141/2009 Sb.
LAW
of 28 June. April 2009,
amending the Act No. 167/1998 Coll., on addictive substances and amending
certain other acts, as amended, and certain other
the laws of the
Parliament has passed the following Act of the United States:
PART THE FIRST
Amendment of the Act on addictive substances
Article. (I)
Act No. 167/1998 Coll., on substance abuse and on the amendment of certain other
laws, as amended by Act No 354/1999 Coll., Act No. 121/2000 Coll., Act
No 132/2000 Coll., from ákona No 57/2001 Coll., Act No. 185/2001 Coll., Act
No. 407/2001 Coll., Act No. 320/2002 Coll., Act No. 222/2003 Coll., Act
No 362/2004 Coll., Act No. 228/2005 Coll., Act No. 74/2006 Coll., Act
No 124/2008 Coll. and Act No. 41/2009 Coll., is amended as follows:
1. in article 1, paragraph 1, including footnote No 1 is added:
"(1) this Act regulates the following on directly applicable provisions of
Of the European Communities ' ^ 1 ') treatment of precursors and other substances and
provides the power and scope of the administrative bodies of compliance with the
the obligations laid down by law and the directly applicable provisions
Of the European Communities ' ^ 1 '), which, according to these directly applicable
regulations of the European Communities shall be exercised by the Member State.
1) European Parliament and Council Regulation (EC) No 273/2004 of 11 March.
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
Community and third countries.
Commission Regulation (EC) No 1277/2005 of 27 June. July 2005
detailed rules for the regulation of the European Parliament and of the Council (EC)
No 273/2004 on drug precursors and for Council Regulation (EC) No 111/2005,
laying down rules for the monitoring of trade in drug precursors between the
Community and third countries. '.
2. In article 1 (1). 2 (a). (c)), the words "a greater amount than the 30 mg
pseudoephedrine in the drive of the formulation "shall be replaced by
"pseudoephedrine".
3. In § 3a paragraph 2. 1, the words "category 2 and 3 ' shall be deleted.
4. In section 3a is inserted after paragraph 1, paragraph 2, which reads as follows:
"(2) the handling of precursors is subject to authorization or special
authorisation in accordance with applicable regulations of the European right
Community ^ 1). ".
The former paragraph 2 becomes paragraph 3.
5. In section 3a, paragraph 3 reads:
"(3) to the treatment of the other category 2 and 3 shall be
registration or special registration under directly applicable regulations
Of the European Communities ^ 1). ".
6. In section 4, 7, § 17 para. 1, § 18 para. 1, § 19 para. 2, § 26 para. 1 to
3 and § 36 odst. 1 (b). (b)), the words "products and precursors"
replaced by the words "and preparations".
7. in § 5 para. 2 (a). (g)), the word "laboratory" is replaced by
"assistants".
8. in § 5 para. 3 the words "products and precursors" shall be replaced by
"and preparations," and the words "products and precursors" shall be replaced by
"and preparations".
9. section 6, including the title.
10. In § 8 para. 1, the second sentence is replaced by the phrase "the authorization to the treatment
is not issued if the person fails to comply with the requirements for a request under
paragraph 7. ".
11. In § 8 para. 3 (b). (b) set out) the words "directly applicable
regulations of the European Communities ^ 1) "is replaced by" 3 years and special
the authorization to the treatment of precursors is issued for an unlimited period of time. "
12. In section 8 paragraph 1. 7, the first sentence of the following sentence "the application shall
provide proof of the applicant's statements that, in the case of activities which are
comes into direct contact with addictive substances and preparations will be elected
the appropriate way to their security pursuant to section 10 and 11 ".
13. in § 9 para. 3 the words "to the treatment of addictive substances" are deleted.
14. in § 13 para. 1, the first sentence is replaced by the phrase "Drug ^ 6) containing the
addictive substances and medicines containing ephedrine and pseudoephedrine may be
issued in a pharmacy to a person that has not been issued a permit to the treatment,
only on prescription, requisition, or no prescription limited ^ 6a). ".
Footnote No. 6 and 6a shall be inserted:
"6) Law No 378/2007 Coll., on pharmaceuticals and on changes of some
related laws (law on medicinal products), as amended.
6a) § 39 para. 3 of the law No 378/2007 Sb. ".
Former footnote No. 6a and 6b are referred to as comments below
line no. 6b and 6 c, including references to footnotes.
15. In § 13 para. 1 the second sentence, the words "a recipe or requisition marked"
replaced by the words "released only on a prescription or requisition marked".
