natgillin/translations-raw huggingface dataset:
Treatment of chronic myeloid leukaemia
Core SPC for Human albumin Note for Guidance on the Clinical
- 03.10.2000
Utsänt på remiss i juni 2000
-
Utsänt på remiss i december 2000
- 19.10.2000
Utsänt på remiss i december 2000
- 19.12.2000
Status Antaget i februari 2000 Antaget i februari 2000 Antaget i februari 2000
- 62 days
treatment of acute coronary syndrome (ACS) without persistent ST- segment elevation Concept paper on the development of a CPMP Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma Concept paper on the development of a CPMP Points to Consider on biostatistical/ methodological issues arising from CPMP discussions on licensing applications: adjustment for baseline covariates Points to consider on Clinical investigation of medicinal products for prophylaxis of intra - and post- operative venous thromboembolic risk Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Points to consider on pharmaco- kinetics
- -
Antaget i februari 2000 Antaget i februari 2000 Antaget i juni 2000 Antaget i juni 2000 Antaget i juli 2000
Mucopolysaccharidosis type VI (Maroteaux -Lamy
EMEA/ CPMP/ EWP/ 2655/ 99 EMEA/ CPMP/ EWP/ 482/ 99 EMEA/ CPMP/ EWP/ 1080/ 00
- 04.10.2000
Antaget i juli 2000 Antaget i juli 2000 Antaget i oktober 2000
-
Antaget i november 2000
Syndrome)
EMEA/ CPMP/ EWP/ 785/ 97
- 19.10.2000 - 19.12.2000 - 62 days
for the treatment of the irritable bowel syndrome
83 EMEA General Report 2000
EMEA/ MB/ 050/ 00 Allmän rapport 2000
EMEA guidelines in 2000
Antaget i november 2000
CPMP Biotechnology Working Party
Sida 81/ 84
Reference number
1
Guidelines/Status
of medicinal products in the treatment of epileptic disorders Points to consider on Clinical investigation
EMEA/ CPMP/ BWP/840/00
EMEA/ CPMP/ EWP/ 2284/ 99
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Adopted April 2000
of medicinal products for the management of Crohn’ s disease Note for Guidance on Evaluation of
Report of the EMEA Expert Workshop on human TSEs and plasma-derived medicinal products, 15-16 May 2000 Adopted July 2000
Utsänt på remiss i juli 2000 Utsänt på remiss i juli 2000 och
EMEA/ CPMP/ BWP/3326/99
1
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adopted November 2000
anticancer medicinal products in man Points to consider on Clinical investigation
Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Released for consultation January 2000
förlängt i september 2000 med ytterligare 2 månader
EMEA/ CPMP/ BWP/3207/00
EMEA/ CPMP/ EWP/ 560/ 98
Note for Guidance on Comparability of medicinal products containing biotechnology-derived proteins as active substances Released for consultation May 2000
of medicinal products in the treatment of acute stroke Points to consider on Validity and
Position statement on the Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products Released for consultation July 2000
Utsänt på remiss i oktober 2000
2
EMEA/ CPMP/ EWP/ 2330/ 99
Revision of section 3.2.5 of CPMP Note for guidance on Plasma-derived medicinal products Released for consultation July 2000
interpretation of meta- analyses, and one pivotal study Points to consider on the Evaluation of
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Released for consultation November 2000
Utsänt på remiss i oktober 2000
Guidelines/Status
EMEA/ CPMP/ EWP/ 1119/ 98
EMEA/CPMP/BPWG/575/99
diagnostic agents Note for Guidance on Clinical investigation
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Utsänt på remiss i november 2000
EMEA/CPMP/BPWG/388/95 rev.
