB
EMEA/CPMP/BWP/2571/00
Treatment of Fabry disease
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Zur Stellungnahme freigegeben im November 2000
- 03.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
CPMP-Arbeitsgruppe Blut und Plasma
- 17.07.2000 - 08.08.2000
Dokumentennummer
Alpha - Galactosidase A
Leitlinien/Stand
Genzyme BV
EMEA/CPMP/BPWG/575/99
Treatment of Fabry disease
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Verabschiedet im Juni 2000
- 12.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
EMEA/CPMP/BPWG/388/95 rev.
- 17.07.2000 - 08.08.2000
EMEA/CPMP/BPWG/574/99
Fluorouracil
EMEA/CPMP/BPWG/859/95 rev.
Ethypharm S.A.
EMEA/CPMP/BPWG/1619/99
Treatment of glioblastoma
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Verabschiedet im Juni 2000
- 26.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
EMEA/CPMP/BPWG/1625/99
- 18.09.2000 - 18.10.2000
Core SPC for Human plasma derived and recombinant coagulation factor IX products Verabschiedet im Juni 2000
Gemtuzumab ozogamicin
EMEA/CPMP/BPWG/198/95 rev.1 Note
Wyeth-Ayerst Research
for Guidance on the Clinical investigation of human plasma derived
Treament of acute myeloid leukaemia
factor VIII and IX products Verabschiedet im Oktober 2000
- 07.06.2000 - 31.07.2000 - 13.09.2000 - 45 days
EMEA/CPMP/BPWG/1561/99
- 18.09.2000 - 18.10.2000
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Verabschiedet im Oktober 2000
1,5 -(Butylimino)- 1,5-dideoxy, D-glucitol
84 EMEA Allgemeiner Tätigkeitsbericht 2000
Oxford GlycoSciences Ltd
EMEA/CPMP/PhvWP/BPWG / 2231/99
Treatment of Gaucher disease
Core SPC for Human albumin Verabschiedet im Oktober 2000
- 07.06.2000 - 31.07.2000 - 13.09.2000 - 45 days
EMEA/CPMP/BPWG/198/95 rev.
- 18.09.2000 - 18.10.2000
EMEA/CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
N -carbamyl-L- glutamic acid
EMEA/CPMP/BPWG/3226/99
Orphan Europe Sarl
Core SPC for Human plasma derived antithrombin Zur Stellungnahme freigegeben im Dezember 2000
Treatment of N-acetylglutamate synthetase (NAGS) deficiency
CPMP-Arbeitsgruppe Wirksamkeit
- 02.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
Dokumentennummer
- 18.09.2000 - 18.10.2000
Leitlinien/Stand
Arsenic trioxide
Note for Guidance on clinical investigation of steroid contraceptives in woman Verabschiedet im Februar 2000
Voisin Consulting Treatment of acute promyelocytic leukaemia Sarl
EMEA/CPMP/EWP/197/99
- 08.05.2000 - 15.06.2000 - 13.09.2000 - 90 days
EMEA/CPMP/EWP/570/98
- 18.09.2000 - 18.10.2000
Points to consider on the clinical investigation of new medicinal products for treatment of acute coronary syndrome (ACS) without persistent ST- segment elevation Verabschiedet im Februar 2000
Thalidomide
EMEA/CPMP/EWP/2922/99
Laboratoires LAPHAL
Concept paper on the development of a CPMP Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma Verabschiedet im Februar 2000
Treatment of erythema nodosum leprosum or type II reactions in Hansen's disease
EMEA/CPMP/EWP/2863/99
- 01.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
EMEA/CPMP/EWP/707/98
- 6.11.2000 - 29.12.2000
EMEA/CPMP/EWP/612/00
Anagrelide hydrochloride
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Verabschiedet im Juni 2000
Shire Pharmaceutical Development Ltd
EMEA/CPMP/EWP/2655/99
Treatment of essential thrombocythaemia
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Verabschiedet im Juli 2000
- 31.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
EMEA/CPMP/EWP/482/99
- 6.11.2000 - 29.12.2000
Points to consider on switching between superiority and non-inferiority Verabschiedet im Juli 2000
Busulfan (intravenous use)
EMEA/CPMP/EWP/1080/00
Pierre Fabre Médicament
Concept paper on the Development of a CPMP Note for Guidance on Clini- cal investigation of medicinal products in the treatment of diabetes mellitus Verabschiedet im Juli 2000
Intravenous conditioning treatment prior to hematopoietic progenitor cell transplantation
EMEA/CPMP/EWP/565/98
- 09.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
Points to consider on Clinical investigation of medicinal products for treatment of Amyotrophic Lateral Sclerosis (ALS) Verabschiedet im Oktober 2000
- 6.11.2000 - 29.12.2000
EMEA/CPMP/EWP/785/97
Nitisinone
Concept paper on the Evaluation of drugs for the treatment of the irritable bowel syndrome Verabschiedet im November 2000
Swedish Orphan AB
1 Note
Treatment of tyrosinaemia type 1
for Guidance on Clinical investigation of medicinal products in the
- 05.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
treatment of epileptic disorders Verabschiedet im November 2000
- 6.11.2000 - 29.12.2000
85 EMEA Allgemeiner Tätigkeitsbericht 2000
82 EMEA General Report 2000
EMEA/CPMP/EWP/2284/99
Product
Points to consider on Clinical investigation of medicinal products for the management of Crohn’s disease Zur Stellungnahme freigegeben im Juli 2000
Sponsor
1 Note
Indication
for Guidance on Evaluation of anticancer medicinal products in man
EMEA/COMP - Submission - Validation - Opinion - Active time
Zur Stellungnahme freigegeben im Juli 2000 und im September 2000 um zwei Monate verlängert
