natgillin/translations-raw huggingface dataset:
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.
Vedtaget i juli 2002
Adopted July 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.
Adopted July 2002
Adopted July 2002
CPMP/ EWP/ 2454/ 98
CPMP/EWP/2454/02
Concept paper on the development of a CPMP Note for Guidance on clinical investigation of medicinal products for the treatment of psoriasis.
Concept paper on the development of a CPMP Note for Guidance on clinical investigation of medicinal products for the treatment of psoriasis.
(CPMP/ EWP/ 2339/ 02)
CPMP/EWP/2339/02
Concept paper on the development of a CPMP Note for Guidance on the evaluation of the pharmacokinetics of medicinal products in patients with hepatic impairment.
Concept paper on the development of a CPMP Note for Guidance on the evaluation of the pharmacokinetics of medicinal products in patients with hepatic impairment.
(CPMP/ EWP/ 2459/ 02)
CPMP/EWP/2459/02
Concept Paper on the development of a CPMP Points to Consider on methodological issues in confirmatory clinical trials with flexible design and analysis plan.
Concept Paper on the development of a CPMP Points to Consider on methodological issues in confirmatory clinical trials with flexible design and analysis plan.
(CPMP/ EWP/ 908/ 99) (CPMP/ EWP/ 4279/ 02)
CPMP/EWP/908/99
Points to consider on multiplicity issues in clinical trials.
Points to consider on multiplicity issues in clinical trials.
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 of medicinal products for the treatment of obsessive compulsive disorder.
Vedtaget i september 2002 Vedtaget i november 2002
Adopted November 2002
(CPMP/ EWP/ 4280/ 02)
CPMP/EWP/4280/02
Concept paper on the development of a CPMP Note for Guidance on clinical investigation on medicinal products for the treatment of panic disorder.
Concept paper on the development of a CPMP Note for Guidance on clinical investigation on medicinal products for the treatment of panic disorder.
Vedtaget i november 2002
Adopted November 2002
(CPMP/ EWP/ 2922/ 01)
CPMP/EWP/2922/01
Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma
Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma
(CPMP/ EWP/ 612/ 00 rev.
CPMP/EWP/612/00 rev.
Note for Guidance on clinical investigation of medicinal products for treatment of nociceptive pain
Note for Guidance on clinical investigation of medicinal products for treatment of nociceptive pain
(CPMP/ EWP/ 4914/ 02)
CPMP/EWP/4914/02
Concept Paper on the Development of a CPMP Note for Guidance on Clinical investigation of medicinal products for the treatment of Generalised Anxiety Disorder
Concept Paper on the Development of a CPMP Note for Guidance on Clinical investigation of medicinal products for the treatment of Generalised Anxiety Disorder
(CPMP/ EWP/ 18/ 01)
CPMP/EWP/18/01
Vedtaget i december 2002
Note for Guidance on the clinical investigation of medicinal Adopted December 2002 products for the treatment of urinary incontinence
(CPMP/ EWP/ 967/ 01)
CPMP/EWP/4151/00
Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with ST segment elevation acute myocardial infarction (STEMI)
Points to consider on the requirements for clinical Release for consultation January 2002 documentation for metered dose inhalers (MDI) EMEA Annual Report 2002 65
Sendt til høring i november 2002
Reference number
(CPMP/ EWP/ 633/ 02)
Document title
Sendt til høring i juli 2002
Status
(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
Sendt til høring i september 2002
Released for consultation February 2002
(CPMP/ EWP/ 596/ 02)
CPMP/EWP/785/97
2) – Addendum on paediatric oncology.
Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome
Sendt til høring i september 2002
Released for consultation April 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
Sendt til høring i juli 2002
Released for consultation July 2002
(CPMP/ EWP/ 556/ 95 rev.
CPMP/EWP/1343/01 rev.
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
Sendt til høring i juli 2002
Release for consultation July 2002
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
Released for consultation July 2002
Referencenummer Titel på dokumentet (CPMP/ EWP/ 785/ 97) Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome.
Note for Guidance on clinical investigation of medicinal products for the treatment of migraine
Status Sendt til høring i april 2002
Released for consultation September 2002
(CPMP/ EWP/ 49/ 01)
CPMP/EWP/596/02
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 evaluation of anticancer medicinal Released for consultation products in man (CPMP/EWP/205/95 rev.
