qanastek/EMEA-V3 huggingface dataset:
Residual Solvents (CVMP/ VICH/ 502/ 99) • Environmental Impact Assessment (EIAs) for VMPs (CVMP/ VICH/ 592/ 98)
Quest’ ultima riceve relazioni sulla sicurezza degli Stati membri dell’ UE e dai paesi terzi per prodotti autorizzati in base alla procedura centralizzata e coordina le azioni relative alla sicurezza e alla qualità dei medicinali.
Guidelines released for consultation • Management of adverse event reports (CVMP/ VICH/ 547/ 00) • Efficacy of anthelmintics:
Questioni riguardanti la farmacovigilanza per i medicinali per uso umano
Specific recommendations for poultry (CVMP/ VICH/ 546/ 00) • Efficacy of anthelmintics:
Referente Noël WATHION Telefono diretto (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eudra. org
Specific recommendations for feline (CVMP/ VICH/ 545/ 00 • Environmental impact assessment (EIAS) for VMPs - Phase I (CVMP/ VICH/ 592/ 98) • Safety studies for veterinary drug residues in human food:
Questioni riguardanti la farmacovigilanza per i medicinali per uso veterinario barbara. freischem@emea. eudra. org
Genotoxicity studies (CVMP/ VICH/ 526/ 00)
Referente Barbara FREISCHEM Telefono diretto (44-20) 74 18 85 81 E-mail:
Details of these and other CVMP guidelines are given in Annex 11.
Prodotti difettosi e altre questioni riguardanti la qualità
EMEA/ CVMP transparency and dialogue in 2000
Stephen FAIRCHILD Numero di fax per allarmi prodotti difettosi (44-20) 74 18 85 90 E-mail: stephen. fairchild@emea. eudra. org
January February March
Certificazione
Celebration of 5th anniversary of EMEA inauguration Bilateral meeting with FEDESA Joint EMEA/ TAIEX meeting for central and eastern European countries CVMP/ interested parties meeting
L’ EMEA rilascia certificati relativi a prodotti medicinali, in linea con le disposizioni previste dall’ Organizzazione mondiale della sanità.
May July October November December
Informazioni sui certificati relativi a medicinali per Referente uso umano o veterinario autorizzati nel quadro della Jonna SUNELL-HUET procedura centralizzata
EMEA-FEDESA Info-day Bilateral meeting with FEDESA CVMP/ interested parties meeting Bilateral meeting with FEDESA EMEA-FEDESA Info-day
Telefono diretto (44-20) 74 18 84 65 E-mail: certificate@emea. eudra. org
45 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Relazione annuale 2000
3.4 Working party activities
Pagina 60/ 91
The CVMP working parties and the Joint CPMP/ CVMP Quality Working Party (see Chapter 4) met regularly in 2000.
Questi ed altri documenti sono disponibili sul sito Internet http: / /www. emea. eu. int, oppure possono essere richiesti scrivendo a:
Details of notes for guidance prepared by the working parties for the CVMP are given in Annex 11.
Subscription Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf London E14 4HB UK
Working Party
Ulteriori informazioni possono essere richieste all’ indirizzo di cui sopra, ovvero a
Chairperson
Referente Iro MAVROPOULOS Telefono diretto (44-20) 74 18 85 82 E-mail: subscriptions@emea. eudra. org
Meetings in 2000
Eventuali richieste riguardanti pacchetti di informazioni
Guidelines and points to
Referente
consider documents approved in 2000
di carattere generale vanno inviate a amanda. bosworth@emea. eudra. org
Pharmacovigilance working party (PhVWP)
Amanda BOSWORTH Telefono diretto (44-20) 74 18 84 08 E-mail:
Gabriella CONTI, then Cornelia IBRAHIM*
Richieste di visione degli elenchi di esperti europei
4
Le richieste possono essere formulate per iscritto all’ EMEA oppure essere inviate ai seguenti indirizzi di posta elettronica:
2
Elenco esperti medicine per uso umano
Immunologicals working party (IWP)
human_experts@emea. eudra. org
Paul-Pierre PASTORET
Elenco esperti medicine per uso veterinario
4
vet_experts@emea. eudra. org
5
Elenco esperti ispettori
Efficacy working party (EWP)
inspectors_experts@emea. eudra. org
Liisa KAARTINEN
Stampa e mass-media
4
Referente Noël WATHION Telefono diretto (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eudra. org
6
Questioni riguardanti medicinali per uso veterinario EMEA/ MB/ 050/ 00
Safety working party (SWP)
Referente Peter JONES Telefono diretto (44-20) 74 18 84 13 E-mail: peter. jones@emea. eudra. org
Michelle DAGORN
Referenti
4
Pagina 61/ 91
6
Martin HARVEY Telefono diretto (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eudra. org
Antimicrobial resistance working group (ARWG)
Antoine CUVILLIER Telefono diretto (44-20) 74 18 84 28 E-mail: antoine. cuvillier@emea. eudra. org
Margarita ARBOIX
Pagina 62/ 91
3
3) Regolamento (CE) N.
3.5 Activities of the veterinary mutual recognition facilitation group
141/ 2000 del Parlamento europeo e del Consiglio, del 16 dicembre 1999 concernente i medicinali orfani (GUCE L 18, 22.1.2000, p.
The EMEA provided full secretariat and administrative support to the group.
1) Stato delle entrate e delle spese dell’ Agenzia europea di valutazione dei medicinali per l’ esercizio 2000, inclusi gli stanziamenti definitivi per il 1999 e l’ esecuzione del bilancio 1998.
Dossier assessment
(GUCE L 184, 24.7.2000, p.
The number of mutual recognition procedures completed increased from 39 in 1999 to 47 in 2000.
1) I testi di queste e di altre disposizioni sono contenuti nella raccolta La disciplina relativa ai medicinali nell’ Unione europea.
There was also a steady increase in the number of variation procedures.
Le suddette pubblicazioni, unitamente alle copie della Gazzetta Ufficiale, possono essere richieste al seguente indirizzo:
Seven Member States acted as reference member state in the procedures.
Ufficio delle pubblicazioni ufficiali delle Comunità europee 2, rue de Mercier L - 2985 Luxembourg
In order to improve the procedure, Member States committed to decrease the number of questions asked to applicants and a follow-up of reasons for withdrawal was performed with a view to solve problems for future applications.