Commission - Opinion received - Date of Designation
EMEA/CPMP/EWP/560/98
Ethyl eicosopentaenoate
Points to consider on Clinical investigation of medicinal products in the treatment of acute stroke Zur Stellungnahme freigegeben im Oktober 2000
Laxdale Ltd
EMEA/CPMP/EWP/2330/99
Treatment of Huntington's disease
Points to consider on Validity and interpretation of meta-analyses, and one pivotal study Zur Stellungnahme freigegeben im Oktober 2000
- 05.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
EMEA/CPMP/EWP/1119/98
- 6.11.2000 - 29.12.2000
Points to consider on the Evaluation of diagnostic agents Zur Stellungnahme freigegeben im November 2000
Iloprost
EMEA/CPMP/EWP/714/98
Schering AG
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Zur Stellungnahme freigegeben im November 2000
Treatment of primary and of the following forms of secondary pulmonary hypertension: connective tissue disease pulmonary hypertension, drug -induced pulmonary hypertension, portopulmonary hypertension, pulmonary hypertension associated with congenital heart disease and chronic thromboembolic pulmonary hypertension
EMEA/CPMP/EWP/QWP/ 1401/98 EMEA/CPMP/EWP/2747/00
- 10.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
CPMP-Arbeitsgruppe Pharmakovigilanz
- 6.11.2000 - 29.12.2000
Dokumentennummer
-
Leitlinien/Stand
-
EMEA/CPMP/PhVWP/2058/99
Treatment of amyotrophic lateral sclerosis
CPMP-Arbeitsgruppe Sicherheit
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
Leitlinien/Stand
- -
EMEA/CPMP/SWP/2775/99
Treatment of acute promyelocytic leukaemia
EMEA/CPMP/SWP/1042/99
- 08.08.2000
Note for Guidance on Repeated dose toxicity Verabschiedet im Juli 2000
-
EMEA/CPMP/SWP/2278/00
- 22.09.2000
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Verabschiedet im Dezember 2000
- 21.11.2000
EMEA/CPMP/SWP/4163/00
- 61 days
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 Verabschiedet im Dezember 2000
- -
EMEA/CPMP/SWP/2145/00 Draft 4
Treatment of acute respiratory distress syndrome
Note for Guidance on Non-clinical local tolerance testing of medicinal products Zur Stellungnahme freigegeben im September 2000
- 01.09.2000
EMEA-Arbeitsgruppe Pflanzliche Arzneimittel
-
Dokumentennummer
- 22.09.2000
Leitlinien/Stand
- 21.11.2000
EMEA/HMPWP/23/00
- 61 days
Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species Von der Arbeitsgruppe im Oktober 2000 verabschiedet
- -
Note for guidance on quality of herbal medicinal products Zur Stellungnahme freigegeben im November 2000
Treatment of cystic fibrosis
CPMP/QWP/2820/00
- 09.08.2000
Note for guidance on specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products Zur Stellungnahme freigegeben im November 2000
-
CVMP-Arbeitsgruppe Wirksamkeit
- 22.09.2000
Dokumentennummer
- 19.12.2000
Leitlinien/Stand
- 89 days
EMEA/CVMP/133/99
- -
Conduct of pharmacokinetic studies in animals Verabschiedet im März 2000
Treatment of patent ductus arteriosus
EMEA/CVMP/344/99
- 02.05.2000
Conduct of efficacy studies for intramammary products for use in cattle Verabschiedet im März 2000
-
EMEA/CVMP/005/00
- 19.10.2000
EMEA/CVMP/016/00
- 19.12.2000
The conduct of bioequivalence studies for veterinary medicinal products Zur Stellungnahme freigegeben im Januar 2000
- 62 days
CVMP/VICH/546/00
- -
Efficacy of anthelmintics:
Treatment of glycogen storage disease type II
CVMP/VICH/545/00
- 10.08.2000
Efficacy of anthelmintics:
-
CVMP-Arbeitsgruppe Immunologische Tierarzneimittel
(Pompe's disease)
Dokumentennummer
- 19.10.2000 - 19.12.2000 - 62 days
CVMP/IWP/52/97
Treatment of acromegaly
Requirements for combined veterinary vaccines Verabschiedet im März 2000
- 11.08.2000 - 19.10.2000 - 19.12.2000 - 62 days
CVMP/IWP/07/98
-
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use Verabschiedet im März 2000
- -
Duration of protection achieved by veterinary vaccines Verabschiedet im Oktober 2000
Treatment of pulmonary arterial hypertension and
EMEA/CVMP/852/99
- 21.08.2000
Field trials with veterinary vaccines Zur Stellungnahme freigegeben im März 2000
-
EMEA/CVMP/743/00
chronic thromboembolic pulmonary hypertension
CVMP-Arbeitsgruppe Pharmakovigilanz
- 19.10.2000 - 19.12.2000 - 62 days
Dokumentennummer
- -
Leitlinien/Stand
Treatment of haemorrhagic fever with renal syndrome
EMEA/CVMP/044/99
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
Conduct of post-marketing surveillance studies of veterinary medicinal products Verabschiedet im April 2000
-
CVMP/VICH/547/00
- -
Management of adverse event reports (AERs) Zur Stellungnahme freigegeben im Juli 2000
Treatment of mucopolysaccharidosis type I
CVMP-Arbeitsgruppe Sicherheit
- 08.09.2000
Leitlinien/Stand
- 19.10.2000
EMEA/CVMP/276/99
- 19.12.2000
Assessment of the effect of antimicrobial substances on dairy starter cultures Verabschiedet im März 2000
- 62 days
EMEA/CVMP/473/98
- -
Determination of withdrawal periods for milk Verabschiedet im März 2000
Treatment of chronic myeloid leukaemia
CVMP/VICH/592/98
- 03.10.2000
Environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1 Verabschiedet im Juli 2000
-
