natgillin/translations-raw huggingface dataset:
νώισερηπυ ςοτα σάφ
Management 3.5%
ςυορήλπ υοτ
Helpdesk support 4.9%
νόδεχσ ότσοσοπ εσ ατητό ισεθαιδ ε νωτά ητσυσ 100%
Other applications and small projects 23.3% Operations and network 41.8%
νωτ ςατητό ισεθαιδ ςητσιχάλε,
48 EMEA General Report 2000
ςητ ςοχότσ ο εκηθφύλακρεπυ
Chapter 4 Technical coordination activities
οτ ησοδόπα νητ αιγ αέ οτ υοτ ςησυε σέδ ςητ οισίαλπ οτΣ 2000, νωίεφαργ ςυορώχ ςυοέν.
Overview of the Technical Coordination Unit
οτ οφορό ο νοτσ ύο σιναγρΟ υοτ ησατκέπε Η 2000 7
Head of Unit Head of Sector for inspections Head of Sector for document management and publishing Head of Sector for conference services
υοίραυοναΙ ςιτσ υοτ αίγρυοτιελ ητσ ατα ήλβορπ ήφανυσ εσιπώτε ιτνα νεδ ςό σιναγρΟ ο ςώθακ ςενέ
Karel de NEEF Stephen FAIRCHILD Beatrice FAYL Sylvie BÉNÉFICE
2000. ηγολοιτια ναξρήπυ
The Technical Coordination Unit provides logistical support
ςυοτέ υοτ νωεσήτιαπα 2000
to human and veterinary
νωτ ησιπώτε ιτνα νητ αιγ ςατητόταβ υσ ςητ ησιλάφσαξε νητ αιγ ςείσα ιοτεορπ ιο ιτό εκηθώτσιπαι∆
medicines evaluation activities regarding inspections and medicinal products certificates, as well as a number of general services to EMEA, including document management and conference services.
νώιροφορηλπ νωτ αίγολονχεΤ
ActiTrak data for technical coordination activities in 2000
αδίλεΣ
Overheads
EMEA/ MB/ 050/ 00 41, 8%
Initial evaluation 5%
ιακ αίγρυοτιεΛ
(specific unit/ Specific post-authorisation 2% sector) 15%
7, 3% SI 2
Overheads
αδίλεΣ
Maintenance
ςετητόιρητσαρδ ςέκιδιΕ 12%) νωέ οτ ο λονύσ (
(all sectors) 12%
19%
activities 19%
ςησηρήταιδ ςετητόιρητσαρ ∆
Administrative Special activities to be earmarked 8%
ActiTrak υσ
charges 8%
αίεχιοτ Σ
EU general contribution 31%
Sylvie BÉNÉFICE
49 EMEA General Report 2000
άτσϊορΠ
4.1 Inspections
άτσϊορΠ άτσϊορΠ άτσϊορΠ
Coordination of inspections for centralised procedures
οτ αιγ νωχγέλε α αργόρπ εκηθίρκγε
Inspections carried-out for centralised procedures 1998-2000
οΤ
70
35 νωχγέλε α αργόρπ οΤ ΑΕΜΕ νοτ ιακ ςηπώρυΕ ςητ υοίλυοβ υΣ υοτ νωκά ραΦ
s Good manufacturing practice inspections 60 s Good clinical practice inspections s Good laboratory practice inspections 50
.
40
)
30
(
20
.
10
,
0
οτ 8. 357 εσ 1999 οτ
1999
9. 652
2000
όπα εκηθώιε νώκιτηιοποτσιπ νωνε ύοτια νωτ ςό θιρα Ο
The number of good manufacturing practice (GMP) inspections performed in 2000 was higher than expected due to a carry-over of 16 inspection requests from 1999 and a significant increase in requests in 2000.
νωτνόϊορπ αίχοτσα νητ ε άκιτεχσ νωεσέθκε ήλοβοπυ νητ νύοροφα υοπ ςιεσί θυρ ιακ. ςώθακ ςησηνπύργαπεοκα ραφ ατα ήτηζ εσ ησηίοποδιεορπ αίεχατ νητσ άροφα νοσό ςαίνωνιοκιπε,
A database of GMP inspections was completed in 2000 in order to provide management reports and information for coordinating inspections and to provide a direct input of data into the SIAMED application tracking system.