Sono inoltre disponibili sul sito Internet di EudraLex: http: / /pharmacos. eudra. org/ eudralex/ index. htm
46 EMEA General Report 2000
Documenti EMEA
Improvement in transparency
Prima relazione generale di attività dell’ Agenzia europea di valutazione dei medicinali 1995 (ISBN92-827-7491-0, Ufficio delle pubblicazioni ufficiali dell’ UE) Seconda relazione generale di attività dell’ Agenzia europea di valutazione dei medicinali 1996 (ISBN 92-9155-002-7, Ufficio delle pubblicazioni ufficiali dell’ UE) Terza relazione generale di attività dell’ Agenzia europea di valutazione dei medicinali 1997 (ISBN 92-9155-010-8, Ufficio delle pubblicazioni ufficiali dell’ UE) Quarta relazione generale di attività dell’ Agenzia europea di valutazione dei medicinali 1998 (ISBN 92-9155-018-3, Ufficio delle pubblicazioni ufficiali dell’ UE) Quinta relazione generale di attività dell’ Agenzia europea di valutazione dei medicinali 1999 (ISBN 92-9155-026-4, EMEA) Dichiarazione dei principi che regolano il partneriato tra le autorità nazionali competenti e L’ EMEA (EMEA/ MB/ 013/ 97) Regolamento finanziario applicabile al bilancio dell’ EMEA (EMEA/ MB/ 011/ 97) Decisione del direttore esecutivo, del 3 dicembre 1997, sulle norme di accesso ai documenti EMEA (EDIR/ 016/ 1997) Decisione del direttore esecutivo, del 1° giugno 1999, sulla cooperazione con l’ Ufficio europeo per la lotta antifrode (OLAF) (EDIR/ 006/ 1999) Catalogo dei documenti pubblici dell’ EMEA (aggiornato regolarmente) Codice di comportamento EMEA (EMEA/ D/ 37674/ 99)
An index of products authorised through the mutual recognition procedure was published in April 2000 on the heads of veterinary agencies (HEVRA) web site: http: / /www. hevra. org.
Questi ed altri documenti sono disponibili sul sito Internet http: / /www. emea. eu. int oppure scrivendo a:
The index gives access to core information for each product, together with the English- language version of the summary of product characteristics.
Sector for Document management and publishing European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf London E14 4HB UK EMEA/ MB/ 050/ 00 Relazione annuale 2000 Allegato 2 Bilanci dell’ EMEA dal 1999 al 2001
Organisational issues
Pagina 63/ 91
A number of organisational issues were discussed and solved.
Qui di seguito sono riportati i bilanci sintetici comparati per gli esercizi dal 1999 al 2001.
Companies were given the possibility of asking questions directly to the VMRF through the HEVRA web site and the VMRF answered 8 questions related to the mutual recognition procedure in 2000.
1999(1)
3.6 Information technology
2000(2)
Preparations for ensuring compliance with year 2000 requirements were found to have been justified and well founded when the Agency opened for business on 2 January 2000 with no associated problems encountered.
2001(3)
The Agency’ s expansion to floor 7 in 2000 required a significant commitment to provide the necessary infrastructure and support to service the needs of staff in their new office accommodation.
Spese Personale
As part of the sector’ s commitment to performance, the target of minimum system availability was exceeded in 2000, with almost 100% availability of the complete range of information technology services.
(31.12.1999)
47 EMEA General Report 2000
(al 31.12.2000)
During 2000, the sector developed and implemented a desktop videoconferencing system (using Internet protocol and ISDN).
(al 20.12.2000)
In addition to its support function, the sector undertook the development and implementation of a number of new mainstream projects, including an EMEA internal web-based news and alert channel called Ticker.
stipendi
The majority of resources in the sector are assigned to operations and network support functions, with a significant proportion also assigned to the development of applications and other small projects.
15
Resource allocation for information technology
074 905
SIAMED 6.3% Other activities 12.9% SI 2 7.3%
36.61%
Management 3.5%
493 000
Helpdesk support 4.9%
33.45%
Other applications and small projects 23.3% Operations and network 41.8%
21
48 EMEA General Report 2000
772 000
Chapter 4 Technical coordination activities
35.15%
Overview of the Technical Coordination Unit
personale interinale e altro personale di sostegno
Head of Unit Head of Sector for inspections Head of Sector for document management and publishing Head of Sector for conference services
955 456
Karel de NEEF Stephen FAIRCHILD Beatrice FAYL Sylvie BÉNÉFICE
2.32%
The Technical Coordination Unit provides logistical support
1
to human and veterinary
058 000
medicines evaluation activities regarding inspections and medicinal products certificates, as well as a number of general services to EMEA, including document management and conference services.
1.91%
ActiTrak data for technical coordination activities in 2000
1
Overheads
379 000
Initial evaluation 5%
2.23%
(specific unit/ Specific post-authorisation 2% sector) 15%
altre spese relative al personale
Overheads
1
Maintenance
191 570
activities 19%
2.89%
Administrative Special activities to be earmarked 8%
1
charges 8%
350 000
EU general contribution 31%
2.44%
49 EMEA General Report 2000
1
4.1 Inspections
501 000
Coordination of inspections for centralised procedures
2.42%
Inspections carried-out for centralised procedures 1998-2000
totale titolo 1 Immobili/ materiale
70
17
40
221 931
30
41.82%
10
37.80%
0
24
1998
652 000
1999
39.80%
2000
136 038
The number of good manufacturing practice (GMP) inspections performed in 2000 was higher than expected due to a carry-over of 16 inspection requests from 1999 and a significant increase in requests in 2000.
5.19%
A database of GMP inspections was completed in 2000 in order to provide management reports and information for coordinating inspections and to provide a direct input of data into the SIAMED application tracking system.
5
There was a marked increase in the number of good clinical practice (GCP) inspections performed for centralised procedures in 2000, involving sponsor, investigator and laboratory sites.
212 220
Sampling and testing
9.43%
Monitoring of centrally authorised medicinal products is performed by the Network of Official Medicines Control Laboratories.
5
A testing programme for 2001 was agreed in 2000.
685 000
A total of 5 reports on quality problems concerning centrally authorised products were received and monitored by the EMEA, leading to 2 product recalls.
9.18%
50 EMEA General Report 2000
spese relative all’ informatica
Mutual recognition agreements
1
On-going discussions or MRAs in transition period
034 357
EC – Canada MRA
2.51%
The equivalence assessment between EC and Canada of GMP compliance systems was completed in 2000.
2
EC – US MRA
423 500
The evaluation of the EC and US legislation and GMP guidelines and compliance systems continued in 2000.
1
EC – Switzerland MRA
400 000
The text of the agreement and explanatory notes were agreed and ratified in May 2000.
2.26%
EC – Australia MRA and EC – New Zealand MRA (veterinary medicinal products)
altre spese relative alle attrezzature
Activities continued in 2000 to evaluate equivalence of these agreements.
1
MRAs in force
824 960
EC – Australia MRA and EC – New Zealand MRA (human medicinal products)
4,43%
Activities in 2000 included the development of a maintenance programme and other documents to facilitate the operation.
2
Certification of medicinal products
353 000
New arrangements for requesting certificates of a medicinal product were introduced in 2000 and posted on the EMEA web site.
4.26%
The number of certificates requested fell from 9 652 in 1999 to 8 357 in 2000.
