Act No. 74 / 2006 Coll.
Act amending Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, as amended, Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, as amended, and Act No. 79 / 1997 Coll., on medicinal products and on the modification and addition of certain related laws, as amended
Valid
Effective from 01.04.2006
74
THE LAW
of 3 February 2006
amending Act No 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended, Act No 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, as amended, and Act No 79 / 1997 Coll., on medicinal products and on the modification and addition of certain related laws, as amended
Parliament has decided on this law of the Czech Republic:
Amendment to the REC
Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 354 / 1999 Coll., Act No. 117 / 2000 Coll., Act No. 132 / 2000 Coll., Act No. 57 / 2001 Coll., Act No. 185 / 2001 Coll., Act No. 407 / 2001 Coll., Act No. 320 / 2002 Coll., Act No. 223 / 2003 Coll., Act No. 362 / 2004 Coll. and Act No. 228 / 2005 Coll., is amended as follows:
1. Paragraph 1, including the title and footnote 1, reads as follows:
Subject matter
(1) This Act provides for the treatment of precursors and auxiliary substances following the directly applicable rules of the European Community1).
(2) This law further regulates
(a) the treatment, export, import and transit operations of addictive substances;
(b) the treatment, export, import and transit operations of products containing or containing addictive substances and precursors (hereinafter referred to as "preparations");
(c) the treatment of products containing ephedrine or more than 30 mg pseudoephedrine per unit of pharmaceutical form;
(d) the cultivation of poppy, hemp and coca and the export and import of macaroni.
1) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors. Council Regulation (EC) No 111 / 2005 of 22 December 2004 laying down rules for the monitoring of trade in drug precursors between the Community and third countries. '
Footnotes 1a and 2 to date are deleted, including references to footnotes.
2. In Section 2, the words "or one or more precursors' shall be added at the end of the text in point (b).
3. in Article 2 (c) and (d), including footnotes 1a and 2:
"(c) by precursor, the substance listed in category 1 of Annex I to the directly applicable Regulation of the European Communities (1a) or in category 1 of the Annex to the directly applicable Regulation of the European Communities (2);
(d) the active substance referred to:
1. in category 2 and 3 of Annex I, the directly applicable Regulation of the European Communities (1a); or
2. in category 2 and 3 of the Annex, the directly applicable regulation of the European Community2),
1a) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council.
(2) Council Regulation (EC) No 111 / 2005. "
4. In Article 2, the words "after harvest 'shall be added at the end of the text of point (e).
5. In Article 2 (h), the words "substances listed in Annexes 9 to 11 to this Act 'are replaced by the words" precursors and excipients of categories 2 and 3 according to the directly applicable regulations of the European Communities (1)'.
6. in Paragraph 2 (i):
"(i) marketing the supply of precursors and excipients of categories 2 and 3 in accordance with the directly applicable regulation of the European Communities (1a),"
7.
Treatment of precursors and excipients
(1) Treatment of precursors and auxiliary substances of categories 2 and 3 means the activities referred to in directly applicable European Community1).
(2) For the treatment of Category 2 and Category 3 auxiliary substances, registration under Article 16 of this Act is required, unless otherwise provided for in this Act. "
8. In Articles 5 (6) and 6 (2), the words "the prison services of the Czech Republic 'shall be inserted after the words" the police of the Czech Republic'.
9. Paragraph 8 (3) reads as follows:
"(3) Authorisation to handle:
(a) addictive substances and preparations are issued for a period of 5 years;
(b) precursors shall be issued for a period laid down directly by the applicable provisions of the European Community1).
Where the applicant so requests, authorisation to handle substances, preparations or precursors may be issued for a shorter period. ';
10. in Article 8 (7), the words "listed in Annex 9 to this Law" shall be deleted;
11. in § 8 (10), § 16 (6) (a) and § 22 (7) (b), the word "false" shall be replaced by "incorrect," § 36 (1) (c), (n), (q), (s), (v) and (x), § 36 (2) (b) and (c), § 36 (3) (b), § 36 (4) (c), (d) and (f), § 36 (5) (b) and Article 39 (1) (b) shall be replaced by the word "false." incorrect. "
12. In Paragraph 12 (1), the words "transmitted or 'shall be inserted after the words" may be'.
13. in Paragraph 12 (2):
"(2) Category 2 precursors and excipients may only be transmitted or sold to persons who submit to the donor or seller a completed declaration of the customer in accordance with the directly applicable European Communities Regulation (1a).";
footnote 5f is deleted.