α σελέτοπα ςω εχίε ςοίοπο ο νώισακιδαιδ νωτ ςοχγελέ ςόκιρετωσε οτ άτακ ςερέ η εσ ορό οσέ άτακ υονε όχρενα ςησοδκέ υονόρχ
There was a marked increase in the number of good clinical practice (GCP) inspections performed for centralised procedures in 2000, involving sponsor, investigator and laboratory sites.
νωτνόϊορπ νώκιτυεκα ραφ ησηίοποτσιΠ
This included a significant number of inspections performed outside of the EU.
ησήρχ ηνιπώρθνα αιγ
Sampling and testing
ατνόϊορπ άκιτυεκα ραφ ςησηίοποτσιπ ατα άργορπ ατ αιγ ςαίδναληΖ ςαέΝ
Monitoring of centrally authorised medicinal products is performed by the Network of Official Medicines Control Laboratories.
ιακ ςησηίοποδιεορπ ατα ήτσυσ νήχρα τακ νακηθήνωφ υΣ ςαίγρυοτιελ ςητ ησνυλόκυειδ ητ αιγ νωφάργγε νωλλά ιακ ςησηρήταιδ ςοτα άργορπ
The activities of the network are coordinated by the European Department for the Quality of Medicines (Council of Europe) and the EMEA.
ΚΕ ιακ ςαίλαρτσυΑ ΚΕ ςησιρώνγανα
The 1999-2000 testing programme was implemented for 35 centrally authorised products.
ηξυτπάνα νητ ναναβ άλιρεπ
No major problems were identified during the testing programme.
οτ άτακ ςετητόιρητσαρδ ιΟ
A testing programme for 2001 was agreed in 2000.
2000 ςησιρώνγανα ςαίαβιο α ςείνωφ υσ ςεσυούχσΙ ατνόϊορπ) άκιτυεκα ραφ άκιρταινητκ ατ αιγ ςαίδναληΖ ςαέΝ (ΚΕ ιακ ςαίλαρτσυΑ
A total of 5 reports on quality problems concerning centrally authorised products were received and monitored by the EMEA, leading to 2 product recalls.
-
50 EMEA General Report 2000
νώινωφ υσ ωγόλ νε νωτ
Mutual recognition agreements
.
On-going discussions or MRAs in transition period
ΚΕ ςησιρώνγανα -
EC – Canada MRA
ςαί ανυδοσι ςητ ςησηγόλοιξα ςετητόιρητσαρδ ιο νακηθσίχενυσ
Also documentation, procedures and monitoring arrangements for the programme were agreed and are ready to be put into operation.
2000
EC – US MRA
ςαίαβιο α ςείνωφ υΣ
The evaluation of the EC and US legislation and GMP guidelines and compliance systems continued in 2000.
υοτ ιρίακολακ οτ ιατεζίροιδσορπ ςούχσι ςηξρανέ αίνη ορε η
The EU finalised its plans for the first evaluation visits to the US in March 2001.
ηνε όπελβορπ Η νωεσέθκε νώκιγολοιτια νωτ ιακ ςαίνωφ υσ ςητ
Current projections by the US indicate that the assessments of the EU would not be finished by the November 2001 end of the transition period.
ΚΕ ςησιρώνγανα -
EC – Switzerland MRA
υονέ ιεκ υοτ ησωρύκ ιακ ηξατνύσ η εκηθώρηλκολο
The text of the agreement and explanatory notes were agreed and ratified in May 2000.
ςαίαβιο α αίνωφ υΣ
The date of entry into force is expected to be summer 2001.
υοτ οιρβ έοΝ νοτ υοδόιρεπ ςήκιταβατε ςητ ηξήλ
EC – Australia MRA and EC – New Zealand MRA (veterinary medicinal products)
ητ ςω ίεθωρηλκολο νυοχέ αν ιατενέ ανα νεδ ΕΕ ςητ ςιεσήγολοιξα ιο ΑΠΗ
Activities continued in 2000 to evaluate equivalence of these agreements.
