XXXXXXXXX XXXXXXXXXX KOMISE (XX) 2017/1445
ze xxx 8. srpna 2017
x xxxxxxx xxxxxxxxx, xxxxxxx hlavní xxxxxxxxxx xxxxxx x xxxxxxxxxx xx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxx xx x xxxxxxxxxx (Vaccinium xxxxxxxxxxx) je prevence xxxx xxxxx xxxxxx xxxxxxxx xxxxxxx
(xxxxxxxx xxx xxxxxx X(2017) 5341)
XXXXXXXX XXXXXX,
x xxxxxxx xx Xxxxxxx x xxxxxxxxx Evropské xxxx,
x xxxxxxx xx xxxxxxxx Rady 93/42/XXX xx xxx 14. xxxxxx 1993 x xxxxxxxxxxxxxx xxxxxxxxxxxx (1), x xxxxxxx xx xx. 13 xxxx. 1 xxxxxxx xxxxxxxx,
s ohledem xx žádost, xxxxxx xxxxxx Xxxxxxx x xxxxxxx x xx. 13 xxxx. 1 xxxx. x) xxxxxxx směrnice,
vzhledem x xxxxx důvodům:
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(1) |
Xxxxxxx xxxxxxxx x xxxxxxx x xx. 13 odst. 1 xxxx. x) xxxxxxxx 93/42/XXX Xxxxxx, aby xxxxxxx xxxxxxxxxx, xx xxxxxxx xxxxxxxxx, jejichž xxxxxx zamýšlenou funkcí x xxxxxxxxxx xx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxx xx xx xxxxxxx z brusinek (Xxxxxxxxx xxxxxxxxxxx) xx xxxxxxxx xxxx xxxxx zánětů xxxxxxxx měchýře, xxxxxxx xx definice xxxxxxxxxxxxxx xxxxxxxxxx xxxxx xx. 1 xxxx. 2 písm. a) xxxxxxxx 93/42/EHS. |
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(2) |
X xxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxxxx x xx. 1 xxxx. 2 xxxx. x) xxxxxxxx 93/42/XXX xx xxxx xxxx xxxxxxx, xx prostředek xxxxx xx xxxxxxx definice, xxxxx nedosahuje své xxxxxx xxxxxxxxx xxxxxx xxxxxxxxxxxxxxx, xxxxxxxxxxxxx nebo xxxxxxxxxxxx účinkem. |
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(3) |
Xxxxxxxx xxxxxxxx xxx léčivé xxxxxxxxx (XXX) dospěla xx xxxx stanovisku xx xxx 22. xxxxxxxx 2016 (2) x xxxxxx, xx xxxxxx xxxxxxxxx xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxx x 1. bodě xxxxxxxxxx xx xxxxxxxxxxxxx xxxxxxxx farmakologickým xxxxxxx, xxxxx xxxxxxxxxx xxxxxxxxxxxxxxxxx x xxxxxxx xxxxxx obsažených x xxxxxxxxxx xxxxxxxx x xxxxxxxx xxxxxxxxxxxxxxxx farmakologické xxxxxx, x xx mechanický způsob xxxxxx xxxxxxxxxxxxxxxxx je xxxxxx xxxxxxxxxxxxxxx. |
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(4) |
Xxxxxxxxxx způsob xxxxxx by xxxxxxxx, xx xxxxxxx xxxxxxx xxxxxxxxx spadá xx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx. Xxxxxxxx x xxxx, xx xxxxxx xxxxxx xxxxxx xx xxxxxx xxxxxxxxxxxxxxx x xxxxxxxxxxxxxx způsob xxxxxx xx xxxxxx pravděpodobný, xxxxxxx xx, xx xxxxxxx xxxxxxx xxxxxxxxx xx xxxxxx spadat xx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx. |
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(5) |
X xxxxxxxxx, xxxxxx byla x xxxxxxxxx 2014 obeslána xxxxxxx xxxxxxx pro xxxxxxxxxxxx xxxxxxxxxx, xxxxxxxxx, xx xxxxxxx xxxxxxxxx xxxxx xx xx xxxxxxx xxxxxxxxx xxxxxxxx xxxx xxxxxx, že xxxxxxx xxxxxxx xxxxxxxxx xx xxxxxx spadat xx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx. |
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(6) |
Xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxxxx xxxx v souladu xx xxxxxxxxxxx výboru xxxxxxxxx xx. 7 xxxx. 1 xxxxxxxx 93/42/XXX. |
XXXXXXX XXXX XXXXXXXXXX:
Xxxxxx 1
Xxxxxxx xxxxxxxxx, jejichž xxxxxx zamýšlenou xxxxxx x xxxxxxxxxx xx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxx xx ve xxxxxxx x xxxxxxxx (Vaccinium xxxxxxxxxxx) xx prevence xxxx xxxxx xxxxxx xxxxxxxx xxxxxxx, xxxxxxx xx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxx čl. 1 xxxx. 2 xxxx. a) xxxxxxxx 93/42/EHS.
Xxxxxx 2
Xxxx xxxxxxxxxx je xxxxxx členským státům.
X Xxxxxxx xxx 8. xxxxx 2017.
Za Komisi
Elżbieta XXXŃXXXXXX
xxxxxx Xxxxxx
(1)&xxxx;&xxxx;Xx. xxxx. X&xxxx;169, 12.7.1993, x.&xxxx;1.
(2)&xxxx;&xxxx;Xxxxxxx xxxxxxxxxx XXXX (Xxxxxx pro xxxxxxx xxxxxx xxxxxxxxx) xxx XX pro xxxxxxx xxx, xxxxxxx, xxxxxxxxx x&xxxx;xxxx x&xxxx;xxxxxxx xxxxxxx, xxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxx x&xxxx;xxxxxxxxx XXXX D.4, x&xxxx;xxxxxxx xxxxxxx xxxxxx xxxxxxxxxxxxxxxxx určených x&xxxx;xxxxxxxx x&xxxx;xxxxx xxxxxxx xxxxxxxx xxxxxxx, XXX/427414/2016, http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=8684&lang=en