natgillin/translations-raw huggingface dataset:
νωτνόκηθακ νώκιτποπε νωλλά ησελέτκε νητ ιακ νωεσέθκε αιελάφσα νητ ε νώκιτεχσ ηξατνύσ ητ αιγ.
Maintenance activities 13% Overheads (all sectors) 12% Scientific advice 2% Arbitration/ referrals 1% Administrative charges 2% Special activities to be earmarked 8%
, 25% 2% ΕΕ ςιεσνύραβιπε ςέκιτηκιοι∆ ςητ άροφσιενυσ ήκινεΓ
EU general contribution 25%
20
The Management Board agreed at its 20 December meeting to continue with the existing mechanism for payment by the EMEA to national competent authorities for the provision of services (the ‘ scale of fees ’) in 2001(EMEA/ MB/ 051/ 00).
ςείσακιδαιδ ςέκιτπ επαραπ αίσητιαι∆
Under the mechanism half of most types of fees are redistributed to national competent authorities, with a special distribution for annual fee revenue.
ςετητόιρητσαρδ ςέκιδιΕ 12%
This redistribution of fees accounts for approximately one-third of total expenditure in the EMEA budget.
ςέλυοβ υσ
Annual fee revenue distribution: • 30% to cover EMEA staff costs • 30% is paid to the rapporteur and co-rapporteur for the medicinal product concerned for the production of annual safety reports and other supervisory tasks • 30% attributed to special activities and projects agreed by the Management Board, in consultation with the scientific committees (i. e. pharmacovigilance meetings, availability of veterinary medicines, crisis management and other post-marketing projects) • up to 10% for sampling and testing costs for centrally authorised medicines under an agreement with the Council of Europe ’ s European Department for the Quality of Medicines and the network of Official Medicines Control Laboratories
ςησηρήτνυσ
Financial control
ςετητόιρητσαρδ ςέκινεΓ
The proposal is for financial control to be replaced by an internal audit function within each of the EU decentralised bodies, including the EMEA.
ςαέ οτ αδάνο /
13 EMEA General Report 2000
ςετητόιρητσαρδ ςέκιδιΕ ηνέ ιρκεκγυσ (
Once adopted by the Commission, this proposal will require a revision of the EMEA financial regulation.
ησηγόλοιξα ήκιχρΑ 13/ 97
It is estimated that this process could take two to three years.
αδίλεΣ
During 2000 the financial control function at the EMEA continued to be ensured by an interim financial controller together with an assistant.
υοτ ολονύσ οτ αιγ
The targets set in the 2000-2001 Work Programme for the time taken to deal with submissions to financial control were exceeded in 2000.
1999
There was also a continued level of improvement in the quality of financial transactions submitted in 2000, with an average of 1.05% of submissions requiring revision (1.37% in 1999).
νώρε η ςότνε5 νώρε η ςότνε
Turnaround time for submissions to financial control 1999-2000
1999).
100% 1999 2000 98%
’
96%
‘
94%
):..
92%
):..
90%
3, 4
88%
’
86%
‘
84%
ατητόκιλοθαΚ
Submissions dealt with in 2 days
ατητό ισεθαι∆
Submissions dealt with in 5 days
ατητόκιτοδοπΑ
Reasons for rejection of financial transactions 1997-2000
ατητόκινοναΚ
5.0% 4.5% 4.0% 3.5% 3.0% 2.5% 2.0% 1.5% 1.0% 0.5% 0%
1999
1997
1997
1999
15/ 97
2000
αδίλεΣ
s Regularity s Availability s Speciality
ησεθκέ αισήτΕ 2000
s Authorisation s Universality
οτ ςιεσέθ ςιτ ςώχενυσ ενωρέ ηνε οτ
s Cost-effectiveness s Annuality
οτ άταΚ
14 EMEA General Report 2000
νολλέ ςύγγε οτσ ςέκιγρυοτιελ ςωρήλπ νύοτσατακ αν οχότσ ε ςέχρα ςέκινθε ςενέ σιρο
Explanatory note: ‘ Formal irregularities’ • Universality (Arts.
