qanastek/EMEA-V3 huggingface dataset:
3.3 MRLs for old substances
Presentación electrónica
The completion of assessment of applications to set MRLs for old substances was met before the 1 January 2000 deadline.
En 2000 se convocó un concurso público para la selección de un sistema de gestión de documentos electrónicos.
However work continued in 2000 to set definitive MRLs for those substances currently in Annex III of Council Regulation (EEC) No 2377/ 90 and allocated provisional status pending provision of additional data, mainly relating to validation of analytical methods for surveillance purposes.
El sistema se centrará en las etapas iniciales del control de documentos para los procesos de asesoramiento científico y la elaboración de informes EPAR modulares.
Opinions and lists of questions adopted for old substances 1995-2000
Servicios de conferencias Reuniones de la EMEA
Other key events in 2000 in brief
En 2000 concluyó un proceso de licitación para la prestación de servicios de agencia de viajes, y se eligió a un proveedor de esos servicios.
Specific recommendations for poultry (CVMP/ VICH/ 546/ 00) • Efficacy of anthelmintics:
Se definieron los requisitos del usuario para mejorar el sistema de gestión de reuniones.
EMEA/ CVMP transparency and dialogue in 2000
Una encuesta realizada en 2000 para evaluar el nivel de satisfacción de los delegados indicó un elevado grado de satisfacción con el nivel del servicio prestado por la EMEA.
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
Las salas de reuniones y los equipos técnicos instalados en ellas se mejoraron durante el año 2000.
EMEA-FEDESA Info-day Bilateral meeting with FEDESA CVMP/ interested parties meeting Bilateral meeting with FEDESA EMEA-FEDESA Info-day
Asimismo, se progresó en el diseño de las nuevas salas de conferencias que se habilitarán en la planta 3.
Details of notes for guidance prepared by the working parties for the CVMP are given in Annex 11.
Foro Paneuropeo sobre Regulación de Productos Farmacéuticos
Meetings in 2000
En el año 2000 concluyó el contrato para la primera fase del Foro Paneuropeo sobre Regulación de Productos Farmacéuticos (PERF I).
Pharmacovigilance working party (PhVWP)
El sector atendió a los 119 delegados que, en total, participaron en el programa y organizó unas 37 reuniones.
Gabriella CONTI, then Cornelia IBRAHIM*
Además, organizó una conferencia en Hungría en febrero de 2000 a la que asistieron más de 350 delegados.
Immunologicals working party (IWP)
53 Informe General EMEA 2000
Paul-Pierre PASTORET
54 Informe General EMEA 2000
5
Capítulo 5 Administración
Antimicrobial resistance working group (ARWG)
Organización de la Unidad de Administración
SIAMED 6.3% Other activities 12.9% SI 2 7.3%
Jefe de Unidad Jefe del Sector de personal,
Management 3.5%
Andreas POTT
Other applications and small projects 23.3% Operations and network 41.8%
presupuestos y servicios logísticos Jefe del Sector de contabilidad
Overview of the Technical Coordination Unit
Frances NUTTALL Gerard O’MALLEY
Head of Unit Head of Sector for inspections Head of Sector for document management and publishing Head of Sector for conference services
La Unidad de Administración es responsable del personal, los presupuestos, la contabilidad y los servicios logísticos.
Karel de NEEF Stephen FAIRCHILD Beatrice FAYL Sylvie BÉNÉFICE
Además, se ha ocupado de una serie de proyectos establecidos en el programa de trabajo:
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.
• Consolidación del euro en los procedimientos financieros y presupuestarios de la Agencia. • Logro de los objetivos de contratación de personal. • Control y ajustes presupuestarios, especialmente en respuesta al aumento de los ingresos y la financiación de nuevas tareas, como las relacionadas con medicamentos huérfanos y PERF II. • Preparación de la reorganización de la Unidad para la evaluación de medicamentos de uso humano. • Reestructuración y acondicionamiento de las oficinas de la EMEA como parte de la política de inmuebles.
ActiTrak data for technical coordination activities in 2000
Personal, presupuestos y servicios logísticos En el año 2000 se creó una base de datos del personal que facilitará la administración de los recursos humanos de la Agencia, en particular los registros de bajas, los informes de evaluación y otros datos personales.
49 EMEA General Report 2000
Miembros del personal de la EMEA por categoría y sexo
s Good manufacturing practice inspections 60 s Good clinical practice inspections s Good laboratory practice inspections 50
50 Número de empleados
1998
Categoría C
1999
Categoría D
2000
55 Informe General EMEA 2000
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.
Miembros del personal de la EMEA por nacionalidad
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.
Bélgica 7%
This included a significant number of inspections performed outside of the EU.
Dinamarca 5% Reino Unido 22%
Sampling and testing
Suecia 5% Grecia 4%
Monitoring of centrally authorised medicinal products is performed by the Network of Official Medicines Control Laboratories.
Finlandia 4% España 7% Portugal 4% Austria 1% Países Bajos 4%
The activities of the network are coordinated by the European Department for the Quality of Medicines (Council of Europe) and the EMEA.
Gracias a una labor constante de vigilancia presupuestaria y control de costes, el equipo responsable de los presupuestos consiguió coordinar la ejecución del presupuesto y trató de conseguir eficiencias en los costes.
No major problems were identified during the testing programme.
Durante el año se llevó a cabo un análisis detallado de las necesidades de formación y se organizaron programas de formación para mejorar las oportunidades ofrecidas a los miembros del personal.
A testing programme for 2001 was agreed in 2000.
El personal de la Unidad para la evaluación de medicamentos de uso humano, casi 100 personas en total, pudo trasladarse a las nuevas oficinas en marzo de 2000.
A total of 5 reports on quality problems concerning centrally authorised products were received and monitored by the EMEA, leading to 2 product recalls.