EMEA/ CPMP/ EWP/ 714/ 98
1
of medicinal products for the treatment of peripheral arterial occlusive disease
Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
Utsänt på remiss i november 2000
EMEA/CPMP/BPWG/574/99
EMEA/ CPMP/ EWP/ QWP /
1
Note for Guidance on the investigation of
Core SPC for Human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
Utsänt på remiss i december 2000
EMEA/ CPMP/ BPWG/1619/99
1401/ 98
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Adopted June 2000
bioavailability and bioequivalence Note for Guidance on co- ordinating
EMEA/ CPMP/ BPWG/1625/99
EMEA/ CPMP/ EWP/ 2747/ 00
EMEA/CPMP/BPWG/198/95 rev.1
investigator signature of clinical study reports
Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adopted October 2000
Utsänt på remiss i december 2000
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adopted October 2000
CPMP: s arbetsgrupp för biverkningsbevakning (PhVWP)
84 EMEA General Report 2000
Referensnummer
1
Riktlinjedokumentets titel Joint Pilot Plan for the implementation of the electronic transmission of individual
Core SPC for Human albumin Adopted October 2000 Note for guidance on the Clinical investigation of human plasma derived factor VIII and IX products Released for consultation June 2000
Status
EMEA/ CPMP/ BPWG/1561/99
EMEA/ CPMP/ PhVWP/ 2058/ 99
Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Released for consultation June 2000
Utsänt på remiss i maj 2000
EMEA/ CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
CPMP: s arbetsgrupp för säkerhet
EMEA/ CPMP/BPWG/3226/99
Referensnummer
CPMP Efficacy Working Party Reference number
Riktlinjedokumentets titel CPMP Position paper on Selective
Guidelines/Status
Status
EMEA/ CPMP/ EWP/519/98
EMEA/ CPMP/ SWP/ 2775/ 99
Note for Guidance on clinical investigation of steroid contraceptives in woman Adopted February 2000
Antaget i april 2000
EMEA/ CPMP/ EWP/197/99
EMEA/ CPMP/ SWP/ 1042/ 99
Points to consider concerning Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells Adopted February 2000
toxicity Discussion paper on Possible pre- clinical studies to investigate addiction and
Points to consider on the clinical investigation of new medicinal products for treatment of acute coronary syndrome (ACS) without persistent ST-segment elevation Adopted February 2000
Antaget i juli 2000
EMEA/ CPMP/ EWP/2922/99
EMEA/ CPMP/ SWP/ 2278/ 00
Concept paper on the development of a CPMP Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma Adopted February 2000
dependence/ withdrawal related to use of SSRIs Concept paper on the Development of a CPMP Points to consider on the need for
Concept paper on the development of a CPMP Points to Consider on biostatistical/methodological issues arising from CPMP discussions on licensing applications: adjustment for baseline covariates Adopted February 2000
Antaget i december 2000
EMEA/ CPMP/ EWP/707/98
EMEA/ CPMP/ SWP/ 4163/ 00
Points to consider on Clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk Adopted June 2000
reproduction toxicity studies in the development of human insulin analogues
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adopted June 2000
Antaget i december 2000
EMEA/ CPMP/ EWP/2655/99
EMEA/ CPMP/ SWP/ 2145/ 00
EMEA/ CPMP/ EWP/482/99
Note for Guidance on Non- clinical local
Points to consider on switching between superiority and non-inferiority Adopted July 2000
Utsänt på remiss i september 2000
EMEA/ CPMP/ EWP/1080/00
Draft 4
EMEA/ CPMP/ EWP/565/98
tolerance testing of medicinal products
Points to consider on Clinical investigation of medicinal products for treatment of Amyotrophic Lateral Sclerosis (ALS) Adopted October 2000
EMEA: s arbetsgrupp för naturläkemedel
EMEA/CPMP/EWP/785/97
Referensnummer
Concept paper on the Evaluation of drugs for the treatment of the irritable bowel syndrome Adopted November 2000
Riktlinjedokumentets titel Position paper on the Risks associated with
1
Status Antaget av arbetsgruppen i oktober
EMEA/CPMP/EWP/2284/99
EMEA/ HMPWP/ 23/ 00
Points to consider on Clinical investigation of medicinal products for the management of Crohn's disease Released for consultation July 2000
the use of Herbal Products containing Aristolochia Species Note for guidance on quality of herbal
85 EMEA General Report 2000
2000
EMEA/ CPMP/ EWP/560/98
