natgillin/translations-raw huggingface dataset:
ράΦ άναφρΟ ατ αιγ ςήπορτιπΕ ςητ ςησαίρδενυσ νώρε η νωτ ησηξύΑ ατνόϊορπ άκιτυεκα ραφ άναφρο αιγ υολλόκοτωρπ ηξιρήτσοπΥ νωτνόϊορπ νώκιτυεκα ραφ νώναφρο ό σιροιδσορπ αιγ ςιεσήτιΑ 2002 2001 2000 1 10 20
CPMP guidelines 20 00-2002 • Stable number of applications for orphan medic inal products designation in 2001 (70) and in increase in 2002 (75) 80 • Increase in protocol assistance for designated orphan 6 medicinal products from 1 in 2000 to 10 in 2001 and
60 70 80
60
2002.
6 2
οτ
6 58
εσ ιακ
20 in 2002
οτ ςιεσώτπιρεπ
2000
νυοχέ υοπ ακα ράφ αιγ υολλόκοτωρπ ησιτράτακ νητ αιγ ςή ορδνυσ ςήχοραπ ςητ ησηξύΑ 2002 (75) οτ ςυοτ ήσηξύα ιακ
2002
υοίρβ εκε∆
EMEA Work Programme 2001-2002
12- 13 υοίρβ
17
υοίρβ εκε∆ 12- 13 υοίρβ εκε∆
– To provide advice and recommendations to CPMP on
17- 18
80
υοίρβ εοΝ υοίρβωτκΟ
Orphan medicinal procedures 2000-2002
14- 15 υοίρβ εοΝ 8- 9 υοίρβωτκΟ
specific procedures being developed by the Commission such as demonstration of compliance with the TSE guideline, facilitation of the processing of data in support of variations to vaccines and blood products, Common Technical
20- 21 25- 26
70
11- 12 υο
71 70
6- 7
75
17- 18 19- 20
Document (CTD)
υοΐαΜ
60 50
22- 23 υοΐ
– Expert Working Group on Influenza Vaccines on the annual selection of virus strains for the influenza vaccine campaign – To review current guidelines and to develop guidelines, points
22- 23
40
υοίλιρπΑ
to consider documents and concept papers to facilitate the evaluation of future applications for marketing authorisations,
29- 30 υοίλι
30
υοίλιρπΑ 29- 30 υοίλιρπΑ
such as: • Note for guidance on minimising the risk of transmitting
9- 10
10
20- 21
20
υοίραυορβεΦ 26- 27 υοίραυορβεΦ
TSE via medicinal products • Note for guidance on plasma-derived medicinal products • Note for guidance on the use of transgenic animals in the
8- 9
1
υοίραυοναΙ) ησωίαβεβιπε 2002
manufacture of biological medicinal products for human use
22- 23 ςορπ
2000
υοίραυοναΙ (2001
2001
οτ ησάβ αίαινη εσ ιεζάιρδενυσ αθ ακα ράΦ άναφρΟ ατ αιγ ήπορτιπΕ Η υολλόκοτωρπ ησιτράτακ νητ αιγ ςηξιρήτσοπυ.
• Note for guidance on the use of transgenic plants in the manufacture of medicinal products
ήχοραπ νητ ιακ
Applications for orphan medicinal product designation
ςητ ογρέ οτ ίερυοκιπε αθ ακα ράφ άναφρο ατ ιακ νώλυοβ υσ νώκινο ητσιπε
Protocol assistance for orphan medicinal products
COMP
•
ήχοραπ νητ αιγ ςαέ οτ ςοέν Ο
Annex to CPMP Note for guidance on influenza vaccines:
υοτ οιλίρπΑ νοτ εκηθύρδι
Cell-derived influenza vaccines
2000.
