qanastek/EMEA-V3 huggingface dataset:
Poultry Antibacterial for systemic use (QJ01MA94)
— 19.5.2000 — 27.10.2000 — JO L 276, 28.10.2000
Oral solution 100 mg/ml 3
Phoxim (extension)
- 09.12.1999 - 21.06.2000 - 152 days - 43 days
19.1.2000 19.4.2000 90 days 0 day
- 21.07.2000 - 16.11.2000 - OJ C 2, 05.01.2001
— 19.5.2000 — 27.10.2000 — JO L 276, 28.10.2000
Bayovac CSF Marker Live vaccine Part A
80 Rapport annuel EMEA 2000
Bayer D
Substance — DCI
Pigs Marker vaccine against Classical Swine Fever (QJ57EA)
Domaine thérapeutique — Espèces visées
Emulsion for injection E2 glycoprotein of Classical Swine Fever virus 4
EMEA-CVMP — Validation — Avis — Temps actif — Temps suspendu
- 16.12.1998 - 19.07.2000 - 210 days - 309 days
Commission — Envoi à la Commission — Date du règlement — Journal officiel
- 07.08.2000
— Flumethrin
Porcilis AR -T- DF Inactivated vaccine Part A
— Flumethrin — Ovine —
Intervet International NL
19.1.2000
Pigs Vaccine against atrophic rhinitis (QJ57EA)
— 19.5.2000
Suspension for injection 2 ml 2
(extension)
- 12.01.1999 - 19.07.2000 - 204 days - 336 days
19.4.2000 90 days 0 day
- 18.08.2000 - 16.11.2000 - OJ C 2, 05.01.2001
— 27.10.2000 — JO L 276, 28.10.2000
Pruban Rescortol butyrate Part B
— Flunixin — Equine —
Intervet International NL
— 21.7.2000
Dogs Anti-inflammatory for cutaneous inflammatory disorders (QD07AC90)
(extension)
Cream 1 mg/g 1
— — —
- 15.09.1998 - 19.07.2000 - 196 days - 477 days
21.6.2000 90 days 0 day
- 18.08.2000 - 16.11.2000 - OJ C 2, 05.01.2001
— 29.12.2000 — JO L 336, 30.12.2000
Pirsue Pirlimycin Part B
— Toltrazuril
Pharmacia Upjohn B
— Porcine
Dairy cattle Clinical & sub-clinical mastitis (QJ51FF90)
— Toltrazuril — Porcine —
Sterile solution for intramammary use 5 mg/ml 4
16.2.1999
- 12.01.1999 - 11.10.2000 - 210 days - 428 days
— 21.7.2000
- 10.11.2000
(extension)
Zubrin Tepoxalin Part B
— — —
Schering - Plough UK
21.6.2000 206 days 284 days
Dogs Treatment of pain & inflammation
— 29.12.2000 — JO L 336, 30.12.2000
Oral lyophilisate 30,50,100 & 200 mg/ml 39
— Porcine, ovine, turkey,
- 18.05.1999 - 08.11.2000 - 210 days - 330 days
— Thiamphenicol — Porcine, ovine, turkey, —
- 08.12.2000
15.5.1998
Eurican herpes 205 Inactivated vaccine Part B
— 8.11.2000
Merial F
(extension)
Dogs Vaccine against canine herpes
fish
Powder plus solvent for emulsion for injection 1 ml 2
— — —
- 13.07.1999 - 08.11.2000 - 209 days - 274 days
21.6.2000 206 days 562 days
- 08.12.2000
— Difloxacin
79 EMEA General Report 2000
— Bovine, porcine
Establishment of maximum residue limits for new substances
— Difloxacin — Bovine, porcine —
Substance - INN
— 21.7.2000
Therapeutic area - Target species
(extension)
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
21.6.2000 205 days 503 days
Commission - Sent to Commission - Date of Regulation - Official Journal
— 29.12.2000 — JO L 336, 30.12.2000
Bismuth subnitrate (extension)
— Halofuginone
Bovine
— Bovine
- 18.06.1999 - 13.10.1999 - 113 days -0
— Halofuginone — Bovine —
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
10.12.1996
Acetyl isovaleryl tylosin tartrate
— 21.7.2000
Porcine
— — —
- 18.10.1995 - 13.10.1999 - 195 days - 1260 days
21.6.2000 281 days 1 008 days
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
— 29.12.2000 — JO L 336, 30.12.2000
Methylprednisolone
— Linear dodecyl benzene
- 13.07.1999 - 13.10.1999 - 92 days -0
— Linear dodecyl benzene — Bovine —
- 12.11.1999 - 19.06.2000 - OJ L 145, 20.06.2000
— 18.8.2000
Deltamethrin (extension)
sulfonic acid
Fin fish
— — —
- 09.12.1999 - 08.03.2000 - 90 days -0
19.7.2000 195 days 321 days
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
— Phoxim — Ovine —
Eggs
— — —
- 09.11.1999 - 08.03.2000 - 90 days -0
19.7.2000 120 days 0 day
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
— Acetyl isovaleryl tylosin
Dicyclanil
— Porcine
Ovine
— Acetyl isovaleryl tylosin — Porcine —
25.02.1997 - 08.03.2000 - 281 days - 825 days
18.1.1995
- 07.04.2000 - 15.09.2000 - OJ L 234, 16.09.2000
— 18.2.2000
Tilmicosin (extension)
tartrate
Rabbit
— — —
- 16.07.1999 - 13.10.1999 - 86 days -0
13.9.2000 274 days 1 790 days
- 12.11.1999 - 20.10.2000 - OJ L 269, 21.10.2000
— Florfenicol
Flumequine (extension)
— Fish
Bovine milk & turkey
— Florfenicol — Fish —
- 27.07.1999 - 10.11.1999 - 89 days -0
29.1.1996
- 09.12.1999 - 20.10.2000 - OJ L 269, 21.10.2000
— 8.11.2000
- 14.10.1999 - 12.01.2000 - 90 days -0
11.11.2000 212 days 1 504 days
- 11.02.2000 - 20.10.2000 - OJ L 269, 21.10.2000
— Meloxicam
Dicyclanil (modification)
— Porcine
Sheep fat
— Meloxicam — Porcine —
- 23.02.2000 - 17.05.2000 - 84 days -0
7.9.2000
- 16.06.2000 - 27.10.2000 - OJ L 276, 28.10.2000
— 4.1.2001
Dairy cattle
— — —
- 19.01.2000 - 19.04.2000 - 90 days -0
6.12.2000 90 days 0 day
Tilmicosin (extension)
— Tilmicosin
Bovine milk
— Turkey
- 22.02.1999 - 19.04.2000 - 203 days - 210 days
— Tilmicosin — Turkey —
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
— 4.1.2001
Phoxim (extension)
z (extension)
Ovine
— — —