EMEA/CVMP/187/00
- 19.10.2000
CVMP/VICH/526/00
- 19.12.2000
CVMP/VICH/525/00
- 62 days
Safety studies for veterinary drug residues in human food:
- -
Gemeinsame CPMP/CVMP-Arbeitsgruppe Qualität
Mucopolysaccharidosis type VI (Maroteaux -Lamy
Dokumentennummer
- 04.10.2000
CPMP/QWP/1676/00
Syndrome)
CPMP/QWP/3015/99
- 19.10.2000 - 19.12.2000 - 62 days
Note for Guidance on Parametric Release Zur Stellungnahme freigegeben im März 2000
83 EMEA General Report 2000
CPMP/QWP/1719/00
Annex 11:
Note for Guidance on Medicinal Gases – Pharmaceutical Information Zur Stellungnahme freigegeben im Juli 2000
EMEA guidelines in 2000
CPMP/QWP/2845/00
CPMP Biotechnology Working Party
CPMP/QWP/2820/00 (CVMP/815/00)
Reference number
Note for Guidance on Specifications:
Guidelines/Status
CPMP/QWP/2819/00 (CVMP/814/00) EMEA/CVMP/065/99
EMEA/ CPMP/ BWP/840/00
Decision trees for the selection of sterilisation methods Verabschiedet im Februar 2000
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Adopted April 2000
EMEA/CVMP/422/99
EMEA/ CPMP/ BWP/1244/00
Declaration of storage conditions for veterinary medicinal products in the product particulars Verabschiedet im Februar 2000
Report of the EMEA Expert Workshop on human TSEs and plasma-derived medicinal products, 15-16 May 2000 Adopted July 2000
CVMP/VICH/501/99
EMEA/ CPMP/ BWP/3326/99
Stability testing of biotechnological/biological veterinary medicinal products Verabschiedet im Juni 2000
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adopted November 2000
CVMP/VICH/502/99
EMEA/ CPMP/ BWP/3354/99 Draft
Impurities: residual solvents Verabschiedet im Juni 2000
Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Released for consultation January 2000
EMEA/CVMP/198/99
EMEA/ CPMP/ BWP/3207/00
Maximum shelf-life for sterile medicinal products after first opening or following reconstitution Verabschiedet im Juli 2000
Note for Guidance on Comparability of medicinal products containing biotechnology-derived proteins as active substances Released for consultation May 2000
CVMP/VICH/595/98
EMEA/CPMP/BWP/1143/00
Good clinical practices Verabschiedet im Juli 2000
Position statement on the Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products Released for consultation July 2000
EMEA/CVMP/846/99
2
Stability testing of existing active substances and related finished products Verabschiedet im November 2000
Revision of section 3.2.5 of CPMP Note for guidance on Plasma-derived medicinal products Released for consultation July 2000
EMEA/CVMP/816/00
EMEA/CPMP/BWP/2571/00
Statistical principles for veterinary clinical trials Zur Stellungnahme freigegeben im November 2000
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Released for consultation November 2000
Ad-hoc-Arbeitsgruppe der GMP-Inspektoren
CPMP Blood and Plasma Working Group
Dokumentennummer
Reference number
Leitlinien/Stand
Guidelines/Status
ENTR/III/5717/99
EMEA/CPMP/BPWG/575/99
Sechster allgemeiner Tätigkeitsbericht der Europäischen Agentur für die Beurteilung von Arzneimitteln — 2000
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
2001 — 88 S. — 21 x 29,7 cm
EMEA/CPMP/BPWG/388/95 rev.
Ltd 5369 Chemin Canotek Road, Unit 1
1
(372) 646 02 44 Fax (372) 646 02 45
Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
Ottawa, Ontario K1J 9J3 Tel.
EMEA/CPMP/BPWG/574/99
URL: http://www.jean-de-lannoy.be La librairie européenne/ De Europese Boekhandel Rue de la Loi 244/Wetstraat 244
Core SPC for Human and anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
B-1040 Bruxelles/Brussel Tél.
EMEA/CPMP/BPWG/859/95 rev.
Mediatrade Ltd Pavla Hatza 1
1
(351) 214 95 87 87
Core SPC for Human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
HR-10000 Zagreb Tel.
EMEA/ CPMP/ BPWG/1619/99
(32-2) 552 22 11
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Adopted June 2000
István krt.12 II emelet 1/A
EMEA/ CPMP/ BPWG/1625/99
Rua da Escola Politécnica, 135 P-1250-100 Lisboa Codex
Core SPC for Human plasma derived and recombinant coagulation factor IX products Adopted June 2000
MALTA Miller Distributors Ltd
EMEA/CPMP/BPWG/198/95 rev.1
Asahi Sanbancho Plaza #206 7-1 Sanbancho, Chiyoda-ku
Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adopted October 2000
Keskuskatu 1/Centralgatan 1
EMEA/CPMP/BPWG/ 1561/99
(49-221) 97 66 80 Fax (49-221) 97 66 82 78 E-Mail: vertrieb@bundesanzeiger.de
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adopted October 2000
(30-1) 331 41 80/1/2/3/4/5
84 EMEA General Report 2000
E-mail: ebic@tm.net.my MÉXICO Mundi Prensa México, SA de CV
EMEA/CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/198/95 rev.
65, sector 1
1
(52-5) 533 56 58 Fax (52-5) 514 67 99
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
Customer Services PO Box 29
EMEA/ CPMP/ BPWG/1561/99
(34) 913 84 17 15 (suscripción)
Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Released for consultation June 2000
Fax (44) 870 60 05-533 E-mail: book.orders@theso.co.uk
EMEA/ CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
Slobody, 19
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
Puyat Ave. cor.
