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tolerant
exact
1 error
approximate
w/o phonetic transcr.
engl. phonetic transcr.
Search for:
ä
ö
ü
ß
2
similar
results for Referenzarzneimittel
Tip:
Search for a phrase:
word1 word2
... or
"word1 word2"
German
English
Anträge
aufgrund
von
Artikel
13
(
generische
Tierarzneimittel
)
müssen
enthalten:
die
in
Titel
I
Teile
1
und
2
dieses
Anhangs
genannten
Daten
zusammen
mit
einer
Umweltverträglichkeitsprüfung
,
Daten
,
die
belegen
,
dass
das
Arzneimittel
dieselbe
qualitative
und
quantitative
Wirkstoffzusammensetzung
und
dieselbe
Darreichungsform
aufweist
wie
das
Referenzarzneimittel
,
sowie
Daten
,
die
die
Bioäquivalenz
mit
dem
Referenzarzneimittel
zeigen
. [EU]
Applications
based
on
Article
13
(generic
veterinary
medicinal
products
)
shall
contain
the
data
referred
to
in
Parts
1
and
2
of
Title
I
of
this
Annex
together
with
an
environmental
risk
assessment
and
data
demonstrating
that
the
product
has
the
same
qualitative
and
quantitative
composition
in
active
substances
and
the
same
pharmaceutical
form
as
the
reference
medicinal
product
and
data
showing
bio-equivalence
with
the
reference
medicinal
product
.
Handelt
es
sich
bei
dem
Referenzarzneimittel
um
ein
biologisches
Arzneimittel
,
sind
die
Dokumentationsvorschriften
von
Abschnitt
2
für
ähnliche
biologische
Tierarzneimittel
zu
erfüllen
. [EU]
If
the
reference
veterinary
medicinal
product
is
a
biological
medicinal
product
,
the
documentation
requirements
in
Section
2
for
similar
biological
veterinary
medicinal
products
shall
be
fulfilled
.
The example sentences [G] were kindly provided by the
Goethe Institute
.
Sentences marked by [EU] derived from
DGT Multilingual Translation Memory
. The European Commission retains ownership of the copyright in the original data.
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