natgillin/translations-raw huggingface dataset:
Concept paper on the development of a CPMP Note for Guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal failure
Concept paper on the development of a CPMP Note for Guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal failure.
Adopted March 2002
Hyväksytty maaliskuussa 2002 Hyväksytty huhtikuussa 2002
CPMP/EWP/518/97 rev.
(CPMP/ EWP/ 518/ 97 rev.
Note for Guidance on clinical investigation of medicinal products in the treatment of depression
Note for Guidance on clinical investigation of medicinal products in the treatment of depression.
Adopted April 2002
Hyväksytty huhtikuussa 2002
CPMP/EWP/714/98 rev.
(CPMP/ EWP/ 714/ 98 rev.
Note for Guidance on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease
Note for Guidance on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease:
CPMP/EWP/1080/00
(CPMP/ EWP/ 1080/ 00)
Note for Guidance on Clinical investigation of medicinal products in the treatment of diabetes mellitus
Note for Guidance on Clinical investigation of medicinal products in the treatment of diabetes mellitus.
CPMP/EWP/968/02
(CPMP/ EWP/ 968/ 02)
Concept paper on the development of a CPMP Points to consider on the evaluation of the pharmacokinetics of medicinal products in the paediatric population
Concept paper on the development of a CPMP Points to consider on the evaluation of the pharmacokinetics of medicinal products in the paediatric population.
CPMP/EWP/2455/02
(CPMP/ EWP/ 2455/ 02)
Concept paper on the development of a CPMP Points to consider on allergic rhino-conjuctivitis.
Concept paper on the development of a CPMP Points to consider on allergic rhino- conjuctivitis.
Adopted July 2002
Hyväksytty heinäkuussa 2002
CPMP/EWP/282/02
(CPMP/ EWP/ 282/ 02)
Position paper on the regulatory requirements for the authorisation of low-dose modified release ASA formulations in the secondary prevention of cardiovascular events.
Position paper on the regulatory requirements for the authorisation of low- dose modified release ASA formulations in the secondary prevention of cardiovascular events.
CPMP/EWP/2454/02
(CPMP/ EWP/ 2454/ 02)
CPMP/EWP/2339/02
(CPMP/ EWP/ 2339/ 02)
CPMP/EWP/2459/02
(CPMP/ EWP/ 2459/ 02)
CPMP/EWP/908/99
(CPMP/ EWP/ 908/ 99) (CPMP/ EWP/ 4279/ 02)
Adopted September 2002
Hyväksytty syyskuussa 2002 Hyväksytty marraskuussa 2002
CPMP/EWP/4279/02
(CPMP/ EWP/ 4280/ 02)
Concept paper on the development of a CPMP Note for Guidance on clinical investigation of medicinal products for the treatment of obsessive compulsive disorder.
Concept paper on the development of a CPMP Note for Guidance on clinical investigation on medicinal products for the treatment of panic disorder.
Adopted November 2002
Hyväksytty marraskuussa 2002
CPMP/EWP/4280/02
(CPMP/ EWP/ 2922/ 01)
Concept paper on the development of a CPMP Note for Guidance on clinical investigation on medicinal products for the treatment of panic disorder.
Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma
Adopted November 2002
Hyväksytty marraskuussa 2002 Hyväksytty marraskuussa 2002
CPMP/EWP/2922/01
1) (CPMP/ EWP/ 4914/ 02)
Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma
Note for Guidance on clinical investigation of medicinal products for treatment of nociceptive pain Concept Paper on the Development of a CPMP Note for Guidance on Clinical investigation of medicinal products for the treatment of Generalised Anxiety Disorder
1
(CPMP/ EWP/ 18/ 01)
Note for Guidance on clinical investigation of medicinal products for treatment of nociceptive pain
Note for Guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence
Adopted November 2002
Hyväksytty joulukuussa 2002
CPMP/EWP/4914/02
(CPMP/ EWP/ 967/ 01)
Concept Paper on the Development of a CPMP Note for Guidance on Clinical investigation of medicinal products for the treatment of Generalised Anxiety Disorder
Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with ST segment elevation acute myocardial infarction (STEMI)
Adopted November 2002
Toimitettu lausuntoa varten marraskuussa 2002
CPMP/EWP/18/01
(CPMP/ EWP/ 633/ 02)
Note for Guidance on the clinical investigation of medicinal Adopted December 2002 products for the treatment of urinary incontinence
Toimitettu lausuntoa varten heinäkuussa 2002.