. ςετσήρχ ςυονέ ητοδοισυοξε εσ ιατεζίροιρεπ ησαβσόρπ η ςαίσαγρε νωδά ο νωρόφαιδ νωτ ςετητόιρητσαρδ
3, 4 and 23 of the Financial Regulation): i. e. booking on incorrect year, of part of the amount • Speciality (Art.
ςέκιτα ηριεχιπε ιο νύοθνυλοκυειδ αν υονέ ιεκορπ
22 of the Financial Regulation): i. e. use of inappropriate budget line • Availability (Arts.
α ητσύσ οτ χ π ςαίσαγρενυσ ασέ ήγο ραφε
4, 29 and 31of the Financial Regulation): i. e. shortfall on commitment or of appropriations • Cost-effectiveness (Art.
εσ νακηθέΤ ςαίναχη οιβ ςητ ιακ νώχρα νώκινθε νωτ ύξατε ήφαπε ήκινεγ ητ αιγ ιακ οσό
2 of the Financial Regulation): i. e. unacceptable contractual clauses, inadequate type of commitment • Authorisation (Art.
ςησηνπύργαπεοκα ραφ υοίδεχσ υοπυτόρπ ύοκϊαπωρυε υοτ οισίαλπ οτσ νωεσέθκε αιελάφσα νητ ε νώκιτεχσ ςυορέ ιπε ησοδάτε ητ αιγ οσότ εκηθώιτλεβ
18 of the Financial Regulation): i. e. disrespect for rules of delegation • Annuality (Arts.
ςοτα ήτσυσ υοτ ωσέ ουτκίδαι∆ οτσ νωφάργγε
1 and 5 of the Financial Regulation): i. e. disrespect for the annual character of budget Minor irregularities’ • Regularity:
α ητσύσ οτσ ςωρήλπ νακηθχάτνε αίγηβροΝ η ιακ αίδναλσΙ Η
Issues concerning i. e. documentation, calculation, beneficiary, etc.
ςιεσάτσατακγε ςιτ αρδέ εΜ ςήπορτιπΕ EMEA
1.2 The EMEA and its partners
ςήκϊαπωρυΕ ςητ νώνυερΕ.
European Union institutions
υορτνέΚ ύονιοΚ υοτ νώτωλαναταΚ ςαίσατσορΠ ιακ ςαίεγΥ υοτύοτιτσνΙ υοτ α ή τ ίελετοπα (ETOMEP) ατνόϊορΠ άκιτυεκα ραΦ ατ αιγ οίεφαρΓ όκινχεΤ όκϊαπωρυΕ
Within the European Commission the EMEA worked closely with the Pharmaceutical and cosmetics Unit of the Directorate-General for Enterprise, together with the services and scientific committees of the Directorate-General for Health and consumer protection.
νωεψέκσαι∆ – ςαίενη ρει∆ ςαίσερηπΥ ςήνιοΚ ςητ ςοτα ή τ ύοκιδναλρι ύοκινατερβ υοτ ιακ νώνυερΕ υορτνέΚ - ύονιοΚ υοτ ατνόϊορΠ άκιτυεκα ραΦ ατ αιγ υοίεφαρΓ ύοκινχεΤ ύοκϊαπωρυΕ υοτ ωσέ (ETOMEP) EMEAυοτ ςιεσάτσατακγε ςιτσ ιατνύοπωσορπκε αν νασηθύολοκαξε ςήπορτιπΕ ςητ ςείσερηπυ ιΟ
The services of the Commission continued to be represented at the EMEA through both the European Technical Office for Medicinal Products (ETOMEP) of the Joint Research Centre and the Anglo-Irish Desk of the Joint Interpretation and Conference Service.
υοτ ιορίατε ιο ιακ
European Technical Office for Medicinal Products (ETOMEP)
οτ άταΚ ΕΕ ςητ νώ σιναγρο νωτ ιακ νωνάγρο νώκι σεθ νωτ ύξατε ςαίσαγρενυσ 2000,.
ETOMEP is part of the European Commission Joint Research Centre’ s Institute for Health and Consumer Protection.
ςυοτσ ιακ οσό ςησωνΈ ςήκϊαπωρυΕ ςητ αναγρό άκι σεθ ατσ οσότ ςείσερηπυ ιεχέραΠ ςετάγρενυσ ςύοκιρετωξε όπα ςυορετόσσιρεπ ιακ νωένη ρειδ
Based at the EMEA in London, the group supports the IT network that connects all national competent authorities, the European Commission and the EMEA itself.