- 19.01.2000 - 19.04.2000 - 90 -0
6.12.2000 90 days 0 day
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
81 Rapport annuel EMEA 2000
80 EMEA General Report 2000
Annexe 10 — Avis du COMP en 2000 sur les médicaments orphelins
Substance - INN
Responsable
Therapeutic area - Target species
Indication
EMEA/CVMP - Validation - Opinion - Active time - Clockstop
EMEA-COMP — Soumission — Validation — Avis — Temps actif
Commission - Sent to Commission - Date of Regulation - Official Journal
Commission — Avis reçu — Date de désignation
Flumethrin (extension)
— Somatropin
Ovine
—
- 19.01.2000 - 19.04.2000 - 90 days -0
28.4.2000 15.6.2000 11.7.2000 27 days
- 19.05.2000 - 27.10.2000 - OJ L 276, 28.10.2000
— 17.7.2000 — 8.8.2000
Flunixin (extension)
Alpha- Galactosidase A
Equine
—
- 23.03.2000 - 21.06.2000 - 90 days -0
TKT Europe- — Treatment of Fabry disease 5S AB
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
3.5.2000 15.6.2000 11.7.2000 27 days
Toltrazuril (extension)
— 17.7.2000 — 8.8.2000
Porcine
—
- 16.02.1999 - 21.06.2000 - 206 days - 284 days
Alpha- Galactosidase A
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
— Genzyme BV
Thiamphenicol (extension)
— Treatment of Fabry disease
Porcine, Ovine, Turkey, Fish
— — — —
- 15.05.1998 - 21.06.2000 - 206 days - 562 days
12.5.2000 15.6.2000 11.7.2000 27 days
- 08.11.2000
— Fluorouracil
Difloxacin (extension)
— Ethypharm SA — Treatment of glioblastoma
Bovine, Porcine
— — — —
- 14.07.1998 - 21.06.2000 - 205 days - 503 days
26.5.2000 31.7.2000 13.9.2000 45 days
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
— 18.9.2000 — 18.10.2000
Halofuginone
Gemtuzumab ozogamicin
Bovine
—
- 10.12.1996 - 21.06.2000 - 281 days - 1008 days
— Treament of acute myeloid leukaemia— — — —
- 21.07.2000 - 29.12.2000 - OJ L 336, 30.12.2000
7.6.2000 31.7.2000 13.9.2000 45 days
Linear dodecyl benzene sulfonic acid
— 18.9.2000 — 18.10.2000
- 22.01.1999 - 19.07.2000 - 195 days - 321 days
1,5-(Butylimino)- — 1,5-dideoxy, D- glucitol
- 18.08.2000
Oxford GlycoSciences Ltd
Phoxim (extension)
— Treatment of Gaucher disease
Ovine
— — — —
- 19.01.2000 - 19.07.2000 - 120 days -0
7.6.2000 31.7.2000 13.9.2000 45 days
- 18.08.2000
Orphan Europe — SARL
Acetyl isovaleryl tylosin tartrate
Treatment of N-acetylglutamate synthetase (NAGS) deficiency
Porcine
— — — —
- 18.01.1995 - 13.09.2000 - 274 days - 1790 days
2.5.2000 31.7.2000 13.9.2000 45 days
- 18.02.2000
— 18.9.2000 — 18.10.2000
Florfenicol (extension)
— Arsenic trioxide
Fish
—
- 29.01.1996 - 11.11.2000 - 212 days - 1504 days
Voisin Consulting SARL
- 08.11.2000
—
Meloxicam (extension)
Treatment of acute promyelocytic leukaemia
- 07.09.2000 - 06.12.2000 - 90 days - 0 days
8.5.2000 15.6.2000 13.9.2000 90 days
- 04.01.2001
— Thalidomide
Tilmicosin z(extension)
Laboratoires Laphal
Turkey
—
- 07.09.2000 - 06.12.2000 - 90 days - 0 days
1.6.2000 25.8.2000 27.10.2000 64 days
- 04.01.2001
— 6.11.2000 — 29.12.2000
81 EMEA General Report 2000
Anagrelide hydrochloride
Annex 10:
—
COMP opinions in 2000 on orphan medicinal products
Shire Pharmaceutical Development Ltd
Product
—
Sponsor
Treatment of essential thrombocythaemia
Indication
— — — —
EMEA/COMP - Submission - Validation - Opinion - Active time
31.5.2000 31.7.2000 27.10.2000 89 days
Commission - Opinion received - Date of Designation
— 6.11.2000 — 29.12.2000
Somatropin
—
Ares-Serono (Europe) Ltd
Busulfan (intravenous use)
AIDS-wasting
Pierre Fabre Médicament
- 28.04.2000 - 15.06.2000 - 11.07.2000 - 27 days
— 9.6.2000 — 31.7.2000 — 27.10.2000 — 89 days
- 17.07.2000 - 08.08.2000
— 6.11.2000 — 29.12.2000
Alpha - Galactosidase A
— Nitisinone
TKT Europe- 5S AB
Swedish Orphan AB
Treatment of Fabry disease
— Treatment of tyrosinaemia type 1
- 03.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
5.6.2000 25.8.2000 27.10.2000 64 days
Alpha - Galactosidase A
82 Rapport annuel EMEA 2000
Genzyme BV
Produit
Treatment of Fabry disease
Responsable
- 12.05.2000 - 15.06.2000 - 11.07.2000 - 27 days
EMEA-COMP — Soumission — Validation — Avis — Temps actif
- 17.07.2000 - 08.08.2000
Commission — Avis reçu — Date de désignation
Fluorouracil
— Ethyl
Ethypharm S.A.
— Laxdale Ltd
Treatment of glioblastoma
— Treatment of Huntington’s disea
- 26.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
— Ethyl — Laxdale Ltd — Treatment of Huntington’s disease —
- 18.09.2000 - 18.10.2000
5.6.2000
Gemtuzumab ozogamicin
— 6.11.2000
Wyeth-Ayerst Research
eicosopentaenoate
Treament of acute myeloid leukaemia
— — —
- 07.06.2000 - 31.07.2000 - 13.09.2000 - 45 days
31.7.2000 27.10.2000 89 days
- 18.09.2000 - 18.10.2000
— 29.12.2000
1,5 -(Butylimino)- 1,5-dideoxy, D-glucitol
—
Oxford GlycoSciences Ltd
Iloprost — Schering AG
Treatment of Gaucher disease
Treatment of primary and of the following forms of secondary pulmonary hypertension: connective —
- 07.06.2000 - 31.07.2000 - 13.09.2000 - 45 days
10.5.2000 31.7.2000 27.10.2000
- 18.09.2000 - 18.10.2000
— 6.11.2000 — 29.12.2000
N -carbamyl-L- glutamic acid
89 days
Orphan Europe Sarl
......
