Amendment Of The Act On Addictive Substances

Original Language Title: změna zákona o návykových látkách

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74/2006 Sb.



LAW



of 3 July 2003. February 2006,



amending the Act No. 167/1998 Coll., on addictive substances and amending

certain other laws, as amended, law No.

258/2000 Coll., on the protection of public health and amendment to certain

related acts, in the wording of later regulations, and Act No. 79/1997

Coll., on pharmaceuticals and on amendments and additions to some related laws,

in the wording of later regulations



Change: 378/2007 Sb.



Parliament has passed the following Act of the Czech Republic:



PART THE FIRST



Amendment of the Act on addictive substances



Article. (I)



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 hereby amended as follows:



1. § 1, including title and footnote No 1 is added:



"section 1



The subject of the edit



(1) This Act regulates the following on directly applicable provisions of

Of the European Communities ^ 1) dealing with precursors and auxiliary substances.



(2) This Act regulates the



and treatment with drugs), their export, import and transit

operations with them,



(b)) treatment with preparations containing addictive substances or precursors

or containing addictive substances and precursors (hereinafter referred to as "products"),

their export, import and transit operations with them,



(c)) the handling of products containing ephedrine or a larger quantity than

30 mg of pseudoephedrine in unit dosage forms,



(d)), cannabis and poppy cultivation of coca and poppy concentrate exports and imports.



1) European Parliament and Council Regulation (EC) No 273/2004 of 11 March 2004.

February 2004 on drug precursors.



Council Regulation (EC) No 111/2005 of 22 December 2004. December 2004

laying down rules for the monitoring of trade in drug precursors between the

The community and third countries. '.



Former footnote No. 1a and 2 are deleted, including the links

on a footnote.



2. In article 2, subparagraph (b) at the end of the text), the words "or one or

more precursors ".



3. In article 2 (c)), and (d)), including footnotes no 1a and 2 are inserted:



"(c)) prekursorem substance listed in category 1 of annex I directly

Regulation of the European communities applicable ^ 1a) or in the category 1

the annex to the regulation directly applicable European Community ^ 2)



d) excipient substance



1. in the category 2 and 3 of annex I to the regulation directly applicable European

Community ^ 1a), or



2. in the category 2 and 3 of the annex to the regulation directly applicable European

Community ^ 2)



1A) the regulation of the European Parliament and of the Council (EC) No 273/2004.



2) of Council Regulation (EC) No 111/2005. ".



4. In section 2, subparagraph (e) at the end of the text), the words "after the harvest".



5. In section 2 (a). (h)), the words "the substances referred to in annexes 9 to 11

This law "shall be replaced by the words" precursors and auxiliary substances of category

2 and 3 according to the applicable regulations of the European communities directly ^ 1) ".



6. In section 2 of the letter i) is added:



"i) placing on the market of delivery of precursors and auxiliary substances of category 2 and 3

According to the regulation of the European communities directly applicable ^ 1a) ".



7. section 3a title, including:



' section 3a



Treatment with precursors and auxiliary substances



(1) handling of precursors and auxiliary substances of category 2 and 3

the activities referred to in the applicable regulations of the European

the community of ^ 1).



(2) for the treatment of ancillary substances of category 2 and 3 need registration

According to § 16 of this Act, unless otherwise provided by this Act. ".



8. In section 5 (3). 6 and section 6 (1). 2, after the words "the police of the Czech Republic"

the words ", the prison service of the Czech Republic."



9. In section 8 paragraph 3 reads:



"(3) the authorization to the treatment of



and) addictive substances and preparations shall be issued for a period of 5 years,



b) precursors embarks on a period to be determined directly applicable provisions

Of the European Communities ^ 1).



If the applicant so requests, the authorisation may be granted for the treatment of addictive

substances, preparations or precursors and issued for a shorter period. ".



10. In section 8 (2). 7, the words "referred to in annex 9 of this law"

shall be deleted.



11. In section 8 (2). 10, § 16. 6 (a). and) and in section 22, paragraph. 7 (b). (b))

the word "false" is replaced by "incorrect" in § 36 odst. 1

(a). (c)), n), (q)),),), and x), § 36 odst. 2 (a). (b)), and (c)), § 36 odst. 3

(a). (b)), § 36 odst. 4 (b). (c)), d) and (f)), § 36 odst. 5 (a). (b)) and in section

paragraph 39. 1 (a). (b)), the word "false" is replaced by "incorrect".



