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ητσ ιατεχέραπ υοπ ηξιρήτσοπυ νητ ορετόσσιρεπ η όκα cpmp
the exchange between the emea and authorities of third countries continued in 2000, with national experts from both japan and us spending extended periods of time at the agency.
Last Update: 2011-10-23
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ςαίλυοβοτωρπ ςητ ηξιρήτσοπυ νητ αιγ ηδίε ανοσσάλε ατσ ανοζίε ατ όπα
post-authorisation applications fo centall authorised medicinal products 2000-2002
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ςετητόιρητσαρδ ιακ ςείλυοβοτωρπ ςέκϊαπωρυΕ νώγο ραφε ηξιρήτσοπυ ςηξιρήτσοπυ οίεφαργ,
additional it facilities several upgrades, new transported by delegates to and from meetings devices and technology • videoconferencing capacities will be developed in 2001-
Last Update: 2011-10-23
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ςησιρώνγανα ςαίαβιο α ςητ ςησνυλόκυειδ αδά ο νητσ ηξιρήτσοπυ εχίεραπ ςήτυα
the emea was pleased to welcome delegations from china, kuwait, malta, russia taiwan and us during the year.
Last Update: 2012-04-11
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ηξιρήτσοπυ ήκιτηκιοιδ ιακ ήκαιετα αργ ηρήλπ αδά ο νητσ εχίεραπ ΑΕΜΕ Ο αίρδεορΠ
an index of products authorised through the mutual recognition procedure was published in april 2000 on the heads of veterinary agencies (hevra) web site: http: / /www. hevra. org.
Last Update: 2011-10-23
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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)
Last Update: 2011-10-23
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ητ αιγ αδά ο ήκιρταινητκ νητσ ηξιρήτσοπυ ήκαιετα αργ ηρήλπ ιεχέραπ αν ιεσίχενυσ αθ αδάνο Η
• ad hoc group on antimicrobial resistance – note for guidance on pre-authorisation studies to assess the potential impact of veterinary medicinal products to antimicrobial resistance
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ΑΠΗ ςιτ ιακ αίνωπαΙ νητσ ςα ςυορίατε ςυοτ ε οδεπίπε ςένθειδ εσ ςησινό ρανε ςετητόιρητσαρδ ιΟ νώρε νωνέ ορεφαιδνε νωτ ηξιρήτσοπυ νητ ε
in my opinion we should maintain this principle as it has a positive influence on the quality of performance of the emea and the national regulatory authorities.
Last Update: 2012-04-11
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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
Last Update: 2012-04-11
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νητ όπα ιατά ιτκε ιακ ιατεζίρωνγανα ορδεόρπ νοτ ςορπ ΑΕΜΕ υοτ ςαίετα αργ ςητ ηξιρήτσοπυ η ιακ ςενή ιξέ εθάκ ΕΕ ςητ αίρδεορπ νητ ε ανωφ ύσ ιατεσσάλλανε ςαδά ο ςητ αίρδεορπ Η νητσ ησαβίβαιδ αιγ ιακ
• safety working party – review on behalf of cvmp draft safety guideline from vich
Last Update: 2011-10-23
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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
Last Update: 2011-10-23
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οιλύοβ υσ όκιτηκιοιδ οτσ ηξιρήτσοπυ ήκαιετα αργ. ςησίπε ιεχέραπ ησνυθύειδ Η ηλέ ητάρκ ατ ιακ ςησωνΈ ςήκϊαπωρυΕ ςητ αναγρό άκι σεθ ατ ε ςέφαπε ςιτ ιακ. ςιεσέχσ ςέκιρετωξε ςιτ ατα ήτηζ άκι ον ατ νωτνόϊορΠ νώκιτυεκα ραΦ νωτ ησηγόλοιξΑ νητ αιγ ύο σιναγρΟ
he is the right person in the right time, because he couples managerial skills with a sound vision how we should collaborate in a network environment supported by high level information and communication technology.
Last Update: 2012-04-11
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cpmp ςησιρώνγανα ςαίαβιο α αίσακιδαιδ ητ όπα νυοτπύκορπ υοπ νώισητιαιδ ιακ νώισακιδαιδ νώκιτπ επαραπ νώκιτονιοκ νωτ ησιρίεχαιδ ητ ςανυερέ ςητ ςετόδοτα ηρχ ςυοτσ υολλόκοτωρπ ησιτράτακ νητ αιγ ςή ορδνυσ ήχοραπ νητ ιακ νώλυοβ υσ νώκινο ητσιπε ήχοραπ νητ ε ηξιρήτσοπυ νητ, νωτνόϊορπ νώκιτυεκα ραφ νώναφρο ύο σιρητκαραχ υοτ ησηθύολοκαραπ ιακ ησιρίεχαιδ ητ ςαίσακιδαιδ ςήκιρτνεκ ςητ ιεσάβ νωτνόϊορπ νώκιτυεκα ραφ νωνέ ιρκεκγε ςαίροφολκυκ ςαιεδά ςησοδκέ ςητ ιατεπέ υοπ ησηνπύργαπεοκα ραφ ητ ιακ ςαίροφολκυκ νώιεδα ησηρήταιδ ητ ςαίσακιδαιδ ςήκιρτνεκ ςητ ιεσάβ ςαίροφολκυκ νώιεδα ςησηγήροχ νωεσήτια νωτ ησηθύολοκαραπ νητ ιακ ησιρίεχαιδ ητ αιγ ςενυθύεπυ ιανίε ησήρχ ηνιπώρθνα αιγ νωτνόϊορπ νώκιτυεκα ραφ ςησηγόλοιξα ςεδάνο ιΟ: ησηπόκσιπε ήκινεΓ ησήρχ ηνιπώρθνα αιγ ατνόϊορπ άκιτυεκα ραΦ
to implement the protocol assistance policy for orphan medicinal products for scientific and regulatory aspects in a framework allowing the interaction and communication expected by sponsors.
Last Update: 2011-10-23
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