Treatment of N-acetylglutamate synthetase (NAGS) deficiency
Treatment of amyotrophic lateral — sclerosis — — —
- 02.05.2000 - 31.07.2000 - 13.09.2000 - 45 days
7.8.2000 25.8.2000 21.11.2000 89 days
Arsenic trioxide
......
Voisin Consulting Treatment of acute promyelocytic leukaemia Sarl
— Treatment of acute promyelocytic —
- 08.05.2000 - 15.06.2000 - 13.09.2000 - 90 days
8.8.2000
- 18.09.2000 - 18.10.2000
leukaemia
Thalidomide
— — —
Laboratoires LAPHAL
22.9.2000 21.11.2000 61 days
Treatment of erythema nodosum leprosum or type II reactions in Hansen's disease
—
- 01.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
Treatment of acute respiratory distress syndrome
- 6.11.2000 - 29.12.2000
— — — —
Anagrelide hydrochloride
1.9.2000 22.9.2000 21.11.2000 61 days
Shire Pharmaceutical Development Ltd
......
Treatment of essential thrombocythaemia
— Treatment of cystic fibrosis —
- 31.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
22.9.2000 19.12.2000 89 days
- 6.11.2000 - 29.12.2000
......
Busulfan (intravenous use)
— Treatment of patent ductus arteriosus—
Pierre Fabre Médicament
2.5.2000
Intravenous conditioning treatment prior to hematopoietic progenitor cell transplantation
— — —
- 09.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
19.10.2000 19.12.2000 62 days
Nitisinone
......
Swedish Orphan AB
—
Treatment of tyrosinaemia type 1
Treatment of glycogen storage disease type II (Pompe’s disease)
- 05.06.2000 - 25.08.2000 - 27.10.2000 - 64 days
10.8.2000 19.10.2000 19.12.2000 62 days
82 EMEA General Report 2000
— Treatment of acromegaly —
Product
11.8.2000
Sponsor
— — —
Indication
......
EMEA/COMP - Submission - Validation - Opinion - Active time
—
Commission - Opinion received - Date of Designation
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Ethyl eicosopentaenoate
21.8.2000 19.10.2000 19.12.2000 62 days
Laxdale Ltd
......
Treatment of Huntington's disease
— Treatment of haemorrhagic fever —
- 05.06.2000 - 31.07.2000 - 27.10.2000 - 89 days
6.9.2000
- 6.11.2000 - 29.12.2000
with renal syndrome
Iloprost
— — —
Schering AG
......
Treatment of primary and of the following forms of secondary pulmonary hypertension: connective tissue disease pulmonary hypertension, drug -induced pulmonary hypertension, portopulmonary hypertension, pulmonary hypertension associated with congenital heart disease and chronic thromboembolic pulmonary hypertension
—
- 10.05.2000 - 31.07.2000 - 27.10.2000 - 89 days
Treatment of mucopolysaccharidosis type I
-
8.9.2000 19.10.2000 19.12.2000 62 days
Treatment of amyotrophic lateral sclerosis
— Treatment of chronic myeloid —
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
19.10.2000 19.12.2000 62 days
Treatment of acute promyelocytic leukaemia
Mucopolysaccharidosis type VI (Maroteaux-Lamy Syndrome)
- 08.08.2000
— — — —
-
4.10.2000 19.10.2000 19.12.2000 62 days
- 22.09.2000
83 Rapport annuel EMEA 2000
- 21.11.2000
Numéro de référence
- 61 days
EMEA/CPMP/BWP/840/00
- -
EMEA/CPMP/BWP/1244/00
Treatment of acute respiratory distress syndrome
Report of the EMEA Expert Workshop on human TSEs and plasma- derived medicinal products, 15-16 May 2000 Adoptée en juillet 2000
- 01.09.2000
EMEA/CPMP/BWP/3326/99
-
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adoptée en novembre 2000
- 22.09.2000
EMEA/CPMP/BWP/3354/99 Draft
- 21.11.2000
EMEA/CPMP/BWP/3207/00
- 61 days
EMEA/CPMP/BWP/1143/00
- -
Position statement on the Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products Transmise pour consultation en juillet 2000
Treatment of cystic fibrosis
EMEA/CPMP/BWP/269/95 rev.
