natgillin/translations-raw huggingface dataset:
EMEA/ MB/ 050/ 00 2001- 2002. ςαίσαγρε ςοτα άργορπ υοτ οισίαλπ οτσ νύοθεχσαραπ αθ ςησωρθράιδανα οιδέχσ οτ ε άκιτεχσ ςείροφορηλπ ςερετόσσιρεΠ 2. οιαλάφεκ οτσ ιατνοχέραπ αίεχιοτσ άκιτυλανΑ ςεδάνο ςέκαισηριεχιπε εσ ίεθσιρωχ αν ιατιεκόρπ ησήρχ ηνιπώρθνα αιγ νωτνόϊορπ
The Management Board........................................................................ ..11 Appointment of new Executive Director......................................................... 11 Budgetary and financial decisions..................................................................... 12 Costing exercise................................................................................................ .12 Financial control............................................................................................. ..13
3. 6
1.2
3. 5 άκιρταινητκ ατ αιγ ςησιρώνγανα ςαίαβιο α ςητ ησνυλόκυειδ ητ αιγ ςαδά ο ςητ ςετητόιρητσαρ∆
The EMEA and its partners..................................................................... 15 European Union institutions........................................................................... .15 Cooperation with national competent authorities.......................................... .17
3. 4 3. 3 MRL
1.3
ςαίσαγρε νωδά ο νωτ ςετητόιρητσαρ∆ ςείσυο ςέιαλαπ αιγ
Transparency and good regulatory practices.......................................... 17
3. 2
1.4
ςαίροφολκυκ ςαιεδά ησηγήροχ ητ άτε ςετητόιρητσαρ∆ ςιεσήγησιΕ ςησοδόπα ςετκίε∆
International aspects.............................................................................. ..20 European Economic Area................................................................................. 20 Central and eastern European countries......................................................... .20 Other international activities........................................................................... .21
CVMP ςητ ςετητόιρητσαρ∆
Chapter 2 Medicines for Human Use......................................................... .23
2. 6
2.1
ςητ ησνυλόκυειδ ητ αιγ ςαδά ο ςητ ςετητόιρητσαρ∆ ατνόϊορπ άκιτυεκα ραφ άκιτυφ ατ αιγ ςαίσαγρε αδά Ο ησινό ρανε νητ αιγ ηψεκσάιδ ςήνθει∆ ςείσητιαιδ ιακ ςείσακιδαιδ ςέκιτπ επαραΠ
Operation of the Committee for Proprietary Medicinal Products...... ..25 Performance indicators.................................................................................... .25 Centralised procedures.................................................................................... .26
2. 6 2. 5
2.2
ςέχρα ςειδό ρα ςιτ ε αίσαγρενυΣ ςαίσαγρε νωδά ο νωτ ςετητόιρητσαρ∆ νωκά ραφ νώναφρο ό σιροιδσορπ νοτ αιγ ςιεσήτιΑ
Post-authorisation activities.................................................................. ..28 Regulatory affairs............................................................................................. .30
2. 4 2. 3
2.3
ακα ράφ άναφρο ατ αιγ ςήπορτιπε ςητ αίγρυοτιεΛ ςέλυοβ υσ ςέκινο ητσιπΕ ςιεσέθοπυ ςέκιτσι θυΡ
Scientific advice....................................................................................... .30
2. 2
2.4
ςαίροφολκυκ ςαιεδά ησηγήροχ ητ άτε ςετητόιρητσαρ∆ ςείσακιδαιδ ςέκιρτνεΚ ςησοδόπα ςετκίε∆
Operation of the Committee on Orphan Medicinal Products............... 31 Applications for orphan designation............................................................... ..32
2. 1
2.5