1. 600 υοπίρεπ όκιπωσορπ ίελοχσαπα ςώθακ ο 500
Iceland and Norway were fully integrated within EudraNet system in 2000.
νοτ ορηλκόλο εσ ηρετύλαγε η ιανίε ςήπορτιπΕ ςήκϊαπωρυΕ ςητ νωεσάιρδενυΣ ςαίενη ρει∆ αίσερηπΥ ήνιοΚ Η
Secure exchange of documents through the Internet, via EudraSafe, was enhanced both for the transmission of individual case safety reports in the framework of the European pharmacovigilance pilot project (http: / /icsr. eudra. org) and for general use between national authorities and industry.
ησεθκέ αισήτΕ 2000
Cooperation tools (e. g.
EMEA/ MB/ 050/ 00 ύοκϊαπωρυΕ υοτ νώταρκ νωτ ιακ ΕΕ ςητ νώλε νώταρκ νωτ ςέχρα ςειδό ρα ςέκινθε ςιτσ άροφα νοσό ςήφαπε αίε ησ ε άκιτεχσ αίεχιοτσ άκιτυλανΑ ιακ αιαλάφεκ ατσ ιατνεθίταραπ ςησιρώνγανα
EudraRoom) have been put in place to facilitate the operational activities of the various working groups; access is restricted to authorised users.
ςαίαβιο α ςητ ησνυλόκυειδ ητ αιγ νωδά ο νωτ ςετητόιρητσαρδ ςιτ ε άκιτεχσ αίεχιοτσ άκιτυλανΑ.
The tracking system for the mutual recognition procedure was progressed in 2000 and version 5.2.10 of EudraTrack is currently in use by Member States.
ΕΕ ςητ ςαίρδεορΠ ςήκιλλαγ ςητ ιακ ςήκιλαγοτροπ ςητ α ητσάιδ οτ άτακ νακηθώναγροιδ ςείοπο ιο ατνόϊορπ άκιτυεκα ραφ άκιρταινητκ ατ αιγ ιακ ησήρχ ηνιπώρθνα αιγ ατνόϊορπ άκιτυεκα ραφ,
Desktop videoconference services were tested between EMEA and some national authorities, with the aim of becoming fully operational in the near future.
ατ αιγ νώχρα νώκινθε νωτ ςήλαφεκιπε νωτ νωεσάιρδενυσ άριεσ αι εσ εχίετε υσ ΑΕΜΕ υοτ νώπορτιπε νώκινο ητσιπε νωτ ιακ ςώθακ.
ETOMEP continuously updated both the EMEA and European Commission Pharmaceutical Unit web sites during 2000, with a new EMEA web site launched at the end of 2000.
EMEA
15 EMEA General Report 2000
υοτ ηλέτ ατΣ ρα ςέκινθε ςιτ ε
Joint Interpreting and Conference Service (JICS)
νωτνόϊορπ νώκιτυεκα ραφ ησηρχάτακ νητσ ιακ ακα ράφ άκιτεθνυσ. αέν ατσ άροφα νοσό νωνύδνικ νωτ ησηγόλοιξα νητσ νασύοροφα υοπ ςιεσάιρδενυσ ςενέ σιρο
It serves the institutions of the European Union, as well as the decentralised agencies and bodies located in the EU Member States.
οΤ ςαίνα οκιξοΤ ιακ νώκιτωκραΝ ςησηθύολοκαραΠ ορτνέΚ 2000,.
A representative JICS is based at the EMEA as part of the cooperation between EU institutions and agencies.
όκϊαπωρυΕ οτ ε ςετητόιρητσαρδ ςένιοκ εναβ άλειρεπ ΕΕ ςητ ςύο σιναγρο ςυολλά ε αίσαγρενυσ Η ςέπορτιπε ωγόλ νε ςιτ ε νωεσήτηζυσ ήγωγαξειδ ητ αιγ νώ σιγολοπϋορΠ.
The JICS representative also advised and lectured on multilingualism, interpreting and communication at Universities in Ireland and the UK.