- 09.08.2000
EMEA/CPMP/BWP/2571/00
-
Groupe de travail «Sang et plasma» du CPMP
- 22.09.2000
Numéro de référence
- 19.12.2000
Lignes directrices/Statut
- 89 days
EMEA/CPMP/BPWG/575/99
Treatment of patent ductus arteriosus
Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) Adoptée en juin 2000
- 02.05.2000
EMEA/CPMP/BPWG/574/99
- 19.10.2000
EMEA/CPMP/BPWG/1619/99
- 19.12.2000
EMEA/CPMP/BPWG/1625/99
- 62 days
EMEA/CPMP/BPWG/198/95 rev.1
- -
EMEA/CPMP/BPWG/1561/99
Treatment of glycogen storage disease type II
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adoptée en octobre 2000
- 10.08.2000
84 Rapport annuel EMEA 2000
(Pompe's disease)
EMEA/CPMP/BPWG/1561/99
- 19.10.2000 - 19.12.2000 - 62 days
EMEA/CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
- -
Core SPC for Human albumin Transmise pour consultation en juin 2000 Note for Guidance on the Clinical investigation of plasma derived antithrombin products Transmise pour consultation en décembre 2000
Treatment of acromegaly
EMEA/CPMP/BPWG/3226/99
- 11.08.2000 - 19.10.2000 - 19.12.2000 - 62 days
Groupe de travail «Efficacité» du CPMP Numéro de référence
-
Lignes directrices/Statut
- -
EMEA/CPMP/EWP/519/98
Treatment of pulmonary arterial hypertension and
Note for Guidance on clinical investigation of steroid contraceptives in woman Adoptée en février 2000
- 21.08.2000
EMEA/CPMP/EWP/570/98
-
Points to consider on the clinical investigation of new medicinal products for treatment of acute coronary syndrome (ACS) without persistent ST- segment elevation Adoptée en février 2000
chronic thromboembolic pulmonary hypertension
EMEA/CPMP/EWP/2922/99
- 19.10.2000 - 19.12.2000 - 62 days
EMEA/CPMP/EWP/2863/99
- -
EMEA/CPMP/EWP/707/98
Treatment of haemorrhagic fever with renal syndrome
Points to consider on Clinical investigation of medicinal products for pro- phylaxis of intra- and post-operative venous thromboembolic risk Adoptée en juin 2000
- 07.08.2000 - 25.08.2000 - 21.11.2000 - 89 days
EMEA/CPMP/EWP/612/00
-
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adoptée en juin 2000
- -
EMEA/CPMP/EWP/2655/99
Treatment of mucopolysaccharidosis type I
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Adoptée en juillet 2000
- 08.09.2000
EMEA/CPMP/EWP/482/99
-
Points to consider on switching between superiority and non-inferiority Adoptée en juillet 2000
- 19.10.2000
EMEA/CPMP/EWP/1080/00
- 19.12.2000
EMEA/CPMP/EWP/565/98
- 62 days
EMEA/CPMP/EWP/785/97
- -
1 Note
Treatment of chronic myeloid leukaemia
for Guidance on Clinical investigation of medicinal products in the
- 03.10.2000
EMEA/CPMP/EWP/560/98
-
Points to consider on Clinical investigation of medicinal products in the treatment of acute stroke Transmise pour consultation en octobre 2000
- 19.10.2000
EMEA/CPMP/EWP/2330/99
- 19.12.2000
EMEA/CPMP/EWP/1119/98
- 62 days
EMEA/CPMP/EWP/714/98
- -
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Transmise pour consultation en novembre 2000
Mucopolysaccharidosis type VI (Maroteaux -Lamy
EMEA/CPMP/EWP/QWP/ 1401/98 EMEA/CPMP/EWP/2747/00
- 04.10.2000
Note for Guidance on the investigation of bioavailability and bioequivalence Transmise pour consultation en décembre 2000 Note for Guidance on co-ordinating investigator signature of clinical study reports Transmise pour consultation en décembre 2000
-
Groupe de travail «Pharmacovigilance» du CPMP
Syndrome)
Numéro de référence
- 19.10.2000 - 19.12.2000 - 62 days
Lignes directrices/Statut
83 EMEA General Report 2000
EMEA/CPMP/PhVWP/2058/99
EMEA guidelines in 2000
Joint Pilot Plan for the implementation of the electronic transmission of individual case safety reports between the EMEA, national competent authorities, and the Pharmaceutical Industry Transmise pour consultation en mai 2000
CPMP Biotechnology Working Party
Groupe de travail «Sécurité» du CPMP
Reference number
Numéro de référence
Guidelines/Status
EMEA/CPMP/SWP/2775/99
EMEA/ CPMP/ BWP/840/00
EMEA/CPMP/SWP/1042/99
Final EU recommendations for the Influenza vaccine composition for the season 2000/2001 Adopted April 2000
Note for Guidance on Repeated dose toxicity Adoptée en juillet 2000
EMEA/ CPMP/ BWP/1244/00
EMEA/CPMP/SWP/2278/00
Report of the EMEA Expert Workshop on human TSEs and plasma-derived medicinal products, 15-16 May 2000 Adopted July 2000
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Adoptée en décembre 2000
EMEA/ CPMP/ BWP/3326/99
EMEA/CPMP/SWP/4163/00
Concept paper on the Development of a Points to consider on xenogeneic cell therapy Adopted November 2000
Concept paper on the Development of a CPMP Points to consider on the need for reproduction toxicity studies in the development of human insulin analogues Adoptée en décembre 2000
EMEA/ CPMP/ BWP/3354/99 Draft
EMEA/CPMP/SWP/2145/00 Draft 4
Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Released for consultation January 2000
Note for Guidance on Non-clinical local tolerance testing of medicinal products Transmise pour consultation en septembre 2000
EMEA/ CPMP/ BWP/3207/00
Numéro de référence
Note for Guidance on Comparability of medicinal products containing biotechnology-derived proteins as active substances Released for consultation May 2000
Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species Adoptée par le groupe de travail en octobre 2000
EMEA/CPMP/BWP/1143/00
CPMP/QWP/2819/00
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
Note for guidance on quality of herbal medicinal products Transmise pour consultation en novembre 2000
2
CPMP/QWP/2820/00
Revision of section 3.2.5 of CPMP Note for guidance on Plasma-derived medicinal products Released for consultation July 2000
Note for guidance on specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products Transmise pour consultation en novembre 2000
EMEA/CPMP/BWP/2571/00
86 Rapport annuel EMEA 2000
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Released for consultation November 2000
Conduct of pharmacokinetic studies in animals Adoptée en mars 2000
CPMP Blood and Plasma Working Group
EMEA/CVMP/344/99
Reference number
EMEA/CVMP/005/00
Guidelines/Status
EMEA/CVMP/016/00
EMEA/CPMP/BPWG/575/99
CVMP/VICH/546/00
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Specific recommendations for poultry Transmise pour consultation en juillet 2000
1
CVMP/VICH/545/00
Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
Specific recommendations for feline Transmise pour consultation en juillet 2000
EMEA/CPMP/BPWG/574/99
Lignes directrices/Statut
Core SPC for Human and anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Requirements for combined veterinary vaccines Adoptée en mars 2000
1
CVMP/IWP/07/98
Core SPC for Human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use Adoptée en mars 2000
EMEA/ CPMP/ BPWG/1619/99
EMEA/CVMP/682/99
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Adopted June 2000
Duration of protection achieved by veterinary vaccines Adoptée en octobre 2000
EMEA/ CPMP/ BPWG/1625/99
EMEA/CVMP/852/99
Core SPC for Human plasma derived and recombinant coagulation factor IX products Adopted June 2000
Field trials with veterinary vaccines Transmise pour consultation en mars 2000
EMEA/CPMP/BPWG/198/95 rev.1
Lignes directrices/Statut
Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adopted October 2000
Conduct of post-marketing surveillance studies of veterinary medicinal products Adoptée en avril 2000
EMEA/CPMP/BPWG/ 1561/99
CVMP/VICH/547/00
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adopted October 2000
Management of adverse event reports (AERs) Transmise pour consultation en juillet 2000
84 EMEA General Report 2000
Lignes directrices/Statut
EMEA/CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/198/95 rev.