16. in article 13, paragraph 5 is added:
"(5) on receipt, inventory, supply, return and the depreciation of the returned
the forms of recipes and requisitions with a blue stripe lead the municipal authorities of municipalities with
extended powers. As part of this registration is done by the annual
counting on the last day of the calendar year. ".
17. in section 16 of title is "Registration bodies engaged in the activities with the
the other ingredients ".
18. in article 16, paragraph 1 reads:
"(1) persons who intend to deal with the activities referred to in
applicable regulations of the European communities on drug precursors, and
it with the other ingredients in category 2 and 3 referred to in these regulations,
are required to register before beginning this activity for
The Ministry of health. An application for registration shall be submitted within 2
copies on forms issued by the Ministry of health. ".
19. in section 17(2). 1 and in section 18 para. 1 the words "and in section 6 (1). 1 (b). and)
(a). 2 ' shall be deleted.
20. in section 19 para. 2, the words "and in section 6 (1). 1 (b). and) "are deleted.
21. section 20a including title and footnote No. 8b:
"section 20a
The export and import of precursors
When you export and import of precursors of the process according to the directly applicable
the laws of the European Community on trade in drug precursors ^ 8b).
8B) 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
Community and third countries.
Commission Regulation (EC) No 1277/2005 of 27 June. July 2005
detailed rules for the regulation of the European Parliament and of the Council (EC)
No 273/2004 on drug precursors and for Council Regulation (EC) No 111/2005,
laying down rules for the monitoring of trade in drug precursors between the
Community and third countries. '.
Footnote No. 8 c-8i are deleted, including links to
the footnote.
22. section 20b including title:
"section 20b
The export of excipients
When you export the excipients listed in category 2 and 3 directly
applicable regulations of the European communities on drug precursors ^ 1)
follow the directly applicable provisions of the European communities on
trade in drug precursors ^ 8b) ".
Footnote # 8 k is deleted, including a link to the note under
line.
23. in section 22 para. 3 at the end of the text of the third sentence, the words ",
including the reason why import or export has not taken place ".
24. in section 26 para. 1 (b). a) to (c)) and in section 26 para. 3 (b). a), the words "
, products and precursors "shall be replaced by the words" and preparations ".
25. in section 26 para. 2 to 4, the words "and in section 6 (1). 3 "shall be deleted.
26. in section 27 para. 1 the first sentence, the words "regional authority" be replaced by
the words "State Institute for drug control", and in the second sentence, the words
"Ministry of health" shall be replaced by the words "State Institute for
drug control ".
27. in section 27 para. 2, the words "regional authority" be replaced by "State
Institute for drug control ".
28. section 28 including the title reads as follows:
"section 28
The obligation for activities with other ingredients
(1) persons who are engaged in, or in the last calendar year
deal with the activities set out in the applicable regulations of the European
Community ^ 1) with the other category 2 and 3 set out in these
regulations, are required to transmit to the Ministry of health
and). February for the previous calendar year summary reports on the
activities with the other category 2 and 3 according to the directly applicable
regulations of the European Communities ' ^ 1 '),
(b)), all information about unusual circumstances by the directly applicable
regulations of the European Communities ^ 1).
(2) persons registered with the Ministry of health in accordance with § 16 are
obliged to under 15. February of the following calendar year inform the
The Ministry of health on the activities with the other category 2
and 3 referred to in legislation directly applicable European
Community ^ 1), even in the case that for the previous calendar year
These activities were over.
(3) the information referred to in paragraph 1 (b). a) submitted on forms
issued by the Ministry of health in writing or in electronic form
equipped with advanced electronic signature ^ 10a). ".
Footnote # 8j and 10f are deleted.
29. in section 29 (b). and) and c) at the end of paragraph 1, the words "or
the identification number of the soil block, or a part of the soil block
registration of land ".
30. In paragraph 29 (b). (c)) at the end of paragraph 2 is replaced by a comma and dot
the following paragraph 3 is added:
"3. the weight, the year of harvesting poppy concentrate or hemp sold or otherwise
the converted and details of the new acquirer. ".
31. in § 31 para. 1, after the words "the Ministry of health,"
the words "except for the information referred to in section 27, which shall be submitted on forms
published by the State Institute for drug control, ".
32. In section 34 para. 1, after the words "this Act", the words "and of the
directly applicable regulations of the European Communities ' ^ 1 ') "and the word" its "
shall be replaced by the word "their".
33. In § 34 paragraph 1. 1 at the end of the text of subparagraph (c)), the words ",
If it's not about inspections of pharmacies or control of compliance with the obligations
arising from the applicable regulations of the European communities directly ^ 1)
and from the decision issued on the basis thereof ".
34. In section 34 para. 1, letter c) the following point (d)), which read as follows:
"(d)) of the State Institute for drug control in matters relating to
pharmacies ".