2001.
MRAs in force
νώ αργ νωιρήτνυθυετακ νωτ
EC – Australia MRA and EC – New Zealand MRA (human medicinal products)
ΑΠΗ ΚΕ ςησιρώνγανα -
Activities in 2000 included the development of a maintenance programme and other documents to facilitate the operation.
, ΑΠΗ νωτ ιακ ΚΕ ςητ ςαίσεθο ον ςητ ησηγόλοιξα η εκηθσίχενυσ
Alert systems and certification schemes have been agreed in principle.
ςαίαβιο α αίνωφ υΣ
Certification of medicinal products
νύοθυλιπε αν ιεπέρπ υοπ νωτά ητηζ νώ ερκκε νωνέ σιρο.
New arrangements for requesting certificates of a medicinal product were introduced in 2000 and posted on the EMEA web site.
ωγόλ εκηθάταραπ ςοδοίρεπ ήκιταβατε η οσότσ ήγο ραφε εσ νύοθετ αν ιατνανύδ ςείοπο ιο ςοτα άργορπ υοτ οισίαλπ οτσ ησηθύολοκαραπ, νητσ ιακ ςείσακιδαιδ ςιτσ ησωίρη κετ νητσ νύοροφα υοπ ςιεσί θυρ
An internal audit of procedures was conducted in 2000, leading to improved internal communication of pharmacovigilance rapid alerts and arrangements for defective product reporting.
νακηθήνωφ υσ ςησίπΕ άδαναΚ ιακ ΚΕ ύξατε
The number of certificates requested fell from 9 652 in 1999 to 8 357 in 2000.
. ςατητόταβ υσ
Joint CPMP/ CVMP Quality working party
ΚΕ ςησιρώνγανα -
The Joint CPMP/ CVMP Quality working party met on three occasions in 2000.
νωτά ητσυσ νωτ ςαί ανυδοσι ςητ ησηγόλοιξα η εκηθώρηλκολο
The group finalised 7 guidelines for consultation and a further 8 guidelines for adoption.
οδοίρεπ ήκιταβατε εσ ςησιρώνγανα ςαίαβιο α ςείνωφ υσ ή ςιεσήτηζυσ ιεξίλεξε νΕ ςησιρώνγανα ςαίαβιο α ςείνωφ υΣ
A meeting with interested parties took place in October 2000.
αδίλεΣ
51 EMEA General Report 2000
ησεθκέ αισήτΕ 2000
4.2 Document management and publishing
EMEA/ MB/ 050/ 00
Product information
ςείροφορηλπ ςιτσ ησαβσόρπ
A joint project on product information management between EMEA and the European Federation of Pharmaceutical Industries and Associations was launched in 2000.
ησε ά αιγ ουτκίδαι∆ οτσ ύο σιναγρΟ υοτ ησέθοτσι νητ νύοιοποιξα ςετσήρχ ιο ςώθακ εκηθώιε ΑΕΜΕ υοτ αφαργγέ αιγ νώτη ορδνυσ νωτ ςό θιρα Ο υοτ οιρβ έοΝ νοτ άροφ
About 150 delegates from national competent authorities, pharmaceutical industry and software companies attended a workshop in September 2000 and welcomed the initiative.
αιγ εκηθύεισο ηδ ςοίοπο ο ΑΕΜΕ υοτ νωφάργγε υογόλατακ υοτ ηξατνύσ ητ εσινότνυσ ςαέ οτ Ο,
The purpose of the product information management (PIM) project is to reduce the workload for industry and regulators for the maintenance of product information documents (summary of product characteristics, patient information and labelling).
ςείσακιδαιδ ατητόνε άτακ
An average of 400 to 500 documents usually have to be revised for each product per change in product information.