Sendt til høring i februar 2002
2) – September 2002 Addendum on paediatric oncology
(CPMP/ EWP/ 4151/ 00)
CPMP/EWP/967/01
Sendt til høring i januar 2002
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)
CPMP’ s arbejdsgruppe vedrørende lægemiddelovervågning Referencenummer CPMP/ PhVWP/ 4838/ 02
CPMP Pharmacovigilance Working Party
Titel på dokumentet Concept Paper on Conduct of Pharmacovigilance For Medicines Used by Children
Concept Paper on Conduct of Pharmacovigilance For Medicines Used by Children
Status Vedtaget i oktober 2002
Adopted October 2002
CPMP/ 1199/ 02
CPMP/1199/02
Points to consider on Xenogeneic Cell Therapy for Medicinal Products
Points to consider on Xenogeneic Cell Therapy for Medicinal Products
Sendt til høring i november 2002
Released for consultation November 2002
CPMP/ ICH4679/ 02
CPMP/ICH/4679/02
Addendum to ICH E2C – Clinical Safety Data Management:
Addendum to ICH E2C – Clinical Safety Data Management:
Periodic Safety Update Reports for Marketed Drugs
Periodic Safety Update Reports for Marketed Drugs
Fremsendt af CPMP til de berørte parter på trin 3 af ICH - processen i september 2002
Transmission by CPMP to Interested Parties at ICH step 3 in September 2002
CPMP’ s arbejdsgruppe vedrørende sikkerhed Referencenummer CPMP/ SWP/ 2600/ 01
CPMP Safety Working Party
Titel på dokumentet Points to consider on the need for assessment of reproductive toxicity of human insulin analogues
Points to consider on the need for assessment of reproductive toxicity of human insulin analogues
Status Vedtaget i marts 2002
Adopted March 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
CPMP/ SWP/ 2599/ 02
CPMP/SWP/398/01
Position Paper on the Non- clinical safety studies to support clinical trials with a single low dose of a compound
Note for Guidance on photosafety testing
Sendt til høring i juni 2002
Adopted June 2002
CPMP/ SWP/ 2592/ 02
CPMP/SWP/2592/02
SWP Conclusions and recommendations with regard to the use of genetically modified animal models for carcinogenicity assessment
SWP Conclusions and recommendations with regard to the use of genetically modified animal models for carcinogenicity assessment
Vedtaget i juni 2002
Adopted June 2002
CPMP/ SWP/ 2877/ 00 rev.
CPMP/SWP/2877/00 rev.
Note for Guidance on carcinogenic potential
Note for Guidance on carcinogenic potential
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
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
Position Paper on the limits of genotoxic impurities
Position Paper on the limits of genotoxic impurities
Sendt til høring i december 2002
Released for consultation December 2002
EMEA' s arbejdsgruppe vedrørende urtemedicin Referencenummer EMEA/ HMPWP/ 41/ 01
EMEA Herbal Medicinal Products Working Party
Titel på dokumentet SOP:
EMEA/HMPWP/41/01
Recording of core data for herbal drugs/ herbal drug preparations (*)
Recording of core data for herbal drugs/herbal drug preparations (*)
Status Offentliggjort i maj 2002
Published May 2002
EMEA/ HMPWP/ 18123/ 0 0
EMEA/HMPWP/18123/00
Compilation of general quality questions answered by the HMPWP (*)
Compilation of general quality questions answered by the HMPWP (*)
Offentliggjort i maj 2002
Published May 2002
EMEA/ HMPWP/ 31/ 99 Rev 3
3
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 (*)
EMEA/ HMPWP/ 13/ 00
EMEA/HMPWP/13/00
Proposal for a core- data for Plantaginis psyllium (Psyllium seed) (*)
Proposal for a core-data for Plantaginis psyllium (Psyllium seed) (*)
EMEA 2003
Reference number
EMEA/ MB/ 055/ 02/ da/ Endelig udg.