EMEA/ CPMP/BPWG/3226/99
Fax (34) 915 38 21 21 (libros), Fax (34) 913 84 17 14 (suscripción)
Core SPC for Human plasma derived antithrombin Released for consultation December 2000
URL: http://www.itsofficial.net
CPMP Efficacy Working Party Reference number
(421-7) 54 41 83 64
Guidelines/Status
Makati City Metro Manilla
EMEA/ CPMP/ EWP/519/98
E-mail: clientes@com.boe.es URL: http://www.boe.es Mundi Prensa Libros, SA Castelló, 37 E-28001 Madrid
Note for Guidance on clinical investigation of steroid contraceptives in woman Adopted February 2000
(354) 552 55 40
EMEA/ CPMP/ EWP/197/99
(63-2) 759 66 80 Fax (63-2) 759 66 90 E-mail: eccpcom@globe.com.ph URL: http://www.eccp.com SOUTH AFRICA
Points to consider concerning Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells Adopted February 2000
(34) 914 36 37 00
EMEA/ CPMP/ EWP/570/98
Fax (34) 915 75 39 98 E-mail: libreria@mundiprensa.es URL: http://www.mundiprensa.com
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
E-mail: bokabud@simnet.is
EMEA/ CPMP/ EWP/2922/99
Eurochamber of Commerce in South Africa PO Box 781738
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
FRANCE Journal officiel
EMEA/ CPMP/ EWP/2863/99
(33) 140 58 77 31 Fax (33) 140 58 77 00 E-mail: europublications@journal-officiel.gouv.fr URL: http://www.journal-officiel.gouv.fr
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
N-0606 Oslo Tel.
EMEA/ CPMP/ EWP/707/98
(82-2) 22 53-5631/4
Points to consider on Clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk Adopted June 2000
Fax (82-2) 22 53-5635/6
EMEA/ CPMP/ EWP/612/00
Fax (54-11) 48 15 81 56 E-mail: wpbooks@infovia.com.ar URL: http://www.wpbooks.com.ar
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adopted June 2000
UNITED STATES OF AMERICA
EMEA/ CPMP/ EWP/2655/99
(1-800) 274 44 47 (toll free telephone)
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Adopted July 2000
_BAR_ESKÁ REPUBLIKA ÚVIS odd.
EMEA/ CPMP/ EWP/482/99
Fax (1-800) 865 34 50 (toll free fax) E-mail: query@bernan.com URL: http://www.bernan.com
Points to consider on switching between superiority and non-inferiority Adopted July 2000
20043-900 Rio de Janeiro Tel.
EMEA/ CPMP/ EWP/1080/00
Office for Official Publications of the European Communities
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
Postbus 20014 2500 EA Den Haag Tel.
EMEA/ CPMP/ EWP/565/98
(357-2) 88 97 52 Fax (357-2) 66 10 44 E-mail: demetrap@ccci.org.cy 05 10 15 TC-36-01-079-DE-C
Points to consider on Clinical investigation of medicinal products for treatment of Amyotrophic Lateral Sclerosis (ALS) Adopted October 2000
Les éditions La Liberté Inc.
EMEA/CPMP/EWP/785/97
(352) 29 29-42455 Fax (352) 29 29-42758 E-mail: info-info-opoce@cec.eu.int URL: http://eur-op.eu.int 1/2001
Concept paper on the Evaluation of drugs for the treatment of the irritable bowel syndrome Adopted November 2000
Renouf Publishing Co.
EMEA/CPMP/EWP/566/98 rev.
(372) 646 02 44 Fax (372) 646 02 45
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders Adopted in November 2000
Ottawa, Ontario K1J 9J3 Tel.
EMEA/CPMP/EWP/2284/99
URL: http://www.jean-de-lannoy.be La librairie européenne/ De Europese Boekhandel Rue de la Loi 244/Wetstraat 244
Points to consider on Clinical investigation of medicinal products for the management of Crohn's disease Released for consultation July 2000
B-1040 Bruxelles/Brussel Tél.
85 EMEA General Report 2000
Distribuidora de Livros Bertrand Ld.ª
EMEA/CPMP/EPW/205/95 rev.
Fax (32-2) 735 08 60 E-mail: mail@libeurop.be URL: http://www.libeurop.be Moniteur belge/Belgisch Staatsblad
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
HR-10000 Zagreb Tel.
EMEA/ CPMP/ EWP/560/98
E-mail: inquiry@meobserver.com URL: http://www.meobserver.com.eg INDIA
Points to consider on Clinical investigation of medicinal products in the treatment of acute stroke Released for consultation October 2000
(32-2) 552 22 11
EMEA/ CPMP/ EWP/2330/99
Fax (351) 214 96 02 55 E-mail: dlb@ip.pt
Points to consider on Validity and interpretation of meta-analyses, and one pivotal study Released for consultation October 2000
B.
EMEA/ CPMP/ EWP/1119/98
Imprensa Nacional-Casa da Moeda, SA
Points to consider on the Evaluation of diagnostic agents Released for consultation November 2000
István krt.12 II emelet 1/A
EMEA/ CPMP/ EWP/714/98
Mumbai 400 021
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Released for consultation November 2000
E-mail: eusales@just.fgov.be
EMEA/ CPMP/EWP/QWP/ 1401/98
Rua da Escola Politécnica, 135 P-1250-100 Lisboa Codex
Note for Guidance on the investigation of bioavailability and bioequivalence Released for consultation December 2000
H-1137 Budapest Tel.
EMEA/CPMP/EWP/2747/00
Fax (91-22) 285 45 64 E-mail: ebicindia@vsnl.com
Note for Guidance on co-ordinating investigator signature of clinical study reports Released for consultation December 2000
Schultz Information A/S Herstedvang 12
CPMP Pharmacovigilance Working Party
(351) 213 94 57 00 Fax (351) 213 94 57 50
Reference number
URL: http://www.ebicindia.com
Guidelines/Status
DK-2620 Albertslund Tlf.