CPMP/EWP/4151/00
(CPMP/ EWP/ 788/ 01)
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
Note for Guidance on clinical investigation of medicinal products for the treatment of migraine.
Released for consultation February 2002
Toimitettu lausuntoa varten syyskuussa 2002
CPMP/EWP/785/97
(CPMP/ EWP/ 596/ 02)
Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome
2) – Addendum on paediatric oncology.
Released for consultation April 2002
Toimitettu lausuntoa varten syyskuussa 2002
CPMP/EWP/556/95 rev.
(CPMP/ EWP/ 1343/ 01 rev.
1
1) (CPMP/ EWP/ 556/ 95 rev.
1
1) EMEA: n vuosikertomus 2002
Points to consider on the evaluation of new anti-fungal agents for invasive fungal infections
Points to consider on the evaluation of new anti- fungal agents for invasive fungal infections.
Release for consultation July 2002
Toimitettu lausuntoa varten heinäkuussa 2002 Toimitettu lausuntoa varten heinäkuussa 2002 EMEA 2003
CPMP/EWP/633/02
EMEA/ MB/ 055/ 02/ fi/ lopull.
Released for consultation July 2002
Sivu 82/ 90
CPMP/EWP/788/01
Viitenumero (CPMP/ EWP/ 785/ 97)
Note for Guidance on clinical investigation of medicinal products for the treatment of migraine
Asiakirjan nimi Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome.
Released for consultation September 2002
Tilanne Toimitettu lausuntoa varten huhtikuussa 2002
CPMP/EWP/596/02
(CPMP/ EWP/ 49/ 01)
Note for Guidance on evaluation of anticancer medicinal Released for consultation products in man (CPMP/EWP/205/95 rev.
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.
2) – September 2002 Addendum on paediatric oncology
Toimitettu lausuntoa varten helmikuussa 2002
CPMP/EWP/967/01
(CPMP/ EWP/ 4151/ 00)
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)
Toimitettu lausuntoa varten tammikuussa 2002
CPMP Pharmacovigilance Working Party
CPMP: n lääkevalvonnan työryhmä Viitenumero CPMP/ PhVWP/ 4838/ 02
Concept Paper on Conduct of Pharmacovigilance For Medicines Used by Children
Asiakirjan nimi Concept Paper on Conduct of Pharmacovigilance For Medicines Used by Children
Adopted October 2002
Tilanne Hyväksytty lokakuussa 2002
CPMP/1199/02
CPMP/ 1199/ 02
Released for consultation November 2002
Toimitettu lausuntoa varten marraskuussa 2002
CPMP/ICH/4679/02
CPMP/ ICH4679/ 02
Transmission by CPMP to Interested Parties at ICH step 3 in September 2002
CPMP toimittanut eturyhmille ICH- konferenssin kolmannessa vaiheessa syyskuussa 2002
CPMP Safety Working Party
CPMP: n turvallisuustyöryhmä Viitenumero CPMP/ SWP/ 2600/ 01
Points to consider on the need for assessment of reproductive toxicity of human insulin analogues
Asiakirjan nimi Points to consider on the need for assessment of reproductive toxicity of human insulin analogues
Adopted March 2002
Tilanne Hyväksytty maaliskuussa 2002
CPMP/SWP/668/02
CPMP/ SWP/ 668/ 02
Concept paper on the development of a CPMP position paper on the non-clinical safety studies to support low dose clinical screening studies in humans
Concept paper on the development of a CPMP position paper on the non- clinical safety studies to support low dose clinical screening studies in humans
Adopted March 2002
Hyväksytty maaliskuussa 2002
CPMP/SWP/398/01
CPMP/ SWP/ 2599/ 02
Note for Guidance on photosafety testing
Position Paper on the Non- clinical safety studies to support clinical trials with a single low dose of a compound
Adopted June 2002
Toimitettu lausuntoa varten kesäkuussa 2002
CPMP/SWP/2592/02
CPMP/ SWP/ 398/ 01 CPMP/ SWP/ 4446/ 00 CPMP/ SWP/ 2592/ 02
SWP Conclusions and recommendations with regard to the use of genetically modified animal models for carcinogenicity assessment
Note for Guidance on photosafety testing Note for Guidance on specification limits for residues of metal catalysts SWP Conclusions and recommendations with regard to the use of genetically modified animal models for carcinogenicity assessment
Adopted June 2002
Hyväksytty kesäkuussa 2002 Toimitettu lausuntoa varten kesäkuussa 2002 Hyväksytty kesäkuussa 2002
CPMP/SWP/2877/00 rev.