Document title
Side 80/ 88
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 (Ispaghula seed) (*)
Sendt til høring i
EMEA/HMPWP/15/00
juli 2002
Released for consultation July 2002
EMEA/ HMPWP/ 15/ 00 Final draft Proposal for a core- data for Plantaginis ovatae testa (Ispaghula husk) (*)
Proposal for a core-data for Calendula flos (Calendulae flower) (*)
Sendt til høring i
EMEA /HMPWP/18/00
EMEA/ HMPWP/ 17/ 00 Proposal for a core- data for Calendula flos (Calendulae flower) (*)
Proposal for a core-data for Melissae folium (Melissa leaf) (*)
Sendt til høring i
EMEA/HMPWP/20/00
EMEA/ HMPWP/ 18/ 00
EMEA/HMPWP/21/00
Proposal for a core- data for Passiflora herba (Passion flower) (*)
Proposal for a core-data for Harpagophyti radix (Devil's Claw root) (*)
EMEA/ HMPWP/ 19/ 00
EMEA/HMPWP/1417/02
Proposal for a core- data for Melissae folium (Melissa leaf) (*)
Proposal for a core-data for Menthae piperitae aetheroleum (Peppermint oil) (*)
Sendt til høring i juli 2002
Released for consultation December 2002
EMEA/ HMPWP/ 20/ 00 EMEA/ HMPWP/ 21/ 00
EMEA/HMPWP/1418/02
Proposal for a core- data for Lupuli flos (Hop strobile) (*) Proposal for a core- data for Harpagophyti radix (Devil’ s Claw root) (*)
Proposal for a core-data for Menthae piperitae folium (Peppermint leaf) (*)
Sendt til høring i juli 2002 Sendt til høring i juli 2002
Released for consultation December 2002
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) (*)
Proposal for a core-data for Urticae folium (Nettle leaf) (*)
Sendt til høring i december 2002 Sendt til høring i december 2002 Sendt til høring i december 2002
Released for consultation December 2002
(*) Synspunkterne, som kommer til udtryk i disse dokumenter, er synspunkterne i HMPWP, der er blevet nedsat som et forum for erfaringsudveksling på det urtemedicinske område.
(*) 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.
Disse dokumenter frigives af hensyn til gennemsigtigheden og har ingen retsvirkning i direktiv 2001/ 83/ EF’ s betydning.
These documents are released for the purpose of transparency and have no legal force with respect to Directive 2001/83/EC.
Arbejdsgruppen vedrørende revision af videnskabelig rådgivning Referencenummer EMEA/ H/ 238/ 02
Scientific Advice Review Group
Titel på dokumentet EMEA guidance for companies requesting protocol assistance regarding scientific issues
EMEA guidance for companies requesting protocol assistance regarding scientific issues
Status Offentliggjort i februar 2002
Published February 2002
Arbejdsgruppen vedrørende revision af særnavn Referencenummer CPMP/ 328/ 00/ rev. 1
3 68 EMEA Annual Report 2002
Titel på dokumentet Guideline on the acceptability of Invented Names For Human Medicinal Products Processed Through The Centralised Procedure
Guideline on the acceptability of Invented Names For Human Medicinal Products Processed Through The Centralised Procedure
CVMP’ s arbejdsgruppe vedrørende virkninger Referencenummer EMEA/ CVMP/ 1166/ 02
CVMP Efficacy Working Party
Titel på dokumentet Standard statements for the SPC of certain classes/ types of veterinary medicinal products
Specific efficacy requirements for ectoparasiticides in sheep
Status Sendt til høring i december 2002
Adopted July 2002
EMEA/ CVMP/ 411/ 01
EMEA/CVMP/612/01
Specific efficacy requirements for ectoparasiticides in sheep
SPC for antimicrobial products
Vedtaget i juli 2002
Adopted December 2002
EMEA/ CVMP/ 612/ 01 EMEA/ CVMP/ 627/ 01
EMEA/CVMP/627/01
SPC for antimicrobial products Demonstration of efficacy for veterinary medicinal products containing antimicrobial subsatnces
Demonstration of efficacy for veterinary medicinal products containing antimicrobial subsatnces
Vedtaget i december 2002 Vedtaget i december 2002
Adopted December 2002
CVMP’ s arbejdsgruppe vedrørende immunologiske veterinærlægemidler Referencenummer CVMP/ VICH/ 095/ 01 CVMP/ VICH/ 096/ 01 EMEA/ CVMP/ 552/ 02
Standard statements for the SPC of certain classes/ types of veterinary medicinal products
Titel på dokumentet Biologicals:
CVMP Immunologicals Working Party
Testing of residual formaldehyde Biologicals:
Testing of residual formaldehyde
Testing of residual moisture EU requirements for batches with maximum and minimum titre or batch potency for developmental safety and efficacy studies
