natgillin/translations-raw huggingface dataset:
EMEA 2003 Σελίδα 97/ 99
(44-7880) 55 06 97 evaluation work.
αποταθείτε είτε στην παραπάνω διεύθυνση είτε στο
The list of these European experts is available for examination on request at the EMEA offices.
Ηλεκτρ. ταχ.: emearequests@ emea. eu. int Φαξ:
Requests should be sent in writing to the EMEA or to:
Οι αιτήσεις για φακέλους γενικής πληροφόρησης πρέπει να αποστέλλονται στην
Certificates of a medicinal product E-mail: europeanexperts@emea.eu.int
Amanda BOSWORTH Άµεση κλήση (44- 20) 74 18 84 08 Ηλεκτρ. ταχ.: amanda. bosworth@ emea. eu. int
The EMEA issues certificates of a medicinal product in
Ετήσια έκθεση του EMEA για το 2002 EMEA/ MB/ 055/ 02/ el/ Τελικó Κατάλογος ευρωπαίων εµπειρογνωµόνων
These certify the marketing authorisation
EMEA 2003 Σελίδα 98/ 99
Integrated quality management
Ο ΕΜΕΑ απασχολεί περίπου 3 000 εµπειρογνώµονες για τις εργασίες επιστηµονικής αξιολόγησης που εκτελεί.
and good manufacturing status of medicinal products in the EU and are intended for use in support of marketing authorisation applications in and export to non-EU countries.
Οι αιτήσεις πρέπει να αποστέλλονται γραπτώς στον ΕΜΕΑ ή στο
For enquiries concerning certificates for centrally authorised medicines for human or veterinary use:
Σύµβουλος ολοκληρωµένης διαχείρισης ποιότητας
IQM adviser Marijke KORTEWEG Direct telephone (44-20) 74 18 85 56 E-mail: iqmanagement@emea.eu.int
Marijke KORTEWEG Άµεση κλήση (44- 20) 74 18 85 56 Ηλεκτρ. ταχ.: iqmanagement@ emea. eu. int
Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65
Εκπρόσωπος Τύπου
E-mail: certificate@emea.eu.int
Martin HARVEY ALLCHURCH Άµεση κλήση (44- 20) 74 18 84 27 Ηλεκτρ. ταχ.: martin. harvey - allchurch@ emea. eu. int
Press officer Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: martin.harvey-allchurch@emea.eu.int
Work Programme in Greek 2001- 2002
Work Programme 2001-2002
Adopted by the Management Board on 21- 22 February 2001 The European Agency for the Evaluation of Medicinal Products
Adopted by the Management Board on 21-22 February 2001 The European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom Tel:
EMEA/ MB/ 003/ 01- EL -
(44-20) 74 18 84 00 Fax:
όκιλεΤ
(44-20) 74 18 84 16 E-mail:
2001- 2002
Internet:
ςιτσ οιλύοβ υσ όκιτηκιοιδ οτ όπα εκηθίρκγΕ
mail@emea. eudra. org http: / /www. emea. eu. int
21- 22
A great deal of additional information on the European Union is available on the Internet.
υοίραυορβεΦ
It can be accessed through the Europa server (http: / /europa. eu. int)
2001
© EMEA 2001
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
3 υοτ ςάροφανα αφαργγέ ιακ ΑΕΜΕ νοτ ε αίνωνιοκιπΕ
Designed and printed in England by The Colour Works Printing Co.
EMEA
Ltd.