CPMP/ SWP/ 2877/ 00 rev.
CPMP/3097/02
CPMP/ 3097/ 02
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:
Annex on Non-Clinical and Clinical Considerations
Annex on Non- Clinical and Clinical Considerations
Released for consultation July 2002
Toimitettu lausuntoa varten heinäkuussa 2002
CPMP/SWP/799/95
CPMP/ SWP/ 799/ 95
Note for Guidance on the Non-Clinical Documentation of Medicinal Products with Well-Established Use
Note for Guidance on the Non- Clinical Documentation of Medicinal Products with Well- Established Use
CPMP/SWP/5199/02
CPMP/ SWP/ 5199/ 02
Released for consultation December 2002
Toimitettu lausuntoa varten joulukuussa 2002
EMEA Herbal Medicinal Products Working Party
EMEA: n luonnonlääkevalmisteiden työryhmä Viitenumero EMEA/ HMPWP/ 41/ 01
EMEA/HMPWP/41/01
Asiakirjan nimi SOP:
Recording of core data for herbal drugs/herbal drug preparations (*)
Recording of core data for herbal drugs/ herbal drug preparations (*)
Published May 2002
Tilanne Julkaistu toukokuussa 2002 Julkaistu toukokuussa 2002
EMEA/HMPWP/18123/00
EMEA/ HMPWP/ 18123/ 0 0
Published May 2002
Julkaistu toukokuussa 2002
3
EMEA/ HMPWP/ 31/ 99 Rev 3
Published May 2002
EMEA/ HMPWP/ 13/ 00 EMEA: n vuosikertomus 2002
Proposal for a core-data for Plantaginis psyllium (Psyllium seed) (*)
Proposal for a core- data for Plantaginis psyllium (Psyllium seed) (*)
Released for consultation July 2002
Toimitettu lausuntoa varten heinäkuussa 2002 EMEA 2003
EMEA Annual Report 2002
EMEA/ MB/ 055/ 02/ fi/ lopull.
Document title
Sivu 83/ 90
EMEA/ HMPWP/14/00
Viitenumero EMEA/ HMPWP/ 14/ 00
Proposal for a core-data for Plantaginis ovatae semen (Ispaghula seed) (*)
Asiakirjan nimi Proposal for a core- data for Plantaginis ovatae semen (Ispaghula seed) (*)
Released for consultation July 2002
Tilanne Toimitettu lausuntoa varten heinäkuussa 2002
EMEA/HMPWP/15/00
EMEA/ HMPWP/ 15/ 00
Final draft Proposal for a core-data for Plantaginis ovatae testa (Ispaghula husk) (*)
Final draft Proposal for a core- data for Plantaginis ovatae testa (Ispaghula husk) (*)
EMEA/HMPWP/17/00
EMEA/ HMPWP/ 17/ 00
Proposal for a core-data for Calendula flos (Calendulae flower) (*)
Proposal for a core- data for Calendula flos (Calendulae flower) (*)
EMEA /HMPWP/18/00
EMEA/ HMPWP/ 18/ 00
Proposal for a core-data for Passiflora herba (Passion flower) (*)
Proposal for a core- data for Passiflora herba (Passion flower) (*)
EMEA/HMPWP/19/00
EMEA/ HMPWP/ 19/ 00
Proposal for a core-data for Melissae folium (Melissa leaf) (*)
Proposal for a core- data for Melissae folium (Melissa leaf) (*)
EMEA/HMPWP/20/00
EMEA/ HMPWP/ 20/ 00
Proposal for a core-data for Lupuli flos (Hop strobile) (*)
Proposal for a core- data for Lupuli flos (Hop strobile) (*)
EMEA/HMPWP/21/00
EMEA/ HMPWP/ 21/ 00
Proposal for a core-data for Harpagophyti radix (Devil's Claw root) (*)
Proposal for a core- data for Harpagophyti radix (Devil’ s Claw root) (*)
EMEA/HMPWP/1417/02
EMEA/ HMPWP/ 1417/ 02 Proposal
Proposal for a core-data for Menthae piperitae aetheroleum (Peppermint oil) (*)
for a core- data for Menthae piperitae aetheroleum (Peppermint oil) (*)
EMEA/HMPWP/1418/02
EMEA/ HMPWP/ 1418/ 02 Proposal
Proposal for a core-data for Menthae piperitae folium (Peppermint leaf) (*)
for a core- data for Menthae piperitae folium (Peppermint leaf) (*)
EMEA/HMPWP/1416/02
EMEA/ HMPWP/ 1416/ 02 Proposal
Proposal for a core-data for Urticae folium (Nettle leaf) (*)
for a core- data for Urticae folium (Nettle leaf) (*)
(*) 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.