14. Paragraph 12 (3) is deleted.
Paragraph 4 shall become paragraph 3.
15. Paragraph 12 (3) reads:
"(3) Persons intending to deal with the activities referred to in the directly applicable regulations of the European Community1) with precursors and auxiliary substances of categories 2 and 3 referred to in those regulations are required to ensure their labelling under those rules."
footnote 5g is deleted.
16. in Article 15 (b), the words "Category 2 and 3" shall be inserted after the words "Category 2 and 3," in accordance with the directly applicable Regulation of the European Communities (2), "and the words" immediately binding "shall be replaced by" directly applicable. "
17. in Article 15 (c) (3), the words "treat addictive substances" are replaced by the words "treat them."
18. in Paragraph 16 (1):
"(1) Persons intending to deal with the activities referred to in the directly applicable regulations of the European Community1) with precursors and auxiliary substances of categories 2 and 3 referred to in those regulations are required to register with the Ministry of Health before commencing this activity. The application for registration shall be made in duplicate on forms issued by the Ministry of Health. ';
footnote 7b is deleted.
19. in Paragraph 16 (2), the words "listed in Annex 11 to this Act, the total quantity of which does not exceed the quantity by direct commitment in the calendar year" shall be replaced by the words "Category 3 under the directly applicable regulation of the European Community2) whose total quantity in the calendar year does not exceed the quantity specified in the directly applicable."
20. In Section 20, the words "containing them 'are deleted.
21. footnote 8 is deleted.
22. in Article 20 (2) (a) and Article 21 (2) (a), the words "2, 6, 7 or 8 of this Act" are replaced by "1, 2, 5, 6, 7 or 8 of this Act."
23. in Article 20b (1), the words "listed in Annexes 10 and 11 to this Act" shall be replaced by the words "Category 2 and 3 according to the directly applicable regulation of the European Communities (2)."
24. Paragraph 20b (2) is deleted and paragraph 1 is deleted.
25. In Section 21, the words "containing them 'are deleted.
26. In Article 21 (4), the words "Category 2 and 3 under the directly applicable regulation of the European Community2 'are inserted after the words" excipients'.
27. in Paragraph 28 (1) (a), the words "listed in Annex 10 to this Act and the export reports of the excipients listed in Annex 11 to this Act" shall be replaced by the words "Category 2 and export reports of Category 3 ingredients according to the directly applicable provisions of the European Communities (1)."
28. in Paragraph 28 (1) (b):
"(b) export reports of Category 2 and 3 excipients under the directly applicable Regulation of the European Communities (2) in cases where export authorities8j are required;"
footnote 10e is deleted.
29. in § 28 (1) (c), § 43a of the introductory part of the provisions of paragraph 1, § 43a (1) (a), § 43a (2) (a) and § 43a (4) (a), the words "category 2 and 3 according to the directly applicable provisions of the European Communities" shall be inserted after the words "ingredients."
30. in Paragraph 28 (1) (d), the words "Category 2 and 3, as directly applicable, of the European Communities," shall be inserted after the words "ingredients."
31. Paragraph 32, including the title:
Registration and documentation
(1) The treatment of precursors and auxiliary substances of categories 2 and 3 is subject to registration and documentation according to the directly applicable rules of the European Communities (1).
(2) The treatment of addictive substances and preparations, as well as their import and export, is carried out in a specified manner 10i). The records shall be kept by persons carrying out activities for which authorisation for treatment, export authorisation or import authorisation is required, persons operating a medical establishment, persons operating an institution of constitutional social care, persons providing veterinary care, and persons referred to in Articles 5 (6) and 5 (7).