ςιτ ιακ νώλυοβ υσ νώκινο ητσιπε ςήχοραπ ςείσακιδαιδ ςιτ αιγ νωφάργγε νωτ υοχγέλε υοτ αιδάτσ άκιχρα ατσ ιατεζάιτσε αθ α ητσύσ οΤ ςατητό ιποκσ ςητέλε ησηνόπκε η εσιχρά ςοτα ήτσυσ υοτ
The product information templates on the EMEA web site were reviewed in 2000 and the template for summary of product characteristics, labelling and package leaflet (template 1a) was revised in all 11 official EU languages following the adoption of the December 1999 Guideline on summary of product characteristics and is available on the EMEA web site.
.
Electronic submission
ήτυεθη ορπ υοτ ήγολιπε ήκιλετ νητ όπα νιρπ
Electronic submission will facilitate data exchange between applicants and marketing authorisation holders with the EMEA.
υοτ ηλέτ ατΣ νωφάργγε ςησιρίεχαιδ ςοτα ήτσυσ 2000,
There are activities on product information management, marketing authorisation applications, maximum residue limits and the Xdossier Internet draft.
ύοκινορτκελη ςόνε ήγολιπε νητ αιγ ςό σινωγαιδ ςόκιτοδοιε ςοισό ηδ εκηθήιοποτα γαρπ
The EMEA actively contributed in 2000 to discussions concerning the electronic common technical dossier (eCTD) and demonstrated a template for the eCTD at the ICH5 meeting in San Diego.
οτσ εκηθώναγροιδ υοπ ησινό ρανε νητ αιγ ςηψεκσάιδ ςύονθειδ ςητ ησαίρδενυσ San Diego. ητπ έπ νητ άτακ υολέκαφ ωγόλ νε υοτ οπυτόρπ εσαίσυοραπ ιακ
An electronic submission development web site was established in 2000 to provide information on work in progress: http: / /esubmission. eudra. org
ολεκάφ όκινχετ ό νιοκ όκινορτκελη (eCTD)
Document management
νοτ ε άκιτεχσ ςιεσήτηζυσ εσ άγρενε εχίετε υσ ΑΕΜΕ ο
A public tender procedure was conducted in 2000 for the selection of an electronic document management system.
2000,
A feasibility study was begun at the end of 2000 prior to the final selection of the system provider.
οιδέχσ οτ ιακ νωπίολατακ αιρό ατατώνα ατ ςαίροφολκυκ νώιεδα ςησηγήροχ ςιεσήτια ςιτ ατνόϊορπ ατ ε
The system will focus in the initial stages on document control for the scientific advice and modular EPAR processes.
, ουτκίδαι∆ οτσ ΑΕΜΕ υοτ ησέθ ητσ νωτνόϊορπ νώιροφορηλπ απυτόρπ ατ νακηθήρωεθανα
The sector coordinated the compilation of the EMEA catalogue of documents, which was published for the first time in November 2000.
ςοτνόϊορπ υοτ νώιροφορηλπ νωτ ησηίοποπορτ άνα αφαργγέ
The number of subscribers for EMEA documents fell in 2000, with users increasingly using the web site to access information directly.
ορό οσέ
52 EMEA General Report 2000
άτακ
4.3 Conference services
400- 500
EMEA meetings
ιατνύορωεθανα αν ςωθήνυσ ιεπέρπ νόϊορπ εθάκ αιΓ ησνα ήσ ιακ ςίενεθσα ςυοτ αιγ ςείροφορηλπ
Activities relating to the organisation of meetings at the EMEA increased by over 37% in 2000.
,
Meetings at the EMEA 1995-2000
).
350
(
300
.
250
.
100
EFPIA
50
οΤ
0
4. 2
1996
58/ 97
1997
αδίλεΣ
1998
EMEA/ MB/ 050/ 00
1999
350νωτ ωνά ήχοτε υσ ε αίραγγυΟ νητσ οιρδένυσ εκηθώναγροιδ
A survey in 2000 to measure the level of satisfaction of the delegates showed a high level of satisfaction with the level of service provided by the EMEA.
υοτ οιράυορβεΦ νοτ ύοτυα 2000,
Meeting facilities and technical equipment in the meeting rooms themselves were improved in 2000.
ςότκΕ ςιεσάιρδενυσ ιακ ςώθακ α αργόρπ οτσ ναχίετε υσ υοπ ςυοπώσορπιτνα
Progress was made in planning the new conference rooms on floor 3.