12. In section 12, paragraph. 1, after the words "may be", the words "passed

or ".



13. In section 12 paragraph 2 is added:



"(2) the Precursors and auxiliary substances in category 2 may be transmitted or

sold only to persons who submit to the controller or to the seller

the completed Declaration of the customer according to the directly applicable regulation

Of the European communities ^ 1a). ".



Footnote No. 5f is hereby repealed.



14. In article 12, paragraph 3 is deleted.



Paragraph 4 becomes paragraph 3.



15. In section 12 paragraph 3 reads:



"(3) persons who intend to deal with the activities referred to in

applicable regulations of the European communities "^ 1") with the precursors and

auxiliary substances of category 2 and 3 referred to in these regulations are

required to ensure their labelling in accordance with these regulations. ".



Footnote No. 5 is repealed.



16. In section 15 (b). (b)), for the words "AIDS", the words

"category 2 and 3 according to the directly applicable European regulation

Community ^ 2) "and the words" immediately the authentic "are replaced by the words

"directly applicable".



17. In article 15 (b). (c)), point 3, the words "treated with addictive substances"

replaced by the words "treat them."



18. In section 16, paragraph 1 reads:



"(1) persons who intend to deal with the activities referred to in

applicable regulations of the European communities "^ 1") with the precursors and

auxiliary substances of category 2 and 3 referred to in these regulations are

required to register before beginning this activity for the Ministry of

health care. The application for registration shall be submitted in duplicate to the

Forms issued by the Ministry of health. ".



Footnote No. 7b shall be repealed.



19. In section 16. 2, the words "referred to in annex 11 of this Act,

the total amount does not exceed the quantity referred to in the calendar year

immediately to the mandatory "shall be replaced by" category 3 according to the right

Regulation of the European communities applicable ^ 2), whose total

the quantity in the calendar year does not exceed the quantity laid down in the

the applicable ".



20. In the heading of section 20, the words "with their content" shall be deleted.



21. Footnote 8 is deleted.



22. In section 20 (2). 2 (a). and) and § 21. 2 (a). and the words ") 2, 6, 7

or 8 of this Act "shall be replaced by" 1, 2, 5, 6, 7 or 8 of this

the law ".



23. In section 20b paragraph. 1, the words "referred to in annexes 10 and 11 of this

the law "is replaced by" category 2 and 3 according to the directly applicable

Regulation of the European communities ^ 2) ".



24. In section b, paragraph 2 shall be deleted and shall be deleted at the same time indication

of paragraph 1.



25. In the heading of section 21, the words "with their content" shall be deleted.



26. In § 21. 4, after the words "adjuvants", the words

"category 2 and 3 according to the directly applicable European regulation

Community ^ 2) ".



27. In section 28 paragraph. 1 (a). and the words ") referred to in annex 10 of this

law and reports on export of excipients listed in annex No 11

This law "shall be replaced by" category 2 and reporting of exports

auxiliary substances of category 3 according to the directly applicable provisions

Of the European Communities ' ^ 1 ') ".



28. In section 28 paragraph. 1 (b)):



"(b)) reports on export of auxiliary substances of category 2 and 3 by directly

Regulation of the European communities applicable ^ 2) in the cases

requires export permits ^ 8j) ".



Footnote No. 10e is hereby repealed.



29. In section 28 paragraph. 1 (a). (c)), section 43a of the introductory part of paragraph 1,

§ 43a paragraph. 1 (a). and, § 43a paragraph). 2 (a)) and in section 43a, paragraph. 4 (b).

a), the words ' of excipients ", the words" category 2 and 3 according to the

directly applicable regulations of the European Communities ' ^ 1 ') ".



30. in the first subparagraph of section 28. 1 (a). (d)), after the words "adjuvants"

the words "category 2 and 3 according to the applicable regulations of the European right

the community of ^ 1) ".