Las obras terminarán a principios de 2001.
50 EMEA General Report 2000
56 Informe General EMEA 2000
Mutual recognition agreements
Planos de la reforma de la tercera planta, oficinas de la EMEA
On-going discussions or MRAs in transition period
3D 3C
EC – Canada MRA
3B 3A
The equivalence assessment between EC and Canada of GMP compliance systems was completed in 2000.
Leyenda
EC – US MRA
Sala 3A:
The EU finalised its plans for the first evaluation visits to the US in March 2001.
Sala de reuniones multifuncional (40 personas)
EC – Switzerland MRA
Sala de reuniones y videoconferencias (35 personas)
The date of entry into force is expected to be summer 2001.
Sala de reuniones (18 personas)
EC – Australia MRA and EC – New Zealand MRA (veterinary medicinal products)
Zona abierta/Recepción
Activities continued in 2000 to evaluate equivalence of these agreements.
Contabilidad En el año 2000 se consiguió una nueva mejora de la productividad, puesto que se procesó un mayor volumen de transacciones sin necesidad de aumentar el personal.
MRAs in force
Se negoció un contrato a plazo sobre tipos de cambio con los bancos de la Agencia para reducir al mínimo los efectos de la debilidad del euro en las finanzas de la Agencia.
EC – Australia MRA and EC – New Zealand MRA (human medicinal products)
En 2000 se efectuaron 6 761 pagos y se procesaron 1 084 ingresos, lo que supone un incremento del 11% y el 45% respectivamente frente a 1999.
Alert systems and certification schemes have been agreed in principle.
57 Informe General EMEA 2000
Certification of medicinal products
Volumen de pagos efectuados en 1999 y 2000
New arrangements for requesting certificates of a medicinal product were introduced in 2000 and posted on the EMEA web site.
6 000
Joint CPMP/ CVMP Quality working party
Personal
The Joint CPMP/ CVMP Quality working party met on three occasions in 2000.
e
51 EMEA General Report 2000
Immuebles instalaciones
4.2 Document management and publishing
Operaciones
Product information
Ponencias
About 150 delegates from national competent authorities, pharmaceutical industry and software companies attended a workshop in September 2000 and welcomed the initiative.
Volumen de operaciones generadoras de ingresos en 1999 y 2000
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
Electronic submission
Ingresos por tasas
Electronic submission will facilitate data exchange between applicants and marketing authorisation holders with the EMEA.
Otros ingresos
An electronic submission development web site was established in 2000 to provide information on work in progress: http: / /esubmission. eudra. org
Total
Document management
y cargos administrativos
A feasibility study was begun at the end of 2000 prior to the final selection of the system provider.
58 Informe General EMEA 2000
The sector coordinated the compilation of the EMEA catalogue of documents, which was published for the first time in November 2000.
Anexos
52 EMEA General Report 2000
59 Informe General EMEA 2000
4.3 Conference services
Anexos
EMEA meetings
Puntos de contacto y documentos de referencia de la EMEA
Activities relating to the organisation of meetings at the EMEA increased by over 37% in 2000.
2.
Meetings at the EMEA 1995-2000
Presupuestos de la EMEA para el período 1999-2001
350
3.
300
Miembros del Consejo de Administración
250
4.
200
Miembros del Comité de Especialidades Farmacéuticas
150
5.
100
Miembros del Comité de Medicamentos Veterinarios
50
6.
0
Miembros del Comité de Medicamentos Huérfanos
1995
7.
1996
Autoridades nacionales competentes asociadas
1997
8.
1998
Dictámenes del CPMP en 2000 para medicamentos de uso humano
1999
9.
2000
Dictámenes del CVMP en 2000 para medicamentos de uso veterinario
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.
Dictámenes del COMP en 2000 para medicamentos huérfanos
A survey in 2000 to measure the level of satisfaction of the delegates showed a high level of satisfaction with the level of service provided by the EMEA.
Directrices de la EMEA en 2000
Meeting facilities and technical equipment in the meeting rooms themselves were improved in 2000.
Puntos de contacto y documentos de referencia de la EMEA Puntos de contacto de la EMEA
Progress was made in planning the new conference rooms on floor 3.
Para asuntos relativos a productos defectuosos y problemas de calidad
Pan-European Regulatory Forum
Certificados de medicamentos
The contract for the conduct of the first phase of the Pan-European Regulatory Forum on Pharmaceuticals (PERF I) was completed in 2000.
La EMEA emite certificados de medicamentos de conformidad con las disposiciones establecidas por la Organización Mundial de la Salud.
A total of 119 delegates involved in the programme was handled by the sector and some 37 meetings.
Esos certificados pueden ser utilizados en apoyo de las solicitudes de autorización de comercialización dentro y fuera de la UE.
In addition a conference was organised in Hungary in February 2000 attended by over 350 delegates.
Para preguntas relativas a los certificados de medicamentos autorizados para uso humano o veterinario por el procedimiento centralizado
53 EMEA General Report 2000
Servicios de documentación
54 EMEA General Report 2000
61 Informe General EMEA 2000
Chapter 5 Administration
Puede obtenerse más información en la anterior dirección o contactando con
Overview of the Administration Unit
Punto de contacto Iro MAVROPOULOS Teléfono directo (44-20) 74 18 85 82 E-mail: subscriptions@emea.eudra.org
Overview of the Administration Unit
Los documentos de información general deben solicitarse a
Head of Unit Head of Sector for personnel, budget and facilities Head of Sector for accounting
Punto de contacto Amanda BOSWORTH Teléfono directo (44-20) 74 18 84 08 E-mail: amanda.bosworth@emea.eudra.org
Andreas POTT Frances NUTTALL Gerard O’ MALLEY
Lista de expertos en medicamentos
The Administration Unit is responsible for personnel, budget,
de uso humano Lista de expertos en medicamentos
accounting and facilities.
human_experts@emea.eudra.org
In addition, a number of projects set out in the Work Programme have been completed:
vet_experts@emea.eudra.org inspectors_experts@emea.eudra.org
• 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
Contactos para la prensa y los medios de comunicación Los representantes de los medios de comunicación deben contactar con las siguientes personas para obtener información:
Personnel, budget and facilities
Para asuntos relacionados con medicamentos de uso humano
A personnel database was selected in 2000 that will facilitate personnel administration, in particular leave records, evaluation reports and other personnel details.