(3) The requirements and content of the records and documentation, their types, forms of documentation management and the way in which it is kept and verified are laid down by the Ministry of Health by decree. "
footnotes 10j, 10k and 10l are deleted.
32. In Article 33 (1), the words "Category 2 and 3 under the directly applicable provisions of the European Communities (1) 'and" Category 2 and 3 under the directly applicable rules of the European Communities (1)' are inserted after the words "Category 2 and (3) '.
33. The title of Title Eight is "ADMINISTRATIVE DEPARTMENTS."
34. The heading of Section 36 reads as follows: "Administrative offences against legal and business natural persons."
35. In Paragraph 36 of the Introductory Part of the provisions of paragraphs 1 and 5, the words "a person or, where appropriate, a natural person who, when doing business or directly related to him, 'are replaced by the words" or an undertaking natural person'.
36. in Articles 36 (1) (a) and 43 (1), the words "category 2 and 3 in accordance with the directly applicable rules of the European Communities" shall be inserted after the words "ingredients."
37. in Article 36 (1) (i):
"(i) forward or sell precursors or Category 2 excipients to persons who do not submit a completed declaration to the donor or seller pursuant to the directly applicable regulation of the European Communities (Section 12 (2)),";
38. in Paragraph 36 (1) (j), the words "listed in Annex 10 to this Act" are replaced by the words "Category 2 under the directly applicable rules of the European Community1)" and the words "(Paragraph 12 (4))" are replaced by "(Paragraph 12 (3))."
39. in Article 36 (1) (p), the words "Category 2 and 3, according to the directly applicable regulation of the European Communities (2)" shall be inserted after the words "ingredients."
40. in Paragraph 36 (1) (r), the words "or imports precursors without import authorisation2" shall be added at the end of the text.
41. in Article 36 (1) (t), the words "or grows plants of the genus Erythroxylon (coca bush)" shall be deleted;
42. In Paragraph 36 of the introductory part of the provisions of paragraphs 4, 41, 43a (1) (e) and 43a (4) (c), the words "category 2 and 3 according to the provisions of the European Communities directly applicable" shall be inserted after the words "ingredients."
43. In Paragraph 36 (4) (a), the words "listed in Annex 10 to this Act and the export of the excipients listed in Annex 11 to this Act" shall be replaced by the words "Category 2 and the export of Category 3 ingredients according to the provisions directly applicable to the European Communities (1)."
44. in Paragraph 36 (4) (b), the words "until the 15th day of the following month" shall be deleted and the words "listed in Annexes 10 and 11 to this Act" shall be replaced by the words "Category 2 and 3 according to the directly applicable provisions of the European Community2)."
45. in Article 36 (4) (c), the words "listed in Annex 10 to this Act for the previous calendar year and in the export declaration for the excipients listed in Annex 11 to this Act" shall be replaced by the words "Category 2 for the previous calendar year and in the export report for Category 3 as directly applicable by the European Communities (1)."
46. in Article 36 (4) (d), the word "monthly" shall be deleted and the words "Annexes 10 and 11 to this Act" shall be replaced by the words "Category 2 and 3 according to the directly applicable provisions of the European Community2)."
47. In Paragraph 36 (4) (e), the words "and other circumstances under the immediately binding regulation of the European Communities 10n)" shall be replaced by the words "Category 2 and 3 and other circumstances under the directly applicable regulations of the European Communities (1), (10n)" and, after the words "transactions with", insert the word "these."
48. The heading of Section 37 reads "Penalties."
49. In Paragraph 37, the word "offences' is replaced by" offences' and the words "letters' are replaced by" letters'.
50. In Article 37, the words "to a legal person or, where appropriate, to a natural person who, in business or in direct connection with it, is deleted 'are deleted.
