natgillin/translations-raw huggingface dataset:
ςεδά ο ςιτ ε αίσαγρενυσ εΣ αιχόλοτσιρα νυοχέιρεπ υοπ νωτνόϊορπ νώκιτυεκα ραφ νώκιτυφ νωτ. ησήρχ ητ ε ιατνοζίτεχσ ιοίοπο ιο νωνύδνικ νωτ ησηπόκσανα νητσ εχίετε υσ ςαίσαγρε αδά ο Η, υοτ αίρδεορπ νητ όπυ ΑΕΜΕ υοτ ςιεσάτσατακγε Konstantin Keller. ςιτσ ςέροφ ςιερτ εσαίρδενυσ ατνόϊορπ άκιτυεκα ραφ άκιτυφ ατ αιγ ςαίσαγρε αδά ο η 2000, οΤ 40/ 97
As one of the established European procedures for the authorisation and supervision of medicines in the European Union, the number of mutual recognition procedures increased in 2000 requiring a solid support from the EMEA and an increase in the number of subgroup meetings and break-out sessions.
ατνόϊορπ άκιτυεκα
A total of 52 breakout sessions were organised by reference Member States (referring to 46 new applications and 6 variations).
ραφ άκιτυφ ατ αιγ ςαίσαγρε αδά
In relation to the number of new applications, the number is higher than in 1999.
ησεθκέ αισήτΕ 2000
35 EMEA General Report 2000
EMEA/ MB/ 050/ 00
Mutual recognition procedure
ατα ήτηζ αλλά ή
Total submitted in 2000*
νωλέκαφ νωτ ησηγόλοιξα
Under evaluation Ended positively in 2000* in 2000*
υοτ οιρβ έτπεΣ νοΤ
Referrals started in 2000
236 (7, 6%).
New applications
,
373
3. 107
78 309
,
2
- 30, 5% - (
Type I variations
ΚΟΕ
953
.
124
,
934
.
--
υοίρβ εκε∆
Type II variations
15
323
2
135
312
312
135
2
323 ςιεσήιοποπορΤ Ι υοπύτ
*The numbers includes multiple procedures and as stated as at 15 December 2000.
-- 2
The number of arbitrations increased from the previous years and as an indirect consequence of the mutual recognition procedures, the number of referrals under Article 11 of Directive 75/ 319/ EEC increased notably.
934 309
The frequency of withdrawals of applications – 30.5% – (at least one withdrawal per procedure) from individual Member States in the mutual recognition procedure continued to be an issue of concern in 2000.
953 ςιεσήιοποπορΤ 373 ςιεσήτια ςεέΝ
It should be noted, however, that out of 3 107 applications in the concerned Member States, 236 were withdrawn (7.6%).
2000
As a result of this analysis, it has been concluded that the main reasons for withdrawals are related to issues arising from the summary of product characteristics (57%), problems linked to the dossier assessment (38%) or other reasons (5%).
οτ νακηθήνικ
There are still some Member States who have not acted as reference Member State.
ςησιρώνγανα
Considerable effort was dedicated to improving the quality of data in the EudraTrack database.
υοπ ςείσακιδαιδ
36 EMEA General Report 2000
οτ 2000 * οτ οτ άκιλονυσ
Applications ended positively in 2000 (1st and 2nd level of classification)
2000 *
Initial
οτ 2000 * οτ
Multiple (copy)
ςαίαβιο α
Repeat use
ςέκιτπ επαραΠ
Additional strength
ηξηλάτακ ήκιτεΘ
applications applications applications
νακηθήλβοπΥ
or form applications
αίσακιδαι∆
Abridged
1999.
119 33 17
(
4
νωδόνυσ
Known active substance
52
44
.
4
,
-
ητ άτακ
New active substance
2000,
27
υοτ ιακ
14
υοτ ονη άξε οτώρπ οτ ςαίρδεορπ ςήκιλαγοτροπ
7
Antonio Melo Gouveia
Line extension
.