ςηπώρυΕ ςήκιλοτανΑ ιακ ςήκιρτνεΚ ςητ ςερώΧ ςορώΧ ςόκι ονοκιΟ ςόκϊαπωρυΕ
Working party activities........................................................................... 33
23 22
2.6
ςέχυτπ ςίενθει∆ ςέκιτκαρπ ςέκιτσινονακ ςέθρο ιακ αιενάφαι∆ ςέχρα ςειδό ρα ςέκινθε ςιτ ε αίσαγρενυΣ ςησωνΈ ςήκϊαπωρυΕ ςητ αναγρό άκι σεΘ
Cooperation with competent authorities................................................ 34 Referrals and arbitrations................................................................................. .34 International Conference on Harmonisation................................................ ..34 Working Party on Herbal Medicinal Products................................................ 35
1. 2
2.7
υοτ ιορίατε ιο ιακ Ο ςοχγελέ ςόκι ονοισο η∆ ησηγό λοτσοΚ
Activities of the mutual recognition facilitation group........................ ..35
1 EMEA 2000
4 EMEA General Report 2000
ΉΤΝΥΘΥΕΙ∆ ΌΚΙΝΕΓ ΟΤ ΌΠΑ ΉΓ ΓΑΣΙΕ
Chapter 3 Medicines for Veterinary Use and Information Technology... ..39
10 10
3.1
1 Ν ΤΝΟΪΟΡΠ Ν ΚΙΤΥΕΚΑΜΡΑΦ Ν Τ.......................................................................................................
Operation of the CVMP........................................................................ ..40 Performance indicators.................................................................................... .40 Rapporteurships................................................................................................ 42
2000
3.2
η εσωδέξε υοπ ςε ώνΓ α ητράραΠ CVMP 9 77 ησήρχ ηνιπώρθνα
Post-authorisation activities.................................................................. ..43
2000
3.3
αιγ ατνόϊορπ άκιτυεκα ραφ ε άκιτεχσ
MRLs for old substances........................................................................ ..44
73
3.4
ακα ράφ άναφρο ατ αιγ ςήπορτιπε ςητ ηλέΜ α ητράραΠ
Working party activities........................................................................... 46
72
3.5
νωτνόϊορΠ νώκιτυεκα ραΦ νώκιρταινητΚ ςήπορτιπΕ ςητ ηλέΜ α ητράραΠ
Activities of the veterinary mutual recognition facilitation group......... 46
71
3.6
νωτά σαυεκσοιδΙ νώκιτυεκα ραΦ ςήπορτιπΕ ςητ ηλέΜ α ητράραΠ
Information technology........................................................................... 47
4
Chapter 4 Technical Coordination Activities............................................. ..49
EMEA
4.1
υοτ ςάροφανα αφαργγέ ιακ ΑΕΜΕ νοτ ε αίνωνιοκιπΕ α ητράραΠ 64
Inspections................................................................................................ 50
1
4.2
63 7/ 97 αδίλεΣ
Document management and publishing................................................ .52
.
4.3
ητ ιεσώνιοκανα εδ ιεχέ νώιριεπ ε ήγαλλατνα νητ ιακ ησώνγ ητ ιεκώιδιπε ΑΕΜΕ Ο ςυοτίρτ
Conference services................................................................................. 53
ε ςησιρκγύσ ορτέ ςω ιατενάβ αλκε αν ιεπέρπ άλλα οπυτόρπ οτυλόπα ανέ ςώλπα ίελετοπα νεδ
Chapter 5 Administration........................................................................... .55 Personnel, budget and facilities................................................................................. ..55 Accounts........................................................................................................................ 57
ατητόιοπ Η ύο σιναγρΟ υοτ νωεσόδιπε νωτ ςατητόιοπ ςητ ησωίτλεβ ητσ ιελλάβ υσ αθ ιακ ΑΕΜΕ.