824 500
Joint CPMP/ CVMP Quality working party
1,33%
A meeting with interested parties took place in October 2000.
spese postali e telecomunicazioni
51 EMEA General Report 2000
370 754
4.2 Document management and publishing
0.90%
Product information
480 000
A joint project on product information management between EMEA and the European Federation of Pharmaceutical Industries and Associations was launched in 2000.
0.87%
The purpose of the product information management (PIM) project is to reduce the workload for industry and regulators for the maintenance of product information documents (summary of product characteristics, patient information and labelling).
537 000
The product information templates on the EMEA web site were reviewed in 2000 and the template for summary of product characteristics, labelling and package leaflet (template 1a) was revised in all 11 official EU languages following the adoption of the December 1999 Guideline on summary of product characteristics and is available on the EMEA web site.
0.87%
Electronic submission
altre spese amministrative
Electronic submission will facilitate data exchange between applicants and marketing authorisation holders with the EMEA.
1
An electronic submission development web site was established in 2000 to provide information on work in progress: http: / /esubmission. eudra. org
194 962
Document management
2,90%
A public tender procedure was conducted in 2000 for the selection of an electronic document management system.
1
The sector coordinated the compilation of the EMEA catalogue of documents, which was published for the first time in November 2000.
593 000
52 EMEA General Report 2000
2.88%
4.3 Conference services
1
EMEA meetings
784 500
Activities relating to the organisation of meetings at the EMEA increased by over 37% in 2000.
2,88%
Meetings at the EMEA 1995-2000
totale titolo 2 Spese di funzionamento
350
6
300
561 071
250
15.93%
200
12
150
061 720
100
21.82%
50
10
1995
274 441
1996
7.95%
1997
487 000
1998
6.31%
1999
6
2000
565 000
A call for tender for the provision of travel agency services was completed in 2000 and a service provider appointed The user requirements for improving the meeting management system were defined.
10.60%
Progress was made in planning the new conference rooms on floor 3.
valutazione dei medicinali traduzioni
Pan-European Regulatory Forum
658 000 428 000
The contract for the conduct of the first phase of the Pan-European Regulatory Forum on Pharmaceuticals (PERF I) was completed in 2000.
31.74%
53 EMEA General Report 2000
studi e consulenze
54 EMEA General Report 2000
0.00% 0.23%
Chapter 5 Administration
5 000
Overview of the Administration Unit
0.69% 0.29%
Overview of the Administration Unit
pubblicazioni
Head of Unit Head of Sector for personnel, budget and facilities Head of Sector for accounting
0.27%
Andreas POTT Frances NUTTALL Gerard O’ MALLEY
220 000
The Administration Unit is responsible for personnel, budget,
0.36%
accounting and facilities.
totale titolo 3
In addition, a number of projects set out in the Work Programme have been completed:
40.38%
• Euro consolidated into the financial and budgetary proceedings of the Agency • recruitment targets achieved • budget monitored and adjusted, particularly in response to increased revenues and the financing of new tasks such as orphan medicinal products and PERF II • preparation of organisational restructuring of the Unit for the Evaluation of Medicines for Human Use • restructuring and refurbishment of EMEA offices as part of building policy
27
Personnel, budget and facilities
051 000
A personnel database was selected in 2000 that will facilitate personnel administration, in particular leave records, evaluation reports and other personnel details.
43.68%
EMEA staff members by category and sex
TOTALE SPESE
70
41
50
61
s Male
934 000
s Female
diritti
40
28
30
39
20
68.81%
0
13
Category A
200 000 23.88%
Category B
14 700 000
Category C
23.73%
Category D
0.00%
55 EMEA General Report 2000
000 000 1.81%
EMEA staff members by nationality
sovvenzione dall’ EEA sovvenzione da programmi UE
Belgium 7%
0.00%
UK 22%
0.40%
Denmark 5%
1.94%
Germany 12%
217 000 0.39%
Sweden 5% Greece 4%
3.94%
Finland 4%
2.30%
Portugal 4% Austria 1% Netherlands 4%
1
Spain 7%
471 000 2.66%
France 12%
2.15%
Luxembourg 0%
100.00%
Italy 8%
55 287 220 100.00%
Ireland 5%
100.00%
By constant budget monitoring and cost control the budget team successfully coordinated the execution of the budget and strove to achieve cost efficiencies.
(3) bilancio 2001: stanziamenti provvisori.
A detailed review of training needs and the provision of training was undertaken during the year to improve the opportunities available to staff members.
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Allegato 3 Composizione del consiglio di amministrazione André BROEKMANS1 Presidente
Additional office space of 1 460 m2 on the seventh floor of 7 Westferry Circus was occupied in 2000 to complement the existing three floors.
Membri
Facilities personnel also planned and began another major fitting out project in 2000 of the third floor for additional meeting rooms and delegate facilities.
Dietrich HENSCHLER, Jean-Pierre REYNIER Commissione europea Fabio COLASANTI3, Bertrand CARSIN4 Supplente:
The work will be concluded in early 2001.
Paul WEISSENBERG
56 EMEA General Report 2000
Belgique/ België Danmark
Refurbishment plans for the third floor, EMEA offices
André PAUWELS, Frans GOSSELINCKX Ib VALSBORG, Jytte LYNGVIG5
3D 3C
Deutschland Vicepresidente Ελλάδα / Greece España 9 BAIXAULI France Ireland
3B 3A
Hermann Josef PABEL, Gerhard Josef KOTHMANN, Marios MARSELOS6, Elias MOSSIALOS7 María Victoria de la CUESTA GARCIA8, Ramón PALOP Philippe DUNETON, Martin HIRSCH10 Tom MOONEY, Colm GAYNOR11
Room 3A – conference room (115 people)
Italia Luxembourg Nederland
Room 3B – multi-function meeting room (40 people)
Nello MARTINI, Romano MARABELLI Mariette BACKES-LIES John LISMAN12, Frits PLUIMERS
Room 3C – meeting room and video- conference suite (35 people)
Österreich Portugal Suomi/ Finland
Room 3D – meeting room (18 people)
Alexander JENTZSCH, Ernst LUSZCZAK Miguel ANDRADE13, Rógerio GASPAR14 Pekka JÄRVINEN15, Hannes WAHLROOS
Open area/ reception
Sverige United Kingdom
Accounts
Birgitta BRATTHALL, Anders BROSTRÖM Keith JONES, Michael RUTTER
Further productivity gains were seen in 2000 as increases in the volume of transactions processed were absorbed without increasing staff numbers.
4 Ha sostituito Joachim HEINE a partire dalla riunione del 22 febbraio 2000.
Following on from its implementation in 1999, further development of the SI2 budgetary accounting system and the implementation of the Sage general ledger system also contributed to increases in productivity.