Subparagraph (d)) and e) shall become letters (e)), and (f)).
35. In section 34 para. 1 at the end of the text of the letter e), the words "and
the control of the Customs authorities of the obligations arising from the right
applicable regulations of the European Communities ' ^ 1 ') and of the decision of the
issued on the basis thereof ".
36. In article 34, paragraph 1, the following paragraph 2 is added:
"(2) inspectors are authorized to make unannounced inspections in advance.".
Paragraphs 2 to 7 shall become paragraphs 3 to 8.
37. In § 36 odst. 1 (b). and) the words "(§ 3a paragraph 2. 2) "is replaced by
"(§ 3a paragraph 2. 3) ".
38. In § 36 odst. 1 p) is added:
"p) takes the addictive substances or preparations with their content without an export
the authorization pursuant to section 20, ".
39. In § 36 odst. 1 the letter q) repealed.
40. In article 36, paragraph 1, the following paragraph 2 is added:
"(2) a legal entity or individual entrepreneur is also committed by the administrative
tort by
and activity,) which is required by directly applicable
Regulation of the European communities on drug precursors ^ 1)
treatment or special treatment permit, without this authorisation,
(b)) when you export or import of precursors in contravention of section 20a,
(c)) shall proceed when you export or import of excipients, contrary to section
20b. ".
Paragraphs 2 to 5 shall become paragraphs 3 to 6.
41. In § 36 odst. 3 (b). a) and (c)), the words "regional authority" be replaced by
the words "State Institute for drug control".
42. In article 36, paragraph 5 is added:
"(5) a legal entity or individual entrepreneur, which deals with the
or in the past calendar year, dealt with the activities with the other
substances of category 2 and 3 set out in the applicable regulations
Of the European communities "^ 1"), is guilty of an administrative offense, by
and the summary report does not pass) activities with the other ingredients category
2 and 3 in violation of § 28 para. 1 (b). (a)) 3 or in the report shall be
incorrect or incomplete information, or
(b)) does not pass all the information about the unusual circumstances in accordance with § 28 para.
1 (b). b).“.
43. In section 36 shall be inserted after paragraph 5 a new paragraph 6 is added:
"(6) a legal entity or individual entrepreneur as a person
registered with the Ministry of health under section 16 commits
the administrative offense that does not inform about the activities with other ingredients
category 2 and 3 in violation of § 28 para. 2. ".
The present paragraph 6 is renumbered as paragraph 7.
44. In § 37 para. 1 (b). (b)) the letter ', q) "is deleted.
45. In article 37, paragraph 1, the following paragraph 2 is added:
"(2) an administrative offence under § 36 odst. 2, fined the
and $10 000 000), in the case of an administrative offence under (a)), (b)) or
subparagraph (c)), if it is for export or import of auxiliary substances of category
2 ^ 1)
(b)) 1 000 000 CZK in the case of an administrative offence referred to in subparagraph (c)), if the
It is for export or import of auxiliary substances of category 3 ^ 1). ".
Paragraphs 2 to 5 shall become paragraphs 3 to 6.
46. In § 37 para. 3, the number "2" is replaced by "3".
47. In § 37 para. 4, the number "3" by "4".
48. In article 37, paragraph 5 is added:
"(5) for the administrative offence under § 36 odst. 5 are imposed to 1 000 000
CZK. ".
49. In article 37, paragraph 5 the following paragraph 6 is added:
"(6) for the administrative offence under § 36 odst. 6 500 000 imposed in
CZK. ".
The present paragraph 6 shall become paragraph 7.
50. in § 37 para. 7, the number "5" shall be replaced by "7".
51. In section 40 para. 4, the number "4" is replaced by "5".
52. In § 40 paragraph 5 is added:
"(5) administrative offenses under § 36 odst. 1 (b). (g))), y), and z), committed
in a medical facility outside the pharmacy, in the first instance hearing
regional authority. ".
53. In § 40 paragraph 5 the following paragraph 6 is added:
"(6) administrative offenses under § 36 odst. 1 (b). (g))), y), and z) and under section
paragraph 36. 3 (b). a), b) and (c)), committed in pharmacies, in the first instance
discusses the State Institute for drug control. ".
Paragraphs 6 to 11 shall become paragraph 7 to 12.
54. In paragraph 2 of section 40. 7, the number "5" shall be replaced by "7".
55. In section 40 para. 8, the number "3" by "4".
56. In section 44b is added after the words "§ 43 para. 6 "the words", including the annexes,
of which they are an integral part of, ".