EMEA/CPMP/PhVWP/2058/99
E-mail: spoce@incm.pt URL: http://www.incm.pt
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
URL: http://www.euroinfo.hu
CPMP Safety Working Party
JAPAN PSI-Japan
Reference number
SUOMI/FINLAND
Guidelines/Status
MALTA Miller Distributors Ltd
EMEA/ CPMP/ SWP/2775/99
Asahi Sanbancho Plaza #206 7-1 Sanbancho, Chiyoda-ku
CPMP Position paper on Selective Serotonin Uptake Inhibitors (SSRIs) and dependency/withdrawal reactions Adopted April 2000
URL: http://www.schultz.dk DEUTSCHLAND
EMEA/ CPMP/ SWP/1042/99
Akateeminen Kirjakauppa/ Akademiska Bokhandeln
Note for Guidance on Repeated dose toxicity Adopted July 2000
Malta International Airport PO Box 25
EMEA/ CPMP/ SWP/2278/00
(81-3) 32 34 69 21 Fax (81-3) 32 34 69 15
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Adopted December 2000
Keskuskatu 1/Centralgatan 1
EMEA /CPMP/SWP/4163/00
Luqa LQA 05
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
E-mail: books@psi-japan.co.jp
EMEA/CPMP/SWP/2145/00 Draft 4
Bundesanzeiger Verlag GmbH Vertriebsabteilung
Note for Guidance on Non-clinical local tolerance testing of medicinal products Released for consultation September 2000
PL/PB 128 FIN-00101 Helsinki/Helsingfors
EMEA Herbal Medicinal Products Working Party
(356) 66 44 88 Fax (356) 67 67 99
Reference number
URL: http://www.psi-japan.co.jp
Guidelines/Status
Amsterdamer Straße 192 D-50735 Köln
EMEA/HMPWP/23/00
P./tfn (358-9) 121 44 18 F./fax (358-9) 121 44 35
Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species Adopted by the Working Party in October 2000
E-mail: gwirth@usa.net
CPMP/QWP/2819/00
(49-221) 97 66 80 Fax (49-221) 97 66 82 78 E-Mail: vertrieb@bundesanzeiger.de
Note for guidance on quality of herbal medicinal products Released for consultation November 2000
POLSKA Ars Polona
CPMP/QWP/2820/00
EBIC Malaysia Suite 45.02, Level 45 Plaza MBf (Letter Box 45)
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
URL: http://www.bundesanzeiger.de
86 EMEA General Report 2000
Krakowskie Przedmiescie 7 Skr. pocztowa 1001
CVMP Efficacy Working Party Reference number EMEA/ CVMP/133/99
8 Jalan Yap Kwan Seng 50450 Kuala Lumpur
Guidelines/Status Conduct of pharmacokinetic studies in animals Adopted March 2000
ELLADA/GREECE
EMEA/ CVMP/344/99
(48-22) 826 12 01
Conduct of efficacy studies for intramammary products for use in cattle Adopted March 2000
(60-3) 21 62 92 98 Fax (60-3) 21 62 61 98
EMEA/ CVMP/005/00
(30-1) 331 41 80/1/2/3/4/5
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
S-221 82 Lund Tlf.
EMEA/CVMP/016/00
Fax (48-22) 826 62 40 E-mail: books119@arspolona.com.pl ROMÂNIA
The conduct of bioequivalence studies for veterinary medicinal products Released for consultation January 2000
E-mail: ebic@tm.net.my MÉXICO Mundi Prensa México, SA de CV
CVMP/VICH/546/00
Fax (30-1) 323 98 21 E-mail: elebooks@netor.gr
Efficacy of anthelmintics:
65, sector 1
Specific recommendations for poultry Released for consultation July 2000
Río Pánuco, 141 Colonia Cuauhtémoc
CVMP/VICH/545/00
URL: elebooks@hellasnet.gr ESPAÑA
Efficacy of anthelmintics:
UNITED KINGDOM The Stationery Office Ltd
Specific recommendations for feline Released for consultation July 2000
(40-1) 315 44 03 Fax (40-1) 312 96 46
CVMP Immunologicals Working Party Reference number CVMP/IWP/52/97
(52-5) 533 56 58 Fax (52-5) 514 67 99
Guidelines/Status Requirements for combined veterinary vaccines Adopted March 2000
Customer Services PO Box 29
CVMP/IWP/07/98
101545.2361@compuserve.com
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use Adopted March 2000
Trafalgar, 27 E-28071 Madrid
EMEA/ CVMP/682/99
(44) 870 60 05-522
Duration of protection achieved by veterinary vaccines Adopted October 2000
PHILIPPINES EBIC Philippines
EMEA/ CVMP/852/99
(34) 913 84 17 15 (suscripción)
Field trials with veterinary vaccines Released for consultation March 2000
Centrum VTI SR Nám.
EMEA/CVMP/743/00
Fax (34) 915 38 21 21 (libros), Fax (34) 913 84 17 14 (suscripción)
Requirements and controls applied to bovine serum (foetal or calf) used in the protection of immunological veterinary medicinal products Released for consultation October 2000
URL: http://www.itsofficial.net
CVMP Pharmacovigilance Working Party
(421-7) 54 41 83 64
Reference number EMEA/ CVMP/044/99
E-mail: clientes@com.boe.es URL: http://www.boe.es Mundi Prensa Libros, SA Castelló, 37 E-28001 Madrid
Guidelines/Status Conduct of post-marketing surveillance studies of veterinary medicinal products Adopted April 2000
(354) 552 55 40
CVMP/VICH/547/00
Fax (421-7) 54 41 83 64 E-mail: europ@tbb1.sltk.stuba.sk URL: http://www.sltk.stuba.sk SLOVENIJA
Management of adverse event reports (AERs) Released for consultation July 2000
(34) 914 36 37 00
CVMP Safety Working Party
Fax (354) 552 55 60
linesStatus number
Gospodarski Vestnik
Reference
E-mail: bokabud@simnet.is
Guidelines/Status
Dunajska cesta 5 SLO-1000 Ljubljana
EMEA/ CVMP/276/99
Eurochamber of Commerce in South Africa PO Box 781738
Assessment of the effect of antimicrobial substances on dairy starter cultures Adopted March 2000
2146 Sandton Tel.
EMEA/ CVMP/473/98
E-mail: europ@gvestnik.si URL: http://www.gvestnik.si
Determination of withdrawal periods for milk Adopted March 2000
Boks 6512 Etterstad
CVMP/ VICH/592/98
(33) 140 58 77 31 Fax (33) 140 58 77 00 E-mail: europublications@journal-officiel.gouv.fr
Environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1 Adopted July 2000
N-0606 Oslo Tel.