•
οτ εσηνίκεξ ατνόϊορπ άκιτυεκα ραφ άναφρο ατ ε
Note for guidance on the quality, pre-clinical and clinical aspects of gene transfer medicinal products (jointly with Efficacy and Safety Working Parties)
υοτ ησέχσ Η
2.9 Working
ακα ράφ άναφρΟ
parties and ad hoc groups
22)
•
ΕΕ ςοτα σάλπ ή ςοτα ία υονιπώρθνα αγωγάραπ L 313 (
Points to consider on live-attenuated influenza vaccines
ύοκϊαπωρυΕ υοτ Κ
• Biotechnology Working Party •
νωτνόϊορπ νώκιτυεκα ραφ ήυεκσαραπ νητ
Points to consider on cumulative stability requirements
ιατνογάραπ υοπ νωτνόϊορπ νώκιτυεκα ραφ ατητόταβ υσ ητ ε άκιτεχσ α ην όπυ όκιτηγηδοθαΚ αιλόβ ε ατσ νωχόδκε
for vaccines – Review the quality aspects of marketing authorisation applications for biological and biotechnological medicinal
, αραττύκ όπα ανε όγαραπ ςηπίργ αιλόβ ε ςηπίργ αιλόβ ε ατ ε άκιτεχσ: ςητ α ην όπυ όκιτηγηδοθακ οτσ α ητράραΠ
Concept paper on requirements for evaluation of new immunological ’adjuvants’ in vaccines
CPMP νωτνόϊορπ νώκιτυεκα ραφ
products – To provide scientific advice on the quality aspects for requests
CPMP οτητίαραπα ίεθιρκ να ατα έθ ωρέτωνα ατ αιγ νωίρητσαγρε ησωνάγρο
Note for guidance on comparability r-DNA-derived medicinal products (joint with Efficacy and Safety Working Parties)
αχοδκέ ςω ιατνύοιοπο ισηρχ υοπ ςοτα σάλπ αγωγάραπ ε ςύοι ςυοτ όπα αιελάφσα νητ ε
for scientific advice for biological and biotechnological medicinal products – To provide advice and recommendations to CPMP on public
(CJD),
• •
υοσόν ςητ ςηνέ οναβ αλιρεπ υσ ςοτα ία ατνόϊορπ ε ιατνοζίτεχσ υοπ ατα έθ, ςειεθάπολαφεκγε ςιεδώγγοπσ ςέκιτοδατε ιο
Note for guidance on immune sera of animal origin Points to consider on human somatic cell therapy products (jointly with Efficacy and Safety Working Parties)
(TSE) ςωπό ατνόϊορπ άκιτυεκα ραφ:,
health issues related to medicinal products, such as: • Transmissible spongiform encephalopathy (TSE)
ε ιατνοζίτεχσ υοπ ςαίεγυ ςαισό ηδ ατα έθ αιγ
Note for guidance on xenogenic cell therapy products (jointly with Efficacy and Safety Working Parties)
νητσ νωεσάτσυσ ιακ νώλυοβ υσ ήχοραΠ CPMP
• Issues related to blood products, including Creutzfeldt- Jakob’s Disease (CJD), viral safety, plasma derivatives
ςήχοραπ ατα ήτια αιγ ςέχυτπ ςέκιτοιοπ ε ησέχσ
Note for guidance on requirements and controls of bovine serum used during the manufacture of medicinal products
ιακ άκιγολοιβ
used as excipients in medicinal products
νώχυτπ νώκιτοιοπ νωτ ησατέξεναπΕ αίγολονχετοιβ ητ αιγ ςαίσαγρε αδά Ο
– New activities relating to the implementation of European
ςαίσαγρε ςεδά ο (ad hoc)
Development of workshops on the above issues, if necessary
ςέκ ιδιε ιακ ςαίσαγρε ςεδά
Parliament and Council Directive 2000/70/EC on medical devices incorporating stable derivatives of human blood or human plasma (OJ L 313, 13.12.2000, p.