Punto de contacto Noël WATHION Teléfono directo (44-20) 74 18 85 92 E-mail: noel.wathion@emea.eudra.org
EMEA staff members by category and sex
Para asuntos relacionados con medicamentos de uso veterinario
70
Punto de contacto Peter JONES Teléfono directo (44-20) 74 18 84 13 E-mail: peter.jones@emea.eudra.org
60
Para información general sobre cualquier otro asunto
50
Puntos de contacto Martin HARVEY Teléfono directo (44-20) 74 18 84 27 E-mail: martin.harvey@emea.eudra.org
s Male
Antoine CUVILLIER Teléfono directo (44-20) 74 18 84 28 E-mail: antoine.cuvillier@emea.eudra.org
s Female
Publicaciones oficiales de la UE
40
1).
30
1).
20
También están disponibles a través del sitio web de EudraLex: http://pharmacos.eudra.org/eudralex/index.htm
10
Documentos de la EMEA
0
• Primer Informe General sobre las actividades de la Agencia Europea para la Evaluación de Medicamentos 1995 (ISBN 92-827-8761-3, Oficina de Publicaciones Oficiales de las Comunidades Europeas). • Segundo Informe General sobre las actividades de la Agencia Europea para la Evaluación de Medicamentos 1996 (ISBN 92-9155-000-0, Oficina de Publicaciones Oficiales de las Comunidades Europeas). • Tercer Informe General sobre las actividades de la Agencia Europea para la Evaluación de Medicamentos 1997 (ISBN 92-9155-008-6, Oficina de Publicaciones Oficiales de las Comunidades Europeas). • Cuarto Informe General sobre las actividades de la Agencia Europea para la Evaluación de Medicamentos 1998 (ISBN 92-9155-016-7, Oficina de Publicaciones Oficiales de las Comunidades Europeas). • Quinto Informe General sobre las actividades de la Agencia Europea para la Evaluación de Medicamentos 1999 (ISBN 92-9155-024-8, EMEA). • Declaración de principios que rigen la colaboración entre las autoridades nacionales competentes y la Agencia Europea para la Evaluación de Medicamentos (EMEA/MB/013/97). • Reglamento Financiero aplicable al presupuesto de la EMEA (EMEA/MB/011/97). • Decisión del Director Ejecutivo, de 3 de diciembre de 1997, relativa a las normas sobre el acceso a los documentos de la EMEA (EDIR/016/1997). • Decisión del Director Ejecutivo, de 1 de junio de 1999, relativa a la colaboración con la Oficina Europea de Lucha contra el Fraude (OLAF) (EDIR/006/1999). • Catálogo de documentos públicos de la EMEA (actualizado periódicamente). • Código de conducta de la EMEA (EMEA/D/37674/99).
Category A
Sector de gestión y publicación de documentos Agencia Europea para la Evaluación de Medicamentos 7 Westferry Circus, Canary Wharf London E14 4HB United Kingdom
Category B
63 Informe General EMEA 2000
Category C
Anexo 2.
Category D
1999 (1)
55 EMEA General Report 2000
2000 (2)
EMEA staff members by nationality
Sueldos Personal provisional
Belgium 7%
36,61%
UK 22%
33,45%
Denmark 5%
35, 15%
Germany 12%
2,32% 2,89%
Sweden 5% Greece 4%
1,91% 2,44%
Finland 4%
2,23% 2,42%
Portugal 4% Austria 1% Netherlands 4%
Total título 1 Inmuebles y equipamiento
Spain 7%
17 221 931
France 12%
41,82%
Luxembourg 0%
20 901 000
Italy 8%
37,80%
Ireland 5%
39,80%
By constant budget monitoring and cost control the budget team successfully coordinated the execution of the budget and strove to achieve cost efficiencies.
Arrendamientos/Carga Proceso de datos Otros gastos de capital Correo y telecomunicaciones Otros gastos administrativos Total título 2 Gastos operativos
A detailed review of training needs and the provision of training was undertaken during the year to improve the opportunities available to staff members.
2 136 038 1 034 3 57 1 824 960 370 754 1 194 962 6 561 071
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.
5 212 220 2 423 500 2 353 000 480 000 1 593 000 12 061 720
The staff of the Unit for the Evaluation of Medicines for Human Use, about 100 in total, were able to move to the new office space in March 2000.
5 685 000 1 400 000 824 500 537 000 1 784 500 10 231 000
Facilities personnel also planned and began another major fitting out project in 2000 of the third floor for additional meeting rooms and delegate facilities.
Reuniones Evaluaciones Traducción Estudios y consultores Publicaciones Total título 3
The work will be concluded in early 2001.
7,95% 33,74% 0,00% 0,23% 0,33% 42,25%
56 EMEA General Report 2000
3 487 000 18 682 500 p.m.