31. section 32, including a title:



"§ 32



Registration and documentation



(1) on treatment with precursors and auxiliary substances of category 2 and 3

leads registration and documentation by directly applicable regulations

Of the European Communities ^ 1).



(2) for the treatment of addictive substances and preparations, as well as their

imports and exports with the specified way leads ^ 10i). The registration of

they are obliged to keep persons who carry out the activities for which it is to be

authorization to the treatment of the export permit or import permit,

persons who operate a health facility, the person operating the

institutional social care, persons who provide health

care, and the persons referred to in section 5 (3). 6 and section 5 (3). 7.



(3) the particulars and content of registration and documentation of their species, forms

management of documentation and the way it provides authentication and retention

The Ministry of Health decree. ".



Footnote No 10j, 10 k and 10 are deleted.
32. In § 33 paragraph. 1 the words "other ingredients", the words

"category 2 and 3 according to the applicable regulations of the European right

the community of ^ 1) "and the words" adjuvants ", the words" category 2 and 3

by directly applicable regulations of the European Communities ' ^ 1 ') ".



33. the title of the head of the eighth: "ADMINISTRATIVE DELICTS".



34. the heading of section 36: "administrative delicts of legal and doing business

natural persons ".



35. In section 36 of the introductory part paragraphs 1 and 5, the words "the person,

or natural person in business or in direct connection with the

him, "shall be replaced by" natural person "or doing business.



36. In § 36 odst. 1 (a). and section 43, paragraph). 1, after the words "extension

substances ", the words" category 2 and 3 according to the directly applicable

regulations of the European Communities ' ^ 1 ') ".



37. In § 36 odst. 1 letter i) is added:



"i) transmit or sell the precursors or auxiliary substances of category 2 persons

that the transferring or the seller does not submit the completed statement

According to the regulation of the European communities directly applicable ^ 1a) (section 12 of the

paragraph. 2),".



38. In § 36 odst. 1 (a). j), the words "referred to in annex 10 of this

the law "is replaced by" category 2 according to the directly applicable provisions

Of the European communities "^ 1") "and the words" (section 12, paragraph. 4) "are replaced by the words

"(section 12, paragraph. 3) ".



39. In § 36 odst. 1 (a). p), the words "AIDS", the words

"category 2 and 3 according to the directly applicable European regulation

Community ^ 2) ".



40. In § 36 odst. 1 (a). r) at the end of the text, the words "or

imported precursors without an import permit ^ 2) ".



41. In § 36 odst. 1 (a). t), the words ", or cultivated plants of the genus

Erythroxylon (Coca shrub) ' shall be deleted.



42. In the introductory part of section 36 the provisions of paragraph 4, § 41, § 43a paragraph. 1

(a). (e)) and in section 43a, paragraph. 4 (b). (c)), for the words "adjuvants"

the words "category 2 and 3 by directly applicable regulations

Of the European Communities ' ^ 1 ') ".



43. In § 36 odst. 4 (b). and the words ") referred to in annex 10 of this

the Act on the export and auxiliary substances set out in annex 11 of this

the law "is replaced by" category 2 and on the export of excipients

category 3 according to the applicable regulations of the European right

the community of ^ 1) ".



44. In § 36 odst. 4 (b). (b)), the words "to the 15th day of the following

month ' shall be deleted and the words "referred to in annexes 10 and 11 of this

the law "is replaced by" category 2 and 3 according to the directly applicable

Regulation of the European communities ^ 2) ".



45. In § 36 odst. 4 (b). (c)), the words "referred to in annex 10 of this

the Bill for the previous calendar year, and in reporting on the export of excipients

referred to in annex 11 of this law "shall be replaced by" category 2

for the previous calendar year, and in reporting on the export of excipients

category 3 according to the applicable regulations of the European right

the community of ^ 1) ".



46. In § 36 odst. 4 (b). (d)), the word "month" is deleted, and the words

"listed in annexes 10 and 11 of this Act" are replaced by the words

"category 2 and 3 according to the directly applicable European regulation

Community ^ 2) ".



47. In § 36 odst. 4 (b). e), the words "and on the other the circumstances under

Regulation of the European communities immediately binding ^ 10n) "

shall be replaced by "categories 2 and 3 and of other circumstances by directly

applicable regulations of the European Communities 1, ^ ^) 10n) "and the words

"the transactions with" insert the word "such".