EMEAοδοίρεπ νητ αιγ
EMEA Work Programme 2001-2002
2000 – 2002 υοτ ύοκιπωσορπ ςακανίΠ 1999 – 2002
Contents Introduction by the Executive Director
5. 4 5. 3
4
νωφάργγε ησυείσο ηδ ιακ ησιρίεχαι∆ ησηκίοι∆
CHAPTER 3 VETERINARY MEDICINES
41
20
ΣΗΞΙΡΉΤΣΟΠΥ ΣΕΤΗΤΌΙΡΗΤΣΑΡ∆ ΙΑΚ ΗΣΗΚΊΟΙ∆ ΟΙΑΛΆΦΕΚ
Structure of the EMEA
39 ςησιρώνγανα ςαίαβιο α ςητ ησνυλόκυειδ ητ αιγ αδά ο ήκιρταινητΚ
3.2 Post-authorisation activities
ΣΙΕΣΉΡ ΕΘΙΠΕ ΟΙΑΛΆΦΕΚ
CHAPTER 1 EMEA IN THE EUROPEAN SYSTEM
38 ςαίσαγρε ςεδά ο 36 ςέκιδιε ιακ ςαίσαγρε ςεδά Ο
3.3 Maintenance activities
3. 11
23
(ad hoc) 36 νωκά ραφ ατητό ισεθαι∆ (MRL) ςείσυο ςέιαλαπ αιγ νωπίολατακ νωίρο νωτατώνα ησωρέιθαΚ
1.1 Management Board
3. 10 3. 9
6
36 νώ αργ νωιρήτνυθυετακ ησιτράταΚ
3.4 Scientific advice
3. 8
23
35 35 ηρέ ανε όρεφαιδνΕ ςείσακιδαιδ ςέκιτπ επαραπ ςέκιτονιοκ ιακ αίσητιαι∆
1.2 National competent authorities
3. 7 3. 6
7
35 35 ςέλυοβ υσ ςέκινο ητσιπΕ 34 ςησηρήταιδ ςετητόιρητσαρ∆ ςαίροφολκυκ ςαιεδά ησηγήροχ ητ άτε ςετητόιρητσαρ∆
3.5 Arbitration and Community referrals
3. 5 3. 4 3. 3
23
34 33 ησηγόλοιξα ήκιχρΑ
1.3 Transparency and regulatory dialogue
3. 2 3. 1
7
ΑΤΝΌΪΟΡΠ ΆΚΙΤΥΕΚΑΜΡΑΦ ΆΚΙΡΤΑΙΝΗΤΚ ΟΙΑΛΆΦΕΚ
3.6 Interested parties
2. 11 2. 10
1.4 Revision of EMEA fees
(ad hoc) 25 ακα ράφ άναφρΟ 24 νώ αργ νωιρήτνυθυετακ ησιτράταΚ 23 ςείσερηπυ ςέκιδιΕ 23 ςείσακιδαιδ ςέκιτπ επαραπ ςέκιτονιοκ ιακ ςείσητιαι∆ 22 ςέλυοβ υσ ςέκινο ητσιπΕ 21 ςησηρήταιδ ςετητόιρητσαρ∆ 21 ςαίροφολκυκ ςαιεδά ησηγήροχ ητ άτε ςετητόιρητσαρ∆ 19 ησηγόλοιξα ήκιχρΑ
7
2. 9 2. 8 2. 7 2. 6 2. 5 2. 4 2. 3 2. 2 2. 1
3.7 Guideline development
14
23
ΗΣΉΡΧ ΗΝΙΠΏΡΘΝΑ
1.5 Review of the European marketing
ΑΙΓ ΑΤΝΌΪΟΡΠ ΆΚΙΤΥΕΚΑΜΡΑΦ ΟΙΑΛΆΦΕΚ 13 ςοχγελέ ςόκι ονοισο η∆
3.8 Establishment of maximum residue limits
2
authorisation system
1. 9
8
νωκά ραΦ νωτ ατητόιοΠ νητ αιγ αίσερηπΥ ήκϊαπωρυΕ
for old substances
12
23
1. 8
8
11
24
ιορίατε ςίενθει∆
3.10 Working parties and ad hoc groups
1. 7
24
ςατητόιοπ ησιρίεχαι∆
3.11 Veterinary mutual recognition facilitation group
1. 6
25
9 ΑΕΜΕ υοτ νώλετ νωτ ησηρώεθανΑ
1.9 Financial control
1. 4
26
ςογολάιδ ςόκιτσινονακ ιακ αιενάφαι∆
CHAPTER 2 MEDICINES FOR HUMAN USE
8
10
1. 3
2.1 Initial evaluation 2.2 Post-authorisation activities
8 7
13 14
ςέχρα ςειδό ρα ςέκινθΕ οιλύοβ υσ όκιτηκιοι∆
SUPPORT ACTIVITIES 5.1 Administration
1. 2 1. 1
27
........................................................................................
2.3 Maintenance activities
7
14
ΑΜΗΤΣΎΣ ΌΚΪΑΠ ΡΥΕ ΟΤΣ
Personnel, budget and facilities
Ο ΟΙΑΛΆΦΕΚ
2.4 Scientific advice
EMEA
15
1
Accounting
ΥΟΤ ΉΜΟ∆ EMEA........................................................................................................................................
