Plné znění - 74/2013 Sb.

Xx. X

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

1. X §3 xxxxxxx x) xxx:

"x) v xxxxxxxxx xxxxxxxxxxx věd a xxxxxxxxxxx nebo xxxxxxxxxx xxx ve xxxxxxxxxx xxxxxxx, xxxxx xx xxxxxx xxxxxxxxx x xxxxxxxxxxxx agens a xxxxxx,".

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

3. X §3 xxxx. x) xx xx slovo "xxxxxxxxxxxxxxxxx" xxxxxxxx xxxxx "xxxx xxxxxxxxxxx" x slovo "xxxx" xx nahrazuje xxxxxx "xxxxxx".

4. X §4 větě xxxxx xx xxxxx "xxxxxx xxxxxxxxxxx" nahrazují slovy "xxxxxx xxxxx", xxxxx "xxxxx" se xxxxxxxxx xxxxxx "která" x xxxxx "xxxxxxx" se xxxxxxxxx slovem "zapsána".

5. X §5 xxxx. 2 písm. a) xxxx 5 xx xxxxx "xxxxxxxxxxx" xxxxxxxxx xxxxxx "xxxxx", slovo "xxxxx" se xxxxxxxxx xxxxxx "která" x xxxxx "xxxxx" xx xxxxxxxxx xxxxxx "xxxxxx".

6. X §5 xxxxxxxx 3 xxx:

"(3) Xxxxxx xxxxx xx xxxxxxxx xxx, aby xxxxxxx xxxxx zůstal xxxxxxx, x xxxxx oprava xx podepsána xxxxxx xxxxxxx xxx xxxxxx xxxxxxxx, xxxxx x xxxxxxx xxxxxxx datum xxxxxxxxx opravy.".

7. X §7 xxxxxxxx 2 xxx:

"(2) Xxxxxxxxx xxxx Xxxxxxxx xxxxx xxx xxxxxxxx bezpečnost xxxxxxxxx x xxxxxxxxxxxx formě xxxxxxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx xxxx xxxxxxxxx doručena prostřednictvím xxxxxx xxxxxxxx, xxxx x xxxxxxxx xxxxx x podpisem xxxxxxxxxxxx xxxxxx x xxxxxxxx x elektronické xxxxx.".

8. Xxxxxxx č. 1 xxx:

"Xxxxxxx x. 1 x xxxxxxxx x. 474/2002 Xx.

Xxxxxx xxxxxx xxxxxxxxxx biologických xxxxx x toxinů (§2 xxxx. x) xxxxxx)

1. Xxxxxx xxxxxxxx x xxxxxxx xxxxxx

1.1 Xxxx

1. xxxxx Andes;

2. xxxxx Xxxxxx;

3. xxxxx Xxxxx;

4. xxxxx Xxxxxxx;

5. virus xxxxxxx údolí Xxxx (Xxxx Valley xxxxx xxxxx);

6. xxxxx Xxxxxxxxxxx;

7. xxxxx xxxxxxxx encefalitidy (Xxxxxxxx xxxxxxxxxxxx xxxxx);

8. xxxxx Xxxxx;

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

10. xxxxx Xxxxx;

11. xxxxx Xxxx;

12. xxxxx xxxxxxxxxxxx xxxxxxxxxxxxxxxxx;

13. xxxxx Xxxxxxx;

14. xxxxx Xxxxxxx;

15. xxxxx xxxxxxx xxxxxxxx (Xxxxxxxxx xxxxx);

16. xxxxx xxxxxxx neštovic (Xxxxxxx xxxxx);

17. xxxxx Sin Xxxxxx;

18. xxxxx xxxxxxxxxxx xxxxxx encefalomyelitidy (Xxxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxx);

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

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

21. virus xxxxx xxxxxxx (Xxxxxx xxxxx xxxxx).

1.2 Xxxxxxxx

1. Bacillus xxxxxxxxx;

2. Xxxxxxxx xxxxxxx;

3. Xxxxxxxx xxxxxxxxxx;

4. Brucella xxxx;

5. Burkholderia xxxxxx (Xxxxxxxxxxx xxxxxx);

6. Xxxxxxxxxxxx xxxxxxxxxxxx (Xxxxxxxxxxx xxxxxxxxxxxx);

7. Xxxxxxxxxxx xxxxxxxxx;

8. Xxxxxxxxxxx xxxx - xxxxxxxxxxxxxx xxxxx (XXXX) xxxxxxxxxxxx xxxxxx, xxxxxxxxxxx průjmy x xxxxxxxxxxx-xxxxxxxx xxxxxxx x xxxx;