άκιλονυσ
Pan-European Regulatory Forum
119
A total of 119 delegates involved in the programme was handled by the sector and some 37 meetings.
ατνόϊορπ άκιτυεκα ραφ ατ αιγ υορόΦ ύοκιτσι θυΡ (PERF).
In addition a conference was organised in Hungary in February 2000 attended by over 350 delegates.
ύοκϊαπωρυεναΠ υοτ ςησάφ ςητώρπ ςητ ήγωγαξειδ ητ αιγ ησαβ ύσ η εκηθώρηλκολο
53 EMEA General Report 2000
οΤ
54 EMEA General Report 2000
2000
Chapter 5 Administration
υορόΦ όκιτσι θυΡ όκϊαπωρυεναΠ
Overview of the Administration Unit
υοφόρο υοτίρτ
Overview of the Administration Unit
υοτ νωεσάιρδενυσ νώσυοθια νωέν νωτ ό σαιδεχσ οτ άροφα νοσό ςοδοόρπ εκηθώιε ηΣ νώσυοθια
Head of Unit Head of Sector for personnel, budget and facilities Head of Sector for accounting
.
Andreas POTT Frances NUTTALL Gerard O’ MALLEY
νωτ ό σιλποξε όκινχετ νοτ ιακ ςησαίρδενυσ ςυορώχ ςυοτ άροφα νοσό ςιεσώιτλεβ ναθλήπε
The Administration Unit is responsible for personnel, budget,
οΤ
accounting and facilities.
2000
In addition, a number of projects set out in the Work Programme have been completed:
ΑΕΜΕ ο ιεχέραπ. υοπ ςείσερηπυ ςιτ αιγ ςησηίοπονακι οδεπίπε όληψυ εξιεδέτακ νωπώσορπιτνα νωτ ςησηίοπονακι
• Euro consolidated into the financial and budgetary proceedings of the Agency • recruitment targets achieved • budget monitored and adjusted, particularly in response to increased revenues and the financing of new tasks such as orphan medicinal products and PERF II • preparation of organisational restructuring of the Unit for the Evaluation of Medicines for Human Use • restructuring and refurbishment of EMEA offices as part of building policy
ςητ ησηρτέ ητ αιγ
Personnel, budget and facilities
οτ εκηθήνοπκε υοπ ητέλεΜ νωεσάιρδενυσ ςησιρίεχαιδ ςοτα ήτσυσ υοτ
A personnel database was selected in 2000 that will facilitate personnel administration, in particular leave records, evaluation reports and other personnel details.
2000
EMEA staff members by category and sex
.
70
οΤ
60
2000
50
1995
s Male
0 50 100 150 200 250 300 350
s Female
2000.
40
υοτ ωνά ότσοσοπ εσ νακηθήξυα 37%
30
ΑΕΜΕ υοτ ςιεσάτσατακγε ςιτσ νωεσάιρδενυσ ησωνάγροιδ ητ νύοροφα υοπ ςετητόιρητσαρδ ιΟ ΑΕΜΕ υοτ ςιεσάιρδενυΣ
20
νωίρδενυσ ςείσερηπΥ
10
4. 3
0
59/ 97
Category A
αδίλεΣ
Category B
ησεθκέ αισήτΕ 2000
Category C
EMEA/ MB/ 050/ 00
Category D
5%
55 EMEA General Report 2000
0%
EMEA staff members by nationality
αίδναλρΙ
Belgium 7%
8%
UK 22%
ογρύοβ εξυοΛ
Denmark 5%
12%
Germany 12%
αίναπσΙ 4%
Sweden 5% Greece 4%
4%
Finland 4%
αίλαγοτροΠ
Portugal 4% Austria 1% Netherlands 4%
αδάλλΕ
Spain 7%
αίδηυοΣ 12% αίνα ρεΓ
France 12%
οιγλέΒ
Luxembourg 0%
υοτ
Italy 8%
PERF II
Ireland 5%
α αργόρπ οτσ ιατνονάβ αλιρεπ υοπ αιδέχσ ανέ σιρο νακηθώρηλκολο ύοτυα ςότκΕ νωεσάτσατακγε
By constant budget monitoring and cost control the budget team successfully coordinated the execution of the budget and strove to achieve cost efficiencies.