HMPWP on perustettu tietojen vaihdon forumiksi luonnonlääkkeiden alalla.
These documents are released for the purpose of transparency and have no legal force with respect to Directive 2001/83/EC.
Nämä asiakirjat on julkaistu avoimuuden edistämiseksi, eikä niillä ole lainvoimaa direktiivin 2001/ 83/ EY perusteella.
Scientific Advice Review Group
Tieteellisen neuvonnan arviointiryhmä Viitenumero EMEA/ H/ 238/ 02
EMEA guidance for companies requesting protocol assistance regarding scientific issues
Asiakirjan nimi EMEA guidance for companies requesting protocol assistance regarding scientific issues
Published February 2002
Tilanne Julkaistu helmikuussa 2002
CPMP/328/98 rev.
Kauppanimien tarkastusryhmä Viitenumero CPMP/ 328/ 98, rev.
3 68 EMEA Annual Report 2002
3
Guideline on the acceptability of Invented Names For Human Medicinal Products Processed Through The Centralised Procedure
Asiakirjan nimi Guideline on the acceptability of Invented Names For Human Medicinal Products Processed Through The Centralised Procedure
CVMP Efficacy Working Party
CVMP: n tehokkuustyöryhmä Viitenumero EMEA/ CVMP/ 1166/ 02 EMEA/ CVMP/ 411/ 01
Specific efficacy requirements for ectoparasiticides in sheep
Asiakirjan nimi Standard statements for the SPC of certain classes/ types of veterinary medicinal products Specific efficacy requirements for ectoparasiticides in sheep
Adopted July 2002
Tilanne Toimitettu lausuntoa varten joulukuussa 2002 Hyväksytty heinäkuussa 2002
EMEA/CVMP/612/01
EMEA/ CVMP/ 612/ 01 EMEA/ CVMP/ 627/ 01
SPC for antimicrobial products
SPC for antimicrobial products Demonstration of efficacy for veterinary medicinal products containing antimicrobial subsatnces
Adopted December 2002
Hyväksytty joulukuussa 2002 Hyväksytty joulukuussa 2002
Demonstration of efficacy for veterinary medicinal products containing antimicrobial subsatnces
CVMP: n immunologisia valmisteita käsittelevä työryhmä Viitenumero CVMP/ VICH/ 095/ 01 CVMP/ VICH/ 096/ 01 EMEA/ CVMP/ 552/ 02
Adopted December 2002
Asiakirjan nimi Biologicals:
EMEA/CVMP/1166/02
Testing of residual formaldehyde Biologicals:
Standard statements for the SPC of certain classes/ types of veterinary medicinal products
Testing of residual moisture EU requirements for batches with maximum and minimum titre or batch potency for developmental safety and efficacy studies
Released for consultation December 2002
Tilanne Hyväksytty toukokuussa 2002 Hyväksytty toukokuussa 2002 Toimitettu lausuntoa varten kesäkuussa 2002
CVMP Immunologicals Working Party
Viitenumero EMEA/ CVMP/ 550/ 02 EMEA: n vuosikertomus 2002
Reference number
Asiakirjan nimi Requirements for compatibility statements for veterinary
CVMP/VICH/095/01
Tilanne Toimitettu lausuntoa varten EMEA 2003
Testing of residual formaldehyde
EMEA/ MB/ 055/ 02/ fi/ lopull.