9. Xxxxxxxxxxx xxxxxxxxxx;

10. Xxxxxxxxxxxxx xxxxxxxx (Xxxxxxxxx xxxxxxxx);

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

12. Xxxxxxxx dysenteriae Xxx 1;

13. Xxxxxx xxxxxxxx;

14. Xxxxxxxx pestis.

1.3 Xxxxxxxxxx

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

2. Xxxxxxxx burnetii,

3. Xxxxxxxxxx xxxxxxxxxx;

4. Xxxxxxxxxx xxxxxxxxxx.

2. Patogeny xxxxxxxxx

2.1 Xxxx

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

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

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

4. virus influenzy xxxxxxx xxxxxxx (Xxxxx xxxxxxxxx virus), x xx:

x. necharakterizovaný xxxx

x. xxxxxxxxxx jako xxxxx x vysokou xxxxxxxxxxx, x xx:

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

2. xxxx xxxx X xxxxxxx X5 nebo X7, x nichž xxxxxxxxxxxx xxxxxxx vykázaly xxxxxxx xxxxxxxx xxxxxxxxxxxxx xx xxxxxx straně xxxxxxxxxxxxx;

5. xxxxx katarální xxxxxxx ovcí (Bluetongue xxxxx);

6. xxxxx xxxxxxxxxx xxxx xxxxxx (Classical xxxxx xxxxx xxxxx);

7. xxxxx moru malých xxxxxxxxxxx (Xxxxx des xxxxxx xxxxxxxxx xxxxx);

8. xxxxx xxxx xxxxx (Xxxxxxxxxx xxxxx);

9. xxxxx xxxxxxxx ovcí (Xxxxxxxx xxxxx);

10. virus xxxxxxxx xxx (Goatpox xxxxx);

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

12. xxxxx nodulární xxxxxxxxxxx xxxxx (Lumpy xxxx disease xxxxx);

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

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

15. xxxxx xxxxxxxxxxx xxxxxxx prasat (Xxxxx xxxxxxxxx disease xxxxx);

16. xxxxx xxxxxxxxxxx xxxxxxxxxxx (Xxxxxxxxx stomatitis xxxxx);

17. xxxxx xxxxxxxxx (Lyssavirus).

2.2 Xxxxxxxxxx

1. Xxxxxxxxxx xxxxxxxx xxxxx. xxxxxxxx SC (xxxxx xxxxxx);

2. Xxxxxxxxxx xxxxxxxxxx xxxxx. capripneumoniae.

3. Xxxxxxxx xxxxxxx

3.1 Xxxx

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

2. xxxxxx xxxxxxxxxxxxxx hlíz xxxxxxxx (Xxxxxx xxxxxxx xxxxx xxxxxx).

3.2 Xxxxx

1. Xxxxxxxxxxxx xxxxxxxxxx (Xxxxxxxxxxxxxxxx oryzae);

2. Xxxxxxxxxxx xxxxxx (Xxxxxxxxxxx xxxxxx, xxx. Xxxxxxxxxxx xxxxxx);

3. Xxxxxxxxxxx xxxx (xxx. Dothidella xxxx).

4. Xxxxxx x xxxxxx xxxxxxxxxxx

1. abrin;

2. aflatoxiny;

3. xxxxxxxx (neurotoxin xxxxxxxxxxxxx);

4. xxxxxxxxxx xxxxxx;

5. bungarotoxin;

6. xxxxxxxxxx;

7. conotoxin;

8. xxxxxxxxxxxx;

9. xxxxxxxxxxx (cyanginosin);

10. xxxxxxx;

11. xxxxx;

12. xxxxxxxxx;

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

14. xxxxxxxxxxxx;

15. xxxxxx Xxxxxxxxxxx xxxxxxxxxxx;

16. xxxxxx Xxxxxxxxxxxxxx xxxxxx;

17. xxxxxxxxxxxxxxx toxiny;

18. xxxxxxxx;

19. volkensin.

5. Xxxxxxxxx xxxxxxxx x xxxxxxxxx xxxxxxxxxxxx organismy

5.1 Xxxxxxxxx xxxxxxxx, xxxxx obsahují xxxxxxxx nukleových xxxxxxx xxxxxxxxxxx s xxxxxxxxxxx xxxxxxxxx uvedených x xxxxxx 1-3.

5.2 Genetické xxxxxxxx, xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx kyselin xxxxxxxx xxxxxxx z xxxxxx uvedených x xxxx 4 nebo xxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxxx x xxxx 4.

5.3 Geneticky xxxxxxxxxxxx xxxxxxxxx, xxxxx xxxxxxxx xxxxxxxx nukleových kyselin xxxxxxxxxxx x xxxxxxxxxxx xxxxxxxxx uvedených x xxxxxx 1-3.

5.4 Xxxxxxxxx xxxxxxxxxxxx organismy, xxxxx xxxxxxxx sekvence nukleových xxxxxxx xxxxxxxx xxxxxxx x toxinů xxxxxxxxx x xxxx 4 xxxx xxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxxx v xxxx 4.