EMEA/CVMP/187/00
The European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom
Risk analysis approach for residues of veterinary medicinal products in food of animal origin Released for consultation May 2000
URL: http://www.journal-officiel.gouv.fr IRELAND
CVMP/VICH/526/00
SCHWEIZ/SUISSE/SVIZZERA Euro Info Center Schweiz
Safety studies for veterinary drug residues in human food:
202, Jangchung-dong 2 Ga, Chung-ku Seoul 100-392 Tel.
Genotoxicity studies Released for consultation July 2000
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16
CVMP/VICH/525/00
Alan Hanna’s Bookshop 270 Lower Rathmines Road Dublin 6
Safety studies for veterinary drug residues in human food:
c/o OSEC Stampfenbachstraße 85 PF 492
Reproduction studies Released for consultation July 2000
ARGENTINA World Publications SA
87 EMEA General Report 2000
E-Mail: mail@emea.eudra.org
Joint CPMP/CVMP Quality Working Party
(353-1) 496 73 98
Reference number
CH-8035 Zürich Tel.
Guidelines/Status
Cordoba 1877
CPMP/ QWP/1676/00
SRI LANKA
Concept Paper on the Development of a CPMP/CVMP Note for Guidance on Quality of Water for Pharmaceutical Use Adopted July 2000
Internet: http://www.emea.eu.int
CPMP/ QWP/3015/99
Fax (353-1) 496 02 28 E-mail: hannas@iol.ie
Note for Guidance on Parametric Release Released for consultation March 2000
Fax (41-1) 365 54 11
CPMP/ QWP/1719/00
(54-11) 48 15 81 56
Note for Guidance on Medicinal Gases – Pharmaceutical Information Released for consultation July 2000
EBIC Sri Lanka Trans Asia Hotel
CPMP/QWP/2845/00
E-mail: eics@osec.ch
Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products Released for consultation November 2000
Fax (54-11) 48 15 81 56
CPMP/QWP/2820/00 (CVMP/815/00)
URL: http://www.osec.ch/eics
Note for Guidance on Specifications:
E-mail: wpbooks@infovia.com.ar URL: http://www.wpbooks.com.ar
Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products Released for consultation November 2000
Gardiner Mawatha Colombo 2
CPMP/QWP/2819/00 (CVMP/814/00) EMEA/ CVMP/065/99
Zahlreiche weitere Informationen zur Europäischen Union sind verfügbar über Internet, Server Europa (http://europa.eu.int).
Note for Guidance on Quality of Herbal Medicinal Products Released for consultation November 2000 Annex to Guideline:
Licosa SpA Via Duca di Calabria, 1/1 Casella postale 552 I-50125 Firenze
Development pharmaceutics for veterinary medicinal products:
B@LGARIJA Europress Euromedia Ltd 59, blvd Vitosha
Decision trees for the selection of sterilisation methods Adopted February 2000
AUSTRALIA Hunter Publications
EMEA/ CVMP/422/99
(94-1) 074 71 50 78 Fax (94-1) 44 87 79 E-mail: ebicsl@slnet.ik
Declaration of storage conditions for veterinary medicinal products in the product particulars Adopted February 2000
BG-1000 Sofia Tel.
CVMP/VICH/501/99
PO Box 404 Abbotsford, Victoria 3067
Stability testing of biotechnological/biological veterinary medicinal products Adopted June 2000
UNITED STATES OF AMERICA
CVMP/ VICH/502/99
E-mail: licosa@licosa.com
Impurities: residual solvents Adopted June 2000
Bernan Associates
EMEA/ CVMP/198/99
Bibliografische Daten befinden sich am Ende der Veröffentlichung.
Maximum shelf-life for sterile medicinal products after first opening or following reconstitution Adopted July 2000
URL: http://www.licosa.com LUXEMBOURG
CVMP/VICH/595/98
(1-800) 274 44 47 (toll free telephone)
Good clinical practices Adopted July 2000
Luxemburg:
EMEA/CVMP/846/99
Messageries du livre SARL 5, rue Raiffeisen L-2411 Luxembourg
Stability testing of existing active substances and related finished products Adopted November 2000
_BAR_ESKÁ REPUBLIKA ÚVIS odd.
EMEA/CVMP/816/00
Fax (1-800) 865 34 50 (toll free fax) E-mail: query@bernan.com URL: http://www.bernan.com
Statistical principles for veterinary clinical trials Released for consultation November 2000
ANDERE LÄNDER/OTHER COUNTRIES/
Ad hoc GMP Inspectors Working Group
ISBN 92-9155-033-7
Reference number
CZ-130 00 Praha 3 Tel.
Guidelines/Status
(55-21) 262 47 76
ENTR/ III/5717/99
Bitte wenden Sie sich an ein Büro Ihrer Wahl/Please contact the sales office of your choice/Veuillez vous adresser au
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
© EMEA, 2001
ENTR/6266/00
Office for Official Publications of the European Communities
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Finalised in April 2000
(31-70) 378 98 80
ENTR/6109/00
3020, chemin Sainte-Foy Sainte-Foy, Québec G1X 3V6
Draft Annex 6 to EU Guide to Good Manufacturing Practice on Medicinal Gases Released for consultation March 2000
(352) 29 29-42455
ENTR/6270/00
(357-2) 88 97 52 Fax (357-2) 66 10 44 E-mail: demetrap@ccci.org.cy
Draft Annex 17 to EU Guide to Good Manufacturing Practice on Parametric Release Released for consultation April 2000
Tel.
88
Der Europäischen Agentur für die Beurteilung von Arzneimitteln
The European Agency for the Evaluation of Medicinal Products
Siebter Jahresbericht 2001
Seventh Annual Report 2001
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.
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.
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
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.
