natgillin/translations-raw huggingface dataset:
Adopted January 2002
Antogs i januari 2002 Antaget i juli 2002
CPMP/BPWG/283/00
CPMP/ BPWG/ 282/ 00
Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular use
Core SPC for Human Normal Immunoglobulin for Subcutaneous and Intramuscular use
Adopted July 2002
Antaget i juli 2002
CPMP/BPWG/282/00
CPMP: s arbetsgrupp för läkemedelseffekt (EWP) Referensnummer (CPMP/ EWP/ 1412/ 01)
Core SPC for Human Normal Immunoglobulin for Subcutaneous and Intramuscular use
Dokumenttitel Concept paper for the development of the revision of the CPMP Note for Guidance on evaluation of new anti - bacterial medicinal products (CPMP/ EWP/ 558/ 95) and the CPMP Note for Guidance on the pharmacodynamic section of the SPC for anti- bacterial medicinal products (CPMP/ EWP/ 520/ 96)
Adopted July 2002
Status Antogs i januari 2002
CPMP/EWP/1412/01
(CPMP/ EWP/ 226/ 02)
Concept paper for the development of the revision of the CPMP Note for Guidance on evaluation of new anti-bacterial medicinal products (CPMP/EWP/558/95) and the CPMP Note for Guidance on the pharmacodynamic section of the SPC for anti-bacterial medicinal products (CPMP/EWP/520/96)
Concept paper on the development of a CPMP Note for Guidance on the clinical pharmacokinetic investigation of the pharmacokinetics of peptides and proteins.
Adopted January 2002
Antogs i mars 2002
Adopted March 2002
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig Referensnummer Dokumenttitel
Adopted March 2002
Antogs i mars 2002 Antaget i april 2002
Adopted September 2002
Antogs i september 2002 Antaget i november 2002
Adopted November 2002
Antaget i november 2002
Adopted November 2002
Antaget i november 2002 Antaget i november 2002
Adopted November 2002
Antogs i november 2002
Adopted November 2002
Utsänt på remiss i november 2002
Note for Guidance on the clinical investigation of medicinal Adopted December 2002 products for the treatment of urinary incontinence
Utsänt på remiss i juli 2002
Released for consultation February 2002
Sändes ut på remiss i september 2002
Released for consultation April 2002
Sändes ut på remiss i september 2002 Utsänt på remiss i juli 2002
Points to consider on clinical investigation of medicinal products for treatment of rheumatoid arthritis
Points to consider on the evaluation of new anti- fungal agents for invasive fungal infections.
Released for consultation July 2002
Utsänt på remiss i juli 2002
CPMP/EWP/1343/01 rev.
(CPMP/ EWP/ 556/ 95 rev.
Points to consider on the evaluation of new anti-fungal agents for invasive fungal infections
Points to consider on clinical investigation of medicinal products for treatment of rheumatoid arthritis.
Release for consultation July 2002
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig Referensnummer Dokumenttitel
CPMP/EWP/633/02
(CPMP/ EWP/ 785/ 97)
Note for Guidance on the clinical development of medicinal products for the treatment of HIV infection
Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome.
Released for consultation July 2002
Sändes ut på remiss i april 2002
CPMP/EWP/788/01
(CPMP/ EWP/ 49/ 01)
Note for Guidance on clinical investigation of medicinal products for the treatment of migraine
Appendix to the NfG on the Clinical investigation of medicinal products in the treatment of schizophrenia (CPMP/ EWP/ 559/ 95) – methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia.
Released for consultation September 2002
Sändes ut på remiss i februari 2002
CPMP/EWP/596/02
(CPMP/ EWP/ 4151/ 00)
Note for Guidance on evaluation of anticancer medicinal Released for consultation products in man (CPMP/EWP/205/95 rev.