48. the heading of section 37 added: "Sanctions".



49. In section 37, the word "offenses" shall be replaced by the word "tort" and the words "in accordance with

the letters "are replaced by the words" according to the letter ".



50. In section 37, the words "legal person or natural person that, when

business or in direct connection with him, "shall be deleted.



51. section 38 of the title, including:



"§ 38



Forfeiture and prevents things



(1) for the administrative offence under section 36, you can save the forfeiture abuse

substances, preparations, precursors and auxiliary substances of category 2 and 3 according to the

directly applicable regulations of the European Communities ^ 1), equipment and

materials needed for their manufacture, if



and belongs to the offender misconduct) and have been to commit the administrative

tort are intended,



(b)) have been used to commit misconduct,



(c)) have been committing misconduct or



(d)) have been acquired as a matter of administrative deliktem obtained.



(2) if it has not been saved, the confiscation of the things referred to in paragraph 1, can be

decide that such a thing works, if the offender belongs,

not for the administrative offence to prosecute, or do not belong to the perpetrator of the administrative

tort or does not belong, and where required by the safety of persons, or

property or another general interest.



(3) the owner of the forfeited or seized things becomes the State. ".



52. the heading of section 39 is "Offences".



53. In the heading of section 40, the words "sanctions" are deleted.



54. In the first subparagraph of section 40. 4, the words "the offence of legal persons according to § 36 odst. 1,

with the exception of the administrative tort "is replaced by" offenses under § 36 odst.

1, with the exception of the administrative tort according to § 36 odst. 1 (a). t) and administrative

offences "and the word" committed "shall be replaced by the word" committed ".



55. In the second subparagraph of section 40. 5, the words "Administrative tort legal persons" shall be replaced by

the words "administrative delicts" and the words "administrative offence" shall be replaced by the

the words "administrative delinquencies by".



56. In the second subparagraph of section 40. 6, the words "Administrative tort legal entities according to the"

replaced by the words "Administrative offenses under § 36 odst. 1 (a). t) and ".



57. In the second subparagraph of section 40. 7, the words "Administrative tort legal persons" shall be replaced by

the words "administrative delicts".



58. In section 41a, the words "other ingredients", the words "category 2

and 3 by directly applicable European Community regulation ^ 2) ".



59. In article 42, the first sentence shall be replaced by the phrase "In any of the official

documents, commercial documents and forms must be used for the names of the

addictive substances in annexes to this law, in the case of precursors and

auxiliary substances of category 2 and 3 by the names directly applicable regulations

Of the European Communities ^ 1). ".



60. In section 43a, paragraph. 2 (a). (b)), for the words "adjuvants"

the words "category 2 and 3 according to the applicable regulations of the European right

the community of ^ 1) "and the words" in annexes 9, 10 and 11 of this Act "

shall be replaced by ' in annex I to the regulation directly applicable European

Community ^ 1a) and in the annex to the regulation directly applicable European

Community ^ 2) ".



61. In section 43a, paragraph 3 is deleted.



Paragraph 4 becomes paragraph 3.



62. In section 43a, paragraph. 3 (b). (b)), for the words "adjuvants"

the words "category 2 and 3 according to the applicable regulations of the European right

the community of ^ 1) "and the words" in annexes 9, 10 and 11 of this Act "

shall be replaced by ' in annex I to the regulation directly applicable European

Community ^ 1a) and in the annex to the regulation directly applicable European

Community ^ 2) ".



63. In section 43a, paragraph. 3 (d)):



"(d)) shall check the exported quantities of auxiliary substances of category 3, that

do not exceed the limits laid down by a regulation directly applicable European

Community ^ 2) ^ 7 c) ".



64. In section 43a, paragraph. 3 (b). (e)), after the words "adjuvants"

the words "category 2 and 3 according to the directly applicable European regulation

Community ^ 2) ".