13
11
2
275
2
2000
7
ανε ύοφαργογατνυΣ
Not classified by reference
2000 (5
Member State
7
- -
ςάροφανα ςολέ ςοτάρκ όπα
Applications ended positively in 2000 (3rd level of classification)
αλλά
Full
οιλόβ ε
Informed
ογωγάραπο ια
Bibliographic
ίεθη ονιξατ
Generic
ατνόϊορπ
Fixed
: νόϊορπ: νόϊορπ
Different use,
νόϊορπ:
Not classified
νυοχέ νε∆
dossier
άκιτυΦ
consent
αίσυο ήκι ηΧ
combination route or dose
οτ ηξηλάτακ ήκιτεθ ε ςιεσήτιΑ
by reference Member State
35
97
1
8
8
24
24
18 35
ςάροφανα ςολέ
Applications ended positively in 2000 (4th level of classification)
ςοτάρκ
Chemical
ησόδ
Biological:
όπα ί
Biological:
ή ησηγήροχ
Biological:
ςό
Herbal
ησωρέ ηνε
Not classified
εθη ονιξατ
substance
ησήρχ
blood
ςιεσήτια ς
product
νιπότακ
vaccine
ςολεκάφ
other
ςηρήλΠ
by reference Member State
)
287
ο
4
-- -- --
7
44
Prescription only
ήκιτσαρδ ήτσωνΓ
Non-prescription (including OTC)
οτ ηξηλάτακ ήκιτεθ ε ςιεσήτιΑ
A number of guidance documents were published in 2000 to assist applicants and marketing authorisation holders in the use of the mutual recognition procedure.
ςαίαβιο α αίσακιδαιδ ητ νύοροφα υοπ νώιροφορηλπ νωνε έθιταιδ νωτ ατητόιοπ η
The MRFG advanced its work on a number of ongoing projects, including one for promoting the preparation of harmonised summary of product characteristics for mutually recognised medicinal products and another for the production of updated assessment reports.
ςησιρώνγανα ίεθωιτλεβ αν
37 EMEA General Report 2000
ιακ ςώθακ ςησάβ ςήκι ον ςητ ιακ νώισακιδαιδ νωτ ςησύφ ςητ ςό σιροιδσορπ ςορετσέφασ ο ςότανυδ,
Norway and Iceland began participation as full members in the mutual recognition procedure and in meetings of the MRFG from the beginning of 2000.
ίετσατακ αν ετσώ νώισακιδαιδ νωτ ηση όνιξατ αέν αι εκηθήνωφ υΣ
In addition two observers from central and eastern European countries also attended MRFG meetings during 2000.
ςησάβ ςητ νωίεχιοτσ νωτ ςατητόιοπ ςητ ησωίτλεβ ητ αιγ νακηθήλβατακ ςειεθάπσορπ ςέκιτνα ηΣ
Contacts with interested parties consisted of liaison meetings between the MRFG and trade associations as well as MRFG members’ participation in conferences and seminars in the pharmaceutical field.
ολόρ οχραίρυκ νυοζίαπ
38 EMEA General Report 2000
αν ηλέ ητάρκ ανέ σιρο ε ςήνεγοιο ονα ιανίε αν ίεθυολοκαξε νώλε νώταρκ νωτ ύξατε ή ονατακ, Η ςάροφανα ηλέ ητάρκ ςω ιεσήγρενε νυοχέ νεδ υοπ ηλέ ητάρκ νυοχράπυ αν νύοθυολοκαξΕ.
Chapter 3 Medicinal products for veterinary use and information technology Overview of the Unit for Veterinary Medicines and Information Technology in 2000 Head of Unit Head of Sector for veterinary marketing
αδίλεΣ
Peter JONES
EMEA/ MB/ 050/ 00 αέ οτ ύοκιτυεκα ραφ υοτ. αιράνι εσ ιακ αιρδένυσ εσ
authorisation procedures Head of Sector for safety of veterinary medicines Head of Sector for information technology Deputy Head of Sector for information technology
ςητ νώλε ήχοτε υσ ητ ιακ ςώθακ νωεσώνε νώκιτα λεγγαπε ιακ
Jill ASHLEY-SMITH Kornelia GREIN Michael ZOURIDAKIS David DRAKEFORD
ςιεσάιρδενυσ ςιτσ νοέλπιπΕ
The Unit for the Veterinary Medicines and Information • management and follow-up of marketing authorisation centralised procedure
υοτ ςέχρα ςιτ όπα
Technology is responsible for: applications under the
ςητ ςιεσάιρδενυσ ςιτσ ιακ ςησιρώνγανα