2. 9
22)
αδίλεΣ
18 EMEA Work Programme 2001-2002
όκιλεΤ
• Efficacy Working Party
ςαίσαγρε α αργόρΠ 2001- 2002
• Pharmacovigilance Working Party
EMEA/ MB/ 003/ 01- EL - ςείσυο ςέιαλαπ άρογα νητσ ςαίροφολκυκ αίριεπ ε αινόρχορκα
– Revision of the following existing guidelines: • Anti-depressive agents • Peripheral arterial occlusive disease* • Osteoporosis in women • Rheumatoid arthritis (revision to be considered) • Schizophrenia, development of an appendix on depot formulations developed for the treatment of schizophrenia – Development of new guidelines: • Bipolar disorders,* multiple sclerosis,* acute stroke,* Crohn's disease,* diagnostic agents,* diabetes mellitus, irritable bowel syndrome, asthma, pain, urinary
ε νώισυο ςέ ικοδ ςέκινιλκ η ςιτ ε άκιτεχσ ςοτα ήν οπυ ύοκιτηγηδοθακ υοίδεχσ ησηρώεθανΑ όκι ανυδ ονόγονικρακ οτ ε άκιτεχσ ςοτα ήν οπυ ύοκιτηγηδοθακ ησηρώεθανΑ νωτνόϊορπ νώκιτυεκα ραφ
– Evaluation of product-related safety issues at the request of the CPMP and national competent authorities – Revision of pharmacovigilance-related guidelines in the light of experience and following Commission Directive 2000/38/EC amending Chapter Va of Council Directive 75/319/EEC – Development of Good Pharmacovigilance Practice – Contribution to multidisciplinary guidelines with regard to medicinal products used for xenogeneic cellular therapy and for treatment of pregnant women
· ·
incontinence • Clinical documentation for metered dose inhalers • Biostatistical/methodological guidelines (adjustment for multiplicity and related topics, missing data,* choice of delta, validity and interpretation of meta-analyses and one pivotal trial,* adjustment for baseline covariates) • Antimicrobial resistance • Thrombolytic treatment of acute myocardial infarction – Development of guidelines through multidisciplinary groups: • Comparability of medicinal products containing biotechnology-derived proteins
ςήχονα ςείσα ικοδ ςέκιποτ ςέκινιλκ η ςιτ ε άκιτεχσ ςοτα ήν οπυ ύοκιτηγηδοθακ ησηρώεθανΑ ςητ νωτά ην οπυ νώκιτηγηδοθακ νωτνόυχσι νωτ ησηρώεθανΑ
– Collaboration and communication with non-EU regulatory authorities, in particular by providing support to the ICH initiative and to the PERF initiative, and by strengthening communication with the US Food and Drug Administration by means of regular videoconferences and mechanisms of urgent information exchange • Safety Working Party – Revision and development of draft ICH safety-related guidelines on behalf of CPMP.
·
Requirements for the marketing authorisation to be discussed
CPMP: ςητ ςοτα όνο ξε αιελάφσα νητ ε ησέχσ εσ ςητ νώ αργ νωιρήτνυθυετακ νωίδεχσ ησιτράτακ ιακ ησηρώεθανΑ
– Revision of existing CPMP safety notes for guidance: • Update of Note for guidance on non-clinical local tolerance testing of medicinal products • Update of Note for guidance on carcinogenic potential • Update of Draft Note for guidance on non-clinical testing of substances with long-term marketing experience (‘old substances’)
αιελάφσα νητ αιγ ςαίσαγρε αδά Ο
• Harmonisation of the summary of product characteristics for authorised antibiotics
ςήγαλλατνα ςασυογίεπε νώ σιναχη ιακ νωεψέκσαιδελητ νώκιτκατ ωσέ ΑΠΗ νωτ νωκά ραΦ
– Development of new CPMP safety guidelines, points to consider documents and discussion papers: • Note for guidance on photosafety testing
νώιρο φορηλπ ιακ
* Documents have previously been released for consultation.