ιακ ςήκιτσιγολ ύο σιγολοπϋορπ ύοκιπωσορπ ατα ήτηζ αιγ ηνυθύεπυ ιανίε ςησηκίοιδ αδάνο Η
A detailed review of training needs and the provision of training was undertaken during the year to improve the opportunities available to staff members.
νωεσάτσατακγε ιακ ύο σιγολοπϋορπ ύοκιπωσορπ αέ οτ ςονε άτσϊορΠ,
Additional office space of 1 460 m2 on the seventh floor of 7 Westferry Circus was occupied in 2000 to complement the existing three floors.
α αργόρπ οέν ανέ εσηγόλο ορδ ιακ εσαίδεχσ νωεσάτσατακγε όκιπωσορπ οτ
The staff of the Unit for the Evaluation of Medicines for Human Use, about 100 in total, were able to move to the new office space in March 2000.
υοτ οιτράΜ νοτ νωίεφαργ ςυορώχ ςυοέν ςυοτσ εσι όκατε α οτά
Facilities personnel also planned and began another major fitting out project in 2000 of the third floor for additional meeting rooms and delegate facilities.
οφορό ο οδβέ νοτσ
The work will be concluded in early 2001.
Α αίρογηταΚ
56 EMEA General Report 2000
ώ ν οτ υ π ρ ο σ ω π κι ο
Refurbishment plans for the third floor, EMEA offices
60 70
3D 3C
61/ 97
3B 3A
EMEA
Legend
υοτ ύοκιπωσορπ υοτ ηλέΜ
Room 3A – conference room (115 people)
(40
Room 3B – multi-function meeting room (40 people)
νωεσήρχ νώλπαλλοπ νωεσάιρδενυσ
Room 3C – meeting room and video- conference suite (35 people)
ασυοθία
Room 3D – meeting room (18 people)
ασυοθίΑ 3B –
Open area/ reception
νω ότα
Accounts
)
Following on from its implementation in 1999, further development of the SI2 budgetary accounting system and the implementation of the Sage general ledger system also contributed to increases in productivity.
νωεσάιρδενυσ (115
A forward exchange facility was negotiated with the Agency’ s banks to reduce to a minimum the effects of a weak Euro on the Agency’ s finances.
ασυοθία
In 2000, 6 761 payments were made and 1 084 receipts processed, which is an increase of 11% and 45% respectively over 1999.
ασυοθίΑ
57 EMEA General Report 2000
3A – α ην όπΥ
Volume of payments made in 1999 and 2000
EMEA
7000
62/ 97
6000
2000
5000
1999
s 1999
ςιεσνύραβιπε ςέκιτηκιοιδ
s 2000
ολονύΣ
4000
αδοσέ άπιοΛ
3000
ιακ ηλέτ όπα αδοσΈ
2000
0 200 400 600 800 1000 1200
1000
2000
Operations
οτ ιακ
Rapporters
1999
Volume of income operations in 1999 and 2000
ολονύΣ
1200
0 1000 2000 3000 4000 5000 6000 7000
1000
1999.
s 2000
11%
800
45%
600
6. 761
400
S12
200
αδίλεΣ
Fee revenue and
EMEA/ MB/ 050/ 00
Other revenue
2000
Total
οτ άτακ
administrative charges
EMEA
58 EMEA General Report 2000
11.
Annexes
ακα ράφ άναφρο ε άκιτεχσ
59 EMEA General Report 2000
οτ
Annexes
COMP
1.
ςητ ςε ώνΓ ατνόϊορπ
EMEA contact points and reference documents
άκιτυεκα ραφ άκιρταινητκ ε άκιτεχσ
EMEA budgets 1998 to 2000
CVMP
3.
