natgillin/translations-raw huggingface dataset:
Released for consultation January 2001
Tilanne Toimitettu lausuntoa varten tammikuussa 2001
CPMP/BWP/2490/00
CPMP/ BWP/ 2490/ 00
Note for guidance on cell culture inactivated influenza vaccines – Annex to Note for guidance on harmonisation of requirements for influenza vaccines CPMP/BWP/214/96
Note for guidance on cell culture inactivated influenza vaccines – Annex to Note for guidance on harmonisation of requirements for influenza vaccines CPMP/ BWP/ 214/ 96
Released for consultation January 2001
Toimitettu lausuntoa varten tammikuussa 2001
CPMP/BWP/3088/99
CPMP/ BWP/ 3088/ 99
Note for guidance on the quality, pre-clinical and clinical Adopted April 2001 aspects of gene transfer medicinal products
Hyväksytty huhtikuussa 2001
EMEA/410/01 Rev.
EMEA/ 410/ 01 Rev.
Note for guidance on minimising the risk of transmitting Adopted by CPMP and CVMP May 2001 animal spongiform encephalopathy agents via human and veterinary medicinal products
CPMP ja CVMP hyväksyneet toukokuussa 2001
CPMP/BWP/3207/00
CPMP/ BWP/ 3207/ 00
Note for guidance on comparability of medicinal products containing biotechnology-derived proteins as drug substance
Note for guidance on comparability of medicinal products containing biotechnology- derived proteins as drug substance
Adopted September 2001
Hyväksytty syyskuussa 2001
Reference number
Viitenumero EMEA/ CPMP/ BWP/ 283/ 00
Document title
Asiakirjan nimi Note for Guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use
Note for Guidance on the clinical investigation of human Released for consultation March 2001 normal immunoglobulin for subcutaneous and intramuscular use
Tilanne Toimitettu lausuntoa varten maaliskuussa 2001
EMEA/CPMP/BPWG/1089/00 Note for guidance on the clinical investigation of plasma derived fibrin sealants
Note for guidance on the clinical investigation of plasma derived fibrin sealants
Released for consultation December 2001
Toimitettu lausuntoa varten joulukuussa 2001
CPMP Efficacy Working Party
CPMP: n tehokkuustyöryhmä
1
Viitenumero EMEA/ CPMP/ EWP/ 552/ 95 rev.
Note for guidance on postmenopausal osteoporosis in women
Asiakirjan nimi Note for guidance on postmenopausal osteoporosis in women
Adopted January 2001
Tilanne Hyväksytty tammikuussa 2001
EMEA/CPMP/EWP/49/01
EMEA/ CPMP/ EWP/ 49/ 00
Adopted March 2001
Hyväksytty maaliskuussa 2001
EMEA/CPMP/EWP/18/01
EMEA/ CPMP/ EWP/ 18/ 00
CPMP/EWP/567/98 rev.
CPMP/ BWP/ 567/ 98 Rev.
Adopted April 2001
Hyväksytty huhtikuussa 2001
CPMP/EWP/205/95 rev.
CPMP/ BWP/ 205/ 95 Rev.
Note for guidance on evaluation of anticancer medicinal Adopted May 2001 products in man
Hyväksytty toukokuussa 2001
EMEA/CPMP/EWP/1045/01
EMEA/ CPMP/ EWP/ 1045/ 00
Concept paper on the revision of the CPMP/BWP Adopted May 2001 Note for guidance (CPMP/BWP/214/96) on harmonisation of requirements for influenza vaccines
Hyväksytty toukokuussa 2001
EMEA/CPMP/EWP/967/01
EMEA/ CPMP/ EWP/ 967/ 00
Adopted May 2001
Hyväksytty toukokuussa 2001
EMEA/CPMP/EWP/512/01
EMEA/ CPMP/ EWP/ 512/ 00
Concept paper on the development of a CPMP Note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia
Concept paper on the development of a CPMP Note for guidance on the evaluation of medicinal
EMEA/CPMP/EWP/788/01
EMEA/ CPMP/ EWP/ 788/ 01
EMEA/CPMP/EWP/2330/99
EMEA/ CPMP/ EWP/ 2330/ 99
Points to consider on application with 1) meta-analyses and 2) one pivotal study
Points to consider on application with 1) meta - analyses and 2) one pivotal study
EMEA/CPMP/EWP/2284/99
EMEA/ CPMP/ EWP/ 2284/ 99
Points to consider on clinical investigation of medicinal products for the management of Crohn’s disease
Points to consider on clinical investigation of medicinal products for the management of Crohn’ s disease
Adopted June 2001
Hyväksytty kesäkuussa 2001
EMEA/CPMP/EWP/PhVWP/ 1417/01
EMEA/ CPMP/ EWP/ PhVWP / 1417/ 01
Joint PhVWP/EWP Concept paper on the development of a CPMP Note for guidance on the use of medicinal products during pregnancy: need for post-marketing data
Joint PhVWP/ EWP Concept paper on the development of a CPMP Note for Guidance on the use of medicinal products during pregnancy: need for post- marketing data
EMEA/CPMP/EWP/1343/01
EMEA/ CPMP/ EWP/ 1343/ 01
Concept paper on the development of a CPMP Points to consider document on the evaluation of new anti-fungal agents for invasive fungal infections
Concept paper on the development of a CPMP Points to consider document on the evaluation of new anti- fungal agents for invasive fungal infections
Adopted July 2001
Hyväksytty heinäkuussa 2001
CPMP/EWP/QWP/1401/98 rev.