νω ίφορΤ υοχγέλΕ αίσερηπΥ νητ ε ςαίνωνιοκιπε ςητ ησωίαρδε νητ
• Points to consider document on the non-clinical assessment of the carcinogenic potential of insulin analogues • Points to consider document on the need for reproduction studies in the development of human insulin analogues • Discussion paper on environmental risk assessments for pharmaceuticals
νώιλυοβοτωρπ PERF
EMEA Work Programme 2001-2002
ICH
19
νωτ ηξιρήτσοπυ νητ ε ςωίρυκ ΕΕ ςητ ςότκε ςέχρα ςέκιτσι θυρ ε αίνωνιοκιπε ιακ αίσαγρενυΣ
– Review of Scientific Advice sought by the industry related to pre-clinical safety testing – Joint revision and development of multidisciplinary guidelines and points to consider documents with other Working Parties: • Note for guidance on gene transfer medicinal products (with Biotechnology Working Party) • Points to consider document on xenogeneic cell therapy (with Biotechnology Working Party) • Note for guidance on specification limits for residues of heavy metal catalysts in active substances and in medicinal products (with Joint Quality Working Party) • Revision of Note for guidance on radiopharmaceuticals (with Joint Quality Working Party)
νωύκγε αίεπαρεθ ητ αιγ ιακ αίεπαρεθοραττυκ ήκιτενεγονεξ νητσ ιατνύοιοπο ισηρχ υοπ
– Development of the following new core summaries of product characteristics: • C1 esterase inhibitor • Human hepatitis B immunoglobulin – Revision of the following core summaries of product characteristics: • Specific immunoglobulins • Factor VII (plasma derived) • IV immunoglobulin (treatment of parvovirus B19 infection) 2.10 Herbal medicinal products
ατνόϊορπ άκιτυεκα ραφ αιγ νώ αργ νωιρήτνυθυετακ νώκινο ητσιπειδ ησιτράτακ νητσ ήχοτε υΣ ςησηνπύργαπεοκα ραφ νώκιτκαρπ νώθρο ηξυτπάνΑ υοίλυοβ υΣ υοτ ΚΟ
• Note for guidance on risk assessment of use of medicinal products during pregnancy and lactation (multidisciplinary) • Update Points to consider on the assessment of the potential for QT interval prolongation by non- cardiovascular medicinal products (multidisciplinary) • Scientific Advice Review Group
ςαίγηδο ςητ α οιαλάφεκ οτ ίειοποπορτ αίοπο η ςήπορτιπΕ ςητ Κ
Support to the Herbal Medicinal Products Working Party will continue in 2001-2002, with the working party expected to meet 3 times a year in 2001 and 2002.
νητ ε ανωφ ύσ ιακ 2000/ 38/ E
– Continue to support the CPMP through provision of scientific
νητ ησάβ ε ησηνπύργαπεοκα ραφ ητ ε ησέχσ εσ νώ αργ νωιρήτνυθυετακ ησηρώεθανΑ νώχρα νώκιτσινονακ νώκινθε νωτ
advice by carrying out scientific reviews of the requests for advice from companies, providing a guarantee of proper and adequate expertise – Strengthen the level of interaction with companies,
ςητ ςοτα ήτια νιπότακ νωτνόϊορπ νωτ ςαιελάφσα ςητ ιατνοτπά υοπ νωτά εθ ησηγόλοιξΑ CPMP ησηνπύργαπεοκα ραφ ητ αιγ ςαίσαγρε αδά Ο
2.11 Mutual recognition facilitation group Useful web sites:
-
particularly through a wide use of oral explanation and by
. νωεσύελυοβαιδ ονε ίεκιτνα νυοσέλετοπα αν υονέ ιεκορπ αφαργγέ ίεθυεισο ηδ ηδή νυοχΈ άκιτοιβιτνα ανέ ιρκεκγε ατ αιγ νωτνόϊορπ νώκιτσιρητκαραχ ςηψονύσ ςητ ησινό ρανΕ
Heads of agencies for medicines for human medicines
. ςαίρο φολκυκ
promotion of the use of the follow-up procedure
ςαιεδά
http://heads.medagencies.org
ησηγήροχ ητ αιγ ςέφαργαιδορπ ιο νύοθητηζυσ αν ιατιεκόρπ νωίδοσιεπε νώκαιεγγαιδρακ:
– Provide appropriate scientific expertise for the implementation of the protocol assistance procedure within the framework of European Community orphan drugs policy
: αίεπαρεθοραττυκ ήκιτενεγονεΞ ηνύσο υκγε νητσ νωτνόϊορπ νώκιτυεκα ραφ ησήρΧ ςησυελέορπ
European product index http://mri.medagencies.com/prodidx
ςήκιγολονχετοιβ ςενΐετωρπ νυοχέιρεπ υοπ νωτνόϊορπ νώκιτυεκα ραφ νωτ ατητό ισιρκγυΣ νωδά ο νώκινο ητσιπειδ ωσέ νώ αργ νωιρήτνυθυετακ ησιτράταΚ
The operation of the Mutual Recognition Facilitation Group • ad hoc Working Group on Blood Products – Input to CPMP on scientific advice requests for blood products (plasma derived and recombinant) and advice to CPMP and MRFG on general and product specific matters related to efficacy and safety of blood products – Development of the following new notes for guidance and core summaries of product characteristics: • Antithrombin (plasma derived) • Human normal immunoglobulin for intramuscular and subcutaneous use • Fibrin sealants • Von Willebrand factor • Alpha1 antitrypsin 20 EMEA Work Programme 2001-2002
: υοίδρακου υοτ ςοτα γάρφ ε ςοέξο υοτ ησιπώτε ιτνα ήκιτυλοβ ορΘ ςετνογάραπ ςύοκαιβορκι ιτνα ςυοτσ ήχονΑ ςάροφανα ή αργ ητ ςορπ ςω νωρτέ αραπ ήγο ρασορπ ή ικοδ ήκιτνα ησ
(MRFG) will continue to be supported by the EMEA at its monthly meetings held on the day preceding the start of CPMP meetings.