8 Ha sostituito María Teresa PAGÉS JIMÉNEZ a partire dalla riunione del 20 dicembre 2000.
A forward exchange facility was negotiated with the Agency’ s banks to reduce to a minimum the effects of a weak Euro on the Agency’ s finances.
10 Ha sostituito Jacques BOISSEAU a partire dalla riunione del 22 febbraio 2000.
In 2000, 6 761 payments were made and 1 084 receipts processed, which is an increase of 11% and 45% respectively over 1999.
12 Ha sostituito André BROEKMANS a partire dalla riunione del 7 giugno 2000.
57 EMEA General Report 2000
15 Ha sostituito Kimmo LEPPO a partire dalla riunione del 22 febbraio 2000.
Volume of payments made in 1999 and 2000
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Osservatori
7000
Pagina 65/ 91
6000
Ísland Liechtenstein Norge/ Noreg
5000
Rannveig GUNNARSDÓTTIR, Ingolf PETERSEN Brigitte BATLINER, Peter MALIN Andreas DISEN, Gro Ramsten WESENBERG
s 1999
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Allegato 4 Composizione del comitato per le specialità medicinali 1 · Jean-Michel ALEXANDRE (France), Presidente
s 2000
Pagina 66/ 91
4000
· Eric ABADIE (France) Mark AINSWORTH (Danmark)2 · · Fernando de ANDRÉS-TRELLÉS (España) · Cristina AVENDAÑO (España) · Michalis AVGERINOS (Ελλάδα / Greece) Rolf BASS (Deutschland)3 · · Daniel BRASSEUR (Belgique/ België) Hans van BRONSWIJK (GUCE), Vicepresidente4 · · Geert DE GREEF (Belgique/ België) · Jens ERSBØLL (Danmark) · Silvio GARATTINI (Italia) · Jacqueline GENOUX-HAMES (Luxembourg) · Willem van der GIESEN (GUCE) · Lars GRAMSTAD (Norge/ Noreg) · Manfred HAASE (Deutschland) · Magnús JÓHANNSSON (Ísland) · Tove KARLSUD (Norge/ Noreg) Pekka KURKI (Suomi/ Finland)5 · · David LYONS (Ireland) Jose Guimarães MORAIS (Portugal)6 · · Per NILSSON (Sverige) · Jean-Louis ROBERT (Luxembourg) Frances ROTBLAT (United Kingdom)7 · Patrick SALMON (Ireland)8 · · Tomas SALMONSON (Sverige) · Cristina SAMPAIO (Portugal) · Sigurdur THORSTEINSSON (Ísland) · Markku TOIVONEN (Suomi/ Finland) · Jean-Hugues TROUVIN (France) · Guiseppe VICARI (Italia) · Patrick WALLER (United Kingdom) · Hans WINKLER (Österreich) · Christa WIRTHUMER-HOCHE (Österreich) · Julia YOTAKI (Ελλάδα / Greece)
3000
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Allegato 5 Composizione del comitato per i medicinali per uso veterinario1
1000
Pagina 67/ 91
0
·
Staff-related
Reinhard KROKER (Deutschland), Presidente
Building and facilities
· · · · · · · · · · · · · · · ·
Operations
Margarita ARBOIX (España) J.
Rapporters
· · · · · ·
Volume of income operations in 1999 and 2000
Liisa KAARTINEN (Suomi/ Finland) Herman LENSING (GUCE) Jan LUTHMAN (Sverige) Agostino MACRI (Italia) Ioannis MALEMIS (Ελλάδα / Greece) Maria Leonor MEISEL (Portugal)3
1200
· · · · · ·
1000
Manfred MOOS (Deutschland) Gérard MOULIN (France) John O’ BRIEN (United Kingdom) Eugen OBERMAY R (Österreich) Sigurdur ÖRN HANSSON (Ísland) Orestis PAPADOPOULOS (Ελλάδα / Greece)4
s 1999
· · · · · ·
s 2000
Paul-Pierre PASTORET (Belgique/ België) Margarida PRATAS (Portugal) Halldór RUNÓLFSSON (Ísland) Jean-Claude ROUBY (France) Liisa SIHVONEN (Suomi/ Finland) Marc WIRTOR (Luxembourg)
800
4 Ha sostituito Christos HIMONAS a partire dalla riunione dell’ aprile 2000.
600
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Allegato 6 Composizione del comitato per i medicinali orfani
Fee revenue and
Pagina 68/ 91
Other revenue
Presidente
Annexes
España
59 EMEA General Report 2000
Josep TORRENT i FARNELL
Annexes
Membri
EMEA contact points and reference documents
Belgique/ België Danmark Deutschland Ελλάδα / Greece
EMEA budgets 1998 to 2000
André LHOIR Jan RENNEBERG Rembert ELBERS1 George STRATHOPOULOS2
Members of the Management Board
France Ireland Italia Luxembourg
Members of the Committee for Proprietary Medicinal Products
François MEYER Brendan BUCKLEY Domenica TARUSCIO Henri METZ3
Members of the Committee for Veterinary Medicinal Products
GUCE Österreich Portugal Suomi/ Finland Sverige United Kingdom
Members of the Committee for Orphan Medicinal Products
Harrie SEEVERENS Hans Georg EICHLER José Manuel Gião TOSCANO RICO Kalle HOPPU Kerstin WESTERMARK Rashmi SHAH4
National competent authority partners
Rappresentanti organizzazioni pazienti
CPMP opinions in 2000 on medicinal products for human use
Moisés ABASCAL ALONSO5 Yann LE CAM, Vicepresidente Alastair KENT6
CVMP opinions in 2000 on medicinal products for veterinary use
Jean-Michel ALEXANDRE7 Rappresentanti EMEA Gianmartino BENZI Mary TEELING8 Osservatori
EMEA guidelines in 2000
Ísland Norge/ Noreg
60 EMEA General Report 2000
Sigurdur THORSTEINSSON Randi NORDAL
Annex 1:
1
EMEA contact points
Ha sostituito Tilman OTT a partire dalla riunione del settembre 2000.
Pharmacovigilance and product defect reporting 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.
6 In rappresentanza dell’ European Alliance of Genetic Support Groups (EAGS).
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.
8 Ha rassegnato le dimissioni nella riunione del settembre 2000.
For matters relating to pharmacovigilance for medicinal products for human use
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Allegato 7 Autorità nazionali competenti partner dell’ EMEA
Contact point Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eudra. org
Ulteriori informazioni sulle autorità nazionali competenti sono disponibili anche sui
For matters relating to pharmacovigilance for medicinal products for veterinary use
Internet delle autorità nazionali: http: / /heads. medagencies. org and http: / /www. hevra. org
Contact point Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara. freischem@emea. eudra. org
(32-2) 227 55 67 Fax (32-2) 227 55 55/ 56 39 E-mail: andre. pauwels@afigp. fgov. be Internet: http: / /www. afigp. fogv. be
For product defect and other quality-related matters
DANMARK
Contact point Stephen FAIRCHILD Fax number for defective product rapid alerts (44-20) 74 18 85 90 E-mail: stephen. fairchild@emea. eudra. org
(45) 44 88 93 34 Fax (45) 44 88 91 09 E-post: jyl@dkma. dk Internet: http: / /www. dkma. dk
Certificates of a medicinal product
DEUTSCHLAND
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organisation.