27
αδίλεΣ
2.5 Arbitration and Community referrals
όκιλεΤ
15
ςαίσαγρε α αργόρΠ 2001- 2002
5.2 Document management and publishing
EMEA/ MB/ 003/ 01- EL - νω ίφορτ. ήγωγαραπ νητ αιγ ιατνοζίροορπ υοπ αώζ ατσ νωπίολατακ νωίρο νώλαφσα ςησωρέιθακ ςητ ιακ ςησηνπύργαπεοκα ραφ υούτκιδ ςόνε ωσέ ςωίδι νωτνόϊορπ νώκιτυεκα ραφ, νώκιρταινητκ νωτ ιακ ςώθακ ησήρχ ηνιπώρθνα
28
αιγ νωτνόϊορπ νώκιτυεκα ραφ νωτ αιελάφσα νητ ςατνοχγέλε ςαίροφολκυκ ςαιεδά ςήκϊαπωρυε ςαίαινε ςησηγήροχ ςητ ωσέ ακα ράφ α ότονιακ εσ νώτσηρχ νωτ ησαβσόρπ ηριακγέ η ήτανυδ ίετσατακ αν ετσώ
2.6 Special services
-
16
ςείσακιδαιδ ςίεναφαιδ ιακ ςέκιτα σελετοπα ςατνοσσύτπανα ςαίεγυ ςητ αέ οτ υοτ ςείτα λεγγαπε ςυοτ ιακ
5.3 Conference services
-
29
ςετσήρχ ςυοτσ ςείροφορηλπ ςε ισήρχ ιακ ςίεφασ ιακ ςώθακ ςηξυτπάνα ιακ ςανυερέ ατα άργορπ ε άκιτεχσ ςέλυοβ υσ, ατνόϊορπ άκιτυεκα ραφ ατσ άροφα νοσό ςατητόιοπ ςήληψυ ησηγόλοιξα ιεχσάραπ αν αιγ ησωνΈ ήκϊαπωρυΕ
2.7 Guideline development
νητ
16
ηλό όπα όκιπωσορπ όκινο ητσιπε ςατνώιοποτηνικ νωώζ νωτ ςαίεγυ ςητ ιακ ςαίεγυ ςαισό ηδ ςητ ήγωγαορπ:
5.4 Information technology
νητ ιακ αίσατσορπ νητσ ιελλάβ υσ αν ιανίε ΑΕΜΕ υοτ ήλοτσοπ EMEA υοτ ήλοτσοπα νητ ε άκιτεχσ ησωλή∆
2.8 Orphan medicinal products 2.9 Working parties and ad hoc groups 2.10 Herbal medicinal products 2.11 Mutual recognition facilitation group
A
16 17 19 19
ΕΕ ςητ ςεσσώλγ ςε ησίπε ςιτ ςελό εσ ςησητία νιπότακ ιατεθίται∆ ηλέ
ANNEXES Annex 1 EMEA establishment plan 1999 – 2002 Annex 2 EMEA budget summaries 2000 – 2002 Annex 3 EMEA contact points and reference documents
.
30 31 33 34
.
2
ητάρκ ατ ιακ ήπορτιπΕ νητ οιλύοβ υΣ οτ οιλύοβονιοΚ όκϊαπωρυΕ οτσ ιατεζάβιβαι∆ υοίλυοβ υΣ
EMEA Work Programme 2001-2002
,,
Annex 4 Profiles of EMEA personalities
.
37
υοτ
EMEA mission statement The Work Programme for 2001-2002 is presented by the Executive Director to the Management Board in accordance
θιρα ΚΟΕ ύο σινονακ
with Article 57(3) of Council Regulation (EEC) No 2309/ 93.
υοτ ςοφαργάραπ
It is available on request in all official EU languages.
2309/ 93
– Developing efficient and transparent procedures to allow timely access by users to innovative medicines through a single European marketing authorisation
)
– 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
(
EMEA Work Programme 2001-2002
3,
3
ορθρά οτ ε ανωφ ύσ ήτνυθυειδ 57,
New EMEA web site http: / /www. emea. eu. int A new EMEA web site was launched at the beginning of 2001.
όκινεγ νοτ όπα οιλύοβ υσ όκιτηκιοιδ οτσ ιατελλάβοπυ
Documents available include: • European public assessment reports for all centrally authorised products for human and veterinary use
οτ αιγ ςαίσαγρε α αργόρπ ο 2001- 2002
Details of developments, events and news on EMEA activities
T
• Summary reports for maximum residue limits of veterinary medicines in food of animal origin • Guidelines from the scientific committees
αδίλεΣ
are regularly posted on the web site.