CPMP/ EWP/ QWP/ 1401/ 98 rev.
EMEA/CPMP/EWP/561/98
EMEA/ CPMP/ EWP/ 561/ 98
EMEA/CPMP/EWP/1533/01
EMEA/ CPMP/ EWP/ 1533/ 01
Concept paper on the development of an addendum on acute cardiac failure to the CPMP Note for guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure
Concept paper on the development of an addendum on acute cardiac failure to the CPMP Note for Guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure
EMEA/CPMP/EWP/560/98
EMEA/ CPMP/ EWP/ 560/ 98
Note for guidance on co-ordinating investigator signature of clinical study reports
Note for guidance on co- ordinating investigator signature of clinical study reports
Adopted October 2001
Hyväksytty lokakuussa 2001
EMEA/CPMP/EWP/2991/01 draft 2
EMEA/ CPMP/ EWP/ 2991/ 01 draft 2
Concept paper on the development of an addendum on the clinical requirements of modified release medicinal products submitted as a line-extension of an existing marketing authorisation to the CPMP Note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation) (CPMP/EWP/280/96)
Concept paper on the development of an addendum on the clinical requirements of modified release medicinal products submitted as a line- extension of an existing marketing authorisation to the CPMP Note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation) (CPMP/ EWP/ 280/ 96)
Adopted November 2001
Hyväksytty marraskuussa 2001
EMEA/CPMP/EWP/1119/98
EMEA/ CPMP/ EWP/ 1119/ 98
Points to consider on missing data
EMEA/ CPMP/ EWP/ 1776/ 99 EMEA/ CPMP/ 602/ 95 rev.
Points to consider on the assessment of anti-HIV medicinal products
Points to consider on missing data Points to consider on the assessment of anti- HIV medicinal products
Adopted December 2001
Hyväksytty marraskuussa 2001 Hyväksytty joulukuussa 2001
CPMP/EWP/1776/99 draft 5
CPMP/ EWP/ 1776/ 99 draft 5
CPMP/EWP/908/99
CPMP/ EWP/ 908/ 99
Released for consultation July 2001
Toimitettu lausuntoa varten heinäkuussa 2001
CPMP/EWP/2863/99
CPMP/ EWP/ 2863/ 99
CPMP/602/95 rev.
CPMP/ 602/ 95 rev.
Points to consider on the assessment of anti-HIV medicinal products
Points to consider on the assessment of anti- HIV medicinal products
Released for consultation May 2001
Toimitettu lausuntoa varten toukokuussa 2001
CPMP/EWP/518/97 rev.
CPMP/ EWP/ 518/ 97 rev.