Determination of withdrawal periods for milk Adoptée en mars 2000
1
Environmental impact assessment (EIAS) for veterinary medicinal products — Phase 1 Adoptée en juillet 2000
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
Risk analysis approach for residues of veterinary medicinal products in food of animal origin Transmise pour consultation en mai 2000
EMEA/ CPMP/ BPWG/1561/99
CVMP/VICH/526/00
Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Released for consultation June 2000
Genotoxicity studies Transmise pour consultation en juillet 2000
EMEA/ CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
Safety studies for veterinary drug residues in human food:
Core SPC for Human albumin Released for consultation June 2000 Note for Guidance on the Clinical investigation of plasma derived antithrombin products Released for consultation December 2000
Concept Paper on the Development of a CPMP/CVMP Note for Guidance on Quality of Water for Pharmaceutical Use Adoptée en juillet 2000
EMEA/ CPMP/BPWG/3226/99
CPMP/QWP/3015/99
Core SPC for Human plasma derived antithrombin Released for consultation December 2000
Note for Guidance on Parametric Release Transmise pour consultation en mars 2000
CPMP Efficacy Working Party Reference number
CPMP/QWP/1719/00
Guidelines/Status
Note for Guidance on Medicinal Gases — Pharmaceutical Information Transmise pour consultation en juillet 2000
EMEA/ CPMP/ EWP/519/98
CPMP/QWP/2845/00
Note for Guidance on clinical investigation of steroid contraceptives in woman Adopted February 2000
Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products Transmise pour consultation en novembre 2000
EMEA/ CPMP/ EWP/197/99
CPMP/QWP/2820/00 (CVMP/815/00)
Points to consider concerning Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells Adopted February 2000
Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products Transmise pour consultation en novembre 2000
EMEA/ CPMP/ EWP/570/98
CPMP/QWP/2819/00 (CVMP/814/00) EMEA/CVMP/065/99
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
Decision trees for the selection of sterilisation methods Adoptée en février 2000
EMEA/ CPMP/ EWP/2922/99
EMEA/CVMP/422/99
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
Declaration of storage conditions for veterinary medicinal products in the product particulars Adoptée en février 2000
EMEA/ CPMP/ EWP/2863/99
CVMP/VICH/501/99
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
Stability testing of biotechnological/biological veterinary medicinal products Adoptée en juin 2000
EMEA/ CPMP/ EWP/707/98
CVMP/VICH/502/99
Points to consider on Clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk Adopted June 2000
Impurities: residual solvents Adoptée en juin 2000
EMEA/ CPMP/ EWP/612/00
EMEA/CVMP/198/99
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adopted June 2000
Maximum shelf-life for sterile medicinal products after first opening or following reconstitution Adoptée en juillet 2000
EMEA/ CPMP/ EWP/2655/99
CVMP/VICH/595/98
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Adopted July 2000
Good clinical practices Adoptée en juillet 2000
EMEA/ CPMP/ EWP/482/99
EMEA/CVMP/846/99
Points to consider on switching between superiority and non-inferiority Adopted July 2000
Stability testing of existing active substances and related finished products Adoptée en novembre 2000
EMEA/ CPMP/ EWP/1080/00
EMEA/CVMP/816/00
Concept paper on the Development of a CPMP Note for Guidance on Clinical investigation of medicinal products in the treatment of diabetes mellitus Adopted July 2000
Statistical principles for veterinary clinical trials Transmise pour consultation en novembre 2000
EMEA/ CPMP/ EWP/565/98
Numéro de référence
Points to consider on Clinical investigation of medicinal products for treatment of Amyotrophic Lateral Sclerosis (ALS) Adopted October 2000
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Finalisée en avril 2000
EMEA/CPMP/EWP/785/97
ENTR/6270/00
Concept paper on the Evaluation of drugs for the treatment of the irritable bowel syndrome Adopted November 2000
Sixième Rapport général sur les activités de l’Agence européenne pour l’évaluation des médicaments — 2000
EMEA/CPMP/EWP/566/98 rev.
2001 — 88 p. — 21 x 29,7 cm
1
5369 Chemin Canotek Road, Unit 1
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders Adopted in November 2000
(Estonian Chamber of Commerce and Industry) Toom-Kooli 17
EMEA/CPMP/EWP/2284/99
(32-2) 538 43 08
Points to consider on Clinical investigation of medicinal products for the management of Crohn's disease Released for consultation July 2000
E-Mail: manz@schwinge.at URL: http://www.manz.at
85 EMEA General Report 2000
Rue de la Loi 244/Wetstraat 244
EMEA/CPMP/EPW/205/95 rev.
B-1040 Bruxelles/Brussel
1
Pavla Hatza 1
Note for Guidance on Evaluation of anticancer medicinal products in man Released for consultation July 2000 and extended in September 2000 for a further 2 months
Rua das Terras dos Vales, 4-A
EMEA/ CPMP/ EWP/560/98
(385-1) 481 94 11
Points to consider on Clinical investigation of medicinal products in the treatment of acute stroke Released for consultation October 2000
URL: http://www.libeurop.be Moniteur belge/Belgisch Staatsblad
EMEA/ CPMP/ EWP/2330/99
Fax (385-1) 481 94 11 MAGYARORSZÁG
Points to consider on Validity and interpretation of meta-analyses, and one pivotal study Released for consultation October 2000
Rue de Louvain 40-42/Leuvenseweg 40-42
EMEA/ CPMP/ EWP/1119/98
(32-2) 552 22 11
Points to consider on the Evaluation of diagnostic agents Released for consultation November 2000
Imprensa Nacional-Casa da Moeda, SA
EMEA/ CPMP/ EWP/714/98
(91-22) 282 60 64
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Released for consultation November 2000
(36-1) 329 21 70
EMEA/ CPMP/EWP/QWP/ 1401/98
E-mail: ebicindia@vsnl.com
Note for Guidance on the investigation of bioavailability and bioequivalence Released for consultation December 2000
Schultz Information A/S Herstedvang 12
EMEA/CPMP/EWP/2747/00
Fax (351) 213 94 57 50 E-mail: spoce@incm.pt
Note for Guidance on co-ordinating investigator signature of clinical study reports Released for consultation December 2000
E-mail: euroinfo@euroinfo.hu URL: http://www.euroinfo.hu
CPMP Pharmacovigilance Working Party