αί ιακ νωεσύλανα ατε αίενη ρε ιακ ατητόρυκγε ατλέδ ήγολιπε ανέ οδεδ ήπιλλε ατα έθ
Improvements to EMEA facilities are expected to be of particular benefit to the operation of the MRFG, in particular the additional meeting and videoconferencing rooms on the third floor of the Agency’s offices.
άκιτεχσ ιακ ςατητόλπαλλοπ ησι θύρ ςέ αργ ςειρήτνυθυετακ ςέκιγολοδοθε ςέκιτσιτατσοιΒ
Chapter 3 Veterinary medicines Overview of the CVMP and the Unit for Veterinary Medicines and Information Technology
ςερήτσυενπσιε ςύοκιρτε οσοδ αιγ ησωίρη κετ ήκινιλΚ νωρύο αιετάρκα
The Unit is responsible for: • management and follow-up of marketing authorisation
, ςονόπ α θσά ςαδιτίλοκ ςήκιτσαπσ ο ορδνύσ ςητήβαιδ ςηδώραχκασ ςετνογάραπ ίοκιτσωνγαιδ
management of Community referrals and arbitrations arising from the mutual recognition procedure
Crohn, * υοτ ςοσόν όκιλαφεκγε ύξο ςακάλπ άτακ ησνυρήλκσ ςέχαραταιδ ςέκιλοπι∆
applications under the centralised procedure • management of applications for the establishment of maximum residue limits of veterinary medicinal products that may be permitted in foodstuffs of animal origin • post-marketing maintenance of authorised medicinal products
, *, *
•
, * νώ αργ νωιρήτνυθυετακ νωέν ησιτράταΚ
provision of support to European and international harmonisation activities of the CVMP and its working parties
: ςαιενέρφοζιχσ
Unit for the veterinary medicines and information technology Head of Unit Peter JONES
) (ςεκίανυγ ςιτσ ησωρόποετσΟ ςοσόν ήκιτκαρφοπα ήκαιρητρα ήκαιερεφιρεΠ
Committee for Veterinary Medicinal Products Chairman of the CVMP Steve DEAN Vice-Chairman of the CVMP
* ςετνογάραπ ίοκιτπιλθατακιτνΑ
Head of Sector for veterinary marketing authorisation procedures
αδίλεΣ
Gérard MOULIN
όκιλεΤ
Jill ASHLEY-SMITH
ςαίσαγρε α αργόρΠ 2001- 2002
Working parties and ad hoc groups Efficacy Working Party
EMEA/ MB/ 003/ 01- EL -
Head of Sector for safety of veterinary medicines Kornelia GREIN
ςενίριαφσοσονα ςέκιδιΕ
Liisa KAARTINEN Immunologicals Working Party
ςαδιτίταπη ςηνιπώρθνα ηνίριαφσοσονΑ
Head of Sector for information technology Michael ZOURIDAKIS
B ςησάρετσε ςαέλοτσανΑ
David MACKAY Pharmacovigilance Working Party
Α ηνίψυρθιτνΑ ςατνογάραΠ
Deputy Head of Sector for information technology David DRAKEFORD
) νωτνόϊορπ νωτ νώκιτσιρητκαραχ:
Cornelia IBRAHIM Joint CPMP/CVMP Quality Working Party
) ιακ CPMP ςιτσ νώλυοβ υσ ήχοραπ ιακ ανέ σαυδνυσανα ιακ ςοτα σάλπ αγωγάραπ ςοτα ία ατνόϊορπ
The work programme for information technology can be found in Chapter 5.