ςήπορτιπΕ ςητ ιακ ςαίεγΥ ςαισό η∆ ιακ νώτωλαναταΚ νωτ ςαίσατσορΠ ςοτνολλάβιρεΠ ςήπορτιπΕ ςητ ςιεσάιρδενυσ ςενέ σιρο εσ ητσέραπ ςό σιναγρΟ ο ςησίπΕ οινύοΙ νοτ υονίδνοΛ υοτ ήχοιρεπ
JICS provided know-how and advice in the refurbishment of the Agency’ s new meeting rooms and for a new meeting management system.
ουτκίδ οτ όπα ςαίσακιδαιδ OMCL. ςήκιρτνεκ ςητ ωσέ ςαίροφολκυκ αιεδά ιεβάλ νυοχέ υοπ νωτνόϊορπ νωτ υοχγέλε υοτ ιακ ςαίψηλοτα γιεδ ςητ ησωνάγρο νητ αιγ
A glossary of specialised and technical EMEA terms was also produced by JICS interpreters in 2000 to assist understanding and communication at the Agency’ s meetings.
υοτ ιακ EDQM
The European Department for the Quality of Medicines (EDQM)
οΤ νώγαλλανυΣ
http: / /www. pheur. org
νωρέθυελΕ ςηνώΖ ςήκϊαπωρυΕ ςητ ςερώχ ςητ αίτεβλΕ νητ ςηπώρυΕ ςήκιλοτανΑ ςητ ιακ ςήκιρτνεΚ ςητ ςερώχ
European Pharmacopoeia The European Pharmacopoeia is part of the Council of Europe and comprises 27 Member States, the European Union and 17 other European and non-European observer countries.
νωκά ραΦ υοχγέλΕ νωίρητσαγρΕ νω ησίπΕ ουτκί∆ όκϊαπωρυΕ
The EMEA participates in the work of the European Pharmacopoeia Commission as part of the EU delegation.
ουτκίδαι∆ οτσ ςαίιοποκα ραΦ ςήκϊαπωρυΕ ςητ ησέθ ητσ ΕΕ ςητ νώσσωλγ νω ησίπε
The Pharmacopoeia secretariat and experts participate in a number of EMEA working groups and undertook several tasks at the request of the EMEA in 2000.
.
The European Pharmacopoeia maintains an up-to-date list of standard terms used in product information for health professionals and patients.
11
A recently revised version is available in 21 languages, including all 11 official EU languages, on the Pharmacopoeia web site.
νωτ ιακ νωνέ οναβ αλιρεπ υσ ςεσσώλγ εσ ιατεθίταιδ ησοδκέ ασίεθηρωεθανα ςωτάφσορπ αιΜ ατνόϊορπ ατ
A contract between EMEA and the EDQM was extended in 2000 to organise sampling and testing of centrally authorised medicinal products by the OMCL network.
,
The Agency also attended a number of meetings of the Committee on the Environment, public health and consumer protection and of the Committee on Budgets for discussion with the Committees.
21
16 EMEA General Report 2000
2000 οτ άτακ ιακ
The EMEA participated in a number of meetings in 2000 relating to evaluation of risks associated with new synthetic drugs and the abuse of medicinal products.
υοτ
Cooperation with national competent authorities
ςαίσαγρε ςεδά ο ςενέ σιρο εσ νυοχέτε υσ ςαίιοποκα ραΦ ςητ ςενο ώνγοριεπ ε EMEA
Refurbishment of the third floor of the EMEA offices began at the end of 2000 with the purpose of providing a number of additional meeting rooms.
ιο ιακ αίετα αργ Η ΕΕ ςητ ςαίπωσορπιτνα ςητ ςορέ ςω ςαίιοποκα ραΦ ςήκϊαπωρυΕ ςητ ςήπορτιπε. ςητ ογρέ οτσ ιεχέτε υσ
This will in particular improve the facilities available for meetings of the mutual recognition facilitation groups for human and veterinary medicines and the EMEA scientific committees.
Ο ςέτηρηταραπ ςερώχ ςελλά ιακ ςέκϊαπωρυε ιακ ησωνΈ ήκϊαπωρυΕ νητ EMEA. -
The EMEA participated in a number of meetings of the heads of national authorities for human and veterinary medicines organised under the Portuguese and French EU presidencies.
