362/2004 Sb.
LAW
of 20 December. in May 2004,
amending the Act No. 167/1998 Coll., on addictive substances and amending
certain other laws, as amended, and Act No.
2/1969 Coll., on establishment of ministries and other central bodies of the State
administration of the Czech Republic, as amended
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. and Act No. 223/2003 Coll.,
amended as follows:
1. In article 1 (1). 2, after the word "precursors", the words "and auxiliary
^ 1a substances) ".
Footnote 1a) is inserted:
"1a) Article. 1 (1). 2 (a). and) Council Regulation (EEC) No 3677/90 of 13 December.
December 1990 on measures to be taken in order to avoid
the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic
substances, as amended by Council Regulation (EC) no 1116/2001. ".
2. In article 1 (1). 2 (b)):
"(b)) in other products, if the composition of those products is such that
precursors and auxiliary substances contained in them may not be the easy way
used or recovered easily applicable ways that provides
directly binding regulation of the European communities. "^ 1a)".
3. In section 2 (a). (c)), the words "the solution or mixture shall be replaced by" solution,
a mixture or natural product. "
4. In section 2 (d) at the end of the text), the words "as well as a mixture or
natural product in any physical state, containing at least one
such a substance, in addition to the substances referred to in § 1 (1). 2 (a). (b))
^ law 1a) ".
5. At the end of section 2 shall be replaced by a comma and dot the following points (g))
(j)), including footnotes no 2a) and 2 c) are added:
"(g)) of coca bush all kinds of shrubs of the genus Erythroxylon coca leaves and leaf
from the bushes, with the exception of coca leaves, from which was extracted all the ekgonin,
cocaine and other alkaloids, ekgoninové ^ 2a)
(h)) the final beneficiary the substances referred to in annexes 9 to 11 of this
the Act any natural person or legal person in accordance with the immediately
a binding act of the European communities, a ^ 2b)
I) placing on the market the supply of substances listed in annexes 9 to 11 of this
the Act made in the countries of the European Community to third parties or to
free circulation in the European Community countries, in return for payment or
free of charge,
j) export or import of substances and preparations containing
their physical movement from one State to another.) ^ ^ 2a, 2 c)
2A) Decree No. 47/1965 Coll., on the single Convention on narcotic drugs, in
the texts of communication No. 458/1991, a Protocol on amendments to the single Convention on
Narcotic Drugs of 1961.
2B) Article. 1 (1). 2 (a). (f)) of Council Regulation (EEC) No 3677/90, as amended by
Council Regulation (EEC) no 900/92.
2 c) the Convention on psychotropic substances, the renowned under no 62/1989 Coll. ".
Footnote No. 2a) is referred to as a footnote
No 2d), and including a reference to a footnote.
6. the heading of section 3: "the treatment of addictive substances and preparations".
7. In section 3, paragraph 3. 1, the words ' substances, preparations and precursors "shall be replaced by
the words "substances and preparations" and the words "substances, preparations and precursors"
replaced by the words "substances and preparations".
8. in section 3, the following new section 3a, including the title and notes
line no 2d):
' section 3a
Treatment with precursors and auxiliary substances
(1) handling of precursors, means
and precursors and their production) the placing on the market, including activities with the
related,
(b)), export, import and transit of precursors listed in the immediately binding
Regulation of the European communities) or ^ 2d in the customs territory of the European
the community.
(2) Treatment with excipients means
and) production and placing on the market of excipients listed in annex No. 10
This law, or their mixtures, with the exception of potassium permanganate,
(b)) the export of auxiliary substances referred to in the immediately binding rules
Of the European communities ^ 2d) from the customs territory of the European communities,
the importation of these substances into the customs territory or transit of these substances
through the said customs territory.
(3) to the treatment of the other ingredients you need to register in accordance with section 16 of the
This law, unless otherwise provided by this act otherwise.
2D) Article. 1 (1). 2 of Council Regulation (EEC) No 3677/90. ".
Footnote No 2d) is referred to as a footnote
No. 2e), and including a reference to a footnote.
9. In section 5 (3). 7, the words "public health laboratories" are replaced by the words
"the laboratory of health institutions".