ςητ ςε ώνΓ
Members of the Management Board
ατνόϊορπ άκιτυεκα ραφ ε άκιτεχσ
Members of the Committee for Proprietary Medicinal Products
νώχρα νωίδο ρα νώκινθε νωτ ιοπωσόρπκΕ
Members of the Committee for Veterinary Medicinal Products
ακα ράφ άναφρο ατ αιγ ςήπορτιπε ςητ ηλέΜ
Members of the Committee for Orphan Medicinal Products
64/ 97 αδίλεΣ
National competent authority partners
ιατνονάβ αλιρεπ υσ αίοπο ατσ νωφάργγε α σάφ ύρυε ανέ αρε ήσ ιρχέ ιεσύεισο ηδ ιεχέ
CPMP opinions in 2000 on medicinal products for human use
Ο
9.
ςαίσακιδαιδ ςήκιρτνεκ ςητ οισίαλπ οτσ
CVMP opinions in 2000 on medicinal products for veterinary use
EMEA
10.
ατητόιοπ νητσ νύοροφα υοπ
COMP opinions in 2000 on orphan medicinal products
Ο
11.
EMEA
EMEA guidelines in 2000
υοτ ιακ νώχρα EMEA.
60 EMEA General Report 2000
(«
Annex 1:
νοτ ε αίνωνιοκιπΕ
EMEA contact points and reference documents
EMEA
EMEA contact points
υοτ ςάροφανα αφαργγέ ιακ ΑΕΜΕ νοτ ε αίνωνιοκιπΕ α ητράραΠ
Pharmacovigilance and product defect reporting The constant monitoring of the safety of medicines after authorisation (‘ pharmacovigilance’) is an important part of the work of the national competent authorities and EMEA.
EMEA/ MB/ 050/ 00 ετοπήδοιοπο ε άκιτεχσ ςείροφορηλπ ςέκινεγ αιΓ E- mail: peter. jones@ emea. eudra. org ονωφέλητ ςαίεθυεπΑ (44- 20) 74 18 84 13 Peter JONES
The EMEA receives safety reports from within the EU and outside concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
ησήρχ ηνιπώρθνα αιγ ατνόϊορπ
For matters relating to pharmacovigilance for medicinal products for human use
άκιτυεκα ραφ άκιρταινητκ νύοροφα υοπ ατα ήτηζ αιΓ E- mail: noel. wathion@ emea. eudra. org ονωφέλητ ςαίεθυεπΑ (44- 20) 74 18 85 92 Noël WATHION
Contact point Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eudra. org
ησήρχ ηνιπώρθνα αιγ ατνόϊορπ
For matters relating to pharmacovigilance for medicinal products for veterinary use
άκιτυεκα ραφ άκιρταινητκ νύοροφα υοπ ατα ήτηζ αιΓ
Contact point Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara. freischem@emea. eudra. org
ςείροφορηλπ αιγ α
For product defect and other quality-related matters
ςιτσ ιατνολλέτσοπα αν ή ΑΕΜΕ νοτσ ςωφάργγε ιατνολλάβοπυ αν ιατνανύδ ςιεσήτιΑ ΑΕΜΕ υοτ
Contact point Stephen FAIRCHILD Fax number for defective product rapid alerts (44-20) 74 18 85 90 E-mail: stephen. fairchild@emea. eudra. org
νητσ ιατνολλέτσοπα αν ιεπέρπ
Certificates of a medicinal product
ςησηρόφορηλπ ςήκινεγ ςυολέκαφ αιγ ςιεσήτια ιΟ
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organisation.
E- mail: subscriptions@ emea. eudra. org ονωφέλητ ςαίεθυεπΑ (44- 20) 74 18 85 82
These certify the marketing authorisation 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.
νητσ ετίε ησνυθύειδ ωνάπαραπ νητσ ετίε
For enquiries concerning certificates for centrally Contact points authorised medicines for human or veterinary use Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65 E-mail: certificate@emea. eudra. org
ήφρο ηπυτνέ εσ ετίε ήκινορτκελη εσ ετίε.
Documentation services A wide range of documents has now been published by the EMEA, including press releases, general information documents, annual reports and work programmes.