, ηλέ ητάρκ ιενάβ αλιρεπ ιακ ςηπώρυΕ ςητ υοίλυοβ υΣ υοτ α ή τ ίελετοπα αίιοποκα ραΦ ήκϊαπωρυΕ Η 27 αίιο ποκα ραΦ ήκϊαπωρυΕ http: // www. pheur. org
Contact details for the national competent authorities of EU Member States and EEA-EFTA states can be found in Annex 7.
(EDQM)
Heads of agencies’ web sites
νωκά ραΦ νωτ ατητόιοΠ νητ αιγ αίσερηπΥ ήκϊαπωρυΕ Η
Heads of agencies for medicines for human use Heads of agencies for medicines for veterinary use
αδίλεΣ
http: / /heads. medagencies. org http: / /www. hevra. org
ησεθκέ αισήτΕ 2000 EMEA/ MB/ 050/ 00 http: // www. hevra. org
1.3 Transparency and good regulatory practices
ατνόϊορπ άκιτυεκα ραφ άκιρταινητκ ατ αιγ ίο σιναγρο ιοιδό ρΑ http: // heads. medagencies. org ησήρχ ηνιπώρθνα αιγ ατνόϊορπ άκιτυεκα ραφ ατ αιγ ίο σιναγρο ιοιδό ρΑ νώ σιναγρο νωιδό ρα νωτ ουτκίδαι∆ οτσ ςιεσνύθυει∆ 7. α ητράραπ οτσ ιατνεθίταραπ νώγαλλανυΣ νωρέθυελΕ ςηνώΖ ςήκϊαπωρυΕ ςητ υορώΧ ύοκι ονοκιΟ
Transparency at the EMEA is based on: • Dialogue with interested parties • Access to documents • Good regulatory practices • Code of conduct for European experts and EMEA staff members
αδίλεΣ
Interested parties
ησεθκέ αισήτΕ 2000
Instead of the regular quarterly meetings, the following was agreed:
EMEA/ MB/ 050/ 00 ησωνΈ ήκϊαπωρυΕ νητ αιγ ατνρετσ Ά υοτ ςηκήθνυΣ. ςητ θιρα ησωλήδ ητ ε ανωφ ύσ ςαιενάφαιδ ςητ ιακ αφαργγέ εσ ςησαβσόρπ ςητ ησωίτλεβ
Proposed topics include orphan medicinal products and the democratisation of health information • two six-monthly meetings bringing together EMEA, CPMP and interested parties focusing on past and future issues arising from the activities of the CPMP • ad hoc meetings and workshops as necessary on technical or specific topics.
17
17 EMEA General Report 2000
υοπ αφαργγέ ατ ςησίπε ιενάβ αλιρεπ ςογολάτακ ο αισό ηδ ςω ιατνοζίρητκαραχ υοπ νωφάργγε
The creation of the Committee for Orphan Medicinal Products at the beginning of 2000 was an important evolution in the EMEA relationship with interested parties.
υοτ οιρβ έκε∆ νοτ νωφάργγε 2000. αφαργγέ εσ ησαβσόρπ Η
Not only is the legislation the result of cooperation between the regulatory authorities, pharmaceutical industry and patient groups, but for the first time patient representatives are full members of an EMEA committee.
αφαργγέ εσ ησαβσόρΠ
Access to documents
ηξιλέξε ήκιτνα ησ εσελέτοπα
Access to EMEA documents was facilitated with the launch of a public document catalogue in December 2000.
υοτ ςέχρα ςιτσ ακα ράφ άναφρο ατ αιγ ςήπορτιπε ςητ ησατσύσ Η 2000
The catalogue is available on the on the Agency’ s web site and allows the public to search documents produced by the EMEA.
υοπ ατα ήτηζ ε άκιτεχσ ςαίνωνιοκιπε ςητ ςηνέ οναβ αλιρεπ υσ ςαιενάφαιδ ατα έθ ιατνονάβ αλιρεπ ατα ήτηζ ατνέθσιροιδσορπ ηδή ατΣ ατα έθ άκιδιε ή
In addition to all documents classified as ‘ public’ the catalogue also covers those classified as ‘ restricted’ and ‘ confidential’, although in some cases the full title may not be given in order to respect the Agency’ s obligations of confidentiality.