• management of applications for the establishment of
MRFGΗ
maximum limits (MRLs) for
ςησιρώνγανα ςαίαβιο α. ςαίσακιδαιδ ςητ οισίαλπ οτσ ςάροφανα ηλέ ητάρκ ατ αιγ ςήκιτκαρπ ςητσιτλέβ ςόγηδο ςανέ ιακ ςαίελαφσα ςύο σιροιρεπ ςετνογίεπε αιγ ςαίγρυοτιελ αίσακιδαιδ ηπυτόρπ αι αιλόβ ε άκιπιργιτνα αιγ, ςοτνόϊορπ υοτ νώκιτσιρητκαραχ νωτ ςηψηλίρεπ ςηνέ σινο ρανε ησατόρπ αι ιατνονάβ αλιρεπ νώτυα 43/ 97
residues of veterinary medicinal products that may be permitted in foodstuffs of animal origin • post-marketing maintenance of authorised medicinal products • provision of information technology support to the EMEA • management of Community referrals and arbitrations arising from the mutual recognition procedure • provision of support to European and international harmonisation activities of the CVMP and its working parties • provision of support to the Veterinary Mutual Recognition Facilitation Group
EMEA/ MB/ 050/ 00 34% ΕΕ ςητ άροφσιενυσ ήκινεΓ 17% ηση όνιξατ ςορπ 11% ςετητόιρητσαρδ ςέκιδιΕ ςησηρήτνυσ ςετητόιρητσαρ∆ 18% 6% νωέ οτ ολονύσ
ActiTrack data for veterinary medicines evaluation in 2000 Overheads (specific unit/ sector) 1% Initial evaluation 13% Overheads (all sectors) 18% Specific post- authorisation 6%
) ςαέ οτ
Maintenance
αδάνο /
Special
ActiTrak
activities 11%
αίεχιοτΣ
activities to be earmarked 17%
νητ ςορπ ςηξιρήτσοπυ ήχοραπ νητ CVMP
EU general contribution 34%
αιγ ηνυθύεπυ
39 EMEA General Report 2000
ιανίε νώιροφορηλπ νωτ ςαίγολονχετ ιακ νωτνόϊορπ νώκιτυεκα ραφ νώκιρταινητκ ςησηγόλοιξα αδάνο Η
During 2000 fee-earning activities have increased in line with the rise in the number of centralised applications forecasted, requiring greater focus on initial evaluation work, whilst new MRL applications have decreased slightly.
David DRAKEFORD
3.1 Operation of the CVMP
ΣΗΚΑ∆ΙΡΥΟ ςηλάχιΜ
Chairman of the CVMP Vice-chairman of the CVMP
Kornelia GREIN Jill ASHLEY- SMITH
Reinhard KROKER J.
Peter JONES
Gabriel BEECHINOR
ςαδάνο ςονε άτσϊορΠ
Details of membership of the Committee can be found in Annex 5.
44/ 97
Total
ησεθκέ αισήτΕ 2000
Centralised procedures
20
1998
32
1999
27
2000
MRL
1995-2000
αέν ε άκιτεχσ ςε ώνΓ
Applications received
0 0
6
1
38
MRL
Withdrawals
40
1
αέν αιγ ςιεσήτιΑ ςείσυο
Opinions adopted by product
593
3
20
9
157
8
114
28
ςέιαλαπ αιγ
Type I variations
MRL
7
ςό σιροιδσορΠ
16
(MRL)
31
νωπίολατακ νωίρο
59
νωτάτωνα ύο σιροιδσορπ ςείσακιδαι∆
Type II variations
1 4
4
6 3
6
7
Maximum residue limit (MRL) procedures
Ι υοπύτ ςιεσήιοποπορΤ
Establishment of MRLs for old substances
8 4
4
8 1
3
9 0
2
3 1
40
νόϊορπ άνα νακηθίρκγε υοπ ςε ώνΓ ςιεσρύσοπΑ
Withdrawal of applications for new MRLs
υοτ
Applications for modifications and extensions
αιεκσέρασυ∆ 0 2 4 6 8 10
10
αιεκσέρασυδ ητυλόπΑ
12
0 2 4 6 8 10
13
FEDESA
62
EMEA/ CVMP
Withdrawal of applications for modifications
ητέλε
and extensions
αίσακιδαιδ ήκιρτνεκ ητέλε
3
αίσακιδαιδ ήκιρτνεκ -
Opinions on new MRLs
νητ ε
27
άκιτεχσ ησηίοπονακΙ νητ ε άκιτεχσ ηση
32
νητ ε άκιτεχσ ησηίοπονακΙ νητ ε
20
άκιτεχσ ησηίοπονακΙ
99
ςαίσακιδαιδ
Performance indicators
ςήκιρτνεκ ςητ ατα σέλετοπα ατ ιακ αίγρυοτιελ ητ αιγ νώρε νωνέ ορεφαιδνε νωτ νωλό ςησηίοπονακι οδεπίπε όληψυ οτ εξιεδέτακ ητέλε Η αίσακιδαιδ ήκιρτνεκ νητ ε άκιτεχσ ησοδόπα νητ αιγ.