(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
It can be accessed through the Europa server (http://europa.eu.int)
It can be accessed through the Europa server (http: / /europa. eu. int)
The European Agency for the Evaluation of Medicinal Products
EMEA Annual Report 2001
EMEA/MB/052/01-DE
Contents
SIEBTER JAHRESBERICHT ÜBER DIE TÄTIGKEIT DER EUROPÄISCHEN AGENTUR FÜR DIE BEURTEILUNG VON ARZNEIMITTELN
Foreword by the Chairman of the Management Board
Verabschiedet vom Verwaltungsrat am 18.
Chapter 3 Veterinary Medicines 3.1 Initial evaluation
Dezember 2001
23 24
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Introduction by the Executive Director
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.eu.int http://www.emea.eu.int Inhalt
4
VORWORT DES VORSITZENDEN DES VERWALTUNGSRATES EINLEITUNG DES DIREKTORS STRUKTUR DER EMEA................
3.2 Establishment of maximum residue limits for old substances
...............
25
........
Structure of the EMEA
KAPITEL 1 DIE EMEA IM EUROPÄISCHEN SYSTEM 1.1 Verwaltungsrat 1.2 Zuständige nationale Behörden 1.3 Transparenz und zulassungsrechtlicher Dialog 1.4 Revision der Gebührenordnung der EMEA
Chapter 1 EMEA in the European System
..........
Scientific advice
8 8 9 9 9
9 9
1.5 Revision des europäischen Zulassungssystems 1.6 Qualitätsmanagement 1.7 Internationale Partner 1.8 Europäische Abteilung für die Qualität von Arzneimitteln 1.9 Finanzkontrolle
Chapter 5 Administration and Support Activities 5.1 Administration 5.2 Document management and publishing
11 11 12 14 14
10 11 12
KAPITEL 2 HUMANARZNEIMITTEL 2.1 Erstbeurteilung 2.2 Folgeverfahren nach Erteilung der Zulassung 2.3 Pharmakovigilanz und Aufrechterhaltung von Zulassungen 2.4 Wissenschaftliche Beratung 2.5 Schiedsverfahren und gemeinschaftliche Überweisung 2.6 Besondere Dienstleistungen 2.7 Internationale Aktivitäten 2.8 Arzneimittel für seltene Leiden 2.9 Arbeitsgruppen und Ad-hoc-Arbeitsgruppen 2.10 Arbeitsgruppe zur Erleichterung der gegenseitigen Anerkennung
Pharmacovigilance and maintenance activities Scientific advice Arbitration and Community referrals
16 18 20 21 22 24 26 26 28 30 34
16
KAPITEL 3 TIERARZNEIMITTEL 3.1 Erstbeurteilung 3.2 Festsetzung von Rückstandshöchstmengen für alte Substanzen 3.3 Folgeverfahren nach Erteilung der Zulassung 3.4 Pharmakovigilanz und Aufrechterhaltung von Zulassungen 3.5 Wissenschaftliche Beratung 3.6 Schiedsverfahren und gemeinschaftliche Überweisung 3.7 Interessengruppen 3.8 Internationale Tätigkeiten 3.9 Arbeitsgruppen und Ad-hoc-Arbeitsgruppen 3.10 Arbeitsgruppe zur Erleichterung der gegenseitigen Anerkennung von Tierarzneimitteln
2.8
38 40 42 42 43 43 43 45 45 46 48
Orphan medicinal products
KAPITEL 4 INSPEKTIONEN
4 Members of the Committee for Orphan
49
2.9
KAPITEL 5 VERWALTUNG UND ORGANISATORISCHE UNTERSTÜTZUNG 5.1 Verwaltung 5.2 Dokumentenverwaltung und -veröffentlichung 5.3 Tagungs- und Konferenzverwaltung 5.4 Informationstechnologie
Working parties and ad hoc groups
53 53 56 57 58
18
ANHÄNGE ...........................................................................................................................................................61
Medicinal Products
Anhang 1 Mitglieder des Verwaltungsrates Anhang 2 Mitglieder des Ausschusses für Arzneispezialitäten Anhang 3 Mitglieder des Ausschusses für Tierarzneimittel Anhang 4 Mitglieder des Ausschusses für Arzneimittel für seltene Leiden Anhang 5 Partner in den zuständigen nationalen Behörden Anhang 6 EMEA-Haushaltspläne für die Jahre 2000 bis 2002 Anhang 7 Gutachten des CPMP zu Humanarzneimitteln 2001 Anhang 8 Gutachten des CVMP zu Tierarzneimitteln 2001 Anhang 9 Gutachten des COMP zur Ausweisung von Arzneimitteln für seltene Leiden 2001 Anhang 10 EMEA-Leitlinien und Arbeitsdokumente 2001 Anhang 11 Ansprechpartner bei der EMEA
42
62 63 64 65 66 70 71 76 79 86 91
2.10 Mutual recognition facilitation group
Der Jahresbericht 2001 wird dem Verwaltungsrat gemäß Artikel 55 Absatz 3 der Verordnung (EWG) Nr.
20
Vorherige Jahresberichte und andere Dokumente sind auf der Website der EMEA http://www.emea.eu.int erhältlich.
5 6 7 8 9
In Kapitel 1 werden die Aktivitäten des Verwaltungsrates behandelt, ferner die Partnerschaften mit den zuständigen nationalen Behörden und europäischen Institutionen sowie weitere globale Aspekte der EMEA, darunter die Bemühungen um Transparenz und internationale Aktivitäten.
National competent authority partners EMEA budget summaries 2000-2002 CPMP opinions in 2001 on medicinal products for human use CVMP opinions in 2001 on medicinal products for veterinary use COMP opinions in 2001 on designation of orphan medicinal products
Über die Tätigkeit der EMEA im Jahre 2001 im Rahmen ihrer Geschäftsaufgaben sowie deren technischer Unterstützung berichten die Kapitel 2 (Humanarzneimittel), 3 (Tierarzneimittel) und 4 (Inspektionen).