Testing of residual moisture
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
Adopted May 2002
Referencenummer Titel på dokumentet
Released for consultation May 2002
Status
EMEA/CVMP/552/02
EMEA 2003 Side 81/ 88
Released for consultation June 2002
EMEA/ CVMP/ 550/ 02
EMEA/CVMP/550/02
Requirements for compatibility statements for veterinary vaccines
Requirements for compatibility statements for veterinary vaccines
Sendt til høring i juni 2002
Released for consultation June 2002
CVMP/ VICH/ 463/ 02
EMEA/CVMP/695/01
Testing for the detection of mycoplasma contamination
Processing of renewals in the centralised procedure
Sendt til høring i maj 2002
Adopted February 2002
CVMP generelt Referencenummer EMEA/ CVMP/ 695/ 01 EMEA/ CVMP/ 328/ 98 – Revision 2
EMEA/CVMP/328/98 – Revision 2
Titel på dokumentet Processing of renewals in the centralised procedure Acceptability of invented names for veterinary medicinal products processed through the centralised procedure
Acceptability of invented names for veterinary medicinal products processed through the centralised procedure
Status Vedtaget i februar 2002 Vedtaget i marts 2002
Adopted March 2002
CVMP’ s arbejdsgruppe vedrørende sikkerhed Referencenummer EMEA/ CVMP/ 234/ 99
CVMP Safety Working Party
Titel på dokumentet Safety evaluation of antimicrobial substances regarding the effects on human gut flora
Safety evaluation of antimicrobial substances regarding the effects on human gut flora
EMEA/ CVMP/ 244/ 01
EMEA/CVMP/244/01
CVMP/ VICH/ 645/ 01
CVMP/VICH/645/01
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
Developmental toxicity testing
Developmental toxicity testing
CVMP/ VICH/ 486/ 02
CVMP/VICH/486/02
General approach to teting
General approach to teting
General approach to testing
General approach to testing
Sendt til høring i maj 2002
Released for consultation May 2002
Safety studies for veterinary drug residues in human foods:
Safety studies for veterinary drug residues in human foods:
Repeat- dose (90days) toxicity testing
Repeat-dose (90 days) toxicity testing
Sendt til høring i maj 2002
Adopted January 2002
Fælles CPMP/ CVMP- arbejdsgruppe vedrørende kvalitet Referencenummer CPMP/ QWP/ 1719/ 00 CPMP/ ICH/ 2737/ 99 CPMP/ ICH/ 142/ 95
CPMP/ICH/2737/99 CPMP/ICH/142/95
Titel på dokumentet Medicinal gases – pharmaceutical documentation ICH Q3A – Impurities testing:
ICH Q3A – Impurities testing:
Impurities in new drug substances
Impurities in new drug substances
Status Vedtaget i januar 2002 Vedtaget i februar 2002
Adopted February 2002
CPMP/ ICH/ 4104/ 00
CPMP/ICH/4104/00
ICH Q1D – Bracketing and matrixing designs of drug substances and drug products
ICH Q1D – Bracketing and matrixing designs of drug substances and drug products
CVMP/ 424/ 02
CVMP/424/02
In- use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)
In-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)
CPMP/ QWP/ 122/ 02 CPMP/ QWP/ 556/ 96
EMEA/CVMP/424/01
Stability testing: stability testing of existing active substances and related finished products – Revision
In-use stability testing of veterinary medicinal products
Sendt til høring i februar 2002
Adopted February 2002
CPMP/ QWP/ 227/ 02 CVMP/ 134/ 02
CPMP/QWP/2845/00
European Drug Master File – Revision
Requirements for pharmaceutical documentation for pressurised metered dose inhalation products
Sendt til høring i februar 2002
Adopted March 2002
CPMP/ ICH/ 420/ 02 CPMP/ ICH/ 421/ 02
CPMP/ICH/1507/02
ICH Q1E Evaluation of stability data ICH Q1F Stability data package for registration in climatic zones III and IV
ICH Q3C (M) Maintenance document for guidance on impurities
Sendt til høring i februar 2002 Sendt til høring i februar 2002
Adopted April 2002
CPMP/ QWP/ 2845/ 00
CPMP/QWP/158/01
Requirements for pharmaceutical documentation for pressurised metered dose inhalation products
Quality of water for pharmaceutical use
Vedtaget i marts 2002
Adopted May 2002
EMEA/ CVMP/ 422/ 99
CVMP/115/01
Declaration of storage conditions for veterinary medicinal products and active substances – Revision
Quality of water for pharmaceutical use – Revision
Sendt til høring i marts 2002
Adopted May 2002
EMEA’ s årsberetning for 2002
Adopted May 2002
EMEA 2003
Residual solvents THF and NMP
EMEA/ MB/ 055/ 02/ da/ Endelig udg.