Annexes...................................................................................................... ..59
υοτ ύοκιπωσορπ υοτ ςετητόνακι ςιτσ άροφα νοσό ησηλκόρπ ίελετοπΑ ό σιναγρΟ νοτ οιδί νοτ
Annex 1 Annex 2 Annex 3 Annex 4 Annex 5 Annex 6 Annex 7 Annex 8 Annex 9
αιγ ςησιρίεχαιδ οσέ όκιτνα ησ ίελετοπα ήτυαθακ ςαιενάφαιδ ςητ ησωίτλεβ αέροφ ύοκιτσινονακ υοτ αίτσιποιξα νητ ιεσώιτλεβ αθ αίοπο η ύονιοκ υοτ ιτνανέ ΑΕΜΕ υοτ ησυε σέδ αι αιγ ιατιεκόρΠ, νωέροφ υοτ νώκινο ητσιπε νωτ ιακ ΑΕΜΕ υοτ νωεσάφοπα νωτ ιακ ςαίγρυοτιελ ςητ ςαιενάφαιδ.
EMEA contact points and reference documents.................................... .61 EMEA budgets for 1999 to 2001............................................................ ..64 Members of the Management Board...................................................... ..65 Members of the Committee for Proprietary Medicinal Products......... ..66 Members of the Committee for Veterinary Medicinal Products............ 67 Members of the Committee for Orphan Medicinal Products............... ..68 National competent authority partners................................................... .69 CPMP opinions in 2000 on medicinal products for human use............ .73 CVMP opinions in 2000 on medicinal products for veterinary use...... ..78
ςητ ςησυχσίνε αιεθάπσορπ αι εσ νακηθόδιπε ο υο ςόχοτάκορπ ο ιακ, Fernandο ςήχραξε ςύθυΕ οπόρτ ηθήνυσ νοτ ε ίεγρυοτιελ αν ίεθυολοκαξε ΑΕΜΕ ο ύξατε ωτ νΕ
Annex 10 COMP opinions in 2000 on orphan medicinal products........................ 82 Annex 11 EMEA guidelines in 2000........................................................................ .84
Strachan Heppell
5 EMEA General Report 2000
νητ ε υοσήρηταιδ αν ιεπέρπ υο ήψοπά νητ άταΚ άρογα νητσ νωτνόϊορπ νώκιτυεκα ραφ ςησεθάιδ
Foreword by the Chairman of the Management Board
νώισακιδαιδ νώκιτεροφαιδ ούδ ατητότανυδ ήκιδανο ητ ιεχέραπ α ητσύσ όκιτσι θυρ όκϊαπωρυε οΤ
The EMEA with its network of national regulatory authorities is an excellent example how we operate and collaborate within the European Union.
ςησηρώεθιπε
This Annual Report demonstrates this.
νωτνόϊορπ νώκιτυεκα ραφ νωτ ησι θύρ ήκιτσινονακ ήκιτσαισυο νητ ςησίπε νυοσάερηπε αθ ΒΕΣ
Although we celebrated the fifth anniversary of the EMEA this year, the European Union has a long tradition of collaboration in the regulatory field.
ό σιναγρο νοτ νυούνκιεδανα ηχέλετσ αΤ
Already in 1975 the first scientific body was created, the ‘ old CPMP’.
André Broekmans υοίλυοβ υσ ύοκιτηκιοιδ υοτ ορδεόρπ νοτ όπα ςογολόρΠ
Since that André Broekmans time national authorities learned to work together and shared resources and expertise.
νοτ ήτνυθυειδ όκινεγ οέν ανέ ε ιεζίχρα
It was a just a next step that the EMEA was set up and with it the establishment of the centralised procedure.
οιοτέτ ιτάκ ιεχύτιπε νυοχέ υοπ. ηχέλετσ άκιτεγη άλλοπ νυοχράπυ νε∆ αινόρχ ςιλό εσ εκηθώρδνα ΑΕΜΕ ο ιτό ωρέφανα αν ίεκρΑ
Of course, the legislative framework enabled the EMEA and the national authorities to arrive at this stage but without the commitment of the national authorities the EMEA would not have arrived at this stage.