Refurbishment plans for the third floor, EMEA offices
6 565 000 19 658 000 428 000 180 000 220 000 27 051 000
3D 3C
100,00%
3B 3A
28 952 500
Legend
70,31%
Room 3A – conference room (115 people)
39 154 000 70,82%
Room 3B – multi-function meeting room (40 people)
42 610 000 68,81%
Room 3C – meeting room and video- conference suite (35 people)
de la Unión Europea Subvención especial de la Unión Europea
Room 3D – meeting room (18 people)
10 481 649
Open area/ reception
13 200 000 23,88%
Accounts
14 700 000 23,73%
Further productivity gains were seen in 2000 as increases in the volume of transactions processed were absorbed without increasing staff numbers.
para medicamentos huérfanos Subvención del EEE Contribución de programas
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.
— 0,00% — 0,00%
In 2000, 6 761 payments were made and 1 084 receipts processed, which is an increase of 11% and 45% respectively over 1999.
1 000 000 1,81% 245 220 0,44%
57 EMEA General Report 2000
600 000 0,97% 250 000 0,40%
Volume of payments made in 1999 and 2000
de la UE (PERF)
7000
1,94%
6000
0,39%
5000
3,94%
s 1999
Otros
s 2000
2,30%
4000
2,66%
3000
2,15%
2000
64 Informe General EMEA 2000
1000
Anexo 3.
0
André BROEKMANS (1)
Staff-related
Miembros
Building and facilities
Parlamento Europeo
Operations
Dietrich HENSCHLER, Jean-Pierre REYNIER
Rapporters
Comisión Europea
Total
Paul WEISSENBERG
Volume of income operations in 1999 and 2000
Belgique/België Danmark Deutschland
1200
André PAUWELS, Frans GOSSELINCKX Ib VALSBORG, Jytte LYNGVIG (5) Hermann Josef PABEL, Gerhard Josef KOTHMANN, Vicepresidente
1000
∂ÏÏ¿‰·/Greece España
s 1999
Marios MARSELOS (6), Elias MOSSIALOS (7) María Victoria de la CUESTA GARCÍA (8), Ramón PALOP BAIXAULI (9)
s 2000
France Ireland Italia Luxembourg Nederland Österreich Portugal Suomi/Finland Sverige United Kingdom
800
Philippe DUNETON, Martin HIRSCH (10) Tom MOONEY, Colm GAYNOR (11) Nello MARTINI, Romano MARABELLI Mariette BACKES-LIES John LISMAN (1 2), 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
600
Observadores Ísland Liechtenstein Norge/Noreg
400
Rannveig GUNNARSDÓTTIR, Ingolf PETERSEN Brigitte BATLINER, Peter MALIN Andreas DISEN, Gro Ramsten WESENBERG
200
(15) Nombrado en sustitución de Kimmo LEPPO desde la reunión del 22 de febrero de 2000.
0
65 Informe General EMEA 2000
Fee revenue and
Anexo 4.
Other revenue
• Jean-Michel ALEXANDRE (France), Presidente
Total
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
administrative charges
Eric ABADIE (France) Mark AINSWORTH (Danmark) (2) Fernando DE ANDRÉS-TRELLÉS (España) Cristina AVENDAÑO (España) Michalis AVGERINOS (∂ÏÏ¿‰·/Greece) Rolf BASS (Deutschland) (3) Daniel BRASSEUR (Belgique/België) Hans van BRONSWIJK (Nederland), Vicepresidente (4) Geert DE GREEF (Belgique/België) Jens ERSBØLL (Danmark) Silvio GARATTINI (Italia) Jacqueline GENOUX-HAMES (Luxembourg) Willem van der GIESEN (Nederland) 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 (∂ÏÏ¿‰·/Greece)
58 EMEA General Report 2000
(1) (2) (3) (4) (5) (6) (7) (8)
Annexes
Nombrado en sustitución de Mary TEELING desde la reunión de septiembre de 2000.
59 EMEA General Report 2000
66 Informe General EMEA 2000
Annexes
Anexo 5.
EMEA contact points and reference documents
• Reinhard KROKER (Deutschland), Presidente
EMEA budgets 1998 to 2000
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
Members of the Management Board
Margarita ARBOIX (España) J.
Members of the Committee for Proprietary Medicinal Products
(3) Nombrado en sustitución de Carlos SINOGAS desde la reunión de julio de 2000.
Members of the Committee for Veterinary Medicinal Products
67 Informe General EMEA 2000
6.
Anexo 6.
Members of the Committee for Orphan Medicinal Products
Miembros del Comité de Medicamentos Huérfanos
National competent authority partners
Presidente (España)
CPMP opinions in 2000 on medicinal products for human use
Josep TORRENT i FARNELL
9.
Miembros
CVMP opinions in 2000 on medicinal products for veterinary use
Belgique/België Danmark Deutschland ∂ÏÏ¿‰·/Greece France Ireland Italia Luxembourg Nederland Österreich Portugal Suomi/Finland Sverige United Kingdom
COMP opinions in 2000 on orphan medicinal products
Representantes de organizaciones de pacientes
EMEA guidelines in 2000
Moisés ABASCAL ALONSO (5) Yann LE CAM (5), Vicepresidente Alastair KENT (6)
60 EMEA General Report 2000
Representantes de la EMEA
EMEA contact points and reference documents
Jean-Michel ALEXANDRE (7) Gianmartino BENZI Mary TEELING (8)
EMEA contact points
Observadores
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.
Ísland Norge/Noreg
For matters relating to pharmacovigilance for medicinal products for human use
Sigurdur THORSTEINSSON Randi NORDAL
Contact point Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eudra. org
(1) (2) (3) (4) (5) (6) (7) (8)
For matters relating to pharmacovigilance for medicinal products for veterinary use
En representación de la Asociación Europea de Enfermedades Huérfanas (Eurodis).
Contact point Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara. freischem@emea. eudra. org
Presentada su renuncia en la reunión de septiembre de 2000.