Released for consultation April 2001
Toimitettu lausuntoa varten huhtikuussa 2001
CPMP/EWP/1080/00
CPMP/ EWP/ 1080/ 00
CPMP/EWP/18/01
CPMP/ EWP/ 18/ 01
Released for consultation November 2001
Toimitettu lausuntoa varten marraskuussa 2001
CPMP/EWP/612/00 draft 7
CPMP/ EWP/ 612/ 00 draft 7
CPMP/EWP/2922/00 draft 6
CPMP/ EWP/ 2922/ 00 draft 6
Released for consultation November 2001 EMEA Annual Report 2001 63
Toimitettu lausuntoa varten marraskuussa 2001
CPMP Pharmacovigilance Working Party
82 CPMP: n lääkevalvonnan työryhmä
CPMP/PhVWP/1618/01
Viitenumero CPMP/ PhVWP/ 1618/ 01
Position paper on compliance with pharmacovigilance regulatory obligations
Asiakirjan nimi Position paper on compliance with pharmacovigilance regulatory obligations
Adopted November 2001
Tilanne Hyväksytty marraskuussa 2001
CPMP/EWP/PhVWP/1417/01
CPMP/ EWP/ PhVWP/ 1417/ 01
Need for post-marketing data
Need for post - marketing data
CPMP/SWP/373/01
CPMP/ SWP/ 373/ 01
CPMP/PhVWP/175/95
CPMP/ PhVWP/ 175/ 95
Published by the European Commission in December 2001 in volume 9 of the 2001 edition of the Rules governing medicinal products in the European Union
Europan komissio julkaissut joulukuussa 2001 Rules governing medicinal products in the European Union – julkaisun 9. osassa vuonna 2001
CPMP/183/97
CPMP/ 183/ 97
CPMP/PhVWP/108/99
CPMP/ PhVWP/ 108/ 99
Notice to marketing authorisation holders - pharmacovigilance guidlines
Notice to marketing authorisation holders – pharmacovigilance guidelines
CPMP Safety Working Party
Viitenumero
Reference number
Asiakirjan nimi
Document title
Tilanne
Status
CPMP: n turvallisuustyöryhmä
CPMP/SWP/2145/00
Viitenumero CPMP/ SWP/ 2145/ 00
Update of Note for guidance on non-clinical local tolerance testing of medicinal products
Asiakirjan nimi Update of Note for guidance on non- clinical local tolerance testing of medicinal products
Adopted March 2001
Tilanne Hyväksytty maaliskuussa 2001
CPMP/SWP/372/01
CPMP/ SWP/ 372/ 01
Points to consider document on the non-clinical assessment of the carcinogenic potential of insulin analogues
Points to consider document on the non- clinical assessment of the carcinogenic potential of insulin analogues
CPMP/SWP/2877/00
CPMP/ SWP/ 2877/ 00
CPMP/SWP/4447/00
CPMP/ SWP/ 4447/ 00
CPMP/SWP/446/00
CPMP/ SWP/ 446/ 00
CPMP/SWP/398/01
CPMP/ SWP/ 398/ 01
Released for consultation March 2001
Toimitettu lausuntoa varten maaliskuussa 2001
CPMP/SWP/2600/01
CPMP/ SWP/ 2600/ 01
Released for consultation September 2001
Toimitettu lausuntoa varten syyskuussa 2001
EMEA Herbal Medicinal Products Working Party
EMEAn luonnonlääkevalmisteiden työryhmä
Reference number
Viitenumero EMEA/ 18123/ 00
Compilation of general quality questions answered by the Herbal Medicinal Products Working Party
Asiakirjan nimi Compilation of general quality questions answered by the Herbal Medicinal Products Working Party
Endorsed in March 2001
Tilanne Vahvistettu maaliskuussa 2001
EMEA/HMPWP/31/99 Rev 1
EMEA/ HMPWP/ 31/ 99 Rev 1
CVMP Efficacy Working Party
83 CVMP: n tehokkuustyöryhmä
EMEA/CVMP/016/00
Viitenumero EMEA/ CVMP/ 016/ 00
Conduct of bioequivalance studies for veterinary medicinal products
Asiakirjan nimi Conduct of bioequivalance studies for veterinary medicinal products
EMEA/CVMP/005/00 Rev 1
EMEA/ CVMP/ 005/ 00 Rev 1
Adopted February 2001
Hyväksytty helmikuussa 2001
CVMP/VICH/833/99
CVMP/ VICH/ 833/ 99
CVMP/VICH/834/99
CVMP/ VICH/ 834/ 99
CVMP/VICH/835/99
CVMP/ VICH/ 835/ 99
CVMP/VICH/545/00
CVMP/ VICH/ 545/ 00
CVMP/VICH/546/00
CVMP/ VICH/ 546/ 00
EMEA/CVMP/237/01
EMEA/ CVMP/ 237/ 01
Conduct of efficacy studies for non-steroidal anti-inflammatory drugs
Conduct of efficacy studies for non- steroidal anti- inflammatory drugs
Adopted December 2001
Hyväksytty heinäkuussa 2001
EMEA/CVMP/816/00
EMEA/ CVMP/ 816/ 00 EMEA/ CVMP/ 237/ 01
Statistical principles for veterinary clinical trials
Statistical principles for veterinary clinical trials Conduct of efficacy studies for non- steroidal anti- inflammatory drugs
Adopted December 2001 EMEA Annual Report 2001
Hyväksytty joulukuussa 2001 Toimitettu lausuntoa varten maaliskuussa 2001
EMEA/CVMP/411/01
EMEA/ CVMP/ 411/ 01
EMEA/CVMP/627/01
EMEA/ CVMP/ 627/ 01
Released for consultation October 2001
Toimitettu lausuntoa varten lokakuussa 2001
EMEA/CVMP/612/01