Harald SCHWEIM Direktor BfArM Friedrich-Ebert-Allee 38 D – 53113 Bonn Tel.
These certify the marketing authorisation and good manufacturing status of medicinal products in the EU and are intended for use in support of marketing authorisation applications in and export to non-EU countries.
(49-22) 82 07 32 03 Fax (49-30) 87 07 55 14 E-Mail: schweim@bfarm. de Internet: http: / /www. bfarm. de
For enquiries concerning certificates for centrally Contact points authorised medicines for human or veterinary use Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65 E-mail: certificate@emea. eudra. org
(49-30) 84 12 23 64 Fax (49-30) 84 12 29 65 E-mail: r. kroker@bgvv. de Internet: http: / /www. bgvv. de
Documentation services A wide range of documents has now been published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Johannes LÖWER Kommissarische Leiter Paul-Ehrlich Institut Paul-Ehrlich Straße 51-59 D – 63225 Langen Tel.
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
(49-6103) 77 20 01 Fax (49-6103) 77 12 52 E-mail: loejo@pei. de Internet: http: / /www. pei. de
61 EMEA General Report 2000
Ελλάδα / GREECE
A subscription service is available for all EMEA public documents, distributing documents electronically or in paper form.
(30-1) 650 72 10 Fax (30-1) 654 95 86 E-mail: hmoutsop@eof. gr
Further information can be obtained from the above address or from
EMEA/ MB/ 050/ 00 Relazione annuale 2000 ESPAÑA
Contact point Iro MAVROPOULOS Direct telephone (44-20) 74 18 85 82 E-mail: subscriptions@emea. eudra. org
(34-91) 596 16 27 Fax (34-91) 596 16 15 E-mail: sdaem@agamed. es Internet: http: / /www. agamed. es
Contact point Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda. bosworth@emea. eudra. org
(33-1) 55 87 30 14 Fax (33-1) 55 87 30 12 E-mail: philippe. duneton@afssaps. sante. fr Internet: http: / /agmed. sante. gouv. fr
Requests for inspection of European experts lists The list of European experts is available for inspection on request at the EMEA offices.
19 F – 94701 Maisons Alfort CEDEX Tel.
Requests may be made either in writing to the EMEA or sent to the following e-mail addresses:
(33-1) 49 77 13 99/ 26 54 Fax (33-1) 49 77 26 26 E-mail: m. hirsch@dg. afssa. fr Internet: http: / /www. afssa. fr
Human medicines’ experts list Veterinary medicines’ experts list Inspectors experts list
IRELAND
human_experts@emea. eudra. org vet_experts@emea. eudra. org inspectors_experts@emea. eudra. org
(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank. hallinan@imb. ie Internet: http: / /www. imb. ie
Media and press contacts
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Ireland Tel.
Representatives of the media should contact the following people for information:
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus. healy@daff. irlgov. ie
For matters concerning medicinal products for human use
ITALIA
Contact point Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eudra. org
(39-6) 59 94 36 66 Fax (39-6) 59 94 34 56 E-mail: farmaci. sanita@interbusiness. it Internet: http: / /www. sanita. it/ farmaci
For matters concerning medicinal products for veterinary use
(39-6) 59 94 39 45 Fax (39-6) 59 94 31 90 E-mail: danspv@izs. it
Contact point Peter JONES Direct telephone (44-20) 74 18 84 13 E-mail: peter. jones@emea. eudra. org
(352) 478 55 90 Fax (352) 26 20 01 47 E-mail: dpmlux@pt. lu
For general information on any other matter
EMEA/ MB/ 050/ 00 Relazione annuale 2000
Contact points Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eudra. org
(31-70) 356 74 50 Fax (31-70) 356 75 15 E-mail: aw. broekmans@cbg. meb. nl Internet: http: / /www. cbg-meb. nl
Antoine CUVILLIER Direct telephone (44-20) 74 18 84 28 E-mail: antoine. cuvillier@emea. eudra. org
(31-31) 747 54 91 Fax (31-31) 742 31 93 E-mail: brd@brd. agro. nl
EU official publications
ÖSTERREICH
• Council Regulation (EEC) No 2309/ 93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, as amended (OJ L 214, 24.8.1993, p.
(43-1) 711 00 47 17 Fax (43-1) 713 86 14 E-Mail: gunter. liebeswar@bmsg. gv. at
1)
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander. jentzsch@bmsg. gv. at
62 EMEA General Report 2000
PORTUGAL
13) • Council Directive 81/ 851/ EEC of 28 September 1981 on the approximation of the laws of Member States relating to veterinary medicinal products, as amended (OJ L 317, 6.11.1981, p.
Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P – 1749-004 Lisboa Tel.
1) • Council Regulation (EC) No 2743/ 98 of 14 December 1998 amending Council Regulation (EC) No 297/ 95 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 345, 19.12.1998, p.
(351) 217 98 71 16 Fax (351) 217 98 71 20/ 24 E-mail: miguel. andrade@infarmed. pt Internet: http: / /www. infarmed. pt
3) • European Parliament and Council Regulation (EC) No 141/ 2000 of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p.
Rui MARQUES LEITÃO Director Geral Direcçao Geral de Veterinária Lg Academia Nacional de Belas Artes 2 P – 1294 Lisboa Tel.
1) • EMEA budget statement for the financial year 2000, including final appropriations for 1999 and outturn for 1998 (OJ L 184, 24.7.2000, p.
(351) 213 23 95 66 Fax (351) 213 46 35 18 E-mail: rleitao@dgv. min-agricultura. pt
1)
SUOMI/ FINLAND
The texts of these and other provisions are available in the series Rules governing medicinal products in the European Community.
Hannes WAHLROOS Ylijohtaja Lääkelaitos Läkemedelsverket Mannerheimintie 166 P. O.
These publications, along with copies of the Official Journal, are available from:
Box 55 FIN – 00301 Helsinki Puh.