άκιτνολλε ιακ άιαλαπ εσ ιατνοζάιτσε αθ ςείοπο ιο νώρε νωνέ ορεφαιδνε
The publication by the EMEA of a catalogue is a positive action by the EMEA towards better access to documents and transparency, in line with Declaration No 17 of the Amsterdam Treaty on European Union.
ςητ ΑΕΜΕ υοτ ήχοτε υσ ε ςιεσάιρδενυσ ςείαινη αξε ού∆ CPMP, ςαίεγυ ατα έθ εσ ςησηρόφορηλπ ςητ ησωρέθυελεπα.
The 1997 Decision on rules on access to documents of the EMEA provides for the classification of and access to documents and is available on the web site in all official EU languages.
υοίτραΜ
New EMEA web site
ησεθκέ αισήτΕ 2000
http: / /www. emea. eu. int
ησι θάβαιδ ητ ιεπέλβορπ EMEA 21/ 97 αδίλεΣ
A new EMEA web site was launched in December 2000, together with a new address.
υοτ αφαργγέ εσ ησαβσόρπ νητ ε άκιτεχσ 1997
The new site is designed to give improved access to the increasing number of documents available.
ησεθκέ αισήτΕ 2000
There are currently over 5 000 documents on the site.
ητσ νωεσόδιπε νωτ ησηρτέ ητσ νύοροφα υοπ ατα ήτηζ νασατέξε ςεδά ο ετνέπ
The site will also be able cope with the increased number of visitors – there were more than 25 million ‘ hits’ on the site in 2000.
ςησηγόλοιξα
30 Number of hits (millions)
, 15
15
,
10
ςαιεδά ησηγήροχ ητ αιγ νώ ωνγ νωτ νωεψήλιρεπ ησυείσο ηδ η εσελέτοπα νώκιτκαρπ νώκιτσινονακ
5
)
0
2000
1995
ωνά
1997
2000
1998
αΘ
1999
5. 000
2000
2000 http: // www. emea. eu. int
18 EMEA General Report 2000
υοτ ησέθ αέΝ
Good regulatory practices
α ητράραπ οτσ ιατνεθίταραπ νωεσήτια νώκιτεχσ νωτ ήλοβοπυ νητ αιγ 1. ςήφαπε αίε ησ αΤ όνιοκ οτ όπα ησατέξε αιγ ΑΕΜΕ νοτ όπα ςοτα ήτια νιπότακ ςησίπε ιατνεθίταιδ. ύοκιπωσορπ υοτ νώλε νωτ νωτνόρεφ υσ ίρεπ ςιεσώληδ ιΟ όνιοκ οτ όπα ησατέξε αιγ
An important initiative in 2000 to improve regulatory transparency was the publication of summaries of opinions on the granting of marketing authorisations, both positive and negative, 15 days after their adoption by the EMEA scientific committees.
υοτ αίεφαργ ατ όπα ςοτα ήτια νιπότακ ιατεθίταιδ αν ίεθυολοκαξε νωτνόρεφ υσ ίρεπ ςιεσώληδ, ςιτ ιακ ατα ώιε ησ ςυοτ άκιφαργοιβ ατ ε ίζα νωνό ωνγοριεπ ε νωτ ςογολάτακ ςηρήλπ Ο,
After public consultation and initial discussions with interested parties, summaries of opinion were introduced in July 2000 for CPMP opinions only.
υοτ αιεκράιδ ητ ηλό θακ άκιτκατ ιατενώρε ηνε ςοίοπο ο νωνό ωνγοριεπ ε νωίαπωρυε νωεσνύθυειδ
Further improvements to pre- and post-authorisation transparency and communication were the main themes of a workshop held with interested parties on 23 November 2000.
νωτ ιακ νωτά ονο νωτ ςογολάτακ ουτκίδαι∆ οτσ ΑΕΜΕ υοτ ησέθ ητσ
The recommendations from the workshop were presented to the Management Board at its 20 December meeting.
υοτ οιράυορβεΦ νοτ 2000,
A new format for the presentation of European public assessment reports (EPARs) on the Agency’ s web site was introduced in 2000.