όκιλεΤ
• Regulatory guidance • General reporting and information documents, including annual reports and work programmes • Press releases and public statements • Links to other related sites
ςαίσαγρε α αργόρΠ 2001- 2002
4 EMEA Work Programme 2001-2002
3
Annex 3 details some of the key EMEA documents.
α ητράραπ οτΣ
Introduction by the Executive Director
EMEA.
Thomas Lönngren
υοτ ςέχρα ςιτΣ
I believe that there are many issues that can be tackled in
2001 http: // www. emea. eu. int
I am pleased to present my first work programme as EMEA
υοτ ησέθοτσι αέΝ
2001-2002 within the current legislative framework before the
αδίλεΣ
Executive Director.
όκιλεΤ
revision is implemented.
ςαίσαγρε α αργόρΠ 2001- 2002
In particular there will be the challenge
EMEA/ MB/ 003/ 01- EL - ανυερέ νητσ ιατεζίρητσ υοπ ςαίναχη οιβοκα ραφ ςητ ατητόκολπυλοπ ηνε όναξυα.
predecessor, Fernand Sauer, who did so much to establish the
ςυοτ ςυολό αιγ αίριακυε ίελετοπα
of an increased workload of incoming new applications, in
υοτ ηξιονά νητ ατητόισο ηδ ητσ ίεθοδ αν ιατενέ ανα 2001,
The EMEA is well managed, but
υοπ ςήπορτιπΕ ςητ ησατόρπ ησάβ ε ΕΕ νητ όπα ςοτα ήτσυσ υοτ ησηρώεθανα ηνε ίεκιπε Η,
particular as a result of the orphan drugs legislation, efforts to
ςαιεδά ςητ ςησηρήταιδ ιακ ςησατέξε ςείσακιδαιδ ςιτσ νυοχέτε υοπ
inevitably all organisations are constantly in need of
οδεπίπε εσ ιακ άλλα υοτ νώπορτιπε νώκινο ητσιπε νωτ ιακ ΑΕΜΕ υοτ ςότνε ονό ιχό ςοτα ήτσυσ
put in place pharmacovigilance system, improvements to
ςω ιεχέ αθ
development and management care.
οτ ιακ 2002
This is all the more
οτ ιατενέ ανα υοπ ςαίσαγρε οτρόφ νοτσ ησηξύα ήκιτνα ησ Η 2001
scientific advice, reorganisation of working methods of scientific
νώιεπαρεθ νώκιτσαπρανυσ
important for the EMEA as it goes into review process and
ιακ νωέν ςιεσήλκορπ ςιτ ε υοσίπωτε ιτνα αν ιο ιοτέ ετσα ίε αν ιεπέρπ ςοτα ώιδινογ
committees, PERF, information technology and communication.
,
The working methods of the CPMP and CVMP will need to be
υονιπώρθνα υοτ ςησηφάργοτπυρκοπα ςητ ογρέ οτ όπα ηλέφο ανε ώκοδσορπ ατσ ιακ νωτνόϊορπ νώκιτυεκα ραφ νωτ αίγολονχετ νητσ ςιεξίλεξε ςεέν ςε θιράυλοπ ςιτσ ονέ αρτσ α έλβ οτ εΜ νολλέ οτ αιγ ςυοτ αίσα ιοτεορπ νητ ιακ άλλα ςυοτ ςαίγρυοτιελ ςητ ησωίτλεβ ητ ονό ιχό οχότσ ε
Aside from my arrival, there were many changes at the
2001,
looked at again in 2001, not only to streamline their operation,
οτσ ασέ νύοτσατεξεναπε αν ιεπέρπ αθ
New chairmen of the Management Board
CVMPνώπορτιπε νωτ
but also to prepare for the future.
ςαίσαγρε ιοδοθέ ιΟ CPMP
and the scientific committees were elected and I am confident
ςαίνωνιοκιπε ςητ ιακ νώιροφορηλπ νωτ ςαίγολονχετ ςητ
new developments in medicines technology and the expected
ατνόϊορπ
that under Keith Jones, Daniel Brasseur and Steve Dean, the
άκιτυεκα ραφ ατ αιγ ςησυελένυΣ ςήκιτσι θυΡ ςήκϊαπωρυεναΠ ςητ νώπορτιπε νώκινο ητσιπε
benefits of the human genome project, we will need to prepare
ςητ ησηίοπολυ νητ όπα νιρπ ιακ υοίσιαλπ ύοκιτεθο ον υονέ ατσιφυ υοτ ςότνε ατα έθ άλλοπ
Management Board, CPMP and CVMP will be able to face the
νύοτσιπωτε ιτνα αν νύοροπ
ourselves to face the challenges of new and exciting therapies.