5.5 Xx xxxx xxxxxxxx syntetizovaný xxxxxxxxx xxxxxxxx a xxxxx vytvořené organismy, xxxxx obsahují sekvence xxxxxxxxxx kyselin xxxxxxxxxxx x xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxx 1-3.

5.6 Xx xxxx xxxxxxxx syntetizovaný genetický xxxxxxxx a uměle xxxxxxxxx xxxxxxxxx, které xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxx xxxxxxx x toxinů xxxxxxxxx x bodě 4 xxxx xxxxxxxx xxxxxxxxxxx xxxxxx uvedených v xxxx 4.

Xxxxxxxx:

1) Xxxxxxxxxxxxxx xxxxxxx x xxxx 1.2 9. xxxxxxxx xxxxxxx kmeny xxxxxxxxxx X26, X45, X91, X103, X104, O111, X113, X121, X145, X157 a xxxxx, xxxxxxxxxxx shiga xxxxxx xx xxxxxxx xxxx xxxxxxxx jejich xxxxxxxx. Xxxxxxxx "xxxxxxxxxxxxxx xxxxx Xxxxxxxxxxx coli (XXXX)" xx xxxxxxxxxxxx k xxxxxxxx "xxxxxxxxxxxxx xxxxx Xxxxxxxxxxx coli (XXXX)".

2) Xxxxxxxx pro xxxxxxxxx x toxiny xx xxxxxxxxxx na botulinové xxxxxx (xxx 4.4.) xxxx xxxxxxxxxx (xxx 4.7.) xxxxxxxx x xxxxxxxx přípravcích xxxxxxxxxxxxxx xxxxx xxxxxx x xxxxxxxx.

3) Xxxxxxxxx elementy xxxxxxxx xxxx xxxxxx xxxxxxxxxx, xxxxxx, xxxxxxxx, xxxxxxxxxxx x xxxxxxx, x to xxx xxxxxxxxx modifikované, tak xxxxxxxxxxxxxx.

Xxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxxxxx s xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxx 1-3 xxxxxxxxxxx xxxxxxxxx sekvenci xxxxxxxxxxx xxx některý z xxxx uvedených xxxxxxxxxxxxxx, xxxxx:

x) xxxx taková xxxx xxxxxxxxxxxxxxx svých xxxxxxxxxxxxxx nebo translačních xxxxxxxx xxxxxxxxxxx významné xxxxxxxxx xxx zdraví xxxx, xxxxxx nebo xxxxxxx, xxxx

x) xx xxxxx tím, že x xxxxxx mikroorganismu xxxx x xxxxxxxxxx xxxxxx organismu, xx xxxxxxx může xxx xxxxxxx xxxx jinak xxxxxxxxxxx, zvyšuje xxxx xxxxxxxxx způsobit xxxxx xxxxxxxxx xxxxxx xxxx, xxxxxx xxxx xxxxxxx.

4) X xxxxxxxxxxxxxx xxxxxxxxx x bodě 1.2 9 xx "genetické xxxxxxxx a xxxxxxxxx xxxxxxxxxxxx xxxxxxxxx" xxxxx xxxx 5 vztahují xxxxx xx xxxxxxxx xxxxxxxx xxxxxxxx, xxxxx xxxxxx shiga toxiny (xxxxxxxxxx) x xxxxxxxx xxxxxxx xxxxx xxxxxx, xxxxx xxxxxxxxxx xxxxxxxx, xxxx jejich xxxxxxxxxxx.".

9. Xxxxxxx č. 2 xxx:

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

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

X. Viry

1. xxxxx xxxxxxxxxx encefalitidy (Xxxxxx Xxxxxx xxxxxxxxxxxx xxxxx);

2. xxxxx Xxxxxxx-Xxxxxxxx;

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

4. xxxxx Xxxxxx;

5. virus Guanarito;

6. xxxxx Hendra (Xxxxxx xxxxxxxx xxxxx);

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

8. xxxxx Xxxxxxx;

9. xxxxx Xxxxxx;

10. virus xxxxxxxx xxxxxxxxxxxx, xxxxx xxxxx jaro-letní xxxxxxxxxxxx (Xxxx-xxxxx xxxxxxxxxxxx virus, Xxxxxxx Spring-Summer xxxxxxxxxxxx xxxxx);

11. xxxxx Xxxxxx Xxxxx;

12. virus Nipah;

13. xxxxx Xxxxxxxxx;

14. xxxxx Xxxxx xxxxxxxxxxx xxxxxxx (Xxxx hemorrhagic xxxxx xxxxx);

15. virus Powassan;

16. xxxxx Xxxxxxx,

17. xxxxx Xxxxx;

18. xxxxx Sabiá,

19. xxxxx Seoul;

20. xxxxx xxxxxxx (Louping xxx xxxxx);

21. xxxxx západonilské xxxxxxx (Xxxx Nile xxxxx).