65. the following section shall be added to § 44a 44b, which including the title:



"section 44b



Forms forms



Forms forms referred to in section 5 (3). 7, § 8 paragraph. 7 and 11, section 9

paragraph. 10, § 16. 1, section 22, paragraph. 2, § 25 paragraph. 1, § 26 paragraph. 1, section 27

paragraph. 1, § 28 paragraph. 3, section 30, section 31, paragraph. 1 and section 43, paragraph. 6 provides

The Ministry of Health decree and published also in a way

enabling remote access. ".



66. In section 45, paragraph. 3, after the words "adjuvants", the words

"category 2 and 3 according to the directly applicable European regulation

^ 1a) community ".



67. in annex No. 1, in the column "International non-proprietary name (INN)

Czech language "after the entry" concentrate of poppy concentrate "is inserted

the entry "Cannabis extract and tincture".



68. In the annex No. 4 at the end of the title, the words "or in accordance with

the decision of the institutions of the European communities ".



69. in annex No 4 in the column "other international non-proprietary name or

the generic name "is" time "the following new item" 2 c-I "and

the column "chemical name" words "4-iodo-2.5-dimethoxyfenetylamin".



70. in annex No 4 in the column "other international non-proprietary name or

the generic name "per item" 2 c-I "the following new item" 2 c-T-2 ", and in the

the column "chemical name" words "2.5-dimethoxy-4-etylthiofenetylamin".



71. in annex No 4 in the column "other international non-proprietary name or

the generic name "per item" 2 c-T-2 "the following new item" 2 c-T-7 "and to

the column "chemical name" words

"2.5-dimethoxy-4-(n)-propylthiofenetylamin".



72. in annex No 4 in the column "other international non-proprietary name or

the generic name "is" DARK "inserted after the entry" TMA-2 "and to

the column "chemical name" words

"dl-2-amino-1-(2, 4, 5-trimethoxyfenyl) propane".



73. Annex No. 9, 10 and 11 shall be deleted.



Article II



The transitional provisions of the



The authorization to the treatment of addictive substances, and precursors

issued by the Ministry of health under Act No. 167/1998 Coll., in

the texts of the effective to date of the entry into force of this Act, shall remain in

valid until the expiry of the period for which it was issued.



PART THE SECOND



Amendment of the Act on the protection of public health
Article. (III)



Act No. 258/2000 Coll., on the protection of public health and amendment to certain

related laws, 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 SB., law No.

362/2003 Coll., Act No. 167/2004 Coll., the 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. and Act No 444/2005 Coll., amended

as follows:



1. In section 84, paragraph. 1 the letter r) reads:



"r") may order the immediate closure of the establishment or suspension

activities for a period of not more than 2 days from the time the following operating

the finding of an infringement, which may result in a threat to the

life or health ".



2. In section 84, paragraph. 2 the first sentence, after the word "h)" comma be deleted, and the words

"l) and r)" shall be replaced by the words "and l)".



3. In section 84, paragraph. 3 the first sentence, after the words "paragraph 1 (b)."

the words "r) and" and the second and third sentences are replaced by the phrases "this measure

notify the employee of the protection of the public health authority orally person referred to

in the section, paragraph 88. 2 the first sentence and make a written record of it. The measures referred to in

paragraph 1 (b). r) and measures referred to in paragraph 1 (b). u), which

staff of the competent authority to protect public health orders

depreciation or disposal of food, raw materials, semi-finished product or food to

the manufacture or preparation of a food or an epidemiological risk food is

effective at the moment of its notification. Unless, in the case referred to in paragraph 1

(a). r) to remove the detected violations of the obligations, the Director of the

the competent authority shall be entitled to the protection of public health, this time limit

extended until the removal of the defect; for this measure does not apply

the administrative code. If the controlled person with measures pursuant to

paragraph 1 (b). u) or with the measures referred to in the fourth sentence, it can against them

submit a written objection, not later than 3 days from the date of the writing of the minutes or

the measures referred to in the fourth sentence. ".



4. In section 94, paragraph. 4, the first sentence, the word "r"), "be deleted.



PART THE THIRD



cancelled



Article IV



cancelled



PART THE FOURTH



The EFFECTIVENESS of the



Article. In



This Act shall take effect on the first day of the first month following

After the date of its publication, with the exception of the latter, which shall take effect

on the day of its publication.



Zaorálek in r.



Klaus r.



Paroubek in r.

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