EMEA/ CVMP/ 612/ 01
CVMP Immunologicals Working Party
CVMP: n immunologisia valmisteita käsittelevä työryhmä
EMEA/CVMP/852/99
Viitenumero EMEA/ CVMP/ 852/ 99 EMEA/ CVMP/ 743/ 00
Field trials with veterinary vaccines
Asiakirjan nimi Field trials with veterinary vaccines Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products
Adopted October 2001
Tilanne Hyväksytty lokakuussa 2001 Hyväksytty lokakuussa 2001
Adopted October 2001
Toimitettu lausuntoa varten lokakuussa 2001
CVMP/VICH/095/01
CVMP/ VICH/ 095/ 01
Released for consultation February 2001
Toimitettu lausuntoa varten lokakuussa 2001
CVMP/VICH/096/01
CVMP/ VICH/ 096/ 01
CVMP Pharmacovigilance Working Party
CVMP: n lääkevalvonnan työryhmä
CVMP/VICH/646/01
Viitenumero CVMP/ VICH/ 646/ 01
Pharmacovigilance of veterinary medicinal products:
Asiakirjan nimi Pharmacovigilance of veterinary medicinal products:
Released for consultation July 2001
Tilanne Toimitettu lausuntoa varten heinäkuussa 2001
CVMP/VICH/647/01
CVMP/ VICH/ 647/ 01
EMEA/CVMP/695/01
EMEA/ CVMP/ 695/ 01
EMEA/CVMP/187/00
Viitenumero EMEA/ CVMP/ 187/ 00
Risk analysis approach for residues of veterinary medicinal products in food of animal origin
Asiakirjan nimi Risk analysis approach for residues of veterinary medicinal products in food of animal origin
EMEA/410/01
EMEA/ 410/ 01
Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products
Minimising the risk of transmitting animal spongiform encephalopathy agents via human
CVMP/VICH/525/00
and veterinary medicinal products CVMP/ VICH/ 525/ 00
EMEA/CVMP/234/01
EMEA/ CVMP/ 234/ 01
CVMP/VICH/644/01
CVMP/ VICH/ 644/ 01
Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance
Guidance on pre- approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance
CVMP/VICH/645/01
CVMP/ VICH/ 645/ 01
EMEA/CVMP/244/01
EMEA/ CVMP/ 244/ 01
Pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
Pre- authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
Joint CPMP/CVMP Quality Working Party
CPMP: n ja CVMP: n yhteinen laatutyöryhmä
EMEA/CVMP/598/99
Viitenumero EMEA/ CVMP/ 598/ 99 EMEA/ CVMP/ 271/ 01
Process validation
Asiakirjan nimi Process validation Limitations to the use of ethylene oxide in the manufacture of medicinal products
Adopted February 2001
Tilanne Hyväksytty helmikuussa 2001 Hyväksytty huhtikuussa 2001
Limitations to the use of ethylene oxide in the manufacture of medicinal products
EMEA/ CVMP/ 453/ 01 EMEA/ CVMP/ 814/ 00 EMEA/ CVMP/ 815/ 00
Start of shelf-life of the finished dosage form
Start of shelf- life of the finished dosage form Quality of herbal medicinal products Specifications:
Quality of herbal medicinal products
Test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products
Adopted July 2001
Hyväksytty toukokuussa 2001 Hyväksytty heinäkuussa 2001 Hyväksytty heinäkuussa 2001
EMEA/CVMP/115/01
EMEA/ CVMP/ 115/ 01 EMEA/ CVMP/ 115/ 01
Quality of water for pharmaceutical use
Quality of water for pharmaceutical use Quality of water for pharmaceutical use
November 2001 EMEA Annual Report 2001
Hyväksytty marraskuussa 2001 Toimitettu lausuntoa varten helmikuussa 2001
EMEA/CVMP/424/01
EMEA/ CVMP/ 424/ 01
In-use stability testing of veterinary medicinal products
In- use stability testing of veterinary medicinal products
EMEA/CVMP/961/01
EMEA/ CVMP/ 961/ 01
Use of near infra-red spectroscopy by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorisation
Use of near infra- red spectroscopy by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorisation
Committee for Orphan Medicinal Products
Harvinaislääkekomitea
Reference number
Viitenumero EMEA/ 14220/ 00
Procedure for orphan medicinal product designation - general principles
Asiakirjan nimi Procedure for orphan medicinal product designation – general principles
Revised January 2001
Tilanne Tarkastettu tammikuussa 2001
EMEA/2677/01
EMEA/ 2677/ 01
Finalised February 2001
Saatu valmiiksi helmikuussa 2001
EMEA/189/01
EMEA/ 189/ 01
EMEA/436/01
EMEA/ 436/ 01
68 EMEA Annual Report 2001
85 Liite 11 EMEAn yhteystiedot
Annex 11 EMEA contact points
Lääkevalvonta ja valmistevioista ilmoittaminen
Pharmacovigilance and product defect reporting
Tärkeä osa kansallisten toimivaltaisten viranomaisten ja EMEAn työtä on myyntiluvan saaneiden lääkevalmisteiden turvallisuuden jatkuva seuranta (lääkevalvonta).
