Plné znění - 74/2013 Sb.

Čl. I

Vyhláška č. 474/2002 Sb., xxxxxx xx provádí xxxxx x. 281/2002 Xx., o xxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxx xx xxxxxxx xxxxxxxxxxxxxxxxx (xxxxxxxxxxxx) x xxxxxxxxxx xxxxxx x o změně xxxxxxxxxxxxxx zákona, xx xxxx xxxxx:

1. X §3 xxxxxxx x) xxx:

"x) x xxxxxxxxx xxxxxxxxxxx xxx x xxxxxxxxxxx nebo xxxxxxxxxx xxx xx xxxxxxxxxx xxxxxxx, xxxxx se xxxxxx nakládání x xxxxxxxxxxxx agens x xxxxxx,".

2. X §3 xxxx. x) xx xx xxxxx "farmacie" xxxxxxxx xxxxx "xxxx xxxxxxxxxxx".

3. X §3 xxxx. d) se xx slovo "xxxxxxxxxxxxxxxxx" xxxxxxxx xxxxx "nebo xxxxxxxxxxx" x slovo "xxxx" xx xxxxxxxxx xxxxxx "xxxxxx".

4. X §4 xxxx xxxxx xx xxxxx "xxxxxx xxxxxxxxxxx" nahrazují slovy "xxxxxx xxxxx", xxxxx "xxxxx" se nahrazuje xxxxxx "xxxxx" x xxxxx "xxxxxxx" se xxxxxxxxx xxxxxx "xxxxxxx".

5. X §5 xxxx. 2 xxxx. x) xxxx 5 xx xxxxx "xxxxxxxxxxx" xxxxxxxxx xxxxxx "osoby", xxxxx "xxxxx" xx xxxxxxxxx xxxxxx "která" x xxxxx "xxxxx" xx xxxxxxxxx xxxxxx "určena".

6. X §5 xxxxxxxx 3 xxx:

"(3) Xxxxxx xxxxx xx xxxxxxxx xxx, aby xxxxxxx xxxxx xxxxxx čitelný, x každá xxxxxx xx podepsána osobou xxxxxxx xxx vedení xxxxxxxx, xxxxx x xxxxxxx připojí datum xxxxxxxxx xxxxxx.".

7. X §7 xxxxxxxx 2 xxx:

"(2) Xxxxxxxxx xxxx Xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxxxxx xxxxxxxxx x xxxxxxxxxxxx xxxxx xxxxxxxxx uznávaným elektronickým xxxxxxxx, pokud není xxxxxxxxx xxxxxxxx xxxxxxxxxxxxxxx xxxxxx xxxxxxxx, nebo x xxxxxxxx xxxxx x xxxxxxxx statutárního xxxxxx x xxxxxxxx x elektronické xxxxx.".

8. Xxxxxxx x. 1 xxx:

"Xxxxxxx x. 1 x vyhlášce č. 474/2002 Xx.

Xxxxxx xxxxxx xxxxxxxxxx xxxxxxxxxxxx agens x xxxxxx (§2 xxxx. d) xxxxxx)

1. Xxxxxx patogeny x xxxxxxx xxxxxx

1.1 Viry

1. xxxxx Andes;

2. xxxxx Xxxxxx;

3. xxxxx Xxxxx;

4. xxxxx Hantaan;

5. virus xxxxxxx xxxxx Xxxx (Xxxx Xxxxxx xxxxx xxxxx);

6. virus Chikungunya;

7. xxxxx xxxxxxxx xxxxxxxxxxxx (Xxxxxxxx xxxxxxxxxxxx xxxxx);

8. xxxxx Xxxxx;

9. virus xxxxxxx-xxxxxxx xxxxxxxxxxx horečky (Xxxxxxx-Xxxxx xxxxxxxxxxxx fever xxxxx);

10. xxxxx Xxxxx;

11. xxxxx Xxxx;

12. virus xxxxxxxxxxxx xxxxxxxxxxxxxxxxx;

13. xxxxx Xxxxxxx;

14. xxxxx Xxxxxxx;

15. xxxxx xxxxxxx xxxxxxxx (Xxxxxxxxx xxxxx);

16. xxxxx xxxxxxx xxxxxxxx (Xxxxxxx xxxxx);

17. xxxxx Xxx Xxxxxx;

18. virus venezuelské xxxxxx encefalomyelitidy (Venezuelan xxxxxx xxxxxxxxxxxx xxxxx);

19. xxxxx xxxxxxxx koňské xxxxxxxxxxxxxxxxx (Xxxxxxx xxxxxx xxxxxxxxxxxx xxxxx);

20. xxxxx xxxxxxx xxxxxx xxxxxxxxxxxxxxxxx (Xxxxxxx xxxxxx xxxxxxxxxxxx xxxxx);

21. xxxxx xxxxx xxxxxxx (Xxxxxx xxxxx xxxxx).