Adopted May 2002
Sivu 84/ 90
CVMP/VICH/096/01
Viitenumero
Testing of residual moisture
Asiakirjan nimi vaccines
Adopted May 2002
Tilanne kesäkuussa 2002
CVMP/VICH/463/02
CVMP/ VICH/ 463/ 02
Testing for the detection of mycoplasma contamination
Testing for the detection of mycoplasma contamination
Released for consultation May 2002
Toimitettu lausuntoa varten toukokuussa 2002
CVMP General
CVMP: n yleiset asiakirjat Viitenumero EMEA/ CVMP/ 695/ 01
Processing of renewals in the centralised procedure
Asiakirjan nimi Processing of renewals in the centralised procedure
Adopted February 2002
Tilanne Hyväksytty helmikuussa 2002 Hyväksytty maaliskuussa 2002
EMEA/CVMP/328/98 – Revision 2
EMEA/ CVMP/ 328/ 98 – Revision 2
CVMP Safety Working Party
CVMP: n turvallisuustyöryhmä Viitenumero EMEA/ CVMP/ 234/ 01
Safety evaluation of antimicrobial substances regarding the effects on human gut flora
Asiakirjan nimi Safety evaluation of antimicrobial substances regarding the effects on human gut flora
CVMP/VICH/484/02
CVMP/ VICH/ 484/ 02
Repeat-dose (90 days) toxicity testing
Repeat- dose (90 days) toxicity testing
CVMP/VICH/485/02
CVMP/ VICH/ 485/ 02
CVMP/VICH/486/02
CVMP/ VICH/ 486/ 02
Repeat-dose (90 days) toxicity testing
Repeat- dose (90days) toxicity testing
Joint CPMP/CVMP Quality Working Party Reference number
CPMP: n ja CVMP: n yhteinen laatutyöryhmä Viitenumero CPMP/ QWP/ 1719/ 00
Medicinal gases – pharmaceutical documentation
Asiakirjan nimi Medicinal gases – pharmaceutical documentation
Adopted January 2002
Tilanne Hyväksytty tammikuussa 2002 Hyväksytty helmikuussa 2002
CPMP/ICH/2737/99 CPMP/ICH/142/95
CPMP/ ICH/ 2737/ 99 CPMP/ ICH/ 142/ 95 CPMP/ ICH/ 4104/ 00
Impurities in new drug substances
Impurities in new drug substances ICH Q1D – Bracketing and matrixing designs of drug substances and drug products
CPMP/ICH/4104/00
CVMP/ 424/ 02
ICH Q1D – Bracketing and matrixing designs of drug substances and drug products
In- use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)
CVMP/424/02
CPMP/ QWP/ 122/ 02 CPMP/ QWP/ 556/ 96
In-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)
Stability testing: stability testing of existing active substances and related finished products – Revision
Adopted February 2002
Toimitettu lausuntoa varten helmikuussa 2002
EMEA/CVMP/424/01
CPMP/ QWP/ 227/ 02 CVMP/ 134/ 02
In-use stability testing of veterinary medicinal products
European Drug Master File – Revision
CPMP/QWP/2845/00
CPMP/ ICH/ 420/ 02
Requirements for pharmaceutical documentation for pressurised metered dose inhalation products
ICH Q1E Evaluation of stability data
Adopted March 2002
Toimitettu lausuntoa varten helmikuussa 2002
CPMP/ICH/1507/02
CPMP/ ICH/ 421/ 02 CPMP/ QWP/ 2845/ 00
ICH Q3C (M) Maintenance document for guidance on impurities
ICH Q1F Stability data package for registration in climatic zones III and IV Requirements for pharmaceutical documentation for pressurised metered dose inhalation products
Adopted April 2002
Toimitettu lausuntoa varten helmikuussa 2002 Hyväksytty maaliskuussa 2002
CPMP/QWP/158/01
EMEA/ CVMP/ 422/ 99
Adopted May 2002
Toimitettu lausuntoa varten maaliskuussa 2002
CVMP/115/01
Viitenumero CPMP/ ICH/ 1507/ 02
Quality of water for pharmaceutical use – Revision
Asiakirjan nimi ICH Q3C (M) Maintenance document for guidance on
Adopted May 2002
Tilanne Hyväksytty huhtikuussa 2002
EMEA/CVMP/115/01 – Revision Quality of water for pharmaceutical use
EMEA 2003 EMEA: n vuosikertomus 2002 EMEA/ MB/ 055/ 02/ fi/ lopull.