υοδόιρεπ ςητ αιεκράιδ ητσ ιτό υο ήσηθίοπεπ ίελετοπΑ
A number of internal changes have also been made, particularly with the creation of two units dealing with evaluation of medicines for human use.
2001- 2002 ησήρχ ηνιπώρθνα αιγ νωτνόϊορπ νώκιτυεκα ραφ νωτ ησηγόλοιξα.
In 2002 expecting increases in workload and call for improved scientific output from the EMEA evaluation and information technology and communication.
άριεσ αι ςησίπε εξρήπΥ νολλέ οτ ιεσσάλυφιπε υοπ ςιεσήλκορπ ςιτσ νυοθλέξεπετνα αν νυοσέροπ. αθ η ιακ
This will necessarily have finance and resource implications to cope with the system and manage it well – not just within the EMEA and its scientific committee, but also at the level of the national experts involved in the review and maintenance.
οτ υο ήξιφά νητ όπα ςότκΕ 2001
The on-going EU review of the system, on the basis of a Commission proposal expected in Spring 2001, is an opportunity for all interested parties to examine how to build on our past successes to ensure a higher level of public and animal health into the future.
ο εσεθέ υοπ αιλέ εθ άρεγ ατσ ςονε όζιρητσ υο ογρέ οτ ωζίχρΑ ΑΕΜΕ υοτ ήτνυθυειδ ύοκινεγ υοτ. ατητόιδι νητ όπυ ςαίσαγρε α αργόρπ υο οτώρπ οτ ωλάβοπυ αν ησέθ ητσιράχυε νητσ ια οκσίρΒ Thomas Lönngren ήτνυθυειδ όκινεγ νοτ όπα ήγωγασιΕ 6/ 65
All this must be done in a global perspective, particularly looking at the needs of our future Member States, research and development activities in Europe and the increasing complexity of the research-based pharmaceutical industry.
νωεσάιρδενυσ
EMEA Work Programme 2001-2002
-
5
νώνυερΕ ορτνέΚ όνιοΚ
Structure of the EMEA EMEA and the European network
ιακ ησιρίεχαι∆
National competent authorities
ςιεσάτσατακγε
EMEA Management Board
ςιεσήρωεθιπΕ
European Union Institutions
όκιπωσορΠ,
2,500 European experts
ονίδνοΛ οτσ
European Pharmacopoeia
υοτ ςιεσάτσατακγε
Committee for Proprietary Medicinal Products
EMEA ςιτ αρδέ ε ςήπορτιπΕ ςητ ςείσερηπΥ
Committee for Veterinary Medicinal Products
Σ ΟΜΣΙΝΟΤΝΥΣ ΣΟ ΚΙΝΧΕΤ
Committee for Orphan Medicinal Products
Η ΣΗΚΙΟΙ∆
EMEA Organisation
ςαι εδά ησηγήροχ
Executive Director
νωτνόϊορπ νώκ ιτ υ εκα ραφ
Directorate Financial controller, Executive support a. i.