) αιγ νώλυοβ υσ νώκινο ητσιπε ςήχοραπ ατα ήτια ε ησέχσ εσ νητσ νωίεχιοτσ ήχοραΠ
Jean-Louis ROBERT Safety Working Party Christian FRIIS
CPMP ςέλυοβ υσ ςέκινο ητσιπε αιγ ςησατέξε αδά Ο ήκινο ητσιπειδ ατνόϊορπ άκιτυεκα ραφ άκαιεγγαιδρακ η ε νωτά ητσαιδ) (
ad hoc Group on Antimicrobial Resistance Margarita ARBOIX
-
Availability of Medicines Task Force Peter JONES
ςησατάραπ ςήκιτοσοπ ατητότανυδ ητ ε άκιτεχσ ησατέξε ςορπ νωίε ησ υοφάργγε ησηρώεθανΑ όκινο ητσιπειδ ςαίχυολαγ ςητ ιακ ςηνύσο υκγε ςητ αιεκράιδ ητσ νωτνόϊορπ) (
EMEA Work Programme 2001-2002
·
21
(ατητόιοπ νητ αιγ ςαίσαγρε αδά ο) ήνιοκ νητ ε αίσαγρενυσ εσ ατνόϊορπ άκιτυεκα ραφ ιακ ςείσυο ςέκιτσαρδ εσ νωλλάτε νωέραβ (
Priorities for veterinary medicines in 2001-2002: • Finalise and adopt a Note for guidance on risk assessment in establishing maximum residue limits (MRL) to facilitate extrapolation of MRLs from major species’ to minor species
(αίγολονχετοιβ ητ αιγ ςαίσαγρε αδά ο νητ ε αίσαγρενυσ εσ νωίδινογ άροφατε) (
Continue to work with FEDESA to reach agreement on improving transparency in the regulatory process through publication of CVMP opinions on dates to be agreed by all parties
ε ιατνοζάυεκσαραπ υοπ ατνόϊορπ άκιτυεκα ραφ ατ ε άκιτεχσ α ην όπυ όκιτηγηδοθαΚ ςαίσαγρε ςεδά ο ςελλά ςιτ ε αίσαγρενυσ εσ ησατέξε:
in support of the availability of medicines initiative • Following the installati on and the testing phase of the EudraVigilance database, to fully implement the effective and
ςορπ νωίε ησ νωφάργγε ιακ νώ αργ νωιρήτνυθυετακ νώκινο ητσιπειδ ησιτράτακ ιακ ησηρώεθανΑ αιελάφσα νητ αιγ ςέ ικοδ ςέκινιλκορπ ςιτ ε ησέχσ.
Optimise the efficiency of the centralised system, thereby encouraging industry to choose this route for the authorisation of medicines as its preferred option
εσ αίναχη οιβ ητ ησυελέορπ ε νώλυοβ υσ νώκινο ητσιπε ςήχοραπ νωτά ητια νωτ ησηπόκσιπΕ ατνόϊορπ άκιτυεκα ραφ
consistent electronic reporting of adverse reactions to veterinary medicines
ατ αιγ νωεσώτπιπε νώκιτνολλαβιρεπ ςιεσή ιτκε ςιτ ε άκιτεχσ ύο σιτα ηλβορπ οφαργγΈ ςηνίλυοσνι ςηνιπώρθνα νωγόλανα ηξυτπάνα νητ άτακ
The increase in number of meeting days for the CVMP, working parties and ad hoc groups reflects the increased workload for
ςητ αίγρυοτιελ Η MRFG
Meet key targets identified in the Committee for Veterinary
ςητ νωεσάιρδενυσ νωτ CPMP.
veterinary medicines in 2001-2002.