1.2 Bakterie

1. Xxxxxxxx xxxxxxxxx;

2. Xxxxxxxx abortus;

3. Xxxxxxxx melitensis;

4. Xxxxxxxx xxxx;

5. Xxxxxxxxxxxx xxxxxx (Xxxxxxxxxxx xxxxxx);

6. Xxxxxxxxxxxx xxxxxxxxxxxx (Pseudomonas xxxxxxxxxxxx);

7. Xxxxxxxxxxx xxxxxxxxx;

8. Escherichia xxxx - xxxxxxxxxxxxxx xxxxx (XXXX) xxxxxxxxxxxx xxxxxx, xxxxxxxxxxx xxxxxx x hemolyticko-uremický xxxxxxx x xxxx;

9. Francisella xxxxxxxxxx;

10. Xxxxxxxxxxxxx psittaci (Xxxxxxxxx psittaci);

11. Xxxxxxxxxx xxxxx (Xxxxxxxxxx xxxxxxxx xxxxx. xxxxxxxx xxxxxxx Xxxxx);

12. Shigella xxxxxxxxxxx Xxx 1;

13. Xxxxxx xxxxxxxx;

14. Yersinia pestis.

1.3 Xxxxxxxxxx

1. Xxxxxxxxxx xxxxxxxx (Xxxxxxxxxx xxxxxxxx, Xxxxxxxxxx xxxxxxxx);

2. Xxxxxxxx xxxxxxxx,

3. Xxxxxxxxxx xxxxxxxxxx;

4. Xxxxxxxxxx xxxxxxxxxx.

2. Xxxxxxxx xxxxxxxxx

2.1 Xxxx

1. xxxxx xxxxxxxxx xxxx xxxx (African xxxxx xxxxxxxx xxxxx);

2. xxxxx xxxxxxxxx xxxx xxxxxx (Xxxxxxx xxxxx xxxxx xxxxx);

3. virus Xxxxxxxxxx xxxxxxx (Xxxxxxx xxxxxx xxxxx (Xxxxxxxx'x xxxxxxx);

4. xxxxx influenzy xxxxxxx xxxxxxx (Xxxxx xxxxxxxxx xxxxx), a xx:

x. xxxxxxxxxxxxxxxxxx xxxx

x. xxxxxxxxxx xxxx virus x vysokou xxxxxxxxxxx, x xx:

1. xxxx xxxx X, xxxxx xxxx XXXX (index xxxxxxxxxx patogenity) u xxxxxxxxxxxxxx xxxxx xxxxx xxx 1,2 xxxx

2. xxxx xxxx A xxxxxxx H5 xxxx X7, u xxxxx xxxxxxxxxxxx xxxxxxx xxxxxxxx xxxxxxx základní aminokyseliny xx xxxxxx xxxxxx xxxxxxxxxxxxx;

5. xxxxx xxxxxxxxx xxxxxxx xxxx (Xxxxxxxxxx xxxxx);

6. xxxxx xxxxxxxxxx xxxx prasat (Xxxxxxxxx xxxxx xxxxx xxxxx);

7. xxxxx moru xxxxxx xxxxxxxxxxx (Peste xxx xxxxxx xxxxxxxxx virus);

8. xxxxx xxxx skotu (Xxxxxxxxxx virus);

9. xxxxx xxxxxxxx xxxx (Xxxxxxxx xxxxx);

10. virus neštovic xxx (Xxxxxxx xxxxx);

11. xxxxx xxxxxxxxxxxx xxxxxxx xxxxxxx (Xxxxxxxxx xxxxxxx xxxxx);

12. xxxxx xxxxxxxxx xxxxxxxxxxx skotu (Xxxxx xxxx xxxxxxx virus);

13. xxxxx xxxxxxxxx a xxxxxxxx (Foot-and-mouth disease xxxxx);

14. xxxxx Těšínské xxxxxxx, xxxxxxxxx xxxxx xxxxxx (Teschen xxxxxxx xxxxx)

15. virus xxxxxxxxxxx xxxxxxx xxxxxx (Xxxxx xxxxxxxxx disease virus);

16. xxxxx xxxxxxxxxxx xxxxxxxxxxx (Xxxxxxxxx xxxxxxxxxx virus);

17. xxxxx xxxxxxxxx (Xxxxxxxxxx).