αν ολοκύε ιανίε νε∆
6 EMEA General Report 2000
ήτνυθυειδ όκινεγ οτ ε ασήτεριαχοπα ςοτέ νοχέρτ οτ άταΚ
At its fifth anniversary in January the EMEA received compliments from its stakeholders for its accomplishments.
Fernand Sauer.
The staff and the executive director, Fernand Sauer, deserved these compliments.
ησεθκέ αισήτΕ 2000
The people make the organisation!
EMEA/ MB/ 050/ 00
The EMEA enters a new era.
νολλέ οτσ ιακ ςείχυτιπε
It faces several new challenges.
ςα αίσαγρενυσ η εκηθσίχενυσ ςησωίρη κετ ςήκινχετ ςήνιοκ ιεσάβ.
The outcome of the revision of the current regulatory framework will impact on the tasks and functions of the EMEA.
οτ άταΚ νωέροφ
And this will also be influenced by developments in other fields.
νώκιτσινονακ νωτ ύξατε υογόλαιδ υοτ νολλέ οτσ ησωίτλεβ ητ αιγ ο όρδ οτ ιεγίονα αίοπο η
Incidents in the food sector like the BSE crisis will also effect the actual regulation of human and veterinary medicines.
οτσ εκηθώναγροιδ υοπ ησινό ρανε νητ αιγ ςηψεκσάιδ ςύονθειδ ςητπ έπ ςητ αιεκράιδ San Diego,
I personally foresee a strengthening of the EMEA, especially in the coordination of pharmacovigilance and inspection.
νοτ οιδάτσ όκιτνα ησ ανέ εσ ναθλήσιε 2000,,
The European regulatory system offers the unique opportunity of two different procedures for medicines to enter the market.
ΑΠΗ ςιτ ιακ αίνωπαΙ νητσ ςα ςυορίατε ςυοτ ε οδεπίπε ςένθειδ εσ ςησινό ρανε ςετητόιρητσαρδ ιΟ νώρε νωνέ ορεφαιδνε νωτ ηξιρήτσοπυ νητ ε
In my opinion we should maintain this principle as it has a positive influence on the quality of performance of the EMEA and the national regulatory authorities.
υοτ ηλέτ ατσ εκηθώρυκιπε ήτυα ήκιτιλοπ 2000
Both procedures need some adjustment, in particular there is a need to apply the resources in an efficient way both for European and national obligations.
Η υοτ ςέπορτιπε ςέκινο ητσιπε ςιτ όπα ιατνονίρκγε υοπ ςε ώνγ ε άκιτεχσ νώιροφορηλπ ησυείσο ηδ. ηριακγέ νητ ε ςαιενάφαιδ ςητ ησωίτλεβ ητσ άροφα νοσό οδοόρπ ςησίπε εσωίε ησ ΑΕΜΕ Ο α ητσάιδ όκινορχ ο οτνύσ.
There are many ways to solve this issue, however to balance the total regulatory system an executive body overlooking the whole system could be a major step forward.
εσ οδοόρπ ήκιτνα ησ ιεσώιε ησ ηδή ιεχέ
Last but not least, we have to absorb the accession of new members of the European Union.
υοτ αίρδεορπ νητ όπυ ήπορτιπε
In this the EMEA is also in the lead.
ωγόλ νε η νώνεθσα ιακ νώχρα νωίδο ρα νώκινθε ήχοτε υσ,
The Pan-European Regulatory Forum serves as an excellent vehicle of sharing knowledge and experience.
Josep Torrent i Farnell, ητ ε ησεθνύσ ςητ ήκιδανο ητσ
I am glad that is project will be continued next year.
αέν ιακ άιαλαπ
In the meantime the EMEA continues its usual business.