CPMP/ QWP/ 2819/ 00
EMEA/ CPMP/ EWP/2330/99
medicinal products
Points to consider on Validity and interpretation of meta-analyses, and one pivotal study Released for consultation October 2000
Utsänt på remiss i november 2000
EMEA/ CPMP/ EWP/1119/98
EMEA/ MB/ 050/ 00 Allmän rapport 2000
Points to consider on the Evaluation of diagnostic agents Released for consultation November 2000
Note for guidance on specifications: test procedures and acceptance criteria for
EMEA/ CPMP/ EWP/714/98
Sida 82/ 84
EMEA/ CPMP/EWP/QWP/ 1401/98
CPMP/ QWP/ 2820/ 00
Note for Guidance on the investigation of bioavailability and bioequivalence Released for consultation December 2000
herbal drugs, herbal drug preparations and herbal medicinal products
Note for Guidance on co-ordinating investigator signature of clinical study reports Released for consultation December 2000
Utsänt på remiss i november 2000
CPMP Pharmacovigilance Working Party
CVMP: s arbetsgrupp för läkemedelseffekt (EWP)
EMEA/CPMP/PhVWP/2058/99
Riktlinjedokumentets titel Conduct of pharmacokinetic studies in
EMEA/ CPMP/ SWP/2775/99
EMEA/ CVMP/ 133/ 99
EMEA/ CPMP/ SWP/1042/99
animals Conduct of efficacy studies for
Note for Guidance on Repeated dose toxicity Adopted July 2000
Antaget i mars 2000
EMEA/ CPMP/ SWP/2278/00
EMEA/ CVMP/ 344/ 99
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Adopted December 2000
intramammary products for use in cattle Testing and evaluation of the efficacy of antiparasitic substances for the treatment
Note for Guidance on Non-clinical local tolerance testing of medicinal products Released for consultation September 2000
Antaget i mars 2000
Guidelines/Status
EMEA/ CVMP/ 005/ 00
EMEA/HMPWP/23/00
and prevention of tick and flea infestation in cats and dogs The conduct of bioequivalence studies for
Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species Adopted by the Working Party in October 2000
Antaget i november 2000
CPMP/QWP/2819/00
EMEA/ CVMP/ 016/ 00
Note for guidance on quality of herbal medicinal products Released for consultation November 2000
veterinary medicinal products Efficacy of anthelmintics:
CPMP/QWP/2820/00
Specific
Note for guidance on specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products Released for consultation November 2000
Utsänt på remiss i januari 2000
86 EMEA General Report 2000
CVMP/ VICH/ 546/ 00
CVMP Efficacy Working Party Reference number EMEA/ CVMP/133/99
Specific
Guidelines/Status Conduct of pharmacokinetic studies in animals Adopted March 2000
Utsänt på remiss i juli 2000
EMEA/ CVMP/344/99
CVMP/ VICH/ 545/ 00
EMEA/ CVMP/005/00
recommendations for feline
Testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in cats and dogs Adopted November 2000
Utsänt på remiss i juli 2000
The conduct of bioequivalence studies for veterinary medicinal products Released for consultation January 2000
CVMP: s arbetsgrupp för immunologiska läkemedel (IWP)
CVMP/VICH/546/00
Reference number
Specific recommendations for poultry Released for consultation July 2000
Guidelines Requirements for combined veterinary
CVMP/VICH/545/00
Status
Efficacy of anthelmintics:
CVMP/ IWP/ 52/ 97
CVMP Immunologicals Working Party Reference number CVMP/IWP/52/97
vaccines DNA vaccines non- amplifiable in
Guidelines/Status Requirements for combined veterinary vaccines Adopted March 2000
Antaget i mars 2000
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use Adopted March 2000
Antaget i mars 2000
Duration of protection achieved by veterinary vaccines Adopted October 2000
Antaget i oktober 2000
Field trials with veterinary vaccines Released for consultation March 2000
Utsänt på remiss i mars 2000
Requirements and controls applied to bovine serum (foetal or calf) used in the protection of immunological veterinary medicinal products Released for consultation October 2000
Utsänt på remiss i oktober 2000
CVMP Pharmacovigilance Working Party
CVMP: s arbetsgrupp för biverkningsbevakning (PhVWP)
Reference number EMEA/ CVMP/044/99
Referensnummer
Guidelines/Status Conduct of post-marketing surveillance studies of veterinary medicinal products Adopted April 2000
Antaget i april 2000
Management of adverse event reports (AERs) Released for consultation July 2000
Utsänt på remiss i juli 2000
CVMP Safety Working Party
CVMP: s arbetsgrupp för säkerhet (SWP)