Points to consider on the requirements for clinical documentation for metered dose inhalers (MDI)
Points to consider on the clinical development of Released for consultation fibrinolytic medicinal products in the treatment of November 2002 patients with ST segment elevation acute myocardial infarction (STEMI)
Utsänt på remiss i januari 2002
CPMP Pharmacovigilance Working Party
CPMP: s arbetsgrupp för biverkningsbevakning Referensnummer CPMP/ PhVWP/ 4838/ 02
Concept Paper on Conduct of Pharmacovigilance For Medicines Used by Children
Dokumenttitel Concept Paper on Conduct of Pharmacovigilance For Medicines Used by Children
Adopted October 2002
Status Antaget i oktober 2002
Released for consultation November 2002
Utsänt på remiss i november 2002
Transmission by CPMP to Interested Parties at ICH step 3 in September 2002
Överfört av CPMP till berörda parter vid ICH steg 3 i september 2002
CPMP Safety Working Party
CPMP: s arbetsgrupp för säkerhet (SWP) Referensnummer CPMP/ SWP/ 2600/ 01
Points to consider on the need for assessment of reproductive toxicity of human insulin analogues
Dokumenttitel Points to consider on the need for assessment of reproductive toxicity of human insulin analogues
Adopted March 2002
Status Antogs i mars 2002
Adopted March 2002
Antogs i mars 2002
Adopted June 2002
Utsänt på remiss i juni 2002
CPMP/SWP/2592/02
CPMP/ SWP/ 2592/ 02
Adopted June 2002
Antaget i juni 2002
Released for consultation December 2002
Utsänt på remiss i december 2002
EMEA Herbal Medicinal Products Working Party
EMEA: s arbetsgrupp för naturläkemedel Referensnummer EMEA/ HMPWP/ 41/ 01
EMEA/HMPWP/41/01
Dokumenttitel SOP:
Published May 2002
Status Publicerad i maj 2002 Publicerad i maj 2002
3
EMEA/ HMPWP/ 31/ 99 Rev 3 EMEA/ HMPWP/ 13/ 00
Points to consider on good agricultural and collection practice for starting materials of herbal origin (*)
Points to consider on good agricultural and collection practice for starting materials of herbal origin (*) Proposal for a core- data for Plantaginis psyllium
Published May 2002
Publicerad i maj 2002 Utsänt på remiss i
EMEA/HMPWP/13/00
(Psyllium seed) (*)
Released for consultation July 2002
juli 2002
67
EMEA 2003 Sida 81/ 88
Document title
Dokumenttitel
EMEA/ HMPWP/14/00
EMEA/ HMPWP/ 14/ 00
Proposal for a core-data for Plantaginis ovatae semen (Ispaghula seed) (*)
Proposal for a core- data for Plantaginis ovatae semen
Released for consultation July 2002
Utsänt på remiss i
Final draft Proposal for a core-data for Plantaginis ovatae testa (Ispaghula husk) (*)
(Ispaghula seed) (*) Final draft Proposal for a core- data for Plantaginis
Released for consultation July 2002
Juli 2002 Utsänt på remiss i
Proposal for a core-data for Calendula flos (Calendulae flower) (*)
ovatae testa (Ispaghula husk) (*) Proposal for a core- data for Calendula flos (Calendulae
EMEA /HMPWP/18/00
flower) (*)
Released for consultation July 2002
Juli 2002
EMEA/HMPWP/19/00
EMEA/ HMPWP/ 18/ 00
Proposal for a core-data for Melissae folium (Melissa leaf) (*)
Proposal for a core- data for Passiflora herba (Passion
EMEA/HMPWP/20/00
EMEA/ HMPWP/ 19/ 00
Proposal for a core-data for Lupuli flos (Hop strobile) (*)
flower) (*) Proposal for a core- data for Melissae folium (Melissa
EMEA/HMPWP/21/00
leaf) (*)
EMEA/HMPWP/1417/02
EMEA/ HMPWP/ 20/ 00
Proposal for a core-data for Menthae piperitae aetheroleum (Peppermint oil) (*)
Proposal for a core- data for Lupuli flos (Hop strobile) (*)
Released for consultation December 2002
Utsänt på remiss i Juli 2002
EMEA/HMPWP/1418/02
EMEA/ HMPWP/ 21/ 00
Proposal for a core-data for Menthae piperitae folium (Peppermint leaf) (*)
Proposal for a core- data for Harpagophyti radix (Devil’ s
Released for consultation December 2002
Utsänt på remiss i
EMEA/HMPWP/1416/02
Claw root) (*)
Released for consultation December 2002
Juli 2002
(*) The views presented in these document are those of the HMPWP, which has been created as a forum for exchange of experience in the field of herbal medicinal products.