Office for Official Publications of the European Communities, 2, rue de Mercier, L - 2985 Luxembourg, and also on the EudraLex Internet site at http: / /pharmacos. eudra. org/ eudralex/ index. htm
(358-9) 47 33 42 00 Fax (358-9) 47 33 43 45 Sähköposti: hannes. wahlroos@nam. fi Internet: http: / /www. nam. fi
EMEA documents
SVERIGE
• First General Report on the Activities of the European Agency for the Evaluation of Medicinal Products 1995 (ISBN 92-827-7491-0, Office for Official Publications of the EU) • Second General Report on the Activities of the European Agency for the Evaluation of Medicinal Products 1996 (ISBN 92-9155-002-7, Office for Official Publications of the EU) • Third General Report on the Activities of the European Agency for the Evaluation of Medicinal Products 1997 (ISBN 92-9155-010-8, Office for Official Publications of the EU) • Fourth General Report on the Activities of the European Agency for the Evaluation of Medicinal Products 1998 (ISBN 92-9155-018-3, Office for Official Publications of the EU) • Fifth General Report on the Activities of the European Agency for the Evaluation of Medicinal Products 1999 (ISBN 92-9155-026-4, EMEA) • Statement of principles governing the partnership between the national competent authorities and the EMEA (EMEA/ MB/ 013/ 97) • Financial Regulation applicable to the budget of the EMEA (EMEA/ MB/ 011/ 97) • Decision of the Executive Director of 3 December 1997 on rules on access to documents of the EMEA (EDIR/ 016/ 1997) • Decision of the Executive Director of 1 June 1999 on cooperation with the European Anti-Fraud Office (OLAF) (EDIR/ 006/ 1999) • Catalogue of EMEA public documents (updated regularly) • EMEA Code of Conduct (EMEA/ D/ 37674/ 99)
Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8 Box 26 S – 751 03 Uppsala Tel.
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
(46-18) 17 46 00 Fax (46-18) 54 85 66 E-post: gunnar. alvan@mpa. se Internet: http: / /www. mpa. se
63 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Relazione annuale 2000 UNITED KINGDOM Keith JONES
Annex 2:
Michael RUTTER
EMEA budgets for 1999 to 2001
Pagina 72/ 91
The summarised comparative budget statements in euro for 1999 to 2001 are given below.
(44-20) 72 73 01 00 Fax (44-20) 72 73 05 48 E-mail: keith. jones@mca. gov. uk Internet: http: / /www. open. gov. uk/ mca
1999(1)
(44-1932) 33 69 11 Fax (44-1932) 33 66 18 E-mail: m. rutter@vmd. maff. gov. uk Internet: http: / /www. open. gov. uk/ vmd
2000(2)
Osservatori:
2001(3)
ÍSLAND
(31.12.1999)
(354) 520 21 00 Fax (354) 561 21 70 E-mail: rannveig. gunnarsdottir@lyfjanefnd. is Internet: http: / /www. lyfjanefnd. is
(as at 31.12.2000)
LIECHTENSTEIN
(as at 20.12.2000)
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte. batliner@alk. llv. li
Expenditure Staff
NORGE/ NOREG
salaries interim and other support persons other staff-related expenditure total title 1
(47-22) 89 77 00 Fax (47-22) 89 77 99 E-mail: gro. wesenberg@slk. no Internet: http: / /www. slk. no
15 074 905 955 456 1 191 570 17 221 931
EMEA/ MB/ 050/ 00 Relazione annuale 2000 Allegato 8
36.61% 2.32% 2.89% 41.82%
Pagina 73/ 91
18 493 000 1 058 000 1 350 000 20 901 000
Pareri del CPMP sulle specialità
33.45% 1.91% 2.44% 37.80%
medicinali per uso umano nel 2000
21 772 000 35.15% 1 379 000 2.23% 1 501 000 2.42% 24 652 000 39.80%
Prodotto Ditta - Nome - Name commerciale
Building/ equipment
Area terapeutica Presentazione - ATC - Form
2 136 038 1 034 357 1 824 960 370 754 1 194 962
EMEA/ CPMP - Convalida
5.19% 2.51% 4.43% 0.90% 2.90%
Commissione -Parere ricevuto
5 212 220 2 423 500 2 353 000 480 000 1 593 000
- DCI - Origine
9.43% 4.38% 4.26% 0.87% 2.88%
- Indicazione - Dosaggio
5 685 000 9.18% 1 400 000 2.26% 824 500 1.33% 537 000 0.87% 1 784 500 2.88%
- Parere
total title 2
- Data della decisione
6 561 071
- Parte A/ B
15.93%
-
12 061 720 21.82%
Numero di presentazioni
10 231 000 16.52%
- Tempo attivo - Tempo inattivo
Operational expenditure
- Data della notifica - Rif.
meetings
- Orgalutran - ganirelix - B
3 274 441
- -
7.95%
N. V.
3 487 000 6.31%
Organon NL
6 565 000 10.60%
- -
evaluations translation studies and consultants publications
H01CC01 Prevention of premature luteinising hormone surges in conteolled ovarian hyperstimulation
5 000 150 000
Solution for injection 0.5 mg/ ml 2 presentations
33.79% 0.00% 0.01% 0.27%
- 29.01.1999 - 19.01.2000 - 162 days - 189 days
19 658 000 31.74% 428 000 0.69% 180 000 0.29% 220 000 0.36%
- 22.02.2000 - 17.05.2000 - 22.05.2000 - OJ C 183, 30.06.2000, p.
17 399 678
SP Europe
42.25%
- -
22 324 500 40.38%
L03AB10 Treatment of
27 051 000 43.68%
Powder and solvent for solution for injection
TOTAL EXPENDITURE
- 26.03.1999 - 17.02.2000
41 182 680 100.00%
- 27.03.2000 - 25.05.2000
55 287 220 100.00%
alfa-2b - A
61 934 000 100.00%
chronic hepatitis C
Revenue
- -
fees general EU contribution special EU orphan medicinal
50 µg/ 0.5 ml, 80 µg/ 0.5 ml, 100 µg/ 0.5 ml 120 µg/ 0.5 ml, 150µg/ 0.5 ml 25 presentations
28 952 500 70.31% 10 481 649 25.45%
- 189 days - 139 days
39 154 000 70.82% 13 200 000 23.88%
3
42 610 000 68.81% 14 700 000 23.73%
- Viraferon PEG
product contribution contribution from EEA contribution from EU
-
-- 0.00% -- 0.00%
SP Europe
1 000 000 1.81% 245 220 0.44%
- -
600 000 0.97% 250 000 0.40%
L03AB10 Treatment of
programmes (PERF) other
-
800 000 1.94% 948 531 2.30%
Powder and solvent for solution for injection
217 000 0.39% 1 471 000 2.66%
- 03.01.2000 - 17.02.2000
2 440 000 3.94% 1 334 000 2.15%
- 27.03.2000 - 25.05.2000
TOTAL REVENUE
- peginterferon alfa-2b - A
41 182 680 100.00%
-
55 287 220 100.00%
US
Notes
- -
(3) 2001 budget: draft appropriations.