νώκ ιρταινη τκ αιελάφσΑ
Quality management
ατητόκ ιτ α σελετοπα ι ακ αιελάφσΑ
Pre-Authorisation
ατνόϊορπ άκ ιτ υ εκα ραφ
Post-Authorisation
αιελάφσα ι ακ η σηνπύ ργ απεοκα ραΦ
Evaluation of Medicines for Human Use Scientific advice and orphan drugs
νωτνόϊορπ νώκ ι τυ εκ α ραφ ατη τόιοΠ
Evaluation of Medicines for Human Use Regulatory affairs and organisational support
ςαι εδά ςηση γήροχ ςεί σακιδαι∆
Veterinary Medicines and IT Veterinary marketing authorisation procedures
ι ακ ςιεσέθοπ υ ςέκ ιτ σι θυΡ
Quality of medicines Safety and efficacy of medicines
ι ακ ςέλυ οβ υ σ ςέκινο η τσιπΕ
Pharmacovigilance and post- authorisation safety and efficacy of medicine
Ν ΙΡ ΟΦΟ ΡΗΛΠ Α ΙΓΟ Λ ΟΝΧΕΤ
Safety of veterinary medicines Information Technology
Σ ΗΣΗΓ ΗΡΟ
Commission Services
Α Σ
Technical
Α ΚΙ Ρ Τ Α Ι Ν Η Τ Κ
Administration
υοτ ησωνάγρΟ
at the EMEA in London
νωτά σαυεκσοιδΙ
Coordination
ΑΕΜΕ οιλύοβ υσ όκιτηκιοι∆
Personnel, budget and
ςενο ώνγοριεπ ε ιοίαπωρυε
European Technical Office for Medicinal Products,
υ οτ ή ο ∆
Inspections
αδίλεΣ
facilities
όκιλεΤ
Joint Research Centre
ςαίσαγρε α αργόρΠ 2001- 2002
Document management
EMEA/ MB/ 003/ 01- EL -
Accounting
ύοκιτηκιοιδ υοτ ςιεσάιρδενυΣ
Anglo-Irish Desk, Joint Interpretation
αιενάφαιδ ητ αιγ
and publishing
:
6
ιατνονάβ αλιρεπ
EMEA Work Programme 2001-2002
Gerhard KOTHMANN Keith JONES
and Conference Service
οιλύοβ υσ όκιτηκιοι∆
Conference services
1
Chapter 1 EMEA in the European system
οτ αιγ νωρόπ νωτ ησαίσυοραπ ήκινεγ αιΜ ΑΕΜΕ
Our network of partners also includes the general public and the
2001- 2002
1.1 Management Board Overview of the Management Board
.
users of medicines, the pharmaceutical industry, health care
νωτά
Chairman of the Management Board
σαυεκσοιδΙ νώκιτυεκα ραΦ ςήπορτιπΕ (CPMP)
professionals and our international partners.
(VICH),
Keith JONES
ςησινό ρανΕ ηψεκσάι∆ ήκιρταινητΚ ήνθει∆ ητ
One of the fundamental tasks of the EMEA is to facilitate
ςησινό
Vice-Chairman of the Management Board
ρανΕ ηψεκσάι∆ ήνθει∆ ητ (ICH),
appropriate communication throughout this network to
2001- 2002:
Gerhard KOTHMANN
οτ ΑΕΜΕ νοτ αιγ ςιεψέλβορΠ
strengthen and reinforce the procedures and competence of the
νωώζ νωτ ςαίεγυ. ιακ ςαίεγυ ςαισό ηδ υοδέπιπε ύοληψυ ςόνε ήχοραπ νητ άροφα νοσό ςοτα ήτσυσ υοτ ςαιεκράπε ςητ ιακ νώισακιδαιδ νωτ ησωίαρδε ιακ ησυχσίνε νητ οχότσ ε ύοτυα υούτκιδ υοτ ςυοπλόκ ςυοτσ ιεχράπυ αν ιεπέρπ υοπ ςαίνωνιοκιπε ςητ ησνυλόκυειδ η ιανίε ΑΕΜΕ υοτ ατνοκήθακ ηδώιλε εθ ατ όπα ανΈ
EMEA in 2001-2002: • Activities will increase as the number of applications increases • Post-marketing activities will increase as a consequence of the increased number of centrally authorised medicinal products • New activities relating to orphan drugs, Pan-European Regulatory Forum II, ICH and VICH, clinical trials, medical devices containing blood derivatives • Increased need for communication, transparency and information technology development • Re-organisation of the human medicines’ units and work of the Committee for Proprietary Medicinal Products (CPMP) in
ςα ςυορίατε
Management Board Management Board meetings in 2001 meetings in 2002
ςίενθειδ ςυοτ ιακ ςαίεγυ ςητ αέ οτ υοτ ςείτα λεγγαπε ςυοτ αίναχη οιβοκα ραφ ητ νωτνόϊορπ
order to strengthen the scientific consistency of opinions All this results in a need for an increase in staff and financial resources for the EMEA.
α ητσύσ όκϊαπωρυΕ οτσ
An overview of resources for
οιαλ άφεΚ
21-22 February 20 February 6 June 5 June
1
2001-2002 is given in Annexes 1 and 2.
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4 October 2 October
αδίλεΣ
18 December 11 December
όκιλεΤ
Liechtenstein will also be able to nominate members and representatives for EMEA scientific committees and their working parties.