2.2 Xxxxxxxxxx

1. Xxxxxxxxxx mycoides xxxxx. xxxxxxxx XX (xxxxx xxxxxx);

2. Xxxxxxxxxx xxxxxxxxxx xxxxx. xxxxxxxxxxxxxxx.

3. Xxxxxxxx xxxxxxx

3.1 Viry

1. xxxxxx latentní xxxxxxx xxxxxxxx (Andean potato xxxxxx xxxxx);

2. viroid xxxxxxxxxxxxxx xxxx xxxxxxxx (Xxxxxx spindle tuber xxxxxx).

3.2 Xxxxx

1. Xxxxxxxxxxxx xxxxxxxxxx (Xxxxxxxxxxxxxxxx xxxxxx);

2. Xxxxxxxxxxx xxxxxx (Pyricularia xxxxxx, syn. Xxxxxxxxxxx xxxxxx);

3. Xxxxxxxxxxx xxxx (xxx. Dothidella xxxx).

4. Xxxxxx x jejich xxxxxxxxxxx

1. xxxxx;

2. xxxxxxxxxx;

3. xxxxxxxx (neurotoxin xxxxxxxxxxxxx);

4. xxxxxxxxxx xxxxxx;

5. xxxxxxxxxxxx;

6. xxxxxxxxxx;

7. xxxxxxxxx;

8. choleratoxin;

9. xxxxxxxxxxx (xxxxxxxxxxx);

10. xxxxxxx;

11. xxxxx;

12. xxxxxxxxx;

13. xxxxx xxxxx, xxxxx xxxxxx 1 x 2 (xxxxxxxxxx) x proteiny xxxxxxx shiga toxinu, xxxxx inaktivují xxxxxxxx;

14. xxxxxxxxxxxx;

15. toxiny Xxxxxxxxxxx xxxxxxxxxxx;

16. xxxxxx Staphylococcus xxxxxx;

17. xxxxxxxxxxxxxxx toxiny;

18. xxxxxxxx;

19. volkensin.

5. Xxxxxxxxx xxxxxxxx x geneticky xxxxxxxxxxxx xxxxxxxxx

5.1 Xxxxxxxxx xxxxxxxx, xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxxxxx s patogenitou xxxxxxxxx xxxxxxxxx v xxxxxx 1-3.

5.2 Xxxxxxxxx xxxxxxxx, které obsahují xxxxxxxx nukleových xxxxxxx xxxxxxxx xxxxxxx z xxxxxx xxxxxxxxx x xxxx 4 xxxx xxxxxxxx xxxxxxxxxxx toxinů xxxxxxxxx x bodě 4.

5.3 Geneticky modifikované xxxxxxxxx, xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxxxxx x xxxxxxxxxxx xxxxxxxxx uvedených x xxxxxx 1-3.

5.4 Xxxxxxxxx xxxxxxxxxxxx xxxxxxxxx, xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxx některý x xxxxxx xxxxxxxxx x bodě 4 xxxx xxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxxx v xxxx 4.

5.5 Xx xxxx xxxxxxxx xxxxxxxxxxxxx xxxxxxxxx xxxxxxxx x xxxxx xxxxxxxxx organismy, xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx kyselin xxxxxxxxxxx x xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxx 1-3.

5.6 De novo xxxxxxxx syntetizovaný xxxxxxxxx xxxxxxxx a xxxxx xxxxxxxxx organismy, které xxxxxxxx xxxxxxxx nukleových xxxxxxx xxxxxxxx xxxxxxx x xxxxxx xxxxxxxxx x bodě 4 xxxx xxxxxxxx podjednotky xxxxxx xxxxxxxxx x xxxx 4.

Poznámky:

1) Mikroorganismy xxxxxxx v bodě 1.2 9. xxxxxxxx xxxxxxx xxxxx xxxxxxxxxx X26, X45, X91, X103, X104, O111, X113, O121, X145, X157 x xxxxx, xxxxxxxxxxx shiga xxxxxx xx xxxxxxx geny xxxxxxxx xxxxxx produkci. Xxxxxxxx "xxxxxxxxxxxxxx kmeny Xxxxxxxxxxx xxxx (XXXX)" xx ekvivalentní x xxxxxxxx "xxxxxxxxxxxxx xxxxx Xxxxxxxxxxx xxxx (VTEC)".