The average time for clock-stop for applicants to respond to questions was
- FEDESA
40 EMEA General Report 2000
ΑΕΜΕ ςανυερέ ςήνιοκ ςητώρπ ςητ ατα σέλετοπα ατ νακηθύεισο ηδ
considerably reduced in 2000, reflecting a better standard of dossier in the original application.
υοτ οιάΜ νοΤ
Average number of days for centralised procedures 1995-2000
ςείριατε ςιτ αιγ αί σεθορΠ
650 600 550 500 223
ςησαφόπα ςησοδκέ αίσακιδαι∆
450
EMEA
235
υοτ ςη ώνγ ησοδκέ νητ άτε ησάΦ
264
ςησηγόλοιξα ησάΦ
286
2000
Days
1999 1998
400
1997
184
1996
94 350
1995 107
300 250
210
110
196 209
139
206
95
208
96
28
64
100 200
200
Η
29
30 64
30
30 96 95
30
30 139
30
29 110
30
94
150
300
28
έ ρ ε
210
184
100
286 264
208
223
206
235
209
400 500 600
196
ς
50 0
.
107
νωτ νωλέκαφ νωτ υοδέπιπε υοτ ησωίτλεβ ητ άλκανατνα υοπ ςόνογεγ
1995
οτ άκιτνα ησ εκηθώιε
1996
2000,
1997
.
1998
/
1999
(MLR)
2000
νωπίολατακ νωίρο νωτάτωνα νωέν ό σιροιδσορπ νοτ αιγ ςιεσήτια ςιτσ ιακ ςώθακ ςαίσακιδαιδ
s Assessment phase s Decision Process
,
s EMEA post-opinion phase s Company clock-stop
ςήκιρτνεκ ςητ οισίαλπ οτσ ιατνολλάβοπυ υοπ ςιεσήτια ςιτσ άροφα νοσό ςεί σεθορπ ςέκιτσι θυρ ςιτ
The results of the first joint EMEA-European Federation of Animal Health (FEDESA) performance survey on the centralised procedure were published in May 2000.
ότσοσοπ εσ ησωφρό υσ ε οπόρτ όκιτηιοπονακι άτακ ςέ αργ ςέκινεγ εσ νακηθχύετιπε, ςάροφανα οδοίρεπ ασύοραπ νητ άτακ νωέ οτ νώκιρταινητκ νωτ ιοχότσ ιο ιακ ίοποκσ ιΟ
Satisfaction with the centralised procedure – EMEA/ CVMP survey
ςησοδόπα ςετκίε∆
Satisfaction with the centralised procedure – FEDESA survey
46/ 97
10 10
αδίλεΣ
8
ησεθκέ αισήτΕ 2000
8
EMEA/ MB/ 050/ 00 ςήτηγησιενυΣ ςήτηγησιΕ
6
UK
6
S
4
F
4
IN
2
P
2
A
s Very dissatisfied s Satisfied
N
s Dissatisfied s Very satisfied
L L I
41 EMEA General Report 2000
IRL F
Rapporteurships
E
Distribution of rapporteurships for centralised and new MRL applications followed a similar pattern in 2000 to previous years with members coming from the larger national authorities accepting responsibility for most of the applications.
EL
Distribution of rapporteurships by national delegations 1995-2000
D
16
DK
14
B
12
0 5 10 15 20 25 30
10
οδοίρεπ νητ άτακ αίπωσορπιτνα ήκινθε 1995- 2000 άτακ νωπίολατακ αιρό ατατώνα αέν αιγ νωεσήγησιε ή οναταΚ ςήτηγησιενυΣ ςήτηγησιΕ
8
F
2
IN
0
P
B
A
DK D
N
E
L
L E
L I οδοίρεπ
IRL I L
IRL F
FIN
E
S
EL
30
D
25
DK
20
B
15
0 2 4 6 8 10 12 14 16
10
1995- 2000 νητ άτακ αίπωσορπιτνα ήκινθε άτακ νωεσήγησιε ή οναταΚ ςιεσήτια ςερετόσσιρεπ ςιτ αιγ ηνύθυε νητ. ιατνοχέδοπα αν ςέχρα ςέκινθε ςερετύλαγε ςιτ όπα ιατνοχρέορπ υοπ ηλέ ατ ε νώτε νωνε ύογηορπ,
5
νωτ ηνίεκε ε αιο όραπ νατή
0
οτ άτακ
B
2000,
DK D
αέν αιγ ςιεσήτια ςιτ αιγ ιακ ςαίσακιδαιδ
E
MRL ςήκιρτνεκ ςητ οισίαλπ οτσ ιατνολλάβοπυ υοπ ςιεσήτια ςιτ αιγ νωεσήγησιε νωτ ή ονατακ Η ςιεσήγησιΕ
L E
47/ 97
F
αδίλεΣ
IRL I L
ησεθκέ αισήτΕ 2000
NL
EMEA/ MB/ 050/ 00
A
ςύοι όπα ςοτνόϊορπ
P
.