ςαίσαγρε α αργόρΠ 2001- 2002
EMEA Work Programme 2001-2002
EMEA/ MB/ 003/ 01- EL - νωνε όρεφαιδνε νωτ ιακ ΕΜΕ υοτ ύξατε νωεσάιρδενυσ νωτ ήφρο Η
Heads of agencies for medicines for human use http: / /heads. medagencies. org
A
Once a stable environment has been created, multi-lingual navigation of the web site will be introduced.
υοτ ιακ υοτ
Heads of agencies for medicines for veterinary use http: / /www. hevra. org
2002.
1.4 Revision of EMEA fees The European Commission is required to present a report on the structure and level of EMEA fees to the European
2001
The expected increases in workload and the broadening of scientific challenges in 2001 and 2002 will have resource implications that will need to be addressed by the EMEA Management Board and by the Heads of Agencies groups.
αιεκράιδ ητσ ίετσιχενυσ αθ ςέπορτιπε ςέκινο ητσιπε ςιτ ιακ ηρέ ανε όρεφαιδνε ατ ε ςογολάιδ Ο ΑΕΜΕ υοτ αίσακιδαιδ ήκιτσινονακ. νητσ ςαιενάφαιδ ςητ ησυχσίνε νητ οχότσ ε νωρτέ ηψήλ ητ ιεσάτεξε αθ οιλύοβ υσ όκιτηκιοιδ οτ αιενάφαιδ ητ α έθ ε
As part of this the Management will continue its costing exercise to determine the costs of the centralised procedure
υοίρβ εοΝ2000 ςιτσ ΑΕΜΕ ο εσωνάγροιδ υοπ οιρήτσαγρε οτ άτεΜ 27
Support to the work of the mutual recognition facilitation groups for human and veterinary medicines will in particular include the completion in 2001 of new meeting and conference facilities at the EMEA, including a videoconferencing suite.
ςογολάιδ ςόκιτσινονακ ιακ αιενάφαι∆
Other areas for support will be explored with the heads of agencies groups in 2001.
1. 3
Data from the EMEA activity tracking system – ActiTrak – will continue to be kept under review by the Management Board.
υοίτραΜ ςιτσ ΑΕΜΕ υοτ ςιεσάτσατακγε ςιτσ ίεθηιοποτα γαρπ αθ ησαίρδενυσ
The information technology and communication links between the EMEA and national authorities will be reinforced in a number of areas in 2001 and 2002, particularly as part of the implementation of the European pharmacovigilance system.
2001.
A benchmarking exercise will begin in 2001 to compare good regulatory practices and quality management systems of competent authorities both in the European Economic Area and central and eastern European countries.
5
The first meeting will be held at the EMEA on 5 March 2001.
νώθρο νωτ ησιρκγύσ ητ
1.3 Transparency and regulatory dialogue
οχότσ ε ςησηγόλοιξα ςήκιτιρκγυσ οιδέχσ ίεθηγολο ορδ αθ ςησηνπύργαπε κα ραφ ςοτα ήτσυσ ύοκϊαπωρυε υοτ ςησηίοπολυ., o
Following the EMEA workshop on transparency of 27 November 2000, the Management Board will consider measures to improve the transparency of the EMEA regulatory process.
2001
Dialogue with interested parties and the scientific committees will continue in 2001 and 2002.
ΑΕΜΕ υοτ ύξατε νώινωνιοκιπε νωτ ιακ νώιροφορηλπ νωτ ςαίγολονχετ ςητ ησήρχ ε ςιεσέδνυσ ιΟ
Meetings between the EMEA and CPMP interested parties will follow a new format including the organisation of an annual meeting on a public health theme.
υοτ ςότνε νώ σιναγρο
Themes under consideration include medicines information.
νωεσνύλοκυειδ νωέν νωτ
8 EMEA Work Programme 2001-2002
όκιτοδοτα ηρχ εσ ςειεπένυσ νυοχέ αθ
1.5 Review of the European marketing
οτ ιακ
authorisation system
ητσιπε νωτ ησατκέπε 2001
1.7 International partners
http: // www. hevra. org
Useful web sites:
ατνόϊορπ άκιτυεκα ραφ ατ αιγ ίο σιναγρο ιοιδό ρΑ
European Commission Unit for Pharmaceuticals: regulatory framework and market authorisations http: / /pharmacos. eudra. org
http: // heads. medagencies. org
Useful web sites:
ςυοτ ςαίσαγρε ςεδά ο ςιτ ιακ ΑΕΜΕ υοτ ςέπορτιπε ςέκινο ητσιπε ςιτ αιγ ςυοπώσορπκε.