10. In section 5, the following paragraph 8 is added:
"(8) a permit is not required for the treatment of a person operating a pharmacy,
which shall take, and stored the addictive substances listed in the annexes to
No. 3 and 4 of this Act for the purpose of their delivery to the persons referred to in
paragraph 7. ".
11. In section 6 (1). 2, after the words "separate" words "
, people representing in a customs procedure, ^ 5b) ^ 5 c) inventory
deponentů5c) ".
Footnote No. 5b and 5 c)):
"5b) section 107, paragraph. 2 of Act No. 13/1993 Coll., as amended.
5 c) Article. 2A, paragraph. 1 Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EEC) no 900/92. ".
Former footnote No. 5b and 5 c)) are renumbered as notes under
line no. 5 d) and 5e), including links to footnotes.
12. In section 8 (2). 3, the number "2" is replaced by "5" and at the end of paragraph
is added the sentence "If the applicant so requests, the permit may be
the treatment given and the shorter period of time. ".
13. In section 8 (2). 10, after the words "in the application for the authorization to the treatment,"
the words "and for the reasons set out immediately binding regulation
Of the European communities, ^ 5 c) ".
14. In section 8 shall at the end of paragraph 11 is added the phrase "cancellation request
the authorization to the treatment is served on the issued by the Ministry of
health. ".
15. In section 9 (2). 4, the fourth sentence deleted.
16. In section 12 paragraph 2, including the footnote No. 5f):
"(2) the auxiliary substances referred to in annex 10 of this Act, with the exception of
potassium permanganate can be transmitted or sold only to persons
that the transferring or the seller shall submit the completed statement
the customer in accordance with the European regulation immediately binding
community. ^ 5f)
5F) Commission Regulation (EC) no 1485/96 of 26 March. July 1996 laying
lays down the detailed rules for the application of Council Directive 92/109/EEC, as regards the
customer Declaration of specific use of certain substances used in the
the illicit manufacture of narcotic drugs and psychotropic substances, as amended by regulation
Commission Regulation (EC) no 1533/2000. ".
Footnote No. 5e) is deleted, including a link to the note
under the line.
17. In article 12 the following paragraphs 3 and 4, which including the footnotes
No. 5 g) are added:
"(3) the obligation referred to in paragraph 2 shall not apply to persons who intend to
pass or sell ancillary substances referred to in annex 10 of this Act,
the total amount does not exceed the quantity in the calendar year
laid down by a decree of the Ministry of health.
(4) persons who intend to produce, import, export, transfer or
sell precursors and auxiliary substances referred to in annex 10 of this
law, are obliged to ensure that these substances were prior
on the market labelled. On the label the name of the substance, must be provided, which
must correspond to the annexes of this law, ^ 5 g) and can be presented on it
her usual commercial description; a similar indication is required even when the
transit of precursors and auxiliary substances (section 23).
5 g) Article. 2 (2). 2 of Council Regulation (EEC) No 3677/90. ".
18. In article 15 (b). and), the words ' substances, preparations and precursors "shall be replaced by
the words "substances and preparations".
19. In section 15 for the letter a) insert a new subparagraph (b)), including
footnote No. 7a) is inserted:
"(b)) import and export precursors and auxiliary substances for the reasons referred to in
immediately binding regulation of the European communities, 7a ^ ^)
7A) Article. 6 (1). 2 of Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EC) no 988/2002. ".
Letters b) to (f)) are renumbered as paragraphs (c) to (g))).
20. the heading of section 16: "Registration of manufacturers, exporters, importers and persons
offering on the market of substances ".
21. In section 16, paragraph 1, including the footnote No. 7b):
"(1) persons who intend to produce, export, import, placing on the market or
they intend to deal with the transit of excipients listed in annex No. 10
This Act, with the exception of the manufacture and the placing on the market of permanganate
potassium, and the persons that intend to export the auxiliary substances listed in
Annex No. 11 of this Act, are required to according to a special legal
^ Regulation 7b), before the start of the activity to register with the Ministry of
health care. The application for registration shall be submitted in duplicate to the
Forms issued by the Ministry of health.
Article 7b). 2A, paragraph. 2 of Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EEC) no 900/92. ".