Documentation services A wide range of documents has now been published by the
Ihmisten käyttöön tarkoitettujen lääkevalmisteiden lääkevalvontaa koskevat asiat:
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.
Noël WATHION Suora puhelinnumero (+44- 20) 74 18 85 92 Sähköposti: noel. wathion@ emea. eu. int
EMEA, including press releases, general information documents, annual reports and work programmes.
Eläinten käyttöön tarkoitettujen lääkevalmisteiden lääkevalvontaa koskevat asiat:
These and other documents are available either on the Internet at http://www.emea.eu.int or by writing to:
Barbara FREISCHEM Suora puhelinnumero (+44- 20) 74 18 85 81 Sähköposti: barbara. freischem@ emea. eu. int
For matters relating to pharmacovigilance for medicinal products for human use:
Valmisteviat ja muut laatua koskevat asiat:
Canary Wharf UK - London E14 4HB
Francisco PEÑARANDA FERNANDEZ Faksinumero, johon voi heti ilmoittaa
Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel.wathion@emea.eu.int
(44- 20) 74 18 85 90 Sähköposti: francisco. penaranda@ emea. eu. int
A subscription service is available for all EMEA public documents, distributing documents electronically or in paper form.
EMEA myöntää lääkevalmistetodistuksia Maailman terveysjärjestön antamien menettelyä koskevien ohjeiden mukaisesti.
Further information can be obtained from the above address
Todistukset vahvistavat lääkevalmisteiden myyntiluvan ja hyvän valmistustavan EU: ssa, ja niillä pyritään tukemaan myyntilupien hakemista Euroopan unionin ulkopuolisissa maissa ja vientiä niihin.
For matters relating to pharmacovigilance for medicinal products for veterinary use:
Keskitetyn menettelyn mukaisen myyntiluvan saaneita ihmisille tai eläimille HUET
or from:
Jonna SUNELL -
Iro MAVROPOULOS
Asiakirjapalvelut
Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara.freischem@emea.eu.int For product defect and other quality-related matters:
EMEA on julkaissut hyvin monenlaisia julkaisuja, kuten lehdistötiedotteita, yleisiä tietoesitteitä, vuosikertomuksia ja työohjelmia.
Amanda BOSWORTH
86 Tilauspalvelusta saa kaikkia EMEAn julkisia asiakirjoja sekä sähköisessä muodossa että paperilla.
Francisco PEÑARANDA FERNANDEZ Fax number for defective product rapid alerts:
Lisätietoja edellä esitetystä osoitteesta tai tästä osoitteesta:
(44-20) 74 18 85 90 E-mail: francisco.penaranda@emea.eu.int
Iro MAVROPOULOS Suora puhelinnumero (+44- 20) 74 18 85 82 Sähköposti: subscriptions@ emea. eu. int
Direct telephone (44-20) 74 18 84 08 E-mail: amanda.bosworth@emea.eu.int European experts lists
Amanda BOSWORTH Suora puhelinnumero (+44- 20) 74 18 84 08 Sähköposti: amanda. bosworth@ emea. eu. int
The list of European experts is available for examination on
Eurooppalaisten asiantuntijoiden luettelo
Certificates of a medicinal product The EMEA issues certificates of a medicinal product in
Luettelo eurooppalaisista asiantuntijoista on saatavissa tarkastuksia varten EMEAn toimistosta.