FIN
ύοκιλετ υοτ ςησνυλό ήγυφοπα νητ αιγ υοχγέλε ύοκιτοιοπ ςέ ικοδ ςετεθσόρπιπε νύοθφηλιρεπ υσ αν υονέ ιεκορπ υοτ ςαίροφολκυκ ςαιεδά ςητ ησηίοποπορτ ενιρκένε ιακ ςησιρώνγανα,
S
ςαίαβιο α ςαίσακιδαιδ ςητ οισίαλπ οτσ ίεθιρκγε εχίε οίοπο οτ
UK
IBR & Rhinobovin Marker Live,
s Rapporteur
Bayovac
s Co-rapporteur
νόϊορπ οτ ε άκιτεχσ αίσακιδαιδ ςητ ήκιτπ επαραπ ητώρπ νητ εσατέξε
42 EMEA General Report 2000
η ςησίπΕ
3.2 Post-authorisation activities
, CVMP εκηθήλκανα υοίοπο υοτ. ςαίροφολκυκ αιεδά η νωρίοχ νωτ ςαίρετνεσυδ ςητ ιακ ςαίνο υενπ ςήκιτοωζνε ςητ ησιπώτε ιτνα νητ,
The significant expansion in 2000 of specific post-authorisation activities reflects the increase in the number of applications for variations to centralised procedures and extensions/ modifications to MRLs as compared to previous years.
αιγ ςέφορτοωζ ςιτ ε ιατίεγηροχ υοπ ςατνογάραπ ςόκαιβορκι ιτνα ςανέ
However some applicants are still uncertain of their obligations in this respect and pharmacovigilance reporting was a key subject on the agenda of the second joint EMEA-FEDESA Info-day held in December 2000 at the EMEA.
οτ νατή νόϊορπ ωγόλ Econor,
Periodic safety update reports 1995-2000
νε οΤ ΕΕ νητσ ςαίσακιδαιδ ςήκιρτνεκ ςητ οισίαλπ οτσ ίεθιρκγε εχίε υοπ νόϊορπ αιγ ςαίροφολκυκ.
30
ςαιεδά ς
25
ητ ήλοτσανα νητ άτσινυσ υοπ η ώνγ άροφ ητώρπ αιγ ενιρκένε 2000 1999 1998 1997 1996 οδοίρεπ νητ άτακ αιελάφσα 1995- 2000 νητ ε άκιτεχσ ςησωρέ ηνε ςιεσέθκε ςέκιδοιρεΠ
20
η 1995
15
οΤ 0 5 10 15 20 25 30 35 40
10
CMVP
5
2000,
0
ΑΕΜΕ υοτ ςιεσάτσατακγε ςιτσ. υοτ οιρβ έκε∆ νοτ εκηθώναγροιδ υοπ
1995
2000
1996
,
1997
οσότσ,
1998
οτ ε ησέχσ εσ 1999.
1999
PSUR
2000
ςιεσήιοποπορτ ςιεσάτκεπε αιγ ιακ ςαίσακιδαιδ ςήκιρτνεκ MRL /
The CVMP adopted its first opinion recommending the suspension of the marketing authorisation for a centralised product in the EU in 2000.
ςητ οισίαλπ οτσ ςιεσήιοποπορτ αιγ νωεσήτια νωτ ύο θιρα υοτ ησηξύα νητ ιεζίρτποτακιτνα ςαίεδα
The product concerned was Econor, an antimicrobial in-feed medication for treatment of enzootic pneumonia and swine dysentery, and was subject to a product recall.