51. Paragraph 38, including the title, reads:
Falling and preventing things
(1) For the administrative offence referred to in Article 36, forfeiture of addictive substances, preparations, precursors and excipients of categories 2 and 3 may be imposed in accordance with the directly applicable rules of the European Communities (1), equipment and materials required for their manufacture if:
(a) belong to the perpetrator of the administrative offence and are intended to commit the administrative offence;
(b) have been used to commit an administrative offence;
(c) have been obtained by committing an administrative offence; or
(d) have been acquired for an administrative delicacy acquired.
(2) Where the confiscation of a case referred to in paragraph 1 has not been imposed, it may be decided that such a case shall take effect if it belongs to an offender who cannot be prosecuted for an administrative offence, or is not the perpetrator of an administrative offence, or is not wholly owned, and where the safety of persons or property so requires, or any other general interest.
(3) The owner of the forfeited or seized thing becomes. "
52. The heading of § 39 reads: "Transfers."
53. In Section 40, the words "on penalties' are deleted.
54. In Article 40 (4), the words "the offence of a legal person referred to in Article 36 (1), with the exception of an administrative offence 'are replaced by the words" offences referred to in Article 36 (1), with the exception of an administrative offence referred to in Article 36 (1) (t), and the words "committed' are replaced by the words" committed '.
55. in Paragraph 40 (5), the words "Administrative offence of legal persons" shall be replaced by the words "Administrative offence" and the words "Administrative offence" shall be replaced by "Administrative offence";
56. in Paragraph 40 (6), the words "Administrative offence of legal persons under" shall be replaced by the words "Administrative offences under Article 36 (1) (t) (a)";
57. in Paragraph 40 (7), the words "Administrative offence of legal persons" are replaced by "Administrative offences."
58. in § 41a, the words "Category 2 and 3, according to the directly applicable regulation of the European Community2," shall be inserted after the words "ingredients."
59. In Paragraph 42, the first sentence is replaced by the following: "In all official documents, commercial documents and forms, substance names shall be used according to the annexes to this Act, in the case of precursors and auxiliary substances of categories 2 and 3, names shall be used according to the directly applicable regulations of the European Communities (1)."
61. in Article 43a (2) (b), the words "Category 2 and 3 of the directly applicable regulations of the European Communities" shall be inserted after the words "Category 2 and 3" and the words "Annexes 9, 10 and 11 to this Act" shall be replaced by the words "Annex I to the directly applicable regulation of the European Communities (1a) and Annex to the directly applicable regulation of the European Communities (2)."
61.Paragraph 43a (3) is deleted.
Paragraph 4 shall become paragraph 3.
62. In Paragraph 43a (3) (b), the words "Category 2 and 3 of the directly applicable regulations of the European Communities" shall be inserted after the words "Category 2 and 3" and the words "Annexes 9, 10 and 11 to this Act" shall be replaced by the words "Annex I, directly applicable regulation of the European Communities" and Annex, directly applicable regulation of the European Communities (2). "
63.In Paragraph 43a (3) (d):
"(d) check that the exported quantities of Category 3 excipients do not exceed the limits set by the directly applicable Regulation of the European Communities (2), (7c),"
(64) In Article 43a (3) (e), the words "Category 2 and 3" shall be inserted after the words "Category 2 and 3" in accordance with the directly applicable Regulation of the European Communities (2). "
65. The following Section 44b is inserted after Section 44a, which includes the title:
Form forms
Forms of forms referred to in Articles 5 (7), 8 (7) and 11, 9 (10), 16 (1), 22 (2), 25 (1), 26 (1), 27 (1), 28 (3), 30, 31 (1) and 43 (6) shall be laid down by the Ministry of Health by decree and shall also be published in a way that allows remote access. '
66. In Article 45 (3), the words "category 2 and 3 under the directly applicable regulation of the European Communities (1a) 'shall be inserted after the words" excipients'.
67. In Annex 1, in the column "International Non-Proprietary Name (INN) in the Czech language ', the entry" Cannabis extract and tincture' is inserted after the entry "Macadamia concentrate '.
68. In Annex 4, the words "or as decided by the institutions of the European Communities' shall be added at the end of the title.
69. In Annex 4, in the column "Other international non-proprietary name or common name ', the entry" 2C- I' is inserted after the entry "DOB 'and in the column" Chemical name' the words "4-iodine-2,5-dimethoxyphenethylamine '.