57. in annex No. 1, in the column "international non-proprietary name (INN)
Czech language "after the entry" Opium "the following item" Oripavin "and
in the column headed "chemical formula" words
"4?-epoxy-6-methoxy-17-methyl-, 6, 7, 8, 14-tetradehydromorfinan-3-ol".
58. in annex No. 7 in the column "other international non-proprietary name or
the generic name "after the entry" Benzfetamin "inserts a new item
"And in the column" Benzylpiperazine "chemical name" Word
"1-benzylpiperazine".
PART TWO
Amendment of the Act on administrative fees
Article. (II)
In the annex to the Act No 634/2004 Coll., on administrative fees, as amended by
Act No. 217/2005 Coll., Act No. 228/2005 Coll., Act No. 361/2005 Coll.
Act No 444/2005 Coll., Act No. 553/2005 Coll., Act No. 545/2005 Coll.
Act No. 48/2006 Coll., Act No. 56/2006 Coll., Act No. 57/2006 Coll.
Act No. 81/2006 Coll., Act No. 109/2006 Coll., Act No. 112/2006 Coll.
Act No. 130/2006 Coll., Act No. 137/2006 Coll., Act No. 137/2006 Coll.,
Act No. 159/2006 Coll., Act No. 179/2006 Coll., Act No. 186/2006 Coll.
Act No 215/2006 Coll., Act No. 227/2006 Coll., Act No. 227/2006 Coll.
Act No. 235/2006 Coll., Act No. 309/2006 Coll., Act No. 575/2006 Coll.
Act No. 106/2007 Coll., Act No. 261/2007 Coll., Act No. 261/2007 Coll.
Act No. 374/2007 Coll., Act No. 379/2007 Coll., Act No. 38/2008 Coll.,
Act No. 130/2008 Coll., Act No. 140/2008 Coll., Act No. 182/2008 Coll.,
Act No. 189/2008 Coll., Act No. 230/2008 Coll., Act No. 239/2008 Coll.,
Act No. 254/2008 Coll., Act No. 297/2008 Coll., Act No. 297/2008 Coll.,
Act No 301/2008 Coll., Act No. 309/2008 Coll., Act No 312/2008 Coll.,
Act No. 382/2008 Coll., Act No. 9/2009 Coll. and Act No. 41/2009, Coll.,
item 100, including footnote # 59:
"Item 100
and the issue of permits to treatment) drugs
substances, psychotropic substances, or
preparations containing $5,000 is
b) authorisation to dealing with precursors-
authorisation in accordance with the applicable legislation directly
Of the European communities on precursors
drugs ^ 59) $3,000
c) authorisation to dealing with precursors-
authorisation in accordance with the applicable legislation directly
Of the European communities on precursors
^ 59) for drug court-toxicology
the laboratory, the laboratory of health
institutes, specialized diagnostic,
research and teaching departments
universities and specialized
diagnostic and scientific research departments
Academy of Sciences of the Czech Republic, Eur 1 000
d) authorisation to dealing with precursors-
a special permit by directly applicable
the laws of the European communities on
drug precursors ^ 59) for the police
The Czech Republic, the army of the Czech Republic,
The prison service of the Czech Republic and customs
the administration of the United States-$ 500
e) authorisation to dealing with precursors-
a special permit by directly applicable
the laws of the European communities on
drug precursors ^ 59) $5,000
f) licence to export or import
narcotic substances, psychotropic substances
or preparations containing £ 1,000
g) licence to export or import
the export of precursors and auxiliary substances
by directly applicable regulations
Of the European communities on precursors
drugs ^ 59) $1,000
h) release the authorization to export or import
poppy concentrate-$ 500
I) registration of individual activities
with the other ingredients by directly
applicable regulations of the European
the community on drug precursors ^ 59) $3,000
j) special registration of individual
activities with the other ingredients according to
the directly applicable provisions of the European
the community on drug precursors ^ 59) $3,000
Exemption
From the fees referred to in subparagraphs (b)), (e)), i) and (j)) of this item shall be exempt
a person operating a pharmacy, and that's only when dealing with precursors and
the other ingredients during the operation of the pharmacy.
59) European Parliament and Council Regulation (EC) No 273/2004 of 11 March.
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. '.
PART THREE
Changing the law on pharmaceuticals
Article. (III)
In § 89 paragraph 1. 2 of law No 378/2007 Coll., on pharmaceuticals and on changes of some
related laws (law on medicinal products), the words "the competent State
by "are replaced by the words" the State, through the regional
the Office ".
PART FOUR
The EFFECTIVENESS of the
Article. (IV)
This Act shall take effect on the first day of the calendar month
following the date of its publication.
Vaidya in the r.
Klaus r.
Fischer v. r.