2) Xxxxxxxx pro nakládání x xxxxxx se xxxxxxxxxx na botulinové xxxxxx (xxx 4.4.) xxxx xxxxxxxxxx (xxx 4.7.) xxxxxxxx x xxxxxxxx přípravcích registrovaných xxxxx zákona x xxxxxxxx.

3) Xxxxxxxxx xxxxxxxx xxxxxxxx xxxx jinými xxxxxxxxxx, xxxxxx, plazmidy, xxxxxxxxxxx x xxxxxxx, x xx xxx xxxxxxxxx xxxxxxxxxxxx, xxx xxxxxxxxxxxxxx.

Xxxxxxxx xxxxxxxxxx kyselin xxxxxxxxxxx x xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxx 1-3 představují xxxxxxxxx xxxxxxxx xxxxxxxxxxx xxx některý z xxxx uvedených mikroorganismů, xxxxx:

x) xxxx xxxxxx xxxx xxxxxxxxxxxxxxx xxxxx xxxxxxxxxxxxxx nebo translačních xxxxxxxx xxxxxxxxxxx xxxxxxxx xxxxxxxxx pro zdraví xxxx, zvířat xxxx xxxxxxx, xxxx

x) xx xxxxx xxx, že x daného xxxxxxxxxxxxxx xxxx x xxxxxxxxxx xxxxxx xxxxxxxxx, do xxxxxxx může xxx xxxxxxx xxxx jinak xxxxxxxxxxx, zvyšuje xxxx xxxxxxxxx xxxxxxxx xxxxx xxxxxxxxx zdraví xxxx, xxxxxx nebo xxxxxxx.

4) X xxxxxxxxxxxxxx xxxxxxxxx x xxxx 1.2 9 xx "xxxxxxxxx xxxxxxxx a geneticky xxxxxxxxxxxx xxxxxxxxx" podle xxxx 5 xxxxxxxx xxxxx xx xxxxxxxx xxxxxxxx kyseliny, které xxxxxx xxxxx xxxxxx (xxxxxxxxxx) a xxxxxxxx xxxxxxx xxxxx xxxxxx, xxxxx xxxxxxxxxx ribozomy, xxxx xxxxxx xxxxxxxxxxx.".

9. Xxxxxxx č. 2 xxx:

"Xxxxxxx x. 2 x xxxxxxxx x. 474/2002 Xx.

Xxxxxx xxxxxxxxxx xxxxxxxxxxxx xxxxx a xxxxxx (§2 xxxx. x) xxxxxx)

X. Xxxx

1. xxxxx australské xxxxxxxxxxxx (Xxxxxx Valley encephalitis xxxxx);

2. xxxxx Xxxxxxx-Xxxxxxxx;

3. xxxxx encefalitidy Xx. Xxxxx (St. Louis xxxxxxxxxxxx xxxxx);

4. xxxxx Xxxxxx;

5. xxxxx Guanarito;

6. xxxxx Hendra (Xxxxxx xxxxxxxx virus);

7. xxxxx xxxxxxx Xxxxxxxxxxxxx xxxx (Xxxxxxxx xxxxxx xxxxxxx xxxxx);

8. xxxxx Chapare;

9. xxxxx Xxxxxx;

10. xxxxx xxxxxxxx xxxxxxxxxxxx, virus xxxxx jaro-letní xxxxxxxxxxxx (Xxxx-xxxxx encephalitis xxxxx, Xxxxxxx Xxxxxx-Xxxxxx encephalitis xxxxx);

11. xxxxx Xxxxxx Xxxxx;

12. xxxxx Xxxxx;

13. xxxxx Xxxxxxxxx;

14. xxxxx Xxxxx hemoragické xxxxxxx (Xxxx xxxxxxxxxxx fever xxxxx);

15. xxxxx Xxxxxxxx;

16. xxxxx Xxxxxxx,

17. xxxxx Xxxxx;

18. xxxxx Xxxxx,

19. xxxxx Xxxxx;

20. virus xxxxxxx (Xxxxxxx xxx xxxxx);

21. virus xxxxxxxxxxxx xxxxxxx (Xxxx Nile xxxxx).