For product defect and other quality-related matters
68 Informe General EMEA 2000
Contact point Stephen FAIRCHILD Fax number for defective product rapid alerts (44-20) 74 18 85 90 E-mail: stephen. fairchild@emea. eudra. org
Autoridades nacionales competentes asociadas Para más información sobre las autoridades nacionales competentes, pueden consultarse también los sitios web de las autoridades nacionales (http://heads.medagencies.org y http://www.hevra.org).
Certificates of a medicinal product
(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
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organisation.
DANMARK Jytte LYNGVIG Direktør Lægemiddelstyrelsen Frederikssundsvej 378 DK-2700 Brønshøj 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.
(45) 44 88 93 34 Fax (45) 44 88 91 09 E-mail: jyl@dkma.dk Internet: http://www.dkma.dk
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
(49-22) 82 07 32 03 Fax (49-30) 87 07 55 14 E-mail: schweim@bfarm.de Internet: http://www.bfarm.de Johannes LÖWER Kommissarische Leiter Paul-Ehrlich Institut Paul-Ehrlich Straße 51-59 D-63225 Langen Tel.
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.
Reinhard KROKER Leiter des Fachbereiches «Tierarzneimittelzulassung und -rückstandskontrolle, Futterzusatzstoffe» BgVV Diedersdorfer Weg, 1 D-12277 Berlin Tel.
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
(49-30) 84 12 23 64 Fax (49-30) 84 12 29 65 E-mail: r.kroker@bgvv.de Internet: http://www.bgvv.de
61 EMEA General Report 2000
69 Informe General EMEA 2000
A subscription service is available for all EMEA public documents, distributing documents electronically or in paper form.
∂ÏÏ¿‰·/GREECE Marios MARSELOS President National Organization for Medicines Mesogion 284 GR-155 62 Holargos Athens Tel.
Further information can be obtained from the above address or from
(30-1) 650 72 10 Fax (30-1) 654 95 86 E-mail: hmoutsop@eof.gr
Contact point Iro MAVROPOULOS Direct telephone (44-20) 74 18 85 82 E-mail: subscriptions@emea. eudra. org
(34) 915 96 16 27 Fax (34) 915 96 16 15 E-mail: sdaem@agamed.es Internet: http://www.agamed.es
Requests for general information packs should be sent to
FRANCE
Contact point Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda. bosworth@emea. eudra. org
(33) 155 87 30 14 Fax (33) 155 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) 149 77 13 99/26 54 Fax (33) 149 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
(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
human_experts@emea. eudra. org vet_experts@emea. eudra. org inspectors_experts@emea. eudra. org
Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Ireland Tel.
Media and press contacts
ITALIA
Representatives of the media should contact the following people for information:
(39) 06 59 94 36 66 Fax (39) 06 59 94 34 56 E-mail: farmaci.sanita@interbusiness.it Internet: http://www.sanita.it/farmaci
For matters concerning medicinal products for human use
(39) 06 59 94 39 45 Fax (39) 06 59 94 31 90 E-mail: danspv@izs.it
Contact point Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eudra. org
70 Informe General EMEA 2000
For matters concerning medicinal products for veterinary use
(352) 478 55 90 Fax (352) 26 20 01 47 E-mail: dpmlux@pt.lu
Contact point Peter JONES Direct telephone (44-20) 74 18 84 13 E-mail: peter. jones@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
For general information on any other matter
(31-31) 747 54 91 Fax (31-31) 742 31 93 E-mail: brd@brd.agro.nl
Contact points Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eudra. org
ÖSTERREICH
Antoine CUVILLIER Direct telephone (44-20) 74 18 84 28 E-mail: antoine. cuvillier@emea. eudra. org
(43-1) 711 00 47 17 Fax (43-1) 713 86 14 E-mail: gunter.liebeswar@bmsg.gv.at
EU official publications
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander.jentzsch@bmsg.gv.at
• 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.
(351) 217 98 71 16 Fax (351) 217 98 71 20/24 E-mail: miguel.andrade@infarmed.pt Internet: http://www.infarmed.pt
1)
(351) 213 23 95 66 Fax (351) 213 46 35 18 E-mail: rleitao@dgv.min-agricultura.pt
62 EMEA General Report 2000
71 Informe General EMEA 2000
• Council Directive 75/ 319/ EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended (OJ L 147, 9.6.1975, p.
Box 55 FIN-00301 Helsinki Tel.
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.
(358-9) 47 33 42 00 Fax (358-9) 47 33 43 45 E-mail: hannes.wahlroos@nam.fi Internet: http://www.nam.fi
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.
(46-18) 17 46 00 Fax (46-18) 54 85 66 E-mail: gunnar.alvan@mpa.se Internet: http://www.mpa.se
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.
Keith JONES Director and Chief Executive Officer Medicines Control Agency Market Towers, Room 1629 1, Nine Elms Lane London, SW8 5NQ United Kingdom Tel.
1)
(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
The texts of these and other provisions are available in the series Rules governing medicinal products in the European Community.
Michael RUTTER Director and Chief Executive Veterinary Medicines Directorate Woodham Lane New Haw, Addlestone Surrey, KT15 3NB United Kingdom Tel.
These publications, along with copies of the Official Journal, are available from:
(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
EMEA documents
Observadores:
• 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)
(354) 520 21 00 Fax (354) 561 21 70 E-mail: rannveig.gunnarsdottir@lyfjanefnd.is Internet: http://www.lyfjanefnd.is
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
NORGE/NOREG Gro Ramsten WESENBERG Director-General Statens legemiddelkontroll Sven Oftedals vei 6 N-0950 Oslo Tel.
Sector for Document management and publishing European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf London E14 4HB UK
(47-22) 89 77 00 Fax (47-22) 89 77 99 E-mail: gro.wesenberg@slk.no Internet: http://www.slk.no
63 EMEA General Report 2000
LIECHTENSTEIN Brigitte BATLINER
EMEA budgets for 1999 to 2001
Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel Postplatz 2 FL-9494 Schaan Tel.