ηξρανέ νητ όπα νιρπ αρέ η αί ιατνύοιοποτα γαρπ ςείοπο ιο ςητ ςιεσάιρδενυσ ςείαινη ςιτσ
Medicinal Products (CVMP) risk management strategic plan on antimicrobial resistance adopted and released by the Committee in January 2000
,
3.1 Initial evaluation
(MRFG)
•
ςησιρώνγανα ςαίαβιο α ςητ ησνυλόκυειδ ητ αιγ αδά ο νητ ιεζίρητσοπυ αν ιεσίχενυσ αθ ΑΕΜΕ Ο
Continue to seek advances in the initiatives identified by the EMEA Task Force to facilitate the availability of veterinary medicines
http: // mri. medagencies. com/ prodidx http: // heads. medagencies. org
•
νωτνόϊορπ οιρήτερυε όκϊαπωρυΕ ησήρχ ηνιπώρθνα αιγ ραφ ατ αιγ ίο σιναγρο ιοιδό ρΑ
Based on preliminary forecasts received from industry, an increase in applications for centralised authorisations is foreseen from 6 in 2000 to 10 in 2001 and 2002 and those for new MRL applications is expected to approximately
2. 11
•
ατνόϊορπ άκιτυεκα ραφ άκαισοδαραπ ιακ άκιτυφ ατ αιγ ήπορτιπΕ ήκϊαπωρυΕ η. ιελάβοπυ αν ιατιεκόρπ υοπ ησατόρπ νητ ησάβ ε ίεθχυτπανα αθ ςαδά ο ςητ ςαίσαγρε α αργόρπ οΤ
Work with market authorisation holders to ensure conformity with the legal framework and deadlines, requiring companies to demonstrate compliance with the Note for guidance on
ςωίσητε
double in number
ςέροφ ςιερτ ιεζάιρδενυσ αθ οδοίρεπ ηνέ ιρκεκγυσ ητ αιγ ιτό ιατά ιτκε υοπ ατνόϊορπ άκιτυεκα ραφ, άκιτυφ ατ αιγ ςαίσαγρε ςαδά ο ςητ ηξιρήτσοπυ η
minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products
οδοίρεπ ήκινορχ ητ άτακ ίετσιχενυσ αΘ
New centralised applications 2000- 2002 10
2001- 2002
•
ραφ άκ ιτυΦ
Achieve improved satisfaction of all parties in the benchmarking study, on the basis of the joint EMEA-
2. 10
10 10 8
ςαίσαγρε α αργόρΠ 2001- 2002
European Animal Health Federation (FEDESA) questionnaire
EMEA/ MB/ 003/ 01- EL -
6 6
Peter JONES Margarita ARBOIX
on the centralised system
νωκά ραφ νωτ ατητό ισεθαιδ ητ αιγ αδά
4 2 0
ο ήκιδιΕ ςετνογάραπ
Number of meeting days 2000-2002
Christian FRIIS
2000 2001 2002
αιελάφσα νητ αιγ ςαίσαγρε αδά Ο
New applications for medicinal products
ατητόιοπ νητ αιγCPMP/ CVMP ησηνπύργαπεοκα ραφ ητ
70 67 60 New applications for maximum residue limits 2000-2002
Gérard MOULIN
50 40 30
CVMP
48
ςητ ςορδεόρπιτνΑ
63
Steve DEAN
10 8 6
CVMP
20 10
ςητ ςορδεόρΠ
4 2
νωτνόϊορπ νώκιτυεκα ραφ νώκιρταινητκ ήπορτιπΕ
2
·
5
2002
2000
0 10 20 30
2002
2000- 2002
Meeting days
αίσακιδαιδ ήκιρτνεκ νητ ε
New applications for maximum residue limits
άκιτεχσ νωώ νωτ αίεγ
22 EMEA Work Programme 2001-2002
νητ αιγ ςαίδνοπσο ςήκϊαπωρυ
The Committee for Veterinary Medicinal Products began a new three-year mandate in January 2001.
νωτνόϊορΠ νώκιτυεκα ραΦ νώκιρταινητΚ ςήπορτιπΕ (CVMP)
3.2 Post-authorisation activities • Steady increase in post-authorisation activities is anticipated
ςητ νωνύδνικ ςηση ίτκε οιδέχσ όκιγηταρτσ οτσ ιατνοζίρο υοπ νωχότσ νώκισαβ νωτ ησωρήλπκΕ ατνόϊορπ άκιτυεκα ραφ άκιρταινητκ εσ νωεσάρδιτνα νωτη ύθιπενα νωτ ςάροφανα ςήκινορτκελη ςήκιτκενυσ ιακ ςήκιτα σελετοπα ςητ ησηίοπολυ
The new Committee will create a strategic planning group to be chaired by Gérard Moulin, with the participation of the CVMP chairman and chairpersons of the working parties together with the secretariat to give guidance to the CVMP on strategic issues and organisational efficiency.