EMEA/ HMPWP/ 1417/ 02 Proposal for a core- data for Menthae piperitae aetheroleum (Peppermint oil) (*) EMEA/ HMPWP/ 1418/ 02 Proposal for a core- data for Menthae piperitae folium (Peppermint leaf) (*) EMEA/ HMPWP/ 1416/ 02 Proposal for a core- data for Urticae folium (Nettle leaf) (*) (*) De synpunkter som framförs i dessa dokument står för arbetsgruppen för naturläkemedel, för utbyte av erfarenheter om naturläkemedel.
These documents are released for the purpose of transparency and have no legal force with respect to Directive 2001/83/EC.
Dessa dokument skickas ut på remiss för att saknar rättsverkan enligt direktiv 2001/ 83/ EG.
Scientific Advice Review Group
Utsänt på remiss i december 2002 Utsänt på remiss i december 2002 Utsänt på remiss i december 2002 som har skapats som ett forum bidra till insyn och öppenhet och
Reference number
Gruppen för granskning av vetenskaplig rådgivning Referensnummer EMEA/ H/ 238/ 02
EMEA guidance for companies requesting protocol assistance regarding scientific issues
Dokumenttitel EMEA guidance for companies requesting protocol assistance regarding scientific issues
Published February 2002
Status Publicerad i februari 2002
CPMP/328/98 rev.
Gruppen för granskning av fantasinamn Referensnummer CPMP/ 328/ 98, rev.
Guideline on the acceptability of Invented Names For Human Medicinal Products Processed Through The Centralised Procedure
Dokumenttitel Guideline on the acceptability of Invented Names For Human Medicinal Products Processed Through The Centralised Procedure
CVMP Efficacy Working Party
CVMP: s arbetsgrupp för läkemedelseffekt (EWP) Referensnummer EMEA/ CVMP/ 1166/ 02 EMEA/ CVMP/ 411/ 01
Specific efficacy requirements for ectoparasiticides in sheep
Dokumenttitel Standard statements for the SPC of certain classes/ types of veterinary medicinal products Specific efficacy requirements for ectoparasiticides in sheep
Adopted July 2002
Status Utsänt på remiss i december 2002 Antaget i juli 2002
Adopted December 2002
Antogs i november 2002 Antogs i november 2002
Demonstration of efficacy for veterinary medicinal products containing antimicrobial subsatnces
CVMP: s arbetsgrupp för immunologiska läkemedel (IWP) Referensnummer CVMP/ VICH/ 095/ 01 CVMP/ VICH/ 096/ 01 EMEA/ CVMP/ 552/ 02
Adopted December 2002
Dokumenttitel Biologicals:
Standard statements for the SPC of certain classes/ types of veterinary medicinal products
Status Antogs i maj 2002 Antogs i maj 2002 Utsänt på remiss i juni 2002
Released for consultation December 2002
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig Referensnummer Dokumenttitel
CVMP/VICH/095/01
EMEA 2003 Sida 82/ 88
CVMP/VICH/096/01
EMEA/ CVMP/ 550/ 02
Testing of residual moisture
Requirements for compatibility statements for veterinary vaccines
Adopted May 2002
Utsänt på remiss i juni 2002
Released for consultation May 2002
Utsänt på remiss i maj 2002
Requirements for compatibility statements for veterinary vaccines
CVMP generellt Referensnummer EMEA/ CVMP/ 695/ 01
Processing of renewals in the centralised procedure
Dokumenttitel Processing of renewals in the centralised procedure
Adopted February 2002
Status Antogs i februari 2002 Antogs i mars 2002
CVMP Safety Working Party
CVMP: s arbetsgrupp för säkerhet Referensnummer EMEA/ CVMP/ 234/ 01
Safety evaluation of antimicrobial substances regarding the effects on human gut flora
Dokumenttitel Safety evaluation of antimicrobial substances regarding the effects on human gut flora
Joint CPMP/CVMP Quality Working Party Reference number
CPMP: s och CVMP: s gemensamma arbetsgrupp för kvalitetsfrågor Referensnummer CPMP/ QWP/ 1719/ 00
Document title
Dokumenttitel Medicinal gases – pharmaceutical documentation
Status
Status Antogs i januari 2002 Antogs i februari 2002
CPMP/QWP/1719/00
CPMP/ ICH/ 2737/ 99 CPMP/ ICH/ 142/ 95 CPMP/ ICH/ 4104/ 00
Medicinal gases – pharmaceutical documentation
ICH Q3A – Impurities testing:
Adopted January 2002
Antogs i februari 2002
CPMP/ICH/2737/99 CPMP/ICH/142/95
CVMP/ 424/ 02
Impurities in new drug substances
In- use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)
CPMP/ICH/4104/00
CPMP/ QWP/ 122/ 02 CPMP/ QWP/ 556/ 96