The summarised comparative budget statements in euro for 1999 to 2001 are given below.
(423) 236 73 25 Fax (423) 236 73 10 E-mail: brigitte.batliner@alk.llv.li
1999(1)
72 Informe General EMEA 2000
2000(2)
Anexo 8.
2001(3)
Producto - Nombre comercial - DCI - Parte A/B
(31.12.1999)
Compañía - Nombre - Origen
(as at 31.12.2000)
Área terapéutica - ATC - Indicación
(as at 20.12.2000)
Presentación - Forma - Dosis - Número de presentaciones
Expenditure Staff
EMEA/CPMP - Validación - Dictamen - Tiempo activo - Tiempo inactivo
salaries interim and other support persons other staff-related expenditure total title 1
Comisión - Dictamen recibido el - Fecha de la decisión - Fecha de la notificación - Diario Oficial
15 074 905 955 456 1 191 570 17 221 931
- Orgalutran
36.61% 2.32% 2.89% 41.82%
Organon
18 493 000 1 058 000 1 350 000 20 901 000
- H01CC01
33.45% 1.91% 2.44% 37.80%
- Orgalutran - N.V.
21 772 000 35.15% 1 379 000 2.23% 1 501 000 2.42% 24 652 000 39.80%
Organon - H01CC01 - Solution for injection - 29.1.1999 -
Building/ equipment
- ganirelix
rent/ charges expenditure on data processing other capital expenditure postage and communications other administrative expenditure
- NL
2 136 038 1 034 357 1 824 960 370 754 1 194 962
- Prevention of
5.19% 2.51% 4.43% 0.90% 2.90%
- ganirelix - NL - Prevention of - 0.5 mg/ml -
5 212 220 2 423 500 2 353 000 480 000 1 593 000
- ganirelix - NL - Prevention of - 0.5 mg/ml - 19.1.2000 -
9.43% 4.38% 4.26% 0.87% 2.88%
17.5.2000
5 685 000 9.18% 1 400 000 2.26% 824 500 1.33% 537 000 0.87% 1 784 500 2.88%
premature luteinising
total title 2
- B premature luteinising - 2 presentations -
6 561 071
- B premature luteinising - 2 presentations - 162 days -
15.93%
22.5.2000
12 061 720 21.82%
hormone surges in conteolled ovarian hyperstimulation
10 231 000 16.52%
189 days -
Operational expenditure
3
meetings
- Pegintron - peginterferon
3 274 441
- SP Europe - US
7.95%
- -
3 487 000 6.31%
L03AB10 Treatment of chronic
6 565 000 10.60%
-
evaluations translation studies and consultants publications
Powder and solvent for solution for injection
13 894 457 93 650 137 130
26.3.1999 - 17.2.2000 -
33.74% 0.00% 0.23% 0.33%
alfa A
18 682 500 p. m.
-2b
5 000 150 000
hepatitis C
33.79% 0.00% 0.01% 0.27%
-
19 658 000 31.74% 428 000 0.69% 180 000 0.29% 220 000 0.36%
50 µg/0.5 ml, 80 µg/0.5 ml, - 100 µg/0.5 ml, - 120 µg/0.5 ml, 150µg/0.5 ml
total title 3
3
17 399 678
25 presentations
42.25%
- Viraferon PEG
22 324 500 40.38%
- SP Europe
27 051 000 43.68%
- L03AB10
TOTAL EXPENDITURE
- Viraferon PEG - SP Europe - L03AB10 - Powder and solvent for -
41 182 680 100.00%
- Viraferon PEG - SP Europe - L03AB10 - Powder and solvent for - 3.1.2000 -
55 287 220 100.00%
27.3.2000
61 934 000 100.00%
- peginterferon
Revenue
- US
fees general EU contribution special EU orphan medicinal
- peginterferon - US - Treatment of chronic solution for injection -
28 952 500 70.31% 10 481 649 25.45%
- peginterferon - US - Treatment of chronic solution for injection - 17.2.2000 -
39 154 000 70.82% 13 200 000 23.88%
25.5.2000
42 610 000 68.81% 14 700 000 23.73%
hepatitis C
product contribution contribution from EEA contribution from EU
50 µg/0.5 ml, 80 µg/0.5 ml, - 100 µg/0.5 ml, - 120 µg/0.5 ml, 150µg/0.5 ml
-- 0.00% -- 0.00%
43 days - 0 days -
1 000 000 1.81% 245 220 0.44%
3
600 000 0.97% 250 000 0.40%
25 presentations
programmes (PERF) other
- Lantus
800 000 1.94% 948 531 2.30%
- Aventis Pharma - A10AE
217 000 0.39% 1 471 000 2.66%
- Lantus - Aventis Pharma - A10AE - Solution for injection -
2 440 000 3.94% 1 334 000 2.15%
- Lantus - Aventis Pharma - A10AE - Solution for injection - 23.4.1999 -
TOTAL REVENUE
23.3.2000
41 182 680 100.00%
- insulin glargine
55 287 220 100.00%
Deutschland
61 934 000 100.00%
- Diabetes mellitus
Notes
GmbH
(1) 1999 budget: outturn figures.
- A GmbH - 7 presentations -
(3) 2001 budget: draft appropriations.