50 µg/ 0.5 ml, 80 µg/ 0.5 ml, 100 µg/ 0.5 ml 120 µg/ 0.5 ml, 150µg/ 0.5 ml 25 presentations
64 EMEA General Report 2000
- 43 days - 0 days
Members of the Management Board
- Lantus - insulin glargine - A
Chairman
-
André BROEKMANS 1
Aventis Pharma Deutschl and GmbH
Members
- -
European Parliament
A10AE Diabetes mellitus
Gianmartino BENZI, José-Luis VALVERDE LÓPEZ 2 Alternates:
Solution for injection 100 IU/ ml 7 presentations
Dietrich HENSCHLER, Jean-Pierre REYNIER
- 23.04.1999 - 17.02.2000 - 215 days - 83 days
Paul WEISSENBERG Belgique/ België Danmark Deutschland
- Aventis - A10AE - Solution for injection - 24.09.19
André PAUWELS, Frans GOSSELINCKX Ib VALSBORG, Jytte LYNGVIG 5 Hermann Josef PABEL, Gerhard Josef KOTHMANN, (Vice-chairman)
- Optisulin - Aventis -
Eλλ δα / Greece España
A10AE - Solution for injection
Marios MARSELOS 6, Elias MOSSIALOS 7 María Victoria de la CUESTA GARCIA 8, Ramón PALOP BAIXAULI 9
- Optisulin - Aventis - A10AE -
France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/ Finland Sverige United Kingdom
- Optisulin - Aventis - A10AE - Solution for injection -
Philippe DUNETON, Martin HIRSCH 10 Tom MOONEY, Colm GAYNOR 11 Nello MARTINI, Romano MARABELLI Mariette BACKES-LIES John LISMAN 12, Frits PLUIMERS Alexander JENTZSCH, Ernst LUSZCZAK Miguel ANDRADE 13, Rógerio GASPAR 14 Pekka JÄRVINEN 15, Hannes WAHLROOS Birgitta BRATTHALL, Anders BROSTRÖM Keith JONES, Michael RUTTER
- Optisulin - Aventis - A10AE - Solution for injection - 24.09.1999 -
Observers
23.03.2000
Ísland
insulin
Rannveig GUNNARSDÓTTIR, Ingolf PETERSEN
Pharma - Diabetes mellitus - 100 IU/ ml - 17.02.
Liechtenstein Norge/ Noreg
- insulin Pharma -
Brigitte BATLINER, Peter MALIN Andreas DISEN, Gro Ramsten WESENBERG
Diabetes mellitus - 100 IU/ ml
1 Resigned at the 20 December 2000 meeting.
- insulin Pharma - Diabetes mellitus -
3 Replaced Jörn KECK as of the 22 February 2000 meeting.
- insulin Pharma - Diabetes mellitus - 100 IU/ ml -
4 Replaced Joachim HEINE as of the 22 February 2000 meeting.
- insulin Pharma - Diabetes mellitus - 100 IU/ ml - 17.02.2000 -
5 Replaced Ib Bo LUMHOLTZ as of the 23 October 2000 meeting.
glargine A
7 Replaced John PSOMAS as of the 20 December 2000 meeting.
Deutschl and GmbH
8 Replaced María Theresa PAGÉS JIMÉNEZ as of the 20 December 2000 meeting.
-
12 Replaced André BROEKMANS as of the 7 June 2000 meeting.
7 presentations - -
65 EMEA General Report 2000
116 days - 28 days -
•
-D -
· Jean-Michel ALEXANDRE (France), Chairman
Nyracta - - A10BG02 - Film coated tablet - 18.12.1998 - 17.04.
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
- Nyracta - -
· Eric ABADIE (France) · Mark AINSWORTH (Danmark) 2 · Fernando de ANDRES-TRELLES (España) · Cristina AVENDAÑO (España) · Michalis AVGERINOS (Eλλ δα/Greece) · Rolf BASS (Deutschland) 3 · Daniel BRASSEUR (Belgique/België) · Hans van BRONSWIJK (Nederlands), Vice-chairman 4 · Geert DE GREEF (Belgique/België) · Jens ERSBØLL (Danmark) · Silvio GARATTINI (Italia) · Jacqueline GENOUX-HAMES (Luxembourg) · Willem van der GIESEN (Nederlands) · Lars GRAMSTAD (Norge/Noreg) · Manfred HAASE (Deutschland) · Magnús JÓHANNSSON (Ísland) · Tove KARLSUD (Norge/Noreg) · Pekka KURKI (Suomi/Finland) 5 · David LYONS (Ireland) · Jose Guimarães MORAIS (Portugal) 6 · Per NILSSON (Sverige) · Jean-Louis ROBERT (Luxembourg) · Frances ROTBLAT (United Kingdom) 7 · Patrick SALMON (Ireland) 8 · Tomas SALMONSON (Sverige) · Cristina SAMPAIO (Portugal) · Sigurdur THORSTEINSSON (Ísland) · Markku TOIVONEN (Suomi/Finland) · Jean-Hugues TROUVIN (France) · Guiseppe VICARI (Italia) · Patrick WALLER (United Kingdom) · Hans WINKLER (Österreich) · Christa WIRTHUMER-HOCHE (Österreich) · Julia YOTAKI (Eλλ δα/Greece)
A10BG02 - Film coated tablet
1 2 3 4 5 6 7 8
- Nyracta - - A10BG02 -
Replaced Eva ALHAVA as of the March 2000 meeting.
- Nyracta - - A10BG02 - Film coated tablet -
66 EMEA General Report 2000
- Nyracta - - A10BG02 - Film coated tablet - 18.12.1998 -
Annex 5:
17.04.2000
Reinhard KROKER (Deutschland), Chairman
rosiglitazone
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
SmithKli - Combination - 1 mg, 2 mg, 4 mg, 8 mg - 21.10.
Margarita ARBOIX (España) J.
- rosiglitazone SmithKli -
1 2 3 4
Combination - 1 mg, 2 mg, 4 mg, 8 mg
Replaced Annika WENNBERG as of the October 2000 meeting.
- rosiglitazone SmithKli - Combination -
Replaced Carlos SINOGAS as of the July 2000 meeting.
- rosiglitazone SmithKli - Combination - 1 mg, 2 mg, 4 mg, 8 mg -
Replaced Christos HIMONAS as of the April 2000 meeting.