70. In Annex 4, in the column "Other international non-proprietary name or common name ', the entry" 2C- T-2' is inserted after the entry "2C- I 'and in the column" Chemical name' the words "2,5-dimethoxy-4-ethylthiofenetylamine '.
71. In Annex 4, in the column "Other international non-proprietary name or common name ', the entry" 2C-T-2' is inserted after the entry "2C- T7 'and in the column" Chemical name' the words "2,5-dimethoxy-4- (n) -propylthiofenetylamine '.
72. In Annex No 4, in the column "Other international non-proprietary name or common name ', the entry" TMA-2' is inserted after the entry "TMA 'and in the column" Chemical name', the words "dl-2-amino-1- (2,4,5-trimethoxyphenyl) propane '.
(73) Annexes 9, 10 and 11 are deleted.
Transitional provision
Authorisations for the treatment of addictive substances, preparations and precursors issued by the Ministry of Health pursuant to Act No. 167 / 1998 Coll., as effective until the date of entry into force of this Act, shall remain valid until the expiry of the period for which it was issued.
Amendment to the Public Health Protection Act
Act No. 258 / 2000 Coll., on the Protection of Public Health and on the Amendment of Certain Related Acts, as amended by Act No. 254 / 2001 Coll., Act No. 274 / 2001 Coll., Act No. 13 / 2002 Coll., Act No. 76 / 2002 Coll., Act No. 86 / 2002 Coll., Act No. 120 / 2002 Coll., Act No. 309 / 2002 Coll., Act No. 320 / 2002 Coll., Act No. 274 / 2003 Coll., Act No. 356 / 2003 Coll., Act No. 253 / 2005 Coll., Act No. 362 / 2005 Coll., Act No. 392 / 2005 Coll., Act No. 326 / 2004 Coll., Act No. 562 / 2004 Coll., Act No. 125 / 2005 Coll., Act No. 253 / 2005 Coll., Act No. 381 / 2005 Coll., Act No. 392 / 2005 Coll., Act No. 444 / 2005 Coll.
1. in Paragraph 84 (1) (r):
"(r) may order the immediate closure of an establishment or the suspension of an establishment for a period of no more than 2 days following the date of the finding of an infringement which may result in a threat to life or health;"
2. In the first sentence of Paragraph 84 (2) "comma 'is deleted and" l) and (r)' is replaced by "a) '.
3. In the first sentence of Article 84 (3), the words "(r) and 'shall be inserted after the words" paragraph 1 (a)' and the words "second and third sentences' shall be replaced by the words" This measure shall be notified orally by the staff member of the public health authority to the person referred to in the first sentence of Article 88 (2) and shall be recorded in writing. The measures referred to in paragraph 1 (r) and those referred to in paragraph 1 (u) by which the staff member of the competent public health authority shall order the disposal or disposal of food, raw materials, semi-finished products or foodstuffs for the production or preparation of food or epidemiologically hazardous food shall be effective at the time of its notification. If, in the case referred to in paragraph 1 (r), there is no remedy for the infringement found, the Director of the competent public health authority shall be entitled to extend the period until the fault has been remedied; the administrative rules do not apply to this measure. If the checked person does not agree with the measure referred to in paragraph 1 (u) or the measure referred to in the fourth sentence, he may object to them in writing, no later than 3 days after the date of the registration or measure referred to in the fourth sentence. ';
4. In the first sentence of Paragraph 94 (4), "(r) 'is deleted.
EFFECTIVE
This Law shall take effect on the first day of the first month following its publication, except for Part Two, which shall take effect on the day of its publication.
Zaoralek v. r.
Klaus v. r.
Paroubek v. r.
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Regulation Information
| Citation | Act No. 74 / 2006 Coll., amending Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, as amended, Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, as amended, and Act No. 79 / 1997 Coll., on medicinal products and on the modification and addition of certain related laws, as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 15.03.2006 |
|---|---|
| Effective from | 01.04.2006 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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