ησοδκέ νητ άτε ησάφ ητ άτακ νωτήτοιρητσαρδ νώκιδιε νωτ
The CVMP also considered its first referral in respect of a product, Bayovac IBR & Rhinobovin Marker Live, authorised under the mutual recognition procedure, and agreed a variation to the marketing authorisation to include additional quality control tests to avoid viral contamination of the final product.
οτ άτακ ησνυρύειδ ήκιτνα ησ Η 2000
43 EMEA General Report 2000
αδίλεΣ
3.3 MRLs for old substances
ησεθκέ αισήτΕ 2000
The completion of assessment of applications to set MRLs for old substances was met before the 1 January 2000 deadline.
EMEA/ MB/ 050/ 00 νακηθίρκγε υοπ ςε ώνΓ νωτά ητωρε ιογολάταΚ
Opinions and lists of questions adopted for old substances 1995-2000
2000
200
1999
150
1998
100
1997
50
1996
0
2000.
1996
MRL
1997
MRL
1998
3. 3
1999
49/ 97
2000
αδίλεΣ
s Lists of questions
ησεθκέ αισήτΕ 2000
s Opinions adopted
νώρε νωνέ ορεφαιδνε ιακ
Other key events in 2000 in brief
ήχοτε υσ ε ησαίρδενυΣ ςοιρβώτκΟ CVMP ητ ε ησαίρδενυσ ςήρε ι∆ FEDESA ςο ιλύοΙ αδίρε η ήκιτωρε ηνΕ
• Workshop on analytical methods for residue surveillance to monitor completed MRLs held at EMEA in January 2000
EMEA- FEDESA
• Availability of medicines task force continued to propose initiatives to the Commission – to be considered as part of the 2001 review of the European marketing authorisation system
νώρε νωνέ ορεφαιδνε ιακ
• EMEA recommendations for a veterinary orphan drug policy submitted to Commission in June 2000
ςητ ήχοτε υσ ε ησαίρδενυΣ CVMP
• CVMP risk management strategic plan on antimicrobial resistance in implementation phase in 2000 by CVMP Safety and Efficacy Working Parties
ςηπώρυΕ ςήκιλοτανΑ ςητ ιακ ςήκιρτνεΚ ςητ ςερώχ ςιτ αιγEMEA/ TAIEX
• Ongoing commitment to international harmonisation with active participation in WHO, Codex Alimentarius and Veterinary International Conference on Harmonisation (VICH).
ητ ε ησαίρδενυσ ςήρε ι∆ ςοιράυορβεΦ FEDESA 5 ΑΕΜΕ υοτ ςαίγρυοτιελ ςηξρανέ ςητ υοίετεπε ςη ςητ ςό σατροΕ ςοιράυοναΙ
Four VICH guidelines adopted for final release in 2000, with a further five were released for consultation by CVMP.
ςογολάιδ
44 EMEA General Report 2000
ιακ αιενάφαι∆ α ητράραπ 11.
Veterinary International Conference on Harmonisation (VICH)
ςητ ςέ αργ ςειρήτνυθυετακ ςελλά ε ιακ ωγόλ νε ςιτ ε άκιτεχσ ςειερέ οτπεΛ
Final guidelines • Good Clinical Practices CVMP/ VICH/ 595/ 98) • Stability Testing of Biotechnological/ Biological VMPs (CVMP/ VICH/ 501/ 99) • Impurities:
Genotoxicity studies( CVMP/ VICH/ 526/ 00) Environmental Impact Assessment (EIAs) for VMPs (CVMP/ VICH/ 592/ 98) Efficacy of anthelmintics:
Residual Solvents (CVMP/ VICH/ 502/ 99) • Environmental Impact Assessment (EIAs) for VMPs (CVMP/ VICH/ 592/ 98)
Specific recommendations for feline (CVMP/ VICH/ 545/ 00) Efficacy of anthelmintics:
Guidelines released for consultation • Management of adverse event reports (CVMP/ VICH/ 547/ 00) • Efficacy of anthelmintics:
Specific recommendations for poultry (CVMP/ VICH/ 546/ 00) Management of adverse event reports (CVMP/ VICH/ 547/ 00)
Specific recommendations for poultry (CVMP/ VICH/ 546/ 00) • Efficacy of anthelmintics:
νωεσύελυοβαιδ ονε ίεκιτνα νυοσέλετοπα αν υονέ ιεκορπ νακηθόδκε υοπ ςέ
Specific recommendations for feline (CVMP/ VICH/ 545/ 00 • Environmental impact assessment (EIAS) for VMPs - Phase I (CVMP/ VICH/ 592/ 98) • Safety studies for veterinary drug residues in human food:
αργ ςειρήτνυθυεταΚ
Genotoxicity studies (CVMP/ VICH/ 526/ 00)
Environmental Impact Assessment (EIAs) for VMPs (CVMP/ VICH/ 592/ 98) Impurities:
Details of these and other CVMP guidelines are given in Annex 11.