- A GmbH - 7 presentations - 215 days -
64 EMEA General Report 2000
14.6.2000
Members of the Management Board
- Optisulin - insulin glargine - A
Chairman
- -
André BROEKMANS 1
- A10AE - Diabetes mellitus
Members
- Nyracta
European Parliament
- SmithKline
Gianmartino BENZI, José-Luis VALVERDE LÓPEZ 2 Alternates:
- A10BG02 - Film coated tablet
Dietrich HENSCHLER, Jean-Pierre REYNIER
- Nyracta - SmithKline - A10BG02 -
European Commission Fabio COLASANTI 3, Bertrand CARSIN 4 Alternates:
- Nyracta - SmithKline - A10BG02 - Film coated tablet -
Paul WEISSENBERG Belgique/ België Danmark Deutschland
- Nyracta - SmithKline - A10BG02 - Film coated tablet - 18.12.1998 -
André PAUWELS, Frans GOSSELINCKX Ib VALSBORG, Jytte LYNGVIG 5 Hermann Josef PABEL, Gerhard Josef KOTHMANN, (Vice-chairman)
Beecham
Eλλ δα / Greece España
- Combination treatment -
Marios MARSELOS 6, Elias MOSSIALOS 7 María Victoria de la CUESTA GARCIA 8, Ramón PALOP BAIXAULI 9
- rosiglitazone Beecham - Combination treatment - 1 mg, 2 mg, 4 mg, -
France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/ Finland Sverige United Kingdom
- rosiglitazone Beecham - Combination treatment - 1 mg, 2 mg, 4 mg, - 21.10.1999 -
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
- B
Observers
Pharmaceuticals
Ísland
of Type II diabetes
Rannveig GUNNARSDÓTTIR, Ingolf PETERSEN
- B Pharmaceuticals of Type II diabetes 8 mg -
Liechtenstein Norge/ Noreg
- B Pharmaceuticals of Type II diabetes 8 mg - 186 days -
Brigitte BATLINER, Peter MALIN Andreas DISEN, Gro Ramsten WESENBERG
12 presentations -
1 Resigned at the 20 December 2000 meeting.
OJ C 244, 25.8.2000, p.
2 Replaced Dietrich HENSCHLER as of the 22 February 2000 meeting.
2
3 Replaced Jörn KECK as of the 22 February 2000 meeting.
- Avandia - rosiglitazone - B
4 Replaced Joachim HEINE as of the 22 February 2000 meeting.
- -
7 Replaced John PSOMAS as of the 20 December 2000 meeting.
SmithKline Beecham Phramaceuticals UK
8 Replaced María Theresa PAGÉS JIMÉNEZ as of the 20 December 2000 meeting.
- -
10 Replaced Jacques BOISSEAU as of the 22 February 2000 meeting.
A10BG02 - Combination treatment - of Type II diabetes mellitus -
12 Replaced André BROEKMANS as of the 7 June 2000 meeting.
Film coated tablet - 1 mg, 2 mg, 4 mg, - 8 mg - 12 presentations -
65 EMEA General Report 2000
18.12.1998 - 21.10.1999 - 186 days - 119 days -
Annex 4:
4
•
- Venvia
· Jean-Michel ALEXANDRE (France), Chairman
- Venvia - SmithKline - A10BG02 - Film coated tablet -
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
- Venvia - SmithKline - A10BG02 - Film coated tablet - 18.12.1998 -
· 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)
- rosiglitazone
1 2 3 4 5 6 7 8
Beecham
Replaced Gorm JENSEN as of the January 2000 meeting.
- Combination treatment -
Replaced Alfred HILDEBRANDT as of the September 2000 meeting.
- rosiglitazone Beecham - Combination treatment - 1 mg, 2 mg, 4 mg, -
Replaced Mary TEELING as Vice-chairman as of the September 2000 meeting.
- rosiglitazone Beecham - Combination treatment - 1 mg, 2 mg, 4 mg, - 21.10.1999 -
Replaced Eva ALHAVA as of the March 2000 meeting.
Pharmaceuticals
Replaced David JEFFERYS as of the March 2000 meeting.
of Type II diabetes
Replaced Mary TEELING as of the September 2000 meeting.
- B Pharmaceuticals of Type II diabetes 8 mg -
66 EMEA General Report 2000
- B Pharmaceuticals of Type II diabetes 8 mg - 186 days -
Annex 5:
26.7.2000
•
- UK
Reinhard KROKER (Deutschland), Chairman
mellitusus -
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •
12 presentations -
Margarita ARBOIX (España) J.
119 days -
1 2 3 4
2
The country of the nominating Member State is given for information purposes only.
- Myocet
67 EMEA General Report 2000
- The Liposome
Annex 6:
- L01DB
Members of the Committee for Orphan Medicinal Products
- Myocet - The Liposome - L01DB - Powder and pre- -
Chairman (España)
- Myocet - The Liposome - L01DB - Powder and pre- - 30.7.1999 -
Josep TORRENT i FARNELL
17.5.2000
Members
- doxorubicin
Belgique/België Danmark Deutschland Eλλ δα/Greece France Ireland Italia Luxembourg Nederlands Österreich Portugal Suomi/Finland Sverige United Kingdom Patient organisation
company
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
- Treatment of metastatic admixtures for
representatives
- doxorubicin company - Treatment of metastatic admixtures for -
Moisés ABASCAL ALONSO 5 Yann LE CAM, 5 Vice-chairman Alastair KENT 6
- doxorubicin company - Treatment of metastatic admixtures for - 12.4.2000 -
EMEA representatives
13.7.2000
Jean-Michel ALEXANDRE 7 Gianmartino BENZI Mary TEELING 8
- US
Observers
breast cancer
Ísland Norge/Noreg
- B - US breast cancer concentrate for, -
Sigurdur THORSTEINSSON Randi NORDAL
- B - US breast cancer concentrate for, - 167 days -
1 2 3 4 5 6 7 8
26.7.2000
Representing the European Association for Orphan Diseases (Eurodis).
liposomal dispersion for infusion 50 mg 1 presentation
68 EMEA General Report 2000
-
Annex 7:
91 days -
National competent authority partners
2
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
- Datscan - ioflupanee - B
BELGIQUE/BELGÏE André PAUWELS Conseiller Général/ Generaal Adviseur Ministère des affaires sociales, de la santé publique et de l’environnement Inspection Générale de la Pharmacie Ministerie van Sociale Zaken, Volksgezondheid en Leefmilieu Algemeine Farmaceutische Inspektie Boulevard Bisschoffsheim / Bisschoffsheimlaan, 33 B – 1000 Bruxelles / Brussel Tel.