ICH Q1D – Bracketing and matrixing designs of drug substances and drug products
Stability testing: stability testing of existing active substances and related finished products – Revision
Adopted February 2002
Sändes ut på remiss i februari 2002
CVMP/424/02
CPMP/ QWP/ 227/ 02 CVMP/ 134/ 02
In-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)
European Drug Master File – Revision
EMEA/CVMP/424/01
CPMP/ ICH/ 420/ 02
In-use stability testing of veterinary medicinal products
ICH Q1E Evaluation of stability data
CPMP/QWP/2845/00
CPMP/ ICH/ 421/ 02 CPMP/ QWP/ 2845/ 00
Requirements for pharmaceutical documentation for pressurised metered dose inhalation products
ICH Q1F Stability data package for registration in climatic zones III and IV Requirements for pharmaceutical documentation for pressurised metered dose inhalation products
Adopted March 2002
Sändes ut på remiss i mars 2002
CPMP/ICH/1507/02
Referensnummer CPMP/ ICH/ 1507/ 02
ICH Q3C (M) Maintenance document for guidance on impurities
Dokumenttitel ICH Q3C (M) Maintenance document for guidance on
Adopted April 2002
Status Antaget i april 2002
Adopted May 2002
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig impurities
CVMP/115/01
EMEA 2003 Sida 83/ 88
Quality of water for pharmaceutical use – Revision
CPMP/ QWP/ 158/ 01 Quality of water for pharmaceutical use CVMP/ 115/ 01 Quality of water for pharmaceutical use – Revision
Adopted May 2002
Antogs i maj 2002 Antogs i maj 2002
EMEA/CVMP/115/01 – Revision Quality of water for pharmaceutical use
Quality of modified release dosage forms for veterinary use
Adopted May 2002
Utsänt på remiss i juli 2002
CPMP/ICH/1940/00 ICH Q3C (M) Maintenance document for guidance on impurities:
ICH Q3C (M) Maintenance document for guidance on impurities:
Adopted September 2002
Antogs i september 2002
EMEA/CVMP/1055/02 70 EMEA Annual Report 2002
CPMP/ ICH/ 4680/ 02
Concept paper for the development of guideline on quality aspects of pharmaceutical veterinary medicines administered via drinking water
ICH M4Q Questions and Answers / Location issues for common technical documents for the registration of pharmaceuticals for human use
Adopted November 2002
Sändes ut på remiss i september 2002
Reference number
EMEA/ CVMP/ 1055/ 02
Stability testing: stability testing of existing active substances and related finished products
Concept paper for the development of guideline on quality aspects of pharmaceutical veterinary medicines administered via drinking water
Adopted December 2002
Antaget i november 2002
Stability testing: stability testing of existing active substances and related finished products – Revision
Stability testing: stability testing of existing active substances and related finished products
Released for consultation February 2002
Antogs i november 2002
European Drug Master File – Revision
EMEA/ CVMP/ 424/ 01 EMEA/ CVMP/ 115/ 01 – Revision
ICH Q1E Evaluation of stability data
In- use stability testing of veterinary medicinal products Quality of water for pharmaceutical use
Released for consultation February 2002
Antogs i februari 2002 Antogs i maj 2002 Sändes ut på remiss i mars 2002
CPMP/ICH/421/02
EMEA/ CVMP/ 422/ 99 – Revision
ICH Q1F Stability data package for registration in climatic zones III and IV
Annex to note for guidance on stability testing of new active substances and medicinal products.
Released for consultation February 2002
Annex to note for guidance on stability testing of existing active substances and related finished products.
EMEA/CVMP/134/02
EMEA/ CVMP/ 134/ 02
European drug master file procedure
European drug master file procedure
Released for consultation February 2002
Sändes ut på remiss i februari 2002
EMEA/CVMP/422/99
EMEA/ CVMP/ 680/ 02
Declaration of storage conditions for veterinary medicinal products and active substances – Revision
Quality of modified release dosage forms for veterinary use
Released for consultation March 2002
Utsänt på remiss i juli 2002
EMEA/CVMP/422/99 – Revision
Kommittén för särläkemedel Referensnummer ENTR/ 6283/ 00
Declaration of storage conditions for pharmaceutical veterinary Released for consultation March 2002 medicinal products in the product particulars and active substances.