αργ ςειρήτνυθυετακ ςέκιλεΤ
EMEA/ CVMP transparency and dialogue in 2000
(VICH)
January February March
νητ όπα νωεσύελυοβαιδ ονε ίεκιτνα νυοσέλετοπα
Celebration of 5th anniversary of EMEA inauguration Bilateral meeting with FEDESA Joint EMEA/ TAIEX meeting for central and eastern European countries CVMP/ interested parties meeting
αν υονέ ιεκορπ νακηθόδκε ετνέπ ςελλά ώνε
May July October November December
οΤ ησινό ρανε νητ αιγ ςηψεκσάιδ ςήκιρταινητκ ςύονθειδ ςητ ιακ
EMEA-FEDESA Info-day Bilateral meeting with FEDESA CVMP/ interested parties meeting Bilateral meeting with FEDESA EMEA-FEDESA Info-day
υοτ ςαίεγΥ
45 EMEA General Report 2000
Codex Alimentarius ησυε σέδ ηνε όζιχενυΣ
3.4 Working party activities
CVMP ακα ράφ άναφρο άκιρταινητκ.
The CVMP working parties and the Joint CPMP/ CVMP Quality Working Party (see Chapter 4) met regularly in 2000.
2000 υοτ οιράυοναΙ νοτ ΑΕΜΕ υοτ ςιεσάτσατακγε ςιτσ εκηθώναγροιδ υοπ
Details of notes for guidance prepared by the working parties for the CVMP are given in Annex 11.
νωνέ ωρηλκολο MRL
Working Party
αδίλεΣ
Chairperson
αί οτνυσ νε
Meetings in 2000
υοτ ατόνογεγ
Guidelines and points to
άκιτνα ησ αλλΆ ησεθκέ αισήτΕ 2000
consider documents approved in 2000
ςύοκαιβορκι ιτνα ςυοτσ
Pharmacovigilance working party (PhVWP)
ςαίσαγρε αδά Ο (SWP) αιελάφσα
Gabriella CONTI, then Cornelia IBRAHIM*
νητ αιγ ςαίσαγρε αδά Ο
Immunologicals working party (IWP)
(IWP) ακα ράφ άκιγολοσονα
Paul-Pierre PASTORET
Paul- Pierre PASTORET IBRAHIM * αιεχένυσ ητσ ιακ
5
ατ αιγ ςαίσαγρε αδά Ο (PhVWP)
Efficacy working party (EWP)
Cornelia
Liisa KAARTINEN
οτ
6
άτακ ςιεσ άιρδενυΣ -
Safety working party (SWP)
ςορδεόρΠ
Michelle DAGORN
(
6
ςαίσαγρε αδά
Antimicrobial resistance working group (ARWG)
ο ήνιοκ η ιακ
Margarita ARBOIX
CPMP/ CVMP ςαίσαγρε νωδά ο νωτ ςετητόιρητσαρ∆
3
51/ 97
*
αδίλεΣ
Acting Chairperson
ησεθκέ αισήτΕ 2000
3.5 Activities of the veterinary mutual recognition facilitation group
EMEA/ MB/ 050/ 00 ςησιρώνγανα ςαίαβιο α.
The veterinary mutual recognition facilitation group (VMRF) met each month in 2000 except August at the EMEA, chaired by the Portuguese and then the French presidency.
αίσακιδαιδ ητ νύοροφα υοπ ατα ήτωρε εσ εσητνάπα 8
The EMEA provided full secretariat and administrative support to the group.
οτ ώνε 2000,
Dossier assessment
ςοτνόϊορπ υοτ νώκιτσιρητκαραχ νωτ ςηψηλίρεπ
The number of mutual recognition procedures completed increased from 39 in 1999 to 47 in 2000.
ιεχέραπ ςογολάτακ Ο
There was also a steady increase in the number of variation procedures.
ουτκίδαι∆ οτσ ατνόϊορπ άκιτυεκα ραφ
Seven Member States acted as reference member state in the procedures.