2 EMEA Annual Report 2001
Gemäß Artikel 15 Absatz c Unterabsatz 1 der Richtlinie 75/319/EWG des Rates und Artikel 23 Absatz c Unterabsatz 1 der Richtlinie 81/851/EWG des Rates enthält dieser Bericht auch einen Überblick über den Ablauf des dezentralisierten Verfahrens (Verfahren der gegenseitigen Anerkennung) im Jahre 2001.
10 11
November 2001 auch neue E-Mail-Adressen für die Mitarbeiter der EMEA eingeführt:
Guidelines and working documents in 2001 EMEA contact points
Vorname.Familienname@emea.eudra.org
60 68
Vorname.Familienname@emea.eu.int
EMEA mission statement
Die generelle E-Mail-Adresse für die EMEA lautet nunmehr mail@emea.eu.int, und die Adressen für spezielle Aufgabenbereiche werden sich in der gleichen Weise ändern, z.
The European system offers two routes for authorisation of medicinal products.
B. certificate@emea.eu.int
The EMEA plays a role in both procedures:
Oktober 2002 gültig sein.
To contribute to the protection and promotion of public and animal health by: • Mobilising scientific resources from throughout the European Union to provide high quality evaluation of medicinal products, to advise on research and development programmes and to provide useful and clear information to users and health professionals
Diese Änderung der Domäne ergibt sich aus der Änderung der Website der Agentur in www.emea.eu.int Anfang 2001 und erfolgt im Rahmen der einheitlichen Ausrichtung der EMEA mit den anderen Organen und Einrichtungen der EU.
products derived from biotechnology, and available at the request of companies for other innovative new products.
Der Auftrag der EMEA
Applications are submitted directly to the EMEA.
Auftrag der EMEA ist der Schutz und die Förderung der Gesundheit von Mensch und Tier durch:
• Developing efficient and transparent procedures to allow timely access by users to innovative medicines through a single European marketing authorisation
die Mobilisierung wissenschaftlicher Ressourcen aus der gesamten Europäischen Union, um Arzneimittel auf höchstem Qualitätsniveau zu beurteilen, um Beratung bei Forschungs- und Entwicklungsprogrammen zu leisten und um Patienten und Angehörigen der Gesundheitsberufe hilfreiche und klare Informationen bereitzustellen;
It provides for the extension of marketing authorisations granted by one
die Entwicklung effizienter und transparenter Verfahrensabläufe, um Patienten auf möglichst schnellem Weg innovative Arzneimittel durch eine einzige europäische Genehmigung für das Inverkehrbringen zur Verfügung zu stellen;
• Controlling the safety of medicines for humans and animals, in particular through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals
die Kontrolle der Sicherheit von Arzneimitteln für Mensch und Tier, insbesondere durch ein leistungsfähiges Pharmakovigilanznetzwerk und die Festsetzung von sicheren Rückstandsgrenzwerten bei Tieren, die zur Lebensmittelerzeugung genutzt werden.
The opinion of the scientific committee is transmitted to the European Commission.
Das europäische System bietet zwei Möglichkeiten für die Zulassung von Arzneimitteln.
The European Commission adopts its decision with the assistance of a standing committee composed of representatives of the Member States.
Die EMEA spielt bei beiden Verfahren eine Rolle:
EMEA Annual Report 2001
Das zentralisierte Verfahren ist für biotechnologisch hergestellte Arzneimittel zwingend vorgeschrieben und kann fakultativ von den Unternehmen auch für andere innovative Produkte beantragt werden.
3
Das dezentralisierte Verfahren (oder Verfahren zur gegenseitigen Anerkennung) wird bei der Mehrzahl der konventionellen Arzneimittel angewendet und basiert auf dem Prinzip der gegenseitigen Anerkennung nationaler Zulassungen.
Foreword by the Chairman of the Management Board Keith Jones The year 2001 was a year of continuing success for the EMEA, achieved against a background of considerable change.
Es sieht vor, dass die von einem Mitgliedstaat gewährten Genehmigungen für das Inverkehrbringen auf einen oder mehrere andere vom Antragsteller benannte Mitgliedstaaten ausgeweitet werden.
We welcomed Thomas Lönngren at the start of the year as the new Executive Director.
Falls eine Anerkennung der ursprünglichen nationalen Zulassung nicht möglich ist, werden die strittigen Punkte der EMEA im Rahmen eines Schiedsverfahrens zugeleitet.
The Management Board elected a new chairman and several organisational changes were adopted within the Agency with a view to improving both efficiency and effectiveness.
Das Gutachten des wissenschaftlichen Ausschusses wird der Europäischen Kommission übermittelt.
The environment within which the EMEA operated also saw significant change, the nature and extent of which is likely to increase even further in the future.
Die Europäische Kommission trifft ihre Entscheidung mit Unterstützung eines ständigen Ausschusses, der sich aus Vertretern der Mitgliedstaaten zusammensetzt.
The Agency, its management, its staff and its advisors, took all of these changes in their stride, and achieved all that was expected of them, as is described in this report.
Zu Beginn des Jahres hießen wir Thomas Lönngren als neuen Direktor willkommen.
None of this will be achieved in isolation and the Agency will work hard to harness the good will, experience, knowledge and expertise of all existing regulators in this venture.
Der Verwaltungsrat wählte einen neuen Vorsitzenden, und in der Agentur wurden verschiedene organisatorische Neuerungen eingeführt, um die Arbeit noch rationeller und effizienter zu gestalten.
A closer association of heads of the national authorities to the Agency’s resource planning will be important in achieving better joint management of the resources available across the entire Community.
Auch im Umfeld der EMEA vollzogen sich bedeutsame Wandlungsprozesse, die künftig noch stärker und umfassender zum Tragen kommen werden.
I, together with my colleagues on the Management Board, would like to thank everyone who has contributed to the success of the EMEA, especially the staff for their hard work and dedication throughout the year.
Wie aus dem vorliegenden Bericht hervorgeht, bewältigten die Agentur, ihre Leitung, ihre Mitarbeiter und Berater all diese Entwicklungen problemlos und erfüllten sämtliche in sie gesetzten Erwartungen.
The Management