Dokumenttitel Guideline on the format and content of applications for designation as orphan medicinal products
Quality of modified release dosage forms for veterinary use Released for consultation July 2002
Status oktober 2002.
CPMP/ICH/4680/02
COMP/ 436/ 01
ICH M4Q Questions and Answers / Location issues for common technical documents for the registration of pharmaceuticals for human use
Points to consider on the calculation and reporting of the prevalence of a condition for orphan designation
Released for consultation September 2002
Antogs i mars 2002
Committee for Orphan Medicinal Products
EMEA/ 14222/ 00
Reference number
Procedures for orphan medicinal product designation – General principles
Document title
Revision 2, oktober 2002
COMP/436/01
EMEA/ 4795/ 00
Points to consider on the calculation and reporting of the prevalence of a condition for orphan designation
General information for sponsors of orphan medicinal products
Adopted March 2002
Revision 1, oktober 2002
COMP/189/01
COMP/ 189/ 01
Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal products
Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal products
EMEA/14222/00
EMEA 2003 Sida 84/ 88
Procedures for orphan medicinal product designation – General principles
Ärenden som hänskjutits till CPMP
Revision 2, October 2002
Typ av hänskjutet Datum för CPMP: s yttrande ärende
ENTR/6283/00
Internationellt generiskt namn (INN)
Guideline on the format and content of applications for designation as orphan medicinal products
Artikel 29. 2 ärenden
Revision 1, October 2002
April 2002
EMEA/4795/00
Dacarbazine
Revision 1, October 2002
Artikel 7. 5 ärenden
EMEA Annual Report 2002
Juni 2002 Pågår Pågår Pågår
International non-proprietary name (INN) Dacarbazine Alteplase Isotretinoin Clostridium botulinum type A neutoxin
Alteplase Isotretinoin Clostridium botulinum type A neutoxin Norditropin
Ongoing Ongoing Ongoing Withdrawn by the company Ongoing Ongoing Ongoing Ongoing Ongoing
Pågår Pågår
Norditropin Genotropin Salmeterol/fluticasone proprionate Fenofibrate Lisinopril Biochemie Lisinopril Cardiostat Somatropin Laurina Mononine
Genotropin Salmeterol/ fluticasone proprionate
Article 30 Referrals
Artikel 30 ärenden
September 2002 January 2002 May 2002 April 2002 February 2002
Januari 2002 Maj 2002 April 2002 Februari 2002
Fluoxetine Fluvoxamine Captopril Captopril/hydrochlorothiazide Midazolam
Fluvoxamine Captopril Captopril/ hydrochlorothiazide Midazolam
September 2002 (company appealed) Enalapril
September 2002 (överklagat av företaget)
June 2002 July 2002 Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing Ongoing
Juni 2002 Juli 2002 Pågår Pågår Pågår Pågår Pågår Pågår Pågår Pågår Pågår
Article 31 Referrals
Artikel 31
November 2002 October 2002 (company appealed) Ongoing June 2002 Ongoing Ongoing Ongoing
Pågår Juni 2002 Pågår
Calcitonins Human coagulation factor VIII Loratadine Sibutramine Gatifloxacin Nimesulide COX-2-Inhibitors:
Loratadine Sibutramine Gatifloxacin
Article 36 Referrals
Artikel 36
March 2002 July 2002 October 2002
Juli 2002 oktober 2002.
Cerivastatin Bupropion Felodipine
Bupropion Felodipine
Referrals made to the CVMP
Datum för CVMP: s yttrande
Community harmonisation and pharmacovigilance referrals
Internationellt generiskt namn (INN)
Type of referral Article 33 Directive 2001/82/EC
Artikel 33 i direktiv 2001/ 82/ EG
Date of CVMP opinion June 2002 June 2002 Ongoing
Juni 2002 Juni 2002 Pågår
International non-proprietary name (INN) Ivermectin Ivermectin Orbifloxacin
Ivermectin Ivermectin Orbifloxacin
Article 20 Council Regulation 81/851 (EEC) now Article 35 Directive 2001/82/EC 72 EMEA Annual Report 2002
Artikel 20 Rådets förordning 81/ 851 (EEG) nuvarande artikel 35 i direktiv 2001/ 82/ EG
December 2002 (under appeal)
December 2002 (överklagat)
Annex 12 EMEA contact points
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig Bilaga 12 EMEA: s kontaktpunkter
Pharmacovigilance and product defect reporting
Frågor rörande biverkningsbevakning avseende veterinärmedicinska läkemedel
Documentation services A wide range of documents has now been published by the
(44- 7880) 55 06 97
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.