(HEVRA): http: // www. hevra. org. άκιρταινητκ ατ αιγ νώ σιναγρο νωιδό ρα νωτ ησέθ ητσ ςησιρώνγανα ςαίαβιο α ςαίσακιδαιδ
In order to improve the procedure, Member States committed to decrease the number of questions asked to applicants and a follow-up of reasons for withdrawal was performed with a view to solve problems for future applications.
οιλίρπΑ νοΤ 2000
46 EMEA General Report 2000
ιακ ςησιρώνγανα
Improvement in transparency
οτ άτακ άκιτκατ εσαίρδενυσ 2000.
The VMRF-FEDESA liaison group met regularly during 2000.
1999
The 1999 joint VMRF- FEDESA survey of the mutual recognition procedure was completed and results were published, this survey was continued in 2000.
ηξιρήτσοπυ ήκιτηκιοιδ ιακ ήκαιετα αργ ηρήλπ αδά ο νητσ εχίεραπ ΑΕΜΕ Ο αίρδεορΠ
An index of products authorised through the mutual recognition procedure was published in April 2000 on the heads of veterinary agencies (HEVRA) web site: http: / /www. hevra. org.
ήκιλλαγ νητ όπυ αιεχένυσ ητσ ιακ ήκιλαγοτροπ νητ όπυ ΑΕΜΕ υοτ ςιεσάτσατακγε ςιτσ υοτσύογυΑ
The index gives access to core information for each product, together with the English- language version of the summary of product characteristics.
,
Organisational issues
υοτ νηλπ ανή εθάκ εσαίρδενυσ
A number of organisational issues were discussed and solved.
ςησιρώνγανα ςαίαβιο α ςητ ησνυλόκυειδ ητ αιγ αδά ο Η (VMRF)
The best practice guide was modified to detail Member States’ work and to allow more time to applicants to answer questions raised by concerned Member States.
ατνόϊορπ άκιτυεκα ραφ άκιρταινητκ ατ αιγ ςησιρώνγανα ςαίαβιο α ςητ ησνυλόκυειδ ητ αιγ ςαδά ο ςητ ςετητόιρητσαρ∆
Companies were given the possibility of asking questions directly to the VMRF through the HEVRA web site and the VMRF answered 8 questions related to the mutual recognition procedure in 2000.
ησεθκέ αισήτΕ 2000
3.6 Information technology
EMEA/ MB/ 050/ 00 αί υνωπε νητ ε ουτκίδαι∆ οτσ ΑΕΜΕ υοτ ςησηίοποδιεορπ
Preparations for ensuring compliance with year 2000 requirements were found to have been justified and well founded when the Agency opened for business on 2 January 2000 with no associated problems encountered.
Ticker.
The Agency’ s expansion to floor 7 in 2000 required a significant commitment to provide the necessary infrastructure and support to service the needs of staff in their new office accommodation.
ιακ νωεσήδιε υολύαιδ ςόνε υονέ οναβ αλιρεπ υσ ςησήρχ ςαίερυε νωίδεχσ νωέν νωνέ σιρο, ησηίοπολυ νητ ιακ ηξυτπάνα νητ εβαλένα ςαέ οτ ο ςαίγρυοτιελ υοτ ςήκιτκιρητσοπυ ςητ ναρέΠ,
As part of the sector’ s commitment to performance, the target of minimum system availability was exceeded in 2000, with almost 100% availability of the complete range of information technology services.
νωρίατε
47 EMEA General Report 2000
νωνέ σιρο αίσαγρενυσ ητ ε ςέ ικοδ νακηθήγολο ορδ
During 2000, the sector developed and implemented a desktop videoconferencing system (using Internet protocol and ISDN).
ήχυτιπε νητ άτεΜ
After successful operation within the EMEA, testing with a number of partners began in 2000.
ιακ υούτκιδαι∆ υοτ ολλοκότωρπ ίειοπο ισηρχ υοπ νωεψέκσαιδονοκιε ISDN).
In addition to its support function, the sector undertook the development and implementation of a number of new mainstream projects, including an EMEA internal web-based news and alert channel called Ticker.
α ητσύσ οιζέπαρτιπε ανέ εσηίοπολυ ιακ εξυτπένα ςαέ οτ ο
The majority of resources in the sector are assigned to operations and network support functions, with a significant proportion also assigned to the development of applications and other small projects.
υοτ αιεκράιδ ητ άταΚ 2000,
Resource allocation for information technology
νώιροφορηλπ νωτ ςαίγολονχετ ςητ.
SIAMED 6.3% Other activities 12.9% SI 2 7.3%