XX. Xxxxxxxx

1. Xxxxxxxxxxx xxxxxxxxxxx - xxxxx xxxxxxxxxxx epsilon toxin;

2. Xxxxxxxxxxx xxxxxx;

3. Legionella xxxxxxxxxxx;

4. Mycobacterium xxxxx (x xxxxxxxx xxxxx XXX);

5. Xxxxxxxxxxxxx xxxxxxxxxxxx (xxxxxxxxxxxxxxxx xxxxx);

6. Xxxxxxxxxxx xxxxxxxxxxx;

7. Xxxxxxxxxxx xxxxxxxxxx xx. xxxxx včetně xxxxx označovaných xxxx Xxxxxxxxxxx campestris pv. xxxxx xxxx A, X, C, X, X xxxx jinak xxxxxxxxxxxxx xxxx Xanthomonas xxxxx, Xxxxxxxxxxx campestris xx. aurantifolia xxxx Xxxxxxxxxxx xxxxxxxxxx xx. Xxxxxxxxx;

8. Xxxxxxxx xxxxxxxxxxxxxxxxxx.

XXX. Xxxxx

1. Coccidioides xxxxxxx;

2. Xxxxxxxxxxxx posadasii;

3. Xxxxxxxxxxxxxx xxxxxxxxx var. Xxxxxxxx (Xxxxxxxxxxxxxx kahawae);

4. Puccinia xxxxxxxx (xxx. Xxxxxxxx xxxxxxxx f. sp. xxxxxxx);

5. Xxxxxxxx striiformis (xxx. Xxxxxxxx glumarum).

IV. Xxxxxx x jejich xxxxxxxxxxx

1. Xxxxxxxxxxx.

X. Xxxxxxxxx xxxxxxxx x xxxxxxxxx xxxxxxxxxxxx xxxxxxxxx

1. Xxxxxxxxx xxxxxxxx, xxxxx xxxxxxxx sekvence xxxxxxxxxx xxxxxxx související x xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxx X-XXX.

2. Xxxxxxxxx xxxxxxxx, xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxx xxxxxxx x xxxxxx uvedených x bodě XX xxxx xxxxxxxx podjednotky xxxxxx xxxxxxxxx x xxxx XX.

3. Xxxxxxxxx xxxxxxxxxxxx xxxxxxxxx, xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxx související x xxxxxxxxxxx xxxxxxxxx uvedených x xxxxxx X-XXX..

4. Xxxxxxxxx xxxxxxxxxxxx organismy, xxxxx obsahují sekvence xxxxxxxxxx xxxxxxx kódující xxxxxxx x toxinů xxxxxxxxx x bodě XX xxxx xxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxxx x bodě XX.

5. Xx xxxx xxxxxxxx xxxxxxxxxxxxx genetický xxxxxxxx x uměle xxxxxxxxx xxxxxxxxx, které xxxxxxxx xxxxxxxx nukleových xxxxxxx xxxxxxxxxxx s patogenitou xxxxxxxxx xxxxxxxxx x xxxxxx I-III.

6. Xx xxxx xxxxxxxx xxxxxxxxxxxxx xxxxxxxxx materiál x xxxxx xxxxxxxxx xxxxxxxxx, xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxx xxxxxxx x toxinů xxxxxxxxx x bodě XX nebo xxxxxxxx xxxxxxxxxxx xxxxxx uvedených x bodě XX.

Xxxxxxxx:

Xxxxxxxxx xxxxxxxx xxxxxxxx xxxx xxxxxx chromozómy, xxxxxx, xxxxxxxx, xxxxxxxxxxx a xxxxxxx, a xx xxx xxxxxxxxx xxxxxxxxxxxx, xxx nemodifikované.

Sekvence nukleových xxxxxxx související x xxxxxxxxxxx organismů uvedených x bodech X-xxX xxxxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxxx pro některý x xxxx xxxxxxxxx xxxxxxxxxxxxxx, xxxxx:

x) jako xxxxxx xxxx xxxxxxxxxxxxxxx xxxxx xxxxxxxxxxxxxx xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxx nebezpečí pro xxxxxx osob, zvířat xxxx xxxxxxx, xxxx

x) xx xxxxx tím, xx x xxxxxx xxxxxxxxxxxxxx nebo u xxxxxxxxxx jiného organismu, xx kterého může xxx xxxxxxx xxxx xxxxx integrována, zvyšuje xxxx schopnost xxxxxxxx xxxxx xxxxxxxxx xxxxxx xxxx, xxxxxx xxxx xxxxxxx.".