Reference
Referensnummer
Assessment of the effect of antimicrobial substances on dairy starter cultures Adopted March 2000
Antaget i mars 2000
Determination of withdrawal periods for milk Adopted March 2000
Antaget i mars 2000
Risk analysis approach for residues of veterinary medicinal products in food of animal origin Released for consultation May 2000
Antaget i juli 2000
CVMP/VICH/526/00
EMEA/ CVMP/ 187/ 00
Safety studies for veterinary drug residues in human food:
veterinary medicinal products in food of animal origin Safety studies for veterinary drug residues
Genotoxicity studies Released for consultation July 2000
Utsänt på remiss i maj 2000
CVMP/VICH/525/00
CVMP/ VICH/ 526/ 00
Safety studies for veterinary drug residues in human food:
Genotoxicity studies Safety studies for veterinary drug residues
Reproduction studies Released for consultation July 2000
Utsänt på remiss i juli 2000
87 EMEA General Report 2000
CVMP/ VICH/ 525/ 00
Joint CPMP/CVMP Quality Working Party
Reproduction studies
Reference number
Utsänt på remiss i juli 2000
Guidelines/Status
EMEA/ MB/ 050/ 00 Allmän rapport 2000 CPMP: s och CVMP: s gemensamma arbetsgrupp för kvalitetsfrågor (QWP)
CPMP/ QWP/1676/00
Sida 83/ 84
Concept Paper on the Development of a CPMP/CVMP Note for Guidance on Quality of Water for Pharmaceutical Use Adopted July 2000
Status Antaget i juli 2000
CPMP/ QWP/3015/99
CPMP/ QWP/ 3015/ 99 CPMP/ QWP/ 1719/ 00
Note for Guidance on Parametric Release Released for consultation March 2000
Utsänt på remiss i mars 2000 Utsänt på remiss i juli 2000
CPMP/ QWP/1719/00
CPMP/ QWP/ 2845/ 00
Note for Guidance on Medicinal Gases – Pharmaceutical Information Released for consultation July 2000
Utsänt på remiss i november 2000
CPMP/QWP/2845/00
CPMP/ QWP/ 2820/ 00 (CVMP/ 815/ 00)
Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products Released for consultation November 2000
Utsänt på remiss i november 2000
CPMP/QWP/2820/00 (CVMP/815/00)
CPMP/ QWP/ 2819/ 00 (CVMP/ 814/ 00)
Note for Guidance on Specifications:
Note for Guidance on Quality of Herbal Medicinal Products Annex to Guideline:
Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products Released for consultation November 2000
Utsänt på remiss i november 2000
CPMP/QWP/2819/00 (CVMP/814/00) EMEA/ CVMP/065/99
EMEA/ CVMP/ 065/ 99
Note for Guidance on Quality of Herbal Medicinal Products Released for consultation November 2000 Annex to Guideline:
Decision trees for the selection of sterilisation methods Declaration of storage conditions for
Decision trees for the selection of sterilisation methods Adopted February 2000
Antaget i februari 2000
Declaration of storage conditions for veterinary medicinal products in the product particulars Adopted February 2000
Antaget i februari 2000
Stability testing of biotechnological/biological veterinary medicinal products Adopted June 2000
Antaget i juni 2000
Impurities: residual solvents Adopted June 2000
Antaget i juni 2000
Maximum shelf-life for sterile medicinal products after first opening or following reconstitution Adopted July 2000
Antaget i juli 2000
Good clinical practices Adopted July 2000
Antaget i juli 2000
Stability testing of existing active substances and related finished products Adopted November 2000
Antaget i november 2000
Statistical principles for veterinary clinical trials Released for consultation November 2000
Utsänt på remiss i november 2000
Ad hoc GMP Inspectors Working Group
Ad hoc- arbetsgrupperna för GMP - inspektörer
Revised Version of Annex 14 - Manufacture of medicinal products derived from human blood or plasma to the EU Guide to Good Manufacturing Practice Finalised in February 2000
from human blood or plasma to the EU Guide to Good Manufacturing Practice Procedure for Handling Rapid Alerts and
ENTR/6266/00
ENTR/ 6266/ 00
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Finalised in April 2000
Färdigställt i april 2000
88
Sida 84/ 84
The European Agency for the Evaluation of Medicinal Products
Europeiska Läkemedelsmyndigheten
Seventh Annual Report 2001
Sjunde allmänna rapporten 2001
Adopted by the Management Board on 18 December 2001 The annual report for 2001 is presented to the Management Board by the Executive Director in accordance with Article 55(3) of Council Regulation (EEC) No 2309/ 93.