υοτ αφαργγέ αισό ηδ ατ αλό αιγ νώ ορδνυσ αίσερηπυ ίεγρυοτιεΛ
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
London E14 4HB Canary Wharf 7 Westferry Circus European Agency for the Evaluation of Medicinal Products Subscription Service ησνυθύειδ ωρέτωτακ νητσ ςωφάργγε ςοτνέθηλβοπυ ςοτα ήτια: νιπότακ ςυονέ ορεφαιδνε ςυοτσ ςώκι ορδυχατ νύολατσοπα αν νύοροπ ετίε α ητήζ ολλά ιονυθύεπΥ Martin HARVEY ονωφέλητ ςαίεθυεπΑ (44- 20) 74 18 84 27 E- mail: martin. harvey@ emea. eudra. org
Subscription Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf London E14 4HB UK
http: // www. emea. eu. html
61 EMEA General Report 2000
Antoine CUVILLIER ονωφέλητ ςαίεθυεπΑ (44- 20) 74 18 84 28 E- mail: antoine. cuvillier@ emea. eudra. org
A subscription service is available for all EMEA public documents, distributing documents electronically or in paper form.
EMEA/ MB/ 050/ 00 2000 ησεθκέ αισήτΕ 67/ 97 αδίλεΣ
Further information can be obtained from the above address or from
υοτ ςαίγολοτνοεδ ςακιδώΚ EMEA (EMEA/ D/ 37674/ 99) ησάβ ήκιτκατ εσ ιατενώρε ηνε
Contact point Iro MAVROPOULOS Direct telephone (44-20) 74 18 85 82 E-mail: subscriptions@emea. eudra. org
υοτ νωφάργγε νωισό ηδ ςογολάταΚ EMEA (ςητάπα ςητ ηση έλοπατακ
Requests for general information packs should be sent to
νητ αιγ αίσερηπυ ήκϊαπωρυε νητ ε αίσαγρενυσ ητ ε άκιτεχσ
Contact point Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda. bosworth@emea. eudra. org
υοίνυοΙ ςη ςητ ήτνυθυειδ ύοκινεγ υοτ ησαφόπΑ 1 1999
Requests for inspection of European experts lists The list of European experts is available for inspection on request at the EMEA offices.
EMEA υοτ αφαργγέ εσ ησαβσόρπ νητ ε άκιτεχσ
Requests may be made either in writing to the EMEA or sent to the following e-mail addresses:
εκε∆ ςη ςητ ήτνυθυειδ ύοκινεγ υοτ ησαφόπΑ 1997 3
Human medicines’ experts list Veterinary medicines’ experts list Inspectors experts list
υοτ ό σιγολοπϋορπ νοτσ ιατεζό ραφε υοπ ςό σινονακ ςόκι ονοισο η∆ (EMEA/ MB/ 013/ 97)
human_experts@emea. eudra. org vet_experts@emea. eudra. org inspectors_experts@emea. eudra. org
1999 (ISBN 92- 9155- 026- 4,
Media and press contacts
νωτνόϊορΠ νώκιτυεκα ραΦ ςησηγόλοιξΑ ύο σιναγρΟ ύοκϊαπωρυΕ υοτ νωτήτοιρητσαρδ νωτ ησεθκέ ήκινεγ ητπ έΠ ΕΕ ςητ νωεσόδκΕ νω ήσιπΕ αίσερηπΥ
Representatives of the media should contact the following people for information:
1997 (ISBN 92- 9155- 010- 8,
For matters concerning medicinal products for human use
1996 (* ISBN 92- 9155- 002- 7 *,
Contact point Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eudra. org
1995 (* ISBN 92- 827- 7491- 0 *,
For matters concerning medicinal products for veterinary use
http: // pharmacos. eudra. org/ eudralex/ index. htm.
Contact point Peter JONES Direct telephone (44-20) 74 18 84 13 E-mail: peter. jones@emea. eudra. org
υοτ αφαργγΈ
For general information on any other matter
ησνυθύειδ ητσ ουτκίδαι∆ οτσ
Contact points Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eudra. org
υοτ ησέθ ητσ ιακ ςησίπε ςωπό,
Antoine CUVILLIER Direct telephone (44-20) 74 18 84 28 E-mail: antoine. cuvillier@emea. eudra. org
ογρύοβ εξυοΛ
EU official publications