(45) 43 63 23 00
Reference number
Fax (45) 43 63 19 69
Guidelines/Status
SUOMI/FINLAND
EMEA/CPMP/PhVWP/2058/99
Asahi Sanbancho Plaza #206
Joint Pilot Plan for the implementation of the electronic transmission of individual case safety reports between the EMEA, national competent authorities, and the Pharmaceutical Industry Released for consultation May 2000
E-mail: schultz@schultz.dk
CPMP Safety Working Party
Miller Distributors Ltd
Reference number
7-1 Sanbancho, Chiyoda-ku
Guidelines/Status
URL: http://www.schultz.dk
EMEA/ CPMP/ SWP/2775/99
DEUTSCHLAND
CPMP Position paper on Selective Serotonin Uptake Inhibitors (SSRIs) and dependency/withdrawal reactions Adopted April 2000
Akateeminen Kirjakauppa/ Akademiska Bokhandeln
EMEA/ CPMP/ SWP/1042/99
E-mail: books@psi-japan.co.jp
Note for Guidance on Repeated dose toxicity Adopted July 2000
Bundesanzeiger Verlag GmbH Vertriebsabteilung
EMEA/ CPMP/ SWP/2278/00
(356) 66 44 88 Fax (356) 67 67 99
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Adopted December 2000
P./tfn (358-9) 121 44 18 F./fax (358-9) 121 44 35
EMEA /CPMP/SWP/4163/00
E-mail: gwirth@usa.net
Concept paper on the Development of a CPMP Points to consider on the need for reproduction toxicity studies in the development of human insulin analogues Adopted December 2000
Sähköposti: sps@akateeminen.com URL: http://www.akateeminen.com
EMEA/CPMP/SWP/2145/00 Draft 4
EBIC Malaysia Suite 45.02, Level 45
Note for Guidance on Non-clinical local tolerance testing of medicinal products Released for consultation September 2000
Krakowskie Przedmiescie 7 Skr. pocztowa 1001
EMEA Herbal Medicinal Products Working Party
8 Jalan Yap Kwan Seng 50450 Kuala Lumpur
Reference number
(60-3) 21 62 92 98
Guidelines/Status
Traktorvägen 11-13
EMEA/HMPWP/23/00
(48-22) 826 12 01
Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species Adopted by the Working Party in October 2000
Fax (60-3) 21 62 61 98
CPMP/QWP/2819/00
Eleftheroudakis SA
Note for guidance on quality of herbal medicinal products Released for consultation November 2000
Fax (48-22) 826 62 40 E-mail: books119@arspolona.com.pl
CPMP/QWP/2820/00
E-mail: ebic@tm.net.my
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
International Bookstore Panepistimiou 17
86 EMEA General Report 2000
(46-46) 18 00 00 Fax (46-46) 30 79 47
CVMP Efficacy Working Party Reference number EMEA/ CVMP/133/99
(30-1) 331 41 80/1/2/3/4/5 Fax (30-1) 323 98 21
Guidelines/Status Conduct of pharmacokinetic studies in animals Adopted March 2000
E-post: btjeu-pub@btj.se URL: http://www.btj.se
EMEA/ CVMP/344/99
ROMÂNIA Euromedia
Conduct of efficacy studies for intramammary products for use in cattle Adopted March 2000
Mundi Prensa México, SA de CV Río Pánuco, 141 Colonia Cuauhtémoc
EMEA/ CVMP/005/00
UNITED KINGDOM
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
(40-1) 315 44 03
EMEA/CVMP/016/00
(52-5) 533 56 58
The conduct of bioequivalence studies for veterinary medicinal products Released for consultation January 2000
The Stationery Office Ltd
CVMP/VICH/546/00
Fax (52-5) 514 67 99
Efficacy of anthelmintics:
Boletín Oficial del Estado
Specific recommendations for poultry Released for consultation July 2000
Customer Services PO Box 29
CVMP/VICH/545/00
E-mail: euromedia@mailcity.com
Efficacy of anthelmintics:
101545.2361@compuserve.com
Specific recommendations for feline Released for consultation July 2000
(44) 870 60 05-522
CVMP Immunologicals Working Party Reference number CVMP/IWP/52/97
(34) 915 38 21 11 (libros)
Guidelines/Status Requirements for combined veterinary vaccines Adopted March 2000
Fax (44) 870 60 05-533 E-mail: book.orders@theso.co.uk
CVMP/IWP/07/98
Centrum VTI SR
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use Adopted March 2000
EBIC Philippines 19th Floor, PS Bank Tower
EMEA/ CVMP/682/99
(34) 913 84 17 15 (suscripción)
Duration of protection achieved by veterinary vaccines Adopted October 2000
URL: http://www.itsofficial.net
EMEA/ CVMP/852/99
Slobody, 19
Field trials with veterinary vaccines Released for consultation March 2000
Fax (34) 915 38 21 21 (libros), Fax (34) 913 84 17 14 (suscripción)
EMEA/CVMP/743/00
(421-7) 54 41 83 64
Requirements and controls applied to bovine serum (foetal or calf) used in the protection of immunological veterinary medicinal products Released for consultation October 2000
E-mail: clientes@com.boe.es URL: http://www.boe.es Mundi Prensa Libros, SA
CVMP Pharmacovigilance Working Party
ÍSLAND Bokabud Larusar Blöndal Skólavördustig, 2
Reference number EMEA/ CVMP/044/99
Fax (421-7) 54 41 83 64 E-mail: europ@tbb1.sltk.stuba.sk URL: http://www.sltk.stuba.sk
Guidelines/Status Conduct of post-marketing surveillance studies of veterinary medicinal products Adopted April 2000
(63-2) 759 66 80 Fax (63-2) 759 66 90 E-mail: eccpcom@globe.com.ph URL: http://www.eccp.com
CVMP/VICH/547/00
(34) 914 36 37 00
Management of adverse event reports (AERs) Released for consultation July 2000
(354) 552 55 40 Fax (354) 552 55 60
CVMP Safety Working Party
SLOVENIJA Gospodarski Vestnik
linesStatus number
SOUTH AFRICA
Reference
Fax (34) 915 75 39 98
Guidelines/Status
E-mail: bokabud@simnet.is
EMEA/ CVMP/276/99
Dunajska cesta 5
Assessment of the effect of antimicrobial substances on dairy starter cultures Adopted March 2000
Eurochamber of Commerce in South Africa
EMEA/ CVMP/473/98
(386) 613 09 16 40
Determination of withdrawal periods for milk Adopted March 2000
(27-11) 884 39 52 Fax (27-11) 883 55 73 E-mail: info@eurochamber.co.za
CVMP/ VICH/592/98
Dünya Infotel AS
Environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1 Adopted July 2000
(33) 140 58 77 31 Fax (33) 140 58 77 00 E-mail: europublications@journal-officiel.gouv.fr
EMEA/CVMP/187/00
(90-212) 629 46 89
Risk analysis approach for residues of veterinary medicinal products in food of animal origin Released for consultation May 2000
Commerce in Korea 5th FI, The Shilla Hotel 202, Jangchung-dong 2 Ga, Chung-ku
CVMP/VICH/526/00
URL: http://www.journal-officiel.gouv.fr
Safety studies for veterinary drug residues in human food:
SCHWEIZ/SUISSE/SVIZZERA Euro Info Center Schweiz
Genotoxicity studies Released for consultation July 2000
Fax (90-212) 629 46 27 E-mail: infotel@dunya-gazete.com.tr
CVMP/VICH/525/00
Seoul 100-392 Tel.