Antagen av stryrelsen den 18 December 2001 The annual report for 2001 is presented to the Management Board by the Executive Director in accordance with Article 55( 3) of Council Regulation (EEC) No 2309/ 93.
EMEA Annual Report 2001
EMEA/ MB/ 052/ 01- SV
1
SJUNDE ALLMÄNNA RAPPORTEN OM VERKSAMHETEN VID EUROPEISKA LÄKEMEDELSMYNDIGHETEN
Contents
2001
Foreword by the Chairman of the Management Board
Antagen av styrelsen den 18 december 2001
Chapter 3 Veterinary Medicines 3.1 Initial evaluation
KAPITEL 1 EMEA: S ROLL I DET EUROPEISKA SYSTEMET..................................................................................... 8
23 24
1. 1 1. 2 1. 3 1. 4
Introduction by the Executive Director
Styrelsen Behöriga nationella myndigheter Öppenhet och tillsynsfrågor Översynen av EMEA: s avgifter
25
8 9 9 9
5
1. 5 1. 6 1. 7 1. 8 1. 9
3.3 Post-authorisation activities 3.4 Pharmacovigilance and maintenance activities
Översyn av det europeiska systemet för beviljande av godkännanden för försäljning Kvalitetsstyrning Internationella samarbetspartner Europarådets avdelning för läkemedelskvalitet (EDQM) Ekonomistyrning
Scientific advice
10 10 11 12 12
27
KAPITEL 2 HUMANLÄKEMEDEL......................................................................................................................... 13
National competent authorities
2. 1 2. 2 2. 3 2. 4 2. 5 2. 6 2. 7 2. 8 2. 9
6
Initial utvärdering Verksamheter efter godkännande för försäljning Biverkningsbevakning och uppföljning Vetenskaplig rådgivning Skiljedomsärenden och hänskjutna gemenskapsärenden Särskilda tjänster Internationella aktiviteter Särläkemedel Arbetsgrupper och ad hoc- grupper
Interested parties
15 17 18 19 21 22 22 23 25
Transparency and regulatory dialogue
2. 10 Gruppen för underlättande av ömsesidigt erkännande
Review of the European marketing authorisation system
KAPITEL 3 VETERINÄRMEDICINSKA LÄKEMEDEL.............................................................................................. 31
3.10 Veterinary mutual recognition facilitation group
3. 1 3. 2 3. 3 3. 4 3. 5 3. 6 3. 7 3. 8 3. 9
29
Initial utvärdering Fastställande av högsta tillåtna restmängder för gamla substanser Verksamheter efter godkännande för försäljning Biverkningsbevakning och uppföljning Vetenskaplig rådgivning Skiljedomsärenden och hänskjutna gemenskapsärenden Berörda parter Internationella aktiviteter Arbetsgrupper och ad hoc- grupper
Quality management International partners
33 35 35 36 36 36 37 37 38
Chapter 4 Inspections
3. 10 Gruppen för underlättande av ömsesidigt erkännande av veterinärmedicinska läkemedel
30
40
European Department for the Quality of Medicines Financial control
KAPITEL 4 INSPEKTIONER.................................................................................................................................. 41
Chapter 5 Administration and Support Activities 5.1 Administration 5.2 Document management and publishing
44
32 32 33
5. 1 5. 2 5. 3 5. 4
Chapter 2 Medicines for Human Use 2.1 Initial evaluation 2.2 Post-authorisation activities
Administration Hantering och publicering av dokument Möten och konferenser Informationsteknik (IT)
5.3 5.4
44 47 48 49
Meeting management and conferences Information technology
BILAGOR............................................................................................................................................................ 51