- rosiglitazone SmithKli - Combination - 1 mg, 2 mg, 4 mg, 8 mg - 21.10.1999 -
67 EMEA General Report 2000
11.07.2000
Annex 6:
B
Chairman (España)
ne
Josep TORRENT i FARNELL
treatment of Type - 12 presentations
Members
- B ne treatment of Type -
Belgique/België Danmark Deutschland Eλλ δα/Greece France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/Finland Sverige United Kingdom Patient organisation
- B ne treatment of Type - 12 presentations -
André LHOIR Jan RENNEBERG Rembert ELBERS 1 George STRATHOPOULOS 2 François MEYER Brendan BUCKLEY Domenica TARUSCIO Henri METZ 3 Harrie SEEVERENS Hans Georg EICHLER José Manuel Gião TOSCANO RICO Kalle HOPPU Kerstin WESTERMARK Rashmi SHAH
- B ne treatment of Type - 12 presentations - 186 days -
representatives
26.07.2000
Moisés ABASCAL ALONSO 5 Yann LE CAM, 5 Vice-chairman Alastair KENT 6
Beecham Pharmac euticals
EMEA representatives
II diabetes mellitus
Jean-Michel ALEXANDRE 7 Gianmartino BENZI Mary TEELING 8
-
Observers
119 days -
Ísland Norge/Noreg
2
Sigurdur THORSTEINSSON Randi NORDAL
UK
Resigned as of the September 2000 meeting.
- SmithKli - ne Beecham Phramac euticals
68 EMEA General Report 2000
A10BG02 Combination treatment of Type II diabetes mellitus
Annex 7:
- - -
National competent authority partners
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
Further information on the national competent authorities is also available on the national authorities’ Internet sites: http://heads.medagencies.org and http://www.hevra.org
- - - -
(32-2) 227 55 67 Fax (32-2) 227 55 55/56 39 E-mail: andre.pauwels@afigp.fgov.be Internet: http://www.afigp.fogv.be
18.12.1998 - 21.10.1999 - 186 days - 119 days -
(45) 44 88 93 34 Fax (45) 44 88 91 09 E-mail: jyl@dkma.dk Internet: http://www.dkma.dk
4
DEUTSCHLAND Harald SCHWEIM Direktor BfArM Friedrich-Ebert-Allee 38 D – 53113 Bonn Tel.
-
Reinhard KROKER Leiter des Fachbereiches ‘Tierarzneimittelzulassung und -rückstandskontrolle, Futterzusatzstoffe’ BgVV Diedersdorfer Weg, 1 D – 12277 Berlin Tel.
UK
Internet: http://www.bgvv.de
Venvia rosiglitazone B
69 EMEA General Report 2000
-
(30-1) 650 72 10 Fax (30-1) 654 95 86 E-mail: hmoutsop@eof.gr
- SmithKli - ne Beecham Pharmac euticals
(33-1) 55 87 30 14 Fax (33-1) 55 87 30 12 E-mail: philippe.duneton@afssaps.sante.fr Internet: http://agmed.sante.gouv.fr
Film coated tablet 1 mg, 2 mg, 4 mg, 8 mg 12 presentations
Martin HIRSCH Directeur-Général Agence Française de Sécurité Sanitaire des aliments 23, avenue du Général de Gaulle B.P.
- - - -
IRELAND
18.12.1998 - 21.10.1999 - 186 days - 119 days -
Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Tel.
2
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Tel.
-
ITALIA
UK
Nello MARTINI Direttore Generale del Dipartimento per Valutazione dei medicinale e la farmacovigilanza Ministero della Sanità Viale Civilità Romana 7 I -00144 Roma Tel.
- - -
70 EMEA General Report 2000
- -
(352) 478 55 90 Fax (352) 26 20 01 47 E-mail: dpmlux@pt.lu
The - Liposom - e Compan y US
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tel.
L01DB Treatment of metastatic breast cancer
(43-1) 711 00 47 17 Fax (43-1) 713 86 14 E-mail: gunter.liebeswar@bmsg.gv.at
Powder and pre- admixtures for concentrate for, liposomal dispersion for infusion 50 mg 1 presentation
Alexander JENTZSCH Ministerialrat Leiter der Gruppe für Pharmazeutische Angelegenheiten Bundesministerium für Soziales, Sicherheit und Generationen Radetzkystraße 2 A - 1030 Wien Tel.
- - - -
PORTUGAL Miguel ANDRADE Presidente Conselho de Administraçao INFARMED Parque Saúde de Lisboa, Av. do Brasil, 53 P - 1749-004 Lisboa Tel.
30.07.1999 - 12.04.2000 - 167 days - 91 days -
(351) 213 23 95 66 Fax (351) 213 46 35 18 E-mail: rleitao@dgv.min-agricultura.pt
2
71 EMEA General Report 2000
- - -
Box 55 FIN - 00301 Helsinki Tel.
Datscan ioflupane B
SVERIGE Gunnar ALVÁN Generaldirektör Läkemedelsverket Husargatan 8, Box 26 S - 751 03 Uppsala Tel.
-
UNITED KINGDOM
- Nycome - d Amersha m
(44-20) 72 73 01 00 Fax (44-20) 72 73 05 48 E-mail: keith.jones@mca.gov.uk Internet: http://www.open.gov.uk/mca
V09AB03 Diagnosis of Parkinson disease
(44-1932) 33 69 11 Fax (44-1932) 33 66 18 E-mail: m.rutter@vmd.maff.gov.uk Internet: http://www.open.gov.uk/vmd
Solution for injection 74 MBq/ ml 1 presentation
ÍSLAND Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS - 170 Seltjarnarnes Tel.
18.12.1998 - 16.03.2000 - 178 days - 272 days -
(47-22) 89 77 00 Fax (47-22) 89 77 99 E-mail: gro.wesenberg@slk.no Internet: http://www.slk.no
05.05.2000 27.07.2000 02.08.2000 OJ C 244, 25.08.2000, p.
72 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Relazione annuale 2000
Annex 8:
Pagina 74/ 91
Product - Brandname - INN - Part A/B
Prodotto - Nome commerciale
Company - Name - Origin
Ditta - Name
Therapeutic area - ATC - Indication
Area terapeutica - ATC
Presentation - Form - Dosage - Number of presentations
Presentazione - Form
EMEA/CPMP - Validation - Opinion - Active time - Clock stop
EMEA/ CPMP - Convalida
Commission - Opinion received - Date of Decision - Notification - Official Journal
Commissione -Parere ricevuto
- Orgalutran
- DCI - Parte A/ B
- N.V.
- Origine - UK
Organon - H01CC01
- Indicazione
- Orgalutran - N.V.
- Dosaggio - Numero di presentazioni
Organon - H01CC01 - Solution for injection -
- Parere - Tempo attivo - Tempo inattivo
- Orgalutran - N.V.
G. U.
Organon - H01CC01 - Solution for injection - 29.01.1999 -
- Ciba - L01XX - Powder for solution for - 27.08.1
22.02.2000
- Visudyne - Ciba -
- ganirelix
- Visudyne - Ciba - L01XX -
- Prevention of
Vision - Treatment of age- infusion - 12.04
- ganirelix - NL - Prevention of - 0.5 mg/ml -
- verteporfin Vision - Treatment of age- infusion -
- ganirelix - NL - Prevention of - 0.5 mg/ml - 19.01.2000 -
- verteporfin Vision - Treatment of age- infusion - 12.04.2000 -
17.05.2000
27.07.2000
-B
- CH