Safety studies for veterinary drug residues in human food:
IRELAND Alan Hanna’s Bookshop 270 Lower Rathmines Road
Reproduction studies Released for consultation July 2000
c/o OSEC Stampfenbachstraße 85 PF 492
87 EMEA General Report 2000
ARGENTINA World Publications SA
Joint CPMP/CVMP Quality Working Party
Fax (82-2) 22 53-5635/6 E-mail: eucck@eucck.org URL: http://www.eucck.org
Reference number
CH-8035 Zürich
Guidelines/Status
Cordoba 1877
CPMP/ QWP/1676/00
SRI LANKA
Concept Paper on the Development of a CPMP/CVMP Note for Guidance on Quality of Water for Pharmaceutical Use Adopted July 2000
(353-1) 496 73 98 Fax (353-1) 496 02 28 E-mail: hannas@iol.ie
CPMP/ QWP/3015/99
C1120 AAA Buenos Aires Tel.
Note for Guidance on Parametric Release Released for consultation March 2000
EBIC Sri Lanka Trans Asia Hotel 115 Sir Chittampalam
CPMP/ QWP/1719/00
URL: http://www.osec.ch/eics
Note for Guidance on Medicinal Gases – Pharmaceutical Information Released for consultation July 2000
E-mail: wpbooks@infovia.com.ar URL: http://www.wpbooks.com.ar
CPMP/QWP/2845/00
(94-1) 074 71 50 78
Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products Released for consultation November 2000
Fax (94-1) 44 87 79
CPMP/QWP/2820/00 (CVMP/815/00)
Casella postale 552 I-50125 Firenze
Note for Guidance on Specifications:
Hunter Publications PO Box 404
Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products Released for consultation November 2000
E-mail: ebicsl@slnet.ik
CPMP/QWP/2819/00 (CVMP/814/00) EMEA/ CVMP/065/99
(39) 055 64 83 1 Fax (39) 055 64 12 57
Note for Guidance on Quality of Herbal Medicinal Products Released for consultation November 2000 Annex to Guideline:
(61-3) 94 17 53 61
Development pharmaceutics for veterinary medicinal products:
E-mail: licosa@licosa.com
Decision trees for the selection of sterilisation methods Adopted February 2000
Milena@mbox.cit.bg
EMEA/ CVMP/422/99
Bernan Associates
Declaration of storage conditions for veterinary medicinal products in the product particulars Adopted February 2000
E-mail: jpdavies@ozemail.com.au
CVMP/VICH/501/99
4611-F Assembly Drive
Stability testing of biotechnological/biological veterinary medicinal products Adopted June 2000
(1-800) 274 44 47 (toll free telephone)
CVMP/ VICH/502/99
Messageries du livre SARL
Impurities: residual solvents Adopted June 2000
_BAR_ESKÁ REPUBLIKA
EMEA/ CVMP/198/99
Livraria Camões
Maximum shelf-life for sterile medicinal products after first opening or following reconstitution Adopted July 2000
Fax (1-800) 865 34 50 (toll free fax) E-mail: query@bernan.com
CVMP/VICH/595/98
5, rue Raiffeisen
Good clinical practices Adopted July 2000
Rua Bittencourt da Silva, 12 C
EMEA/CVMP/846/99
URL: http://www.bernan.com
Stability testing of existing active substances and related finished products Adopted November 2000
(352) 40 10 20 Fax (352) 49 06 61
EMEA/CVMP/816/00
(55-21) 262 47 76
Statistical principles for veterinary clinical trials Released for consultation November 2000
ANDERE LÄNDER/OTHER COUNTRIES/ AUTRES PAYS
Ad hoc GMP Inspectors Working Group
E-mail: mail@mdl.lu
Reference number
(420-2) 22 72 07 34
Guidelines/Status
Fax (55-21) 262 47 76
ENTR/ III/5717/99
Fax (420-2) 22 71 57 38
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
Wahl/Please contact the sales office of
ENTR/6266/00
NEDERLAND
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Finalised in April 2000
your choice/Veuillez vous adresser au bureau de vente de votre choix
ENTR/6109/00
CANADA
Draft Annex 6 to EU Guide to Good Manufacturing Practice on Medicinal Gases Released for consultation March 2000
Office for Official Publications of the European
ENTR/6270/00
2500 EA Den Haag Tel.
Draft Annex 17 to EU Guide to Good Manufacturing Practice on Parametric Release Released for consultation April 2000
(1-418) 658 37 63 Fax (1-800) 567 54 49 E-mail: liberte@mediom.qc.ca
88
(352) 29 29-42455 Fax (352) 29 29-42758 E-mail: info-info-opoce@cec.eu.int URL: http://eur-op.eu.int 1/2001
The European Agency for the Evaluation of Medicinal Products
L'agence Européenne pour l'évaluation des médicaments
Seventh Annual Report 2001
Septième rapport annuel 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.
Adopté par le conseil d'administration le 18 décembre 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.