άροφ ητώρπ αιγ εκηθύεισο ηδ αιενάφαιδ ηρετύλαγε αιγ ύο σιναγρΟ υοτ ησυε σέδ ητ ε ανωφ ύΣ, ΑΕΜΕ υοτ ύοκιπωσορπ υοτ νώλε νωτ ιακ νωνό ωνγοριεπ ε νωίαπωρυε νωτ ολονύσ. οτσ άροφα ςακιδώκ Ο ουτκίδαι∆ οτσ ΑΕΜΕ υοτ ησέθ ητσ ΕΕ ςητ ςεσσώλγ ςε ησίπε ςιτ ςελό
The new modular presentation is intended to facilitate access to the different parts of the assessment report, in particular to the information for health professionals, patients and users of medicines that is available in all 11 EU official languages.
υοίραυοναΙ η νητ ύχσι εσ εκηθέτ ΑΕΜΕ υοτ ςαίγολοτνοεδ ςακιδώκ Ο ςαίγολοτνοεδ ςακιδώΚ
Ensuring the consistency of EMEA internal procedures is an important aspect of regulatory transparency.
νώ αργ νωίρητνυθυετακ νωτ ιακ ςαίσεθο ον ςητ ήγο ραφε νητ αιγ νωίρητιρκ νωτ ιακ ςαίγολοδοθε ςητ ςατητόκιτκενυσ ςητ ησιλάφσαξε ητ αιγ ςέκιτκαρπ ςέκιτσινονακ ςέθρΟ ςατητόιοπ
Within the framework of the quality management system (QMS), five groups looked at performance measurement, Agency’ s partnership with interested parties, product information management, staff performance evaluation issues and the development of an electronic ‘ quality manual’.
ςοτα ήτσυσ ςόνε ησηίοπολυ νητ άτακ νώιριεπ ε ήγαλλατνα η ιανίε υοίδεχσ υοτ ςόποκΣ ςηπώρυΕ ςήκιλοτανΑ ςητ ιακ ςήκιρτνεΚ ςητ ςερώχ ςιτ ιακ ΣΕΖΕ ςητ ςερώχ ςιτ ησωνΈ ήκϊαπωρυΕ νητ όπα,
Eighteen internal audits were conducted, including in the areas of pharmacovigilance, pre- submission guidance and scientific advice, leading to valuable improvements in EMEA performance.
νώχρα ησάφ ητώρπ εσ ήχοτε υσ ητ ιεπέλβορπ οιδέχσ οΤ νώκιτκαρπ νώκιτσινονακ νωτσιτλέβ
As announced in the EMEA Work Programme 2000-2001, a benchmarking project for the harmonisation of best regulatory practices was presented to the Management Board in October 2000.
, 22,
The project will initially involve 22 authorities from European Union, EFTA and central and eastern European countries.
νωτ ησινό ρανε νητ αιγ ςησηγόλοιξα ςήκιτιρκγυσ οιδέχσ οιλύοβ υσ όκιτηκιοιδ οτσ εκηθήλβοπυ υοτ οιρβώτκΟ νοτ
The purpose of the project is the exchange of experience in the implementation of a quality system (‘ Good Regulatory Practices’) to ensure consistency in methodology and criteria for the implementation of EU legislation and guidelines.
EMEA/ MB/ 050/ 00
Code of conduct
ςητ ιακ αιαλάφεκ ατσ ιατνεθίταραπ
The EMEA Code of conduct entered into force on 1 January 2000 and is available in all official EU languages on the EMEA web site.
ςείλυοβοτωρπ ατνόϊορπ άκιτυεκα ραφ VICH) ICH
The Code applies to all European experts and EMEA members of staff.
ςιτ ιακ νάβϊαΤ νητ αίσωΡ νητ ατλάΜ νητ τιέβυοΚ οτ ανίΚ νητ όπα ςείπωσορπιτνα εσηνέξολιφ
In line with the Agency’ s commitment to greater transparency, a list of the names and addresses of European experts was published on the EMEA web site for the first time in February 2000 and was regularly updated throughout the year.
αιγ νακηθήνεξολιφ
19 EMEA General Report 2000
ΑΠΗ ςιτ ιακ αίνωπαΙ νητ όπα ςενο ώνγοριεπ ε ίοκινθε
The full list of experts, together with their curriculum vitae and declarations of interests, continues to be available for public consultation by prior written request at the EMEA offices.