Requests may be made either in writing to the EMEA or sent to the following e-mail addresses:
Luettelo ihmisille tarkoitettujen lääkkeiden asiantuntijoista
conformity with the arrangements laid down by the World Health Organisation.
human_ experts@ emea. eu. int
Human medicines’ experts list: human_experts@emea.eu.int Veterinary medicines’ experts list: vet_experts@emea.eu.int
Luettelo eläinlääkeasiantuntijoista
and are intended for use in support of marketing authorisation applications in and export to non-EU countries.
vet_ experts@ emea. eu. int
Inspectors’ experts list: inspectors_experts@emea.eu.int
Luettelo tarkastusasiantuntijoista
For enquiries concerning certificates for centrally authorised medicines for human or veterinary use
inspectors_ experts@ emea. eu. int
Press officer
Tiedotustoimisto
Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65 E-mail: certificate@emea.eu.int
Tiedottaja
Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin.harvey@emea.eu.int
Martin HARVEY Suora puhelinnumero (+44- 20) 74 18 84 27 Sähköposti: martin. harvey@ emea. eu. int
The European Agency for the Evaluation of Medicinal Products
Euroopan lääkearviointivirasto
Eighth Annual Report 2002
Kahdeksas vuosikertomus 2002
Adopted by the Management Board on 19 December 2002 The annual report for 2002 is presented to the Management Board by the Executive Director in accordance with Article 55(3) of Council Regulation (EEC) No 2309/ 93.
Hallintoneuvosto hyväksyi tämän työohjelman 19. joulukuuta 2002 The European Agency for the Evaluation of Medicinal Products
This report covers activities of the EMEA in 2002.
EMEA/ MB/ 055/ 02/ fi/ lopull.
Telematics, administration and other support activities are described in Chapters 5 and 6.
Kahdeksas vuosikertomus Euroopan lääkearviointiviraston toiminnasta
The ‘ @emea. eudra. org’ e-mail address format was disconnected on 1 October 2002 and messages sent to this address will no longer be delivered.
2002 Hallintoneuvosto hyväksyi tämän vuosikertomuksen 19. joulukuuta 2002
The European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom Tel:
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
(44-20) 74 18 84 16 E-mail: mail@emea. eu. int Internet: http: / /www. emea. eu. int
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2003 Reproduction and/ or distribution of this document is authorised for non- commercial purposes only provided the EMEA is acknowledged Sisällys
It can be accessed through the Europa server (http: / /europa. eu. int)
HALLINTONEUVOSTON PUHEENJOHTAJAN ESIPUHE...............................................................................................
1.3 Review of the European marketing authorisation
JOHTAJAN ESIPUHE.................................................................................................................................................
Revision of EMEA fees Transparency Interested parties International partners Quality management
EMEA: N ORGANISAATIOKAAVIO...........................................................................................................................
7 7 7 8 8
8
5.1 Implementation of the EU telematics strategy 5.2 Project management 5.3 Meeting management and conferences 5.4 Document management and publishing
LUKU 1 EMEA EUROOPAN UNIONIN JÄRJESTELMÄSSÄ........................................................................................
Chapter 6 Administration
1. 1 1. 2 1. 3 1. 4 1. 5 1. 6 1. 7 1. 8 1. 9
37
9 Kansalliset toimivaltaiset viranomaiset.................................................................................................
9
9 Euroopan unionin myyntilupien myöntämisjärjestelmän tarkistaminen............................................
Personnel and budget Infrastructure services
10 EMEA: n perimien palkkioiden tarkistaminen.....................................................................................
Chapter 2 Medicines for Human Use 2.1 Initial evaluation
11 Kansainväliset kumppanit....................................................................................................................
Post-authorisation activities Pharmacovigilance and maintenance activities Scientific advice and protocol assistance
13 Euroopan neuvoston lääkkeiden laatua käsittelevä yksikkö...............................................................
13 14 15
13
Annexes 1 Members of the Management Board 2 Members of the Committee for Proprietary
1. 10 Varainhoidon valvonta.........................................................................................................................
39 41
14
2.5
15
Arbitration and Community referrals
2. 1 2. 2 2. 3 2. 4 2. 5 2. 6 2. 7 2. 8 2. 9
16
33
Medicinal Products
2. 10 Vastavuoroista tunnustamista helpottava työryhmä............................................................................
42
33
2.6
36
Parallel distribution
3. 1 3. 2 3. 3 3. 4 3. 5 3. 6 3. 7 3. 8