I enlighet med WHO: s regler utfärdar EMEA läkemedelscertifikat där godkännande för försäljning och GMP- status i EU intygas.
The EMEA receives safety reports from within the EU and outside concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
Certifikaten är avsedda att användas som stöddokumentation vid ansökan om försäljningstillstånd i länder utanför EU och vid export till sådana länder.
For matters relating to pharmacovigilance for medicinal products for human use:
Frågor rörande certifikat för centralt godkända humanläkemedel och veterinärmedicinska läkemedel
EMEA, including press releases, general information documents, annual reports and work programmes.
Jonna SUNELL- HUET Tfn direkt (44- 20) 74 18 84 65 E- post: certificate@ emea. eu. int
These and other documents are available either on the Internet at http://www.emea.eu.int or by writing to:
Dessa och andra dokument finns på webbplatsen http: // www. emea. eu. int eller kan rekvireras skriftligen från:
EMEA Documentation service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf UK - London E14 4HB
EMEA Documentation service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf UK – London E14 4H
Panos TSINTIS Direct telephone (44-20) 75 23 71 08 E-mail: panos.tsintis@emea.eu.int
Mer information kan erhållas från adressen ovan eller från
(44-20) 74 18 86 70
E- post: emearequests@ emea. eu. int Fax (44- 20) 74 18 86 70
For matters relating to pharmacovigilance for medicinal products for veterinary use:
Informationspaket kan rekvireras från
Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda.bosworth@emea.eu.int
Amanda BOSWORTH Tfn direkt (44- 20) 74 18 84 08 E- post: amanda. bosworth@ emea. eu. int
For product defect and other quality-related matters:
EMEA årsrapport för 2002 EMEA/ MB/ 055/ 02/ sv/ Slutlig Förteckning över europeiska experter
European experts lists E-mail: qualitydefects@emea.eu.int Fax:
EMEA 2003 Sida 87/ 88
(44-20) 74 18 85 90 Approximately 3 000 are used by the EMEA in its scientific Out of hours telephone:
EMEA anlitar omkring 3 000 experter för det vetenskapliga utvärderingsarbetet.
The list of these European experts is available for examination on request at the EMEA offices.
En förteckning över dessa europeiska experter finns tillgänglig och kan på begäran studeras på EMEA: s kontor.
Requests should be sent in writing to the EMEA or to:
Begäran skall göras skriftligen till EMEA eller till
The EMEA issues certificates of a medicinal product in
E- post: europeanexperts@ emea. eu. int
These certify the marketing authorisation
Integrerad kvalitetsstyrning
Integrated quality management
IQM- sakkunnig
IQM adviser Marijke KORTEWEG Direct telephone (44-20) 74 18 85 56 E-mail: iqmanagement@emea.eu.int
Marijke KORTEWEG Tfn direkt (44- 20) 74 18 85 56 E- post: iqmanagement@ emea. eu. int
Press officer
Presskontor
E-mail: certificate@emea.eu.int
Pressansvarig
Press officer Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: martin.harvey-allchurch@emea.eu.int
Martin HARVEY ALLCHURCH Tfn direkt (44- 20) 74 18 84 27 E- post: martin. harvey- allchurch@ emea. eu. int
FOURTH GENERAL REPORT
EMEA/ MB/ 040/ 98( SV)
FOURTH GENERAL REPORT ON THE ACTIVITIES OF THE EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS
FJÄRDE ALLMÄNNA RAPPORTEN OM VERKSAMHETEN VID EUROPEISKA LÄKEMEDELSMYNDIGHETEN
Adopted by the Management Board on 2 December 1998 The European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom Tel.
Godkänd av styrelsen den 2 december 1998
It can be accessed through the Europa server (http: / /europa. eu. int).
Public EMEA/ MB040/ 98