- -
DANMARK Jytte LYNGVIG Direktør Lægemiddelstyrelsen Frederikssundsvej 378 DK – 2700 Brønshøj Tel.
Nycomed Amersham UK
DEUTSCHLAND Harald SCHWEIM Direktor BfArM Friedrich-Ebert-Allee 38 D – 53113 Bonn Tel.
- -
(49-30) 84 12 23 64 Fax (49-30) 84 12 29 65 E-mail: r.kroker@bgvv.de
V09AB03 Diagnosis of Parkinson disease
Johannes LÖW ER Kommissarische Leiter Paul-Ehrlich Institut Paul-Ehrlich Straße 51-59 D – 63225 Langen Tel.
- - -
Internet: http://www.bgvv.de
Solution for injection 74 MBq/ml 1 presentation
69 EMEA General Report 2000
18.12.1998 - 16.3.2000 - 178 days - 272 days -
Eλλ δα/GREECE Marios MARSELOS President National Organization for Medicines Mesogion 284 GR – 155 62 Holargos Athens Tel.
5.5.2000 27.7.2000 2.8.2000 OJ C 244, 25.8.2000, p.
(30-1) 650 72 10 Fax (30-1) 654 95 86 E-mail: hmoutsop@eof.gr
10
(34-91) 596 16 27 Fax (34-91) 596 16 15 E-mail: sdaem@agamed.es Internet: http://www.agamed.es
73 Informe General EMEA 2000
Philippe DUNETON Directeur-Général Agence Française de Sécurité Sanitaire des Produits de Santé 143-147, blvd Anatole France F - 93200 Saint-Denis CEDEX Tel.
Producto - Nombre comercial - DCI - Parte A/B
19 F – 94701 Maisons Alfort CEDEX Tel.
Compañía - Nombre - Origen
IRELAND
Área terapéutica - ATC - Indicación
(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank.hallinan@imb.ie Internet: http://www.imb.ie
Presentación - Forma - Dosis - Número de presentaciones
(353-1) 607 24 34 Fax (353-1) 676 29 89 E-mail: seamus.healy@daff.irlgov.ie
EMEA/CPMP - Validación - Dictamen - Tiempo activo - Tiempo inactivo
Nello MARTINI Direttore Generale del Dipartimento per Valutazione dei medicinale e la farmacovigilanza Ministero della Sanità Viale Civilità Romana 7 I -00144 Roma Tel.
Comisión - Dictamen recibido el - Fecha de la decisión - Fecha de la notificación - Diario Oficial
(39-6) 59 94 39 45 Fax (39-6) 59 94 31 90 E-mail: danspv@izs.it
- Visudyne - verteporfin - B
70 EMEA General Report 2000
- Ciba Vision - CH
LUXEMBOURG Mariette BACKES-LIES Pharmacien-Inspecteur Chef de Division Directeur de la Santé Division de la pharmacie et des médicaments Villa Louvigny – 1er étage L – 2120 Luxembourg Tel.
- -
Kalvermarkt 53 Postbus 16229 2500 BE Den Haag Nederland Tel.
L01XX Treatment of age - related macular degeneration
Kees KUIPER Hoofd van het Agentschap voor de registratie van diergeneesmiddelen Bureau Registratie Diergeneesmiddelen Postbus 289 6700 AG Wageningen Nederland Tel.
- - -
(43-1) 711 00 47 17 Fax (43-1) 713 86 14 E-mail: gunter.liebeswar@bmsg.gv.at
Powder for solution for infusion 15 mg 1 presentation
(43-1) 711 00 46 73 Fax (43-1) 714 92 22 E-mail: alexander.jentzsch@bmsg.gv.at
- 27.8.1999 - - 12.4.2000 - - 138 days - - 63 days -
(351) 213 23 95 66 Fax (351) 213 46 35 18 E-mail: rleitao@dgv.min-agricultura.pt
10
71 EMEA General Report 2000
- NovoMix 30 - insulin aspart - A
Box 55 FIN - 00301 Helsinki Tel.
- Novo Nordisk - DK
UNITED KINGDOM
- A10AD - Diabetes mellitus
Observers:
- - -
ÍSLAND Rannveig GUNNARSDÓTTIR Chief Executive Director Icelandic Medicines Control Agency Eidistorg 13 - 15 IS - 170 Seltjarnarnes Tel.
Suspension for - injection - 100 IU/ml - 8 presentations -
NORGE/NOREG Gro Ramsten WESENBERG Director-General Statens legemiddelkontroll Sven Oftedals vei 6 N - 0950 Oslo Tel.
24.9.1999 - 12.4.2000 - 144 days - 55 days -
LIECHTENSTEIN Brigitte BATLINER Amt für Lebensmittelkontrolle und Veterinärwesen Kontrollstelle für Arzneimittel Postplatz 2 FL – 9494 Schaan Tel.
17.5.2000 1.8.2000 1.8.2000 OJ C 244, 25.8.2000, p.
72 EMEA General Report 2000
- Kogenate Bayer - octocog alfa - A
Annex 8:
- Bayer AG - D
CPMP opinions in 2000 on medicinal products for human use
B02BD02 Treatment and prophylaxis of bleeding in haemophilia A
Product - Brandname - INN - Part A/B
- - -