ςήπορτιπΕ ςητ υορδέορπ υοτ ησέθ ητσ ςείετηθ ούδ ςησίπε νυονώρηλπ υσ ιοίοπο ιο ιακ
From the beginning Fernand Sauer and my predecessor, Strachan Heppell, invested in making the operation and the decisions of the EMEA and its scientific bodies more transparent.
νωτ ςαίετηθ ςητ ςοτέ οίατυελετ οτ ςησίπε ιανίΕ ήτυα ησέθ
The EMEA owes that to the public and it will enhance the credibility of the regulator.
υοτ ςήξυτπάνα
In itself it also an important management tool for the Agency itself.
οιδάτσ ονε όπε οτσ ΑΕΜΕ νοτ νυοσήγηδο αθ υοίλυοβ υσ ύοκιτηκιοιδ υοτ ορδεόρπ ατνέγελκεοεν,
It challenges the talents of the EMEA staff and will contribute to the quality of the performance of the EMEA.
υοίρβωτκΟ ςητ ςησαίρδενυσ ςητ αιεκράιδ ητ άτακ οιλύοβ υσ 2000, 23
Quality is not only an absolute standard but should also be perceived in comparison with others.
όκιτηκιοιδ οτ ήπορτιπΕ ήκϊαπωρυΕ νςη τ όπα εκηθήλβοπυ υοπ νωίφηψοπυ υογόλατακ ιεσάΒ
The EMEA wants to learn and share experience and announced a benchmarking exercise at the end of 2000 with its international partners.
ήτνυθυειδ ύοκινεγ υοέν ςό σιροι∆
This year we said goodbye to the Executive Director, Fernand Sauer.
2000υοίρβ εκε∆ 2000 υοίρβωτκΟ υοίνυοΙ
It is not easy to mention the contributions of Fernand to the birth and development of the EMEA.
·
The best way to phrase is that the EMEA reached maturity in 5 years!
υοίραυορβεΦ
Not many fathers can say that.
ςέροφ ςιρεσσέτ εσαίρδενυσ οιλύοβ υσ όκιτηκιοιδ οΤ:
In 2001 we start with the new executive director, Thomas Lönngren.
οιλύοβ υσ όκιτηκιοιδ οΤ
He has proved himself as an excellent manager as Deputy Director-General of the Medical Product Agency in Sweden.
οιλύοβ υσ όκιτηκιοιδ οτσ ηξιρήτσοπυ ήκαιετα αργ. ςησίπε ιεχέραπ ησνυθύειδ Η ηλέ ητάρκ ατ ιακ ςησωνΈ ςήκϊαπωρυΕ ςητ αναγρό άκι σεθ ατ ε ςέφαπε ςιτ ιακ. ςιεσέχσ ςέκιρετωξε ςιτ ατα ήτηζ άκι ον ατ νωτνόϊορΠ νώκιτυεκα ραΦ νωτ ησηγόλοιξΑ νητ αιγ ύο σιναγρΟ
He is the right person in the right time, because he couples managerial skills with a sound vision how we should collaborate in a network environment supported by high level information and communication technology.
,
7 EMEA General Report 2000
,
Introduction by the Executive Director
ύοκϊαπωρυΕ υοτ αίγρυοτιελ ιακ ησιρίεχαιδ ήκινεγ ητσ ήτνυθυειδ όκινεγ οτ άθηοβ αδά ο ήρκι αιΜ
As I leave to return to the European Commission to deal with public health policy, I am confident that the Agency will be in good hands with Thomas Lönngren when he takes over as Executive Director from the beginning of 2001.
ςόνιρωσορπ ςήτκγελε ςόκι ονοισο η∆,
Together with André Broekmans, the newly elected chairman of the Management Board, he will guide the EMEA into its next phase of development.
Fernand SAUER
Fernand Sauer
Gerhard Josef KOTHMANN
8 EMEA General Report 2000
ςορδεόρπιτνΑ
There were a number of other important changes in 2000.