Pan-European Regulatory Forum http: / /perf. eudra. org International Conference on Harmonisation http: / /www. ifpma. org/ ich1. html
υοίραυορβεΦ 20 υοίραυορβεΦ
The Commission is expected to bring forward a report to the
2001
European Parliament and Council of Ministers in 2001 reviewing the operation of the European marketing authorisation system.
οτ υοίλυοβ υσ
Veterinary International Conference on Harmonisation http: / /vich. eudra. org
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The forum is by the Commission and cooperate as necessary. funded by the European Commission under the PHARE
ςαίσαγρε α αργόρΠ
The Board will in particular be concerned to understand the
2001- 2002
programme and a total of approximately
όκιλεΤ
2 658 000 will be
EMEA/ MB/ 003/ 01- EL -
resource implications of any measures proposed by the
ατνόϊορπ ατ νύοροφα υοπ νώιροφορηλπ ςησιρίεχαιδ οιδέχσ οτ νυοζίρητσ αν ιακ ηρέ ανε όρεφαιδνε. ατ ε ύο σιναγρΟ υοτ νωεσέχσ νώκιριατε νωτ αέ οτ νοτσ ιατνοζάγρε αν νυοσίχενυσ αθ ςησωίτλεβ ςεδά Ο ςό σαιδεχσ ςόκαισηριεχιπε ςόκιγηταρτσ ο ιακ ησητόδοτα ηρχ η όκιπωσορπ οτ ησοδόπα
available in 2001.
ήκινο ητσιπε η ςωπό ΑΕΜΕ υοτ ςησοδόπα ςετκίεδ ςύοκισαβ ά ιτκενυσ οίοπο οτ ΑΕΜΕ υοτ
Commission and to ensure that the structures of the EMEA Involving the national competent authorities of the EU are able to meet the future challenges of science and the associated countries (Bulgaria, Cyprus, Czech Republic, enlargement of the European Union.
ςησιρίεχαιδ οίελαγρε όκιρετωσε ανέ ό θαβ ορετύλαγε εσ ίεθχυτπανα αν ιατιεκόρπ
Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovenia and Slovak Republic), the purpose of PERF II is help candidate countries prepare their regulatory systems before
οΤ
1.6 Quality management
2001- 2002
accession to the EU.
ιατνονώρτνεκιπε αθ υοπ ιοχγελέ ίοκιρετωσε υοπίρεπ
Internal audits, part of the EMEA quality management system will be continued in 2001-2002.
νύοτσιτα αργορπ αΘ 15
Approximately 15 internals audits will be scheduled focusing on key and core tasks, processes and on the quality management system itself, which is supported by the quality manual.
νητ νύοτσιχενυσ αθ ΑΕΜΕ υοτ ςατητόιοπ ςησιρίεχαιδ ςοτα ήτσυσ υοτ ςορέ ιοχγελέ ίοκιρετωσε ιΟ
The forum will concentrate on the following priority action areas: • Implementation of Community pharmaceutical legislation and policy (‘ acquis communautaire’) • Good manufacturing practices • Pharmacovigilance
ςήπορτιπΕ ςήκϊαπωρυΕ ςητ νωτνόϊορπ νώκιτυεκα ραφ αδάνοΜ: ησνυθύειδ ήκινορτκελη η ισήρΧ:
In 2001-2002 an internal EMEA management tool, looking at key EMEA performance indicators, including scientific output, personnel, finance and strategic business planning, will be further developed.
υοτ ησατέξεναπΕ υοίλυοβ υσ ύοκιτηκιοιδ υοτ ησηγόλοιξα νητσ ιατνιεκόπυ.
Improvement teams will continue to work in the area of the Agency’ s partnerships with stakeholders and support the product information management project.
ΑΕΜΕ υοτ ςατητόιρητσαρδ ςησυενχίνα α ητσύσ οτ όπα αίεχιοτσ αΤ ςιεσήγησιε ιακ ςιεσήρωεθιπε αιγ ςέχρα.
• Inter-agency training • Veterinary issues The priority action area for veterinary medicines will include specific issues relating to quality, safety (including pharmacovigilance) and efficacy issues for veterinary medicines.