Adopted May 2002
impurities
CPMP/ICH/1940/00 ICH Q3C (M) Maintenance document for guidance on impurities:
Quality of water for pharmaceutical use Quality of water for pharmaceutical use – Revision Quality of modified release dosage forms for veterinary use ICH Q3C (M) Maintenance document for guidance on impurities:
Residual solvents THF and NMP
Residual solvents THF and NMP
Adopted September 2002
Toimitettu lausuntoa varten syyskuussa 2002
EMEA/CVMP/1055/02 70 EMEA Annual Report 2002
EMEA/ CVMP/ 1055/ 02
Concept paper for the development of guideline on quality aspects of pharmaceutical veterinary medicines administered via drinking water
Concept paper for the development of guideline on quality aspects of pharmaceutical veterinary medicines administered via drinking water
CPMP/QWP/122/02 CPMP/QWP/556/96
CPMP/ QWP/ 122/ 02 CPMP/ QWP/ 556/ 96
Stability testing: stability testing of existing active substances and related finished products
Stability testing: stability testing of existing active substances and related finished products
Adopted December 2002
Hyväksytty joulukuussa 2002
CPMP/QWP/122/02 CPMP/QWP/556/96
EMEA/ CVMP/ 424/ 01 EMEA/ CVMP/ 115/ 01 – Revision
Stability testing: stability testing of existing active substances and related finished products – Revision
In- use stability testing of veterinary medicinal products Quality of water for pharmaceutical use
Released for consultation February 2002
Hyväksytty helmikuussa 2002 Hyväksytty toukokuussa 2002
CPMP/QWP/227/02 CVMP/134/02
EMEA/ CVMP/ 422/ 99 – Revision
European Drug Master File – Revision
Annex to note for guidance on stability testing of new active substances and medicinal products.
Released for consultation February 2002
Toimitettu lausuntoa varten maaliskuussa 2002
CPMP/ICH/420/02
EMEA/ CVMP/ 134/ 02
ICH Q1E Evaluation of stability data
European drug master file procedure
Released for consultation February 2002
Toimitettu lausuntoa varten helmikuussa 2002
CPMP/ICH/421/02
EMEA/ CVMP/ 680/ 02
ICH Q1F Stability data package for registration in climatic zones III and IV
Quality of modified release dosage forms for veterinary use
Released for consultation February 2002
Toimitettu lausuntoa varten heinäkuussa 2002
EMEA/CVMP/134/02
Harvinaislääkekomitea Viitenumero ENTR/ 6283/ 00
European drug master file procedure
Asiakirjan nimi Guideline on the format and content of applications for designation as orphan medicinal products
Released for consultation February 2002
Tilanne Hyväksytty lokakuussa 2002
EMEA/CVMP/422/99
COMP/ 436/ 01
Declaration of storage conditions for veterinary medicinal products and active substances – Revision
Points to consider on the calculation and reporting of the prevalence of a condition for orphan designation
Released for consultation March 2002
Hyväksytty maaliskuussa 2002
EMEA/CVMP/422/99 – Revision
EMEA/ 14222/ 00
Declaration of storage conditions for pharmaceutical veterinary Released for consultation March 2002 medicinal products in the product particulars and active substances.
Procedures for orphan medicinal product designation – General principles
Annex to note for guidance on stability testing of new active substances and medicinal products.
Tarkastus 2, lokakuussa 2002
EMEA/CVMP/680/02
EMEA/ 4795/ 00
Quality of modified release dosage forms for veterinary use Released for consultation July 2002
General information for sponsors of orphan medicinal products
CPMP/ICH/4680/02
COMP/ 189/ 01
ICH M4Q Questions and Answers / Location issues for common technical documents for the registration of pharmaceuticals for human use
Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal products
Released for consultation September 2002
Hyväksytty huhtikuussa 2002
Committee for Orphan Medicinal Products
EMEA 2003 EMEA: n vuosikertomus 2002 EMEA/ MB/ 055/ 02/ fi/ lopull.
Status
Liite 11
COMP/436/01
Sivu 86/ 90
Adopted March 2002
Katsaus välimiesmenettelyihin ja yhteisön lausuntopyyntöihin vuonna 2002
COMP/189/01
CPMP: lle tehdyt lausuntopyynnöt
Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal products
Lausuntopyynnön tyyppi
Adopted April 2002
CPMP: n lausunnon päivämäärä
EMEA/14222/00
Kansainvälinen yleisnimi (INN)
Procedures for orphan medicinal product designation – General principles
29 artilan 2 kohdan
Revision 2, October 2002
Huhtikuu 2002
ENTR/6283/00
Dacarbazine
Guideline on the format and content of applications for designation as orphan medicinal products
mukaiset lausuntopyynnöt
Revision 1, October 2002
Kesäkuu 2002
EMEA/4795/00
Alteplase
General information for sponsors of orphan medicinal products
Meneillä Meneillä
Revision 1, October 2002
Isotretinoin Clostridium botulinum type A neutoxin
EMEA Annual Report 2002
7 artilan 5 kohdan
71
Meneillä
Annex 11 Arbitration and Community referrals overview 2002
Norditropin
Referrals made to the CPMP Type of referral Article 29 (2) Referrals
mukaiset lausuntopyynnöt