οισίαλπ οτΣ νώρωχ νωτίρτ νώχρα νωτ ιακ ΑΕΜΕ υοτ ύξατε ςέγαλλατνα ιο νακηθσίχενυσ
Declarations of interest for staff members are also available for public inspection on prior request at EMEA.
ςετητόιρητσαρδ ςίενθειδ ςελλΆ
Contact points for requests are given in Annex 1.
2000
1.4
http: // perf. eudra. org υούτκιδ
International aspects
ουτκίδαι∆ οτσ
European Economic Area
ςοτα άργορπ υοτ ησνυθύει∆
Iceland and Norway completed their first year as members of the CPMP and CVMP.
υοτ ήγο ραφε νητσ νύοροφα υοπ ατα έθ εδ ςωίδι νώιροφορηλπ νωτ ςαίγολονχετ ατα ήτηζ,
The EMEA was pleased to note that a member of the CPMP from Norway was appointed to act as co-rapporteur for a centralised procedure in 2000.
νύοροφα υοπ ςέχυτπ ςέκιδιε ςήγωγαραπ ςέκιτκαρπ ςέθρο
A guidance document for industry on the extension of the centralised procedure to Iceland and Norway was made available on the EMEA web site in March 2000.
νώιροφορηλπ νωτ ςαίγολονχετ ςητ ατα ήτηζ ςήγωγαραπ ςέκιτκαρπ ςέθρο
The document addresses the practical arrangements of the processing of applications for centrally authorised products and their subsequent harmonisation with respect to Iceland and Norway.
νώχρα νωίδο ρα νωτ αίετηθ ιακ ςετητόιδο ρα
Liechtenstein completed preparations for the creation of independent national structures and began its participation in EMEA activities at the end 2000.
ατητόκιτα σελετοπα)
Central and eastern European countries
ςητ ςαίσεθο ον ςήκιτυεκα ραφ ςητ ήγο ραφε ησηνπύργαπεοκα ραφ
Following the success of the first Pan-European Regulatory Forum (PERF) programme, the European Commission agreed funding for a second programme for the period 2000- 2001 of 2 440 000.
ΕΕ ςητ αίσεθο ον ήκιτυεκα ραφ ησηνπύργαπεοκα ραφ
The PERF II programme focuses on implementation and practical issues to assisting associated countries as part of their preparations for accession to the European Union.
PERF I
Topics covered by PERF I
αργόρπ οτ ιετπύλακ υοπ ατα έΘ PERF I α ησωνΈ ήκϊαπωρυΕ νητσ ςυοτ ήξατνέ νητ αιγ ςυοτ ςαίσα ιοτεορπ.
• pharmacovigilance • EU pharmaceutical legislation • dossier assessment (quality, safety and efficacy) • responsibilities and mandate of competent authorities • good manufacturing practices • information technology issues • establishment of maximum residue limits for veterinary medicines
α αργόρπ οΤ
20 EMEA General Report 2000
οδοίρεπ νητ αιγ ςοτα άργορπ PERF
Topics to be covered by PERF II
2000- 2001.
• pharmacovigilance • implementing EU pharmaceutical legislation • dossier assessment (quality, safety and efficacy) • good manufacturing practices • specific aspects relating to veterinary medicines • implementation of quality systems • information technology issues, in particular relating to EudraNet implementation
υορετύεδ ςόνε ώρυε
PERF web site: http: / /perf. eudra. org
υορόΦ ύοκιτσι θυΡ ύοκϊαπωρυεναΠ υοτ ςοτα άργορπ υοτώρπ υοτ αίχυτιπε νητ όπα αρετσΎ ςηπώρυΕ ςήκιλοτανΑ ιακ ςήκιρτνεΚ ςητ ςερώΧ
A number of national experts from the Czech Republic, Estonia, Poland, Slovak Republic and Slovenia were on secondment to the EMEA in 2000 for training
ησεθκέ αισήτΕ 2000
Other international activities
EMEA/ MB/ 050/ 00 νωδάνο νωέν ούδ νωτ ςιεσέθ ςιτ αιγ ίο σιροιδ ιοθυολόκα ιο νακηθώνιοκανα
The joint EMEA-World Health Organisation project for the co-development of an application tracking system (SIAMED 2000) came near to completion in 2000.