XX. Xxxxxxxx

1. Xxxxxxxxxxx xxxxxxxxxxx - xxxxx xxxxxxxxxxx epsilon xxxxx;

2. Xxxxxxxxxxx tetani;

3. Xxxxxxxxxx xxxxxxxxxxx;

4. Mycobacterium bovis (x xxxxxxxx xxxxx XXX);

5. Mycobacterium xxxxxxxxxxxx (xxxxxxxxxxxxxxxx xxxxx);

6. Xxxxxxxxxxx xxxxxxxxxxx;

7. Xxxxxxxxxxx xxxxxxxxxx xx. citri včetně xxxxx xxxxxxxxxxxx xxxx Xxxxxxxxxxx xxxxxxxxxx xx. xxxxx xxxx X, X, X, X, X xxxx xxxxx xxxxxxxxxxxxx xxxx Xxxxxxxxxxx xxxxx, Xanthomonas xxxxxxxxxx xx. xxxxxxxxxxxx nebo Xxxxxxxxxxx xxxxxxxxxx xx. Xxxxxxxxx;

8. Yersinia pseudotuberculosis.

III. Xxxxx

1. Xxxxxxxxxxxx xxxxxxx;

2. Xxxxxxxxxxxx posadasii;

3. Xxxxxxxxxxxxxx xxxxxxxxx xxx. Virulans (Xxxxxxxxxxxxxx xxxxxxx);

4. Xxxxxxxx xxxxxxxx (xxx. Xxxxxxxx xxxxxxxx x. xx. xxxxxxx);

5. Xxxxxxxx xxxxxxxxxxx (xxx. Xxxxxxxx xxxxxxxx).

XX. Xxxxxx x jejich xxxxxxxxxxx

1. Xxxxxxxxxxx.

X. Xxxxxxxxx elementy x xxxxxxxxx modifikované xxxxxxxxx

1. Xxxxxxxxx xxxxxxxx, které xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxxxxx s xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxx X-XXX.

2. Xxxxxxxxx elementy, které xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxx kódující xxxxxxx x toxinů xxxxxxxxx x bodě XX xxxx xxxxxxxx podjednotky xxxxxx xxxxxxxxx v xxxx XX.

3. Xxxxxxxxx xxxxxxxxxxxx xxxxxxxxx, xxxxx xxxxxxxx xxxxxxxx nukleových xxxxxxx xxxxxxxxxxx x xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxx I-III..

4. Xxxxxxxxx modifikované xxxxxxxxx, xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxx xxxxxxx z xxxxxx xxxxxxxxx x xxxx XX xxxx kódující xxxxxxxxxxx xxxxxx xxxxxxxxx x xxxx XX.

5. Xx xxxx xxxxxxxx xxxxxxxxxxxxx xxxxxxxxx xxxxxxxx x xxxxx xxxxxxxxx xxxxxxxxx, xxxxx xxxxxxxx xxxxxxxx nukleových kyselin xxxxxxxxxxx x xxxxxxxxxxx xxxxxxxxx xxxxxxxxx v xxxxxx I-III.

6. Xx xxxx xxxxxxxx xxxxxxxxxxxxx xxxxxxxxx xxxxxxxx a xxxxx xxxxxxxxx xxxxxxxxx, xxxxx xxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxx kódující xxxxxxx x xxxxxx xxxxxxxxx x xxxx XX xxxx xxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxxx x xxxx XX.

Xxxxxxxx:

Xxxxxxxxx xxxxxxxx xxxxxxxx xxxx xxxxxx xxxxxxxxxx, xxxxxx, xxxxxxxx, transpozony x xxxxxxx, a xx xxx xxxxxxxxx xxxxxxxxxxxx, xxx nemodifikované.

Sekvence xxxxxxxxxx xxxxxxx související x xxxxxxxxxxx xxxxxxxxx xxxxxxxxx x xxxxxx X-xxX xxxxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxxxx xxx některý x xxxx uvedených xxxxxxxxxxxxxx, xxxxx:

x) xxxx xxxxxx nebo xxxxxxxxxxxxxxx xxxxx xxxxxxxxxxxxxx nebo xxxxxxxxxxxx produktů představuje xxxxxxxx xxxxxxxxx xxx xxxxxx xxxx, zvířat xxxx xxxxxxx, xxxx

x) xx známa xxx, xx x xxxxxx xxxxxxxxxxxxxx xxxx u xxxxxxxxxx xxxxxx organismu, xx xxxxxxx může xxx xxxxxxx xxxx xxxxx xxxxxxxxxxx, xxxxxxx xxxx schopnost xxxxxxxx xxxxx xxxxxxxxx xxxxxx xxxx, xxxxxx nebo xxxxxxx.".