υοίλυοβ υσ ύοκιτηκιοιδ
Strachan Heppell stepped down in February as chairman of the Management Board after having completed two terms of office.
υοτ ησνυθύειδ η ιακ οιλύοβ υσ όκιτηκιοιδ οΤ
It is also the last year for Jean-Michel Alexandre and Reinhard Kroker who have each served two terms of office as chairmen of the Committee for Proprietary Medicinal Products and of the Committee for Veterinary Medicinal Products.
EMEA 1οιαλ άφεΚ 11/ 97
Behind the work of the Management Board and the scientific committees are the enthusiasm and skills of the EMEA staff.
ςειο όραπ εσ ιατνοχένε ιοίοπο ιο ΕΕ ςητ ςύο σιναγρο ςυονέ ωρτνεκοπα ςυολλά εσ ςησηγόλοτσοκ,
They have created a world-class regulatory system that has delivered hundreds of decisions based on the best science in the interests of all citizens and users of human and veterinary medicines in the European Union.
αίγολοδοθε ητ ιακ
I take this opportunity to thank all past and current staff members.
α ητσύσ οτ εσαίσυοραπ ΑΕΜΕ Ο υοίρδενυΣ ύοκιτκγελΕ ActiTrak
One of the most significant developments in terms of public health is the introduction of the European policy for encouraging medicines for rare diseases (‘ orphan medicinal products’).
ύοκϊαπωρυΕ υοτ ιακ υοίλυοβονιοΚ ύοκϊαπωρυΕ υοτ ςοτα ήτια νιπότακ ιατεγάξειδ ησηγόλοτσοκ Η όκι σιγολ οτ ςησίπε νυοσήιοπο ισηρχ αν ςιεσώτπιρεπ εδ ςενέ σιρο εσ ςετητόιρητσαρδ
With its unique membership of national competent authorities and patients, the Committee has already made remarkable progress in a short period of time under the chairmanship of Josep Torrent i Farnell.
ςυοτ ςέκιδ ςιτσ ςησηγόλοτσοκ αίγολοδοθε ητ νυοσό ραφε αν νορέφαιδνε νασαρφέξε ςέχρα ςειδό ρα ςέκινθε ςενέ σιρΟ ςησεθκέ ςαισήτε ςασύοραπ ςητ αιαλάφεκ ήφανυσ ατσ ιατνεθίταραπ
The confirmation of this policy at the end of 2000 was done with the support of our interested parties.
οτ άτακ ςατητόιρητσαρδ ςίε οτ ςυοροφάιδ ςυοτ ιακ ςώθακ ολονύσ ςω ό σιναγρΟ νοτ νύοροφα υοπ), ΑΕΜΕ υοτ υονόρχ ιακ ςατητόιρητσαρδ ςησυενχίνα α ητσύσ οτ
The international harmonisation activities with our partners in Japan and US reached an important stage in November 2000 when agreement was reached during the ICH5 conference in San Diego that paves the way to better dialogue between regulators in the future on the basis of common technical documentation.
α ητσύσ οτ όπα αίεχιοτΣ ActiTrak (
Our work with the national authorities of central and eastern European countries continued in 2000 through the Pan-European Regulatory Forum.
ςησηρώεθιπε ςείσερηπυ ςέκινθε ιακ ςέτηγησιενυσ ςέτηγησιε όπα ςενάπαδ
As we look ahead to the revision of the European marketing authorisation system, I send my warmest regards to the staff and all those associated with the EMEA and wish them continued success in the future.
.