Chapter 3 Veterinary Medicines 3.1 Initial evaluation
Adopté par le conseil d'administration le 18 décembre 2001
3.2 Establishment of maximum residue limits for old substances
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
3.3 Post-authorisation activities 3.4 Pharmacovigilance and maintenance activities
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int Table des matières
Chapter 1 EMEA in the European System
AVANT-PROPOS DU PRESIDENT DU CONSEIL D'ADMINISTRATION INTRODUCTION DU DIRECTEUR EXECUTIF STRUCTURE DE l'EMEA CHAPITRE 1 L'EMEA DANS LE SYSTEME EUROPEEN 1.1 Conseil d’ administration
6
6 7 8 9 9
3.5
1.2 Autorités nationales compétentes 1.3 Transparence et dialogue réglementaire 1.4 Révision des redevances de l'EMEA 1.5 Révision du système européen d’ autorisation de mise sur le marché 1.6 Gestion de la qualité 1.7 Partenaires internationaux 1.8 Département européen pour la qualité des médicaments 1.9 Contrôle financier CHAPITRE 2 MEDICAMENTS A USAGE HUMAIN 2.1 Évaluation initiale 2.2 Activités après autorisation 2.3 Activités de maintenance et de pharmacovigilance 2.4 Avis scientifiques 2.5 Arbitrages et saisines communautaires 2.6 Services spéciaux 2.7 Activités internationales 2.8 Médicaments orphelins 2.9 Groupes de travail et groupes ad hoc 2.10 Groupe de facilitation de la reconnaissance mutuelle CHAPITRE 3 MEDICAMENTS A USAGE VETERINAIRE 3.1 Évaluation initiale 3.2 Établissement de limites maximales de résidus pour les anciennes substances 3.3 Activités après autorisation 3.4 Activités de maintenance et de pharmacovigilance 3.5 Avis scientifiques 3.6 Arbitrages et saisines communautaires 3.7 Parties intéressées 3.8 Activités internationales 3.9 Groupes de travail et groupes ad hoc 3.10 Groupe de facilitation de la reconnaissance mutuelle pour les médicaments à usage
10 11 12
10 10 10 11 11 12 13 13 14 16 18 19 20 22 23 23 24 26 29 32 34 36 36 37 37 37 39 39 40
5.3 5.4
vétérinaire CHAPITRE 4 INSPECTIONS CHAPITRE 5 ADMINISTRATION ET ACTIVITES DE SOUTIEN 5.1 Administration 5.2 Gestion et édition des documents 5.3 Service de gestion des réunions et de conférence 5.4 Technologies de l'information ANNEXES Annexe 1 Membres du conseil d’ administration Annexe 2 Membres du comité des spécialités pharmaceutiques Annexe 3 Membres du comité des médicaments vétérinaires Annexe 4 Membres du comité des médicaments orphelins Annexe 5 Représentants des autorités nationales compétentes Annexe 6 Résumés des budgets de l'EMEA 2000 – 2002 Annexe 7 Avis du CPMP en 2001 sur les médicaments à usage humain Annexe 8 Avis du CVMP en 2001 sur les médicaments à usage vétérinaire 67 Annexe 9 Avis du COMP en 2001 sur la désignation de médicaments orphelins 70 Annexe 10 Lignes directrices et documents de travail en 2001 77 Annexe 11 Points de contact de l'EMEA 82 Le rapport annuel 2001 est présenté au conseil d’ administration par le directeur exécutif
42
42 43 46 46 49 50 51 53 54 55 56 57 58 62 63
2.10 Mutual recognition facilitation group
conformément à l’ article 55, paragraphe 3, du règlement (CEE) n° 2309/ 93 du Conseil.
20
Les précédents rapports annuels et autres documents de référence sont disponibles sur le site web de l'EMEA, à l'adresse http: / /www. emea. eu. int.
5 6 7 8 9
Il porte également sur le partenariat de l'agence avec les autorités nationales compétentes et les institutions européennes et sur d'autres aspects généraux de l'EMEA, notamment la transparence et les activités internationales.
National competent authority partners EMEA budget summaries 2000-2002 CPMP opinions in 2001 on medicinal products for human use CVMP opinions in 2001 on medicinal products for veterinary use COMP opinions in 2001 on designation of orphan medicinal products
Les activités opérationnelles et techniques de l'EMEA en 2001 sont rapportées au chapitre 2 (médicaments à usage humain), au chapitre 3 (médicaments à usage vétérinaire) et au chapitre 4 (inspections).
2 EMEA Annual Report 2001
L'administration et autres activités de soutien sont décrites au chapitre 5.
10 11
Le rapport, conformément à l'article 15, paragraphe 1, de la directive 75/ 319/ CEE du Conseil et à l'article 23, paragraphe 1, de la directive 81/ 851/ CEE du Conseil, résume également le fonctionnement de la procédure décentralisée (reconnaissance mutuelle) en 2001.
Guidelines and working documents in 2001 EMEA contact points
De nouvelles adresses électroniques pour les membres du personnel de l'EMEA ont été introduites le 1er novembre 2001, date correspondant à l'introduction du domaine "emea. eu. int" pour le courrier électronique:
60 68
prénom. nom@emea. eudra. org
EMEA mission statement
prénom. nom@emea. eu. int
EMEA mission statement • The centralised procedure is compulsory for medicinal
L'adresse électronique générale de l'EMEA devient mail@emea. eu. int et d'autres adresses électroniques fonctionnelles changeront de la même façon, p. ex. certificate@emea. eu. int
To contribute to the protection and promotion of public and animal health by: • Mobilising scientific resources from throughout the European Union to provide high quality evaluation of medicinal products, to advise on research and development programmes and to provide useful and clear information to users and health professionals
Le format d'adresse électronique "emea. eudra. org" continuera d'être reconnu jusqu'au 1er octobre 2002.
products derived from biotechnology, and available at the request of companies for other innovative new products.
Ce changement de domaine fait suite à la modification de l'adresse du site web de l'Agence (désormais www. emea. eu. int) survenue au début 2001 et s'inscrit dans la volonté de l'EMEA de s'aligner sur d'autres organes et institutions de l'Union européenne.
Applications are submitted directly to the EMEA.
Missions de l' EMEA
At the conclusion of the scientific evaluation undertaken in 210 days within the Agency, the opinion of the scientific committee is transmitted to the European Commission to be transformed into a single market authorisation applying to the whole European Union.
la mobilisation des ressources scientifiques à travers l'Union européenne afin d'assurer une évaluation de haut niveau, de fournir des avis sur les programmes de recherche et de développement et de produire des informations claires et pertinentes pour les utilisateurs et les professionnels de la santé;
• Developing efficient and transparent procedures to allow timely access by users to innovative medicines through a single European marketing authorisation
la mise au point de procédures efficaces et transparentes permettant aux utilisateurs d'avoir accès dans les meilleurs délais à des médicaments innovants par le biais d'une seule autorisation européenne de mise sur le marché;
•
le contrôle de la sécurité des médicaments à usage humain et vétérinaire, grâce, en particulier, à un réseau de pharmacovigilance et à l'établissement de limites sûres pour les résidus dans les animaux producteurs d'aliments.
The decentralised procedure (or mutual recognition procedure) applies to the majority of conventional medicinal products and is based upon the principle of mutual recognition of national authorisations.
Le système européen propose deux méthodes d'autorisation des médicaments.
It provides for the extension of marketing authorisations granted by one
L'EMEA joue un rôle dans les deux procédures:
• Controlling the safety of medicines for humans and animals, in particular through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals
À la clôture de l'évaluation scientifique menée en 210 jours au sein de l'Agence, l'avis du comité scientifique est transmis à la Commission européenne afin d'être transformé en une autorisation de mise sur le marché unique valable dans l'ensemble de l'Union européenne.