Adopted September 2002
Referencenummer Titel på dokumentet
EMEA/CVMP/1055/02 70 EMEA Annual Report 2002
Status
Document title
Side 82/ 88
Status
CPMP/ ICH/ 1507/ 02
CPMP/QWP/122/02 CPMP/QWP/556/96
ICH Q3C (M) Maintenance document for guidance on impurities
Stability testing: stability testing of existing active substances and related finished products
Vedtaget i april 2002
Adopted December 2002
CPMP/ QWP/ 158/ 01 CVMP/ 115/ 01 EMEA/ CVMP/ 680/ 02
CPMP/QWP/122/02 CPMP/QWP/556/96
Quality of water for pharmaceutical use Quality of water for pharmaceutical use – Revision Quality of modified release dosage forms for veterinary use
Stability testing: stability testing of existing active substances and related finished products – Revision
Vedtaget i maj 2002 Vedtaget i maj 2002 Sendt til høring i juli 2002
Released for consultation February 2002
CPMP/ ICH/ 1940/ 00
CPMP/QWP/227/02 CVMP/134/02
Residual solvents THF and NMP
European Drug Master File – Revision
Vedtaget i september 2002
Released for consultation February 2002
CPMP/ ICH/ 4680/ 02
CPMP/ICH/420/02
ICH M4Q Questions and Answers / Location issues for common technical documents for the registration of pharmaceuticals for human use
ICH Q1E Evaluation of stability data
EMEA/ CVMP/ 1055/ 02
CPMP/ICH/421/02
Concept paper for the development of guideline on quality aspects of pharmaceutical veterinary medicines administered via drinking water
ICH Q1F Stability data package for registration in climatic zones III and IV
Vedtaget i november 2002
Released for consultation February 2002
CPMP/ QWP/ 122/ 02 CPMP/ QWP/ 556/ 96
EMEA/CVMP/134/02
Stability testing: stability testing of existing active substances and related finished products
European drug master file procedure
Vedtaget i december 2002
Released for consultation February 2002
EMEA/ CVMP/ 424/ 01 EMEA/ CVMP/ 115/ 01 – Revision
EMEA/CVMP/422/99
In- use stability testing of veterinary medicinal products Quality of water for pharmaceutical use
Declaration of storage conditions for veterinary medicinal products and active substances – Revision
Vedtaget i februar 2002 Vedtaget i maj 2002
Released for consultation March 2002
EMEA/ CVMP/ 422/ 99 – Revision
EMEA/CVMP/422/99 – Revision
Declaration of storage conditions for pharmaceutical veterinary medicinal products in the product particulars and active substances.
Declaration of storage conditions for pharmaceutical veterinary Released for consultation March 2002 medicinal products in the product particulars and active substances.
Annex to note for guidance on stability testing of new active substances and medicinal products.
Annex to note for guidance on stability testing of new active substances and medicinal products.
Annex to note for guidance on stability testing of existing active substances and related finished products.
Annex to note for guidance on stability testing of existing active substances and related finished products.
Sendt til høring i marts 2002
Quality of modified release dosage forms for veterinary use Released for consultation July 2002
EMEA/ CVMP/ 134/ 02 EMEA/ CVMP/ 680/ 02
CPMP/ICH/4680/02
European drug master file procedure Quality of modified release dosage forms for veterinary use
ICH M4Q Questions and Answers / Location issues for common technical documents for the registration of pharmaceuticals for human use