9 EMEA General Report 2000
,
10 EMEA General Report 2000
ςιτ ιακ ονόρχ οτ ε άκιτεχσ νωίεχιοτσ ήγολλυσ ήκιτα ητσυσ ητ οχότσ ε ςησηγόλοτσοκ νωπύτνε, απυτόρπ ανέ ηρωεθανα ενιρκένε οιλύοβ υσ όκιτηκιοιδ οτ υοίνυοΙ ςη ςητ ησαίρδενυσ ητ άταΚ 7 ΑΕΜΕ υοτ ςοτα ήτια νιπότακ ςέχρα ςειδό ρα ςέκινθε ςιτ όπα ιατνοχέραπ. υοπ ςησηρώεθιπε ιακ ςησηθύολοκαραπ ςησηγόλοιξα νώισερηπυ νωτ ςενάπαδ ςιτσ ησαφ έ,
Chapter 1 The EMEA in 2000
ηρετίαιδι ε
The Management Board and EMEA Directorate
ςαίσαγρε α αργόρπ οτ ε ανωφ ύσ ησηγόλοτσοκ η εκηθσίχενυσ
Chairman of the Management Board André BROEKMANS Vice-chairman
2000- 2001,
Gerhard Josef KOTHMANN
ςοτα άργορπ υορετύεδ PERF.
Executive Director Financial controller, a. i.
ησηγόλοτσοΚ
Fernand SAUER Claus CHRISTIANSEN
υοτ ησιχένυσ ητσ νύοροφα υοπ ςετητόιρητσαρδ αιγ ώρυε ιακ ακα ράφ άναφρο ατσ νύοροφα υοπ ςετητόιρητσαρδ αιγ ώρυε
A small team assists the Executive Director in the general management and functioning of the European Agency for the Evaluation of Medicinal Products, legal affairs, external relations and liaison with the European Union institutions and Member States.
ςυοψύ ςάροφσιενυσ ςήκιδιε 2. 440. 000
The Directorate also provides the secretariat of the Management Board.
,
1.1 The Management Board
ςυοψύ ςάροφσιενυσ 600. 000
The Management Board met four times:
ςήκιδιε ςηνέ οναβ αλιρεπ υσ ώρυε
• 22 February 2000 • 7 June 2000 • 23 October 2000 • 20 December 2000
ιατεχρένα ΕΕ ςητ ό σιγολοπϋορπ όκινεγ οτ όπα 15. 300. 000,
The composition of the Board changed a number of times during the year, in particular with the election in February of André Broekmans as the new chairman and Gerhard Kothmann as vice-chairman.
. ςυοψύ νωδόσε νωρόφαιδ ιακ ώρυε
This is the third mandate of the Board and members are appointed until the end of 2002.
1. 584. 000
Details of membership can be found in Annex 3.
ατ όπα νωδόσε νωνε όπελβορπ νωνέ οναβ αλιρεπ υσ υοίρβ εκε∆ ςη ςητ ησαίρδενυσ ητ άτακ
Heads of national authorities from EU and central and eastern European countries joined members of the Board on 7 June for an informal discussion on the impact of EU enlargement on the EMEA.
οιλύοβ υσ όκιτηκιοιδ οτ όπα εκηθίρκγε ώρυε
Items of particular concern include the composition and operation of the Management Board and the scientific committees, and the conduct of pharmacovigilance.
οτ αιγ ςό σιγολοπϋορπ Ο 61. 934. 000
These points will be considered as part of the review of the European marketing authorisation system currently being undertaken by the European Commission.
υοίνυοΙ η ςητ υοτ ησαίρδενυσ
Appointment of new Executive Director
αιγ ύο σιγολοπϋορπ υοτ ησελέτκε νητ ε άκιτεχσ ό σιγολοςπϋορπ νοτ αιγ ογολόπυ 1999,
On the basis of a shortlist presented by the European Commission, the Management Board appointed Thomas Lönngren as Executive Director of the EMEA at its meeting of 23 October 2000.
14),
11 EMEA General Report 2000
α ητράραπ οτσ ιατνεθίταραπ ςητ
Budgetary and financial decisions
οτ όπα νώ σιγολοπϋορπ 2001
The initial budget for 2000 of 49 559 000 comprised of 34 775 000 in fee revenue and a general contribution from the EU general budget of 13 200 000.