νωνέ οδεδ ςησάβ ςητ ησάφ ήκιτσα ικοδ ητ ιακ ησατσάτακγε νητ άτεΜ
in line with the increased number of products authorised through the centralised procedure • A significant number of the expected variations are anticipated to ensure compliance with the TSE guideline
EudraVigilance, νωκά ραφ νωτ ατητό ισεθαιδ ητ αιγ
The CVMP will continue to meet in 2 001 and 2002 on a monthly basis, with 4 meetings per year with interested parties.
ςαίλυοβοτωρπ ςητ ηξιρήτσοπυ νητ αιγ ηδίε ανοσσάλε ατσ ανοζίε ατ όπα
Post-authorisation applications fo centall authorised medicinal products 2000-2002
ςητ ησνυλόκυειδ ητ οχότσ ε
CVMP meetings in 2001
2001- 2002
CVMP meetings in 2002 (to be confirmed)
οτ ατνόϊορπ άκιτυεκα ραφ άκιρταινητκ ατ αιγ ςετητόιαρετορπ ςιτΣ
Type I variations Type II variations
33/ 65
60
αδίλεΣ
8-10 January 12-14 February
όκιλεΤ
50 40 30
ςαίσαγρε α αργόρΠ 2001- 2002
Extensions 45
EMEA/ MB/ 003/ 01- EL - ίετσαιερχ νοσόφε νονόΜ 1
13-15 March
υοίρβ εκε∆
12-14 March
10- 12 υο
18-19 April
υοίρβ εκε∆ 10- 12 υοίρβ εκε∆
16-18 April
4- 6
20
υοίρβ εοΝ
15-17 May
12- 14 υοίρβ
14-16 May
υοίρβ εοΝ 12- 14 υοίρβ εοΝ
10
6- 8
8
8- 10 υοίρ
10
υοίρβ ετπεΣ 1
12-14 June
οτ ιακ
11-13 June
0 1
0 4 1
ιακ
10-12 July
οτ
9-11 July
3. 1
7-9 August1
EMEA/ MB/ 003/ 01- EL -
13-15 August1
2002. οτ ιακ3
11-13 September
οτ
10-12 September
ησητία ε ςαίροφολκυκ νώιεδα ςησωένανα νωεσήτια νωτ ησηξύΑ 2001 1
Applications for extentions/modification of maximum
άτακ
9-11 October
CVMP
8-10 October
ςητ ησηνπύργαπεοκα ραφ ητ αιγ ςαίσαγρε ςαδά ο ςητ νωεσάιρδενυσ ύο θιρα υοτ ησηξύΑ
residue limits 2000-2002
2002
6-8 November
2001
12-14 November
0 10 20
4-6 December
30 40 50 60
10-12 December
οτ ιακ
12 13 10 12
2002.
1 Only if required
2001
8 9 6 4 2 0 2000 2001 2002
νητ όπα ςυοτ ςήσηγόλοιξα ςητ ιακ CVMP,
Applications for extensions/modifications
ςιεσάτκεπΕ
EMEA Work Programme 2001-2002
3. 3
23
ΙΙ υοπύτ ςιεσήιοποπορΤ
3.3 Maintenance activities
Ι υοπύτ ςιεσήιοποπορΤ
3.7 Guideline development
2002
The continued rise in the number of centrally authorised veterinary medicines has led to an increase in adverse event reporting.
2000
A range of new guidelines embracing safety, biologicals quality monitoring, pharmacovigilance and others are anticipated in the two years ahead.
0 2
• Increase in number of meetings of the CVMP
2002
Pharmacovigilance Working Party by 25%
2001
Guidelines
2000
2000-2002
5
•
1
Increase in applications for renewal of marketing authorisations with 1 application in 2001 to 3 in 2002
9
Periodic safety update reports 2000-2002
31
15
12
15
13
18
45
56
40 50 60
40
3. 2
47
·
30
·
39
3. 10
20 10 0
υοτ αίετα αργ η ιακ
3.8 Establishment of maximum residue
όκιλετ, 5. 12. 2000),
2000
3. 9
2001
2001
3.4 Scientific advice
2000
3.5 Arbitration and Community referrals
0 5 10
Opinions for
15
maximum residue limits for old 2000-2002 20 20 15
15 2002
substances
20
15 10
15 20
15
2000 -
2000