34 35
Bilaga 3 Styrelsemedlemmar Bilaga 2 Medlemmar i Kommittén för farmaceutiska specialiteter (CPMP) Bilaga 3 Ledamöterna av Kommittén för veterinärmedicinska läkemedel (CVMP) Bilaga 4 Ledamöterna av Kommittén för särläkemedel Bilaga 5 Behöriga nationella myndigheter Bilaga 6 Budgetsammanfattningar för EMEA 2000– 2002 Bilaga 7 CPMP: s yttranden under 2001 om humanläkemedel Bilaga 8 CVMP: s yttranden under 2001 om veterinärmedicinska läkemedel Bilaga 9 COMP: s yttranden under 2001 om klassificering av särläkemedel Bilaga 10 Riktlinjer och arbetsdokument 2001 Bilaga 11 EMEA: s kontaktpunkter
2.3 2.4 2.5
52 53 54 55 56 60 61 65 68 75 80
Pharmacovigilance and maintenance activities Scientific advice Arbitration and Community referrals
Årsrapporten för 2001 läggs fram för styrelsen av verkställande direktören enligt artikel 55. 3 i rådets förordning (EEG) nr 2309/ 93.
Annexes 1 Members of the Management Board 2 Members of the Committee for Proprietary
Den överlämnas till Europaparlamentet, rådet, kommissionen och medlemsstaterna.
Special services
Rapporten kan rekvireras på samtliga officiella EU- språk.
16
Tidigare årsrapporter och andra referensdokument finns på EMEA: s webbplats http: // www. emea. eu. int
Medicinal Products
Rapporten omfattar EMEA: s verksamhet under 2001.
International activities
I kapitel 1 beskrivs styrelsens verksamhet.
16
EMEA: s operativa och tekniska arbete under 2001 redovisas i kapitel 2 (humanläkemedel), kapitel 3 (veterinärmedicinska läkemedel) och kapitel 4 (inspektioner).
3 Members of the Committee for Veterinary Medicinal Products
Administration och annan stödverksamhet tas upp i kapitel 5.
41
Rapporten innehåller dessutom – i enlighet med artikel 15 c. 1 i rådets direktiv 75/ 319/ EEG och artikel 23 c. 1 i rådets direktiv 81/ 851/ EEG – en sammanfattning av hur det decentraliserade förfarandet (dvs. ömsesidigt erkännande) har fungerat under 2001.
2.8
EMEA: s medarbetare fick nya e- postadresser den 1 november 2001 i och med att den nya domänen ‘ emea. eu. int ’ infördes för e- post:
Orphan medicinal products
förnamn. efternamn@ emea. eudra. org
4 Members of the Committee for Orphan
förnamn. efternamn@ emea. eu. int
2.9
EMEA: s generella e- postadress är numera mail@ emea. eu. int och särskilda e- postadresser kommer att ändras på samma sätt, t. ex. certificate@ emea. eu. int
Working parties and ad hoc groups
E- postadresser med domänen ‘ emea. eudra. org ’ kommer att kunna användas fram till den 1 oktober 2002.
18
Denna ändring av domänen är en följd av att EMEA: s webbplats ändrades till www. emea. eu. int i början av 2001 och är ett led i EMEA: s anpassning till övriga institutioner och organ i Europeiska unionen.
Medicinal Products
EMEA: s uppdrag
2.10 Mutual recognition facilitation group
Bidra till att skydda och främja människors och djurs hälsa genom att
20
mobilisera vetenskapliga resurser i hela Europeiska unionen för att göra högkvalitativa utvärderingar av läkemedel, ge råd i frågor som rör forsknings - och utvecklingsprogram och ge användbar och tydlig information till användare och till yrkesverksamma inom vården,
5 6 7 8 9
utveckla effektiva och överblickbara förfaranden som gör det möjligt för användarna att utan onödiga dröjsmål få tillgång till innovativa läkemedel tack vare användning av ett enda godkännande för försäljning på EU- nivå,