νωτ ςιεψήλιρεΠ 1999
Miscellaneous revenue amounted to 1 584 000.
1.
The final budget for 2000 totalled 55 287 220.
L 184
The budget statement for 2000, including final appropriations for 1999 and outturn for 1998, is published in OJ L 184, 24.7.2000, p.
οτ
1.
1999
A summary of the budgets for 1999 to 2001 can be found in Annex 2.
αιγ νωεσώτσιπ νώκιλετ νωτ νωνέ οναβ αλιρεπ υσ
The Management Board granted discharge at its 9 June meeting to the Executive Director and to the EMEA accounting officer for the execution of the 1999 budget following a report by the European Court of Auditors (OJ C 373, 27.12.2000, p.
ώρυε
14).
οτ αιγ ςό σιγολοπϋορπ ςόκιλετ
The 2001 budget, amounting to 61 934 000, was adopted by the Board at its meeting on 20 December, including forecast fee revenue of 42 610 000 and miscellaneous revenue of 1 584 000.
Ο νώλετ ςηξαρπσίε νωτήτοιρητσαρδ αδεπίπε υονε όνε ανα υοτ αρετόληψυ ατ ιακ
The general contribution from the EU general budget is 15 300 000, including a special contribution of 600 000 for activities relating to orphan medicinal products, and 2 440 000 for activities relating to the continuation of the second PERF programme.
ατνόϊορπ
Costing exercise
άκιτυεκα ραφ ατ αιγ υορόΦ ύοκιτσι θυΡ ύοκϊαπωρυεναΠ υοτ ςαίγρυοτιελ ςητ ησιχένυσ ητσ ακα ράφ άναφρο ατσ νύοροφα υοπ ςετητόιρητσαρδ αιγ ύοκιτα εθοπα ύοκιδιε αίγρυοι ηδ η ηψόπυ,
As set out in the 2000-2001 Work Programme, the costing exercise continued during 2000 with particular emphasis on the costs of evaluation, surveillance and inspection services provided by national competent authorities at the request of the EMEA.
ίεθφηλ αν υονέ ιεκορπ ιοίακγανα αρετόκιδιε νασητσέτακ ίο σιγολοπϋορπ ωγόλ νε ιΟ οιρβ έκε∆
The Management Board adopted a revised model cost questionnaires at its 7 June meeting, with the aim of systematically collecting time and cost data from rapporteurs, co- rapporteurs and national inspection services.
νοτ ςορετύεδ ο ιακ υοίρβωτκΟ υοτ ησαίρδενυσ ητ άτακ ςοτώρπ ο νακηθίρκγε υοπ ίο σιγολοπϋορπ
Data from ActiTrak (the EMEA activity and time tracking system) for the Agency as a whole and for different areas of activity in 2000 are presented in the relevant chapters of this annual report.
ίοκιτωθροιδ ιακ ίοκιτα ωρηλπ υσ ούδ ιοίακγανα νασητσέτακ
A number of national competent authorities expressed an interest in applying the costing methodology to their own operations and in some cases also using the ActiTrak software.
εσ νατνοχρένα αδοσέ αροφάιδ αΤ ώρυε
The costing exercise is carried out at the request of the European Parliament and of the European Court of Auditors.
ΕΕ ςητ ό σιγολοπϋορπ όκινεγ νοτ όπα άροφσιενυσ ήκινεγ αι όπα ιακ ώρυε
The EMEA presented the ActiTrak system and costing methodology to other EU decentralised bodies who are also carrying out similar exercises.
ςόκιχρα Ο 2000,
12 EMEA General Report 2000
υοτ
ActiTrak data for all EMEA in 2000
ησεθκέ αισήτΕ 2000
Overheads (specific unit/ sector) 20%
ςοχγελέ ςόκι ονοισο η∆
Initial evaluation 12% Specific post-authorisation 5%