22. In article 16, paragraph 1, the following paragraph 2, including the
footnote No. 7 c) is added:
"(2) the obligation referred to in paragraph 1 shall not apply to persons who intend to
to export the auxiliary substances set out in annex 11 of this law, the
the total amount does not exceed the quantity referred to in the calendar year
immediately binding regulation of the European communities. ^ 7 c)
Article 7 c). 1 (1). 1 Commission Regulation (EEC) no 3769/92 of 21 December. December
1992 implementing and amending Council Regulation (EEC) No 3677/90, as amended by
Commission Regulation (EC) No 1232/2002. ".
Paragraphs 2 to 4 shall be renumbered as paragraphs 3 to 5.
23. In section 16. 3 the words "and the conditions laid down by specific legal
Regulation ' shall be deleted.
24. In article 16, the following paragraph 6 is added:
"(6) the Ministry of health decides for persons referred to in paragraph 1
to reject an application for a marketing authorisation or on the suspension, withdrawal or
the cancellation of the already issued registration
and when a false or) incomplete information in the application for
the registration,
(b)) in breach of the obligations arising from this Act or from the
decision issued on its basis, or
(c) if the holder of the registration) been convicted of an offence,
the merits of which is related to this activity, unless he
looking as if he has been convicted ".
25. In section 19 (1):
"(1) as the responsible person can appoint a natural person who has reached the
University Master's degree in the area of pharmacy, medicine,
veterinary medicine or in the field of chemical technology ".
26. the heading of section 20 reads: "export of substances and preparations with their
the content ".
27. In section 20 (2). 1, the words ' substances, preparations, precursors and auxiliary
substances in the cases referred to in paragraph 3 shall be replaced by "substances and
preparations ".
28. In article 20, paragraph 3 is deleted.
Paragraphs 4 to 6 shall be renumbered as paragraphs 3 to 5.
29. In section 20, at the end of the text of paragraph 3, the words "shall be added; While not
be exceeded the limit set by the International Office for the control of narcotic drugs
substances to the country of importation ^ 8a) ".
Footnote No. 8a):
"8a) Decree No. 47/1965 Coll., as amended by communication No. 458/1991.
The Convention on psychotropic substances, the renowned under no 62/1989 Coll. ".
30. In section 20 (2). 5 the third sentence shall be deleted.
31. under section 20, the following new section 20a and 20b, including headings and
footnote No. 8b) up to 8 k) are added:
"section 20a
The export of precursors
(1) for the export of precursors as immediately binding
Regulation of the European communities. ^ 8b)
(2) the Ministry of health shall issue a notice of estimated export
under special legislation ^ 8 c) ^ 8 d) and send it to the State, to
which export takes place. On the basis of the comments of the competent
authority of the State in which the export takes place, the Ministry shall decide
health care for the issue of an export permit. ^ 8e)
(3) the decision on the application for export outside the Member States of the European
the Community Health Department must issue within 15 working days
from the date of receiving the reply of the competent authority of the State in which the
exports effected. ^ 8f), ^ g)
(4) the Ministry of health shall decide on the refusal of requests for extradition
an export permit or a withdrawal of already issued an export permit,
If it is the illicit trade under international treaties, which
the Czech Republic is bound, or, in the case of fixed
immediately binding regulation of the European communities. ^ 8 h)
(5) the Ministry of health shall suspend or revoke an export authorisation,
If there are grounds under European regulation immediately binding
^ 8i) community.
§ 20b
The export of excipients
(1) export of excipients listed in annexes 10 and 11 of this
the Act is in accordance with European regulation immediately binding
Community ^ ^ 8j), 8 k) and pursuant to section 20a of this Act apply mutatis mutandis.
(2) in the case of exports of potassium permanganate or acid anhydride
acetic in quantities above the limit set by a decree of the Ministry of
health care shall proceed as follows:
and) the natural or legal person shall communicate this fact to the
The Ministry of health,
(b)), the Ministry of health on the basis of this communication issue
notice of the expected export immediately binding regulation
Of the European communities), ^ ^ 8 c 8 d) and send it to the State in which the
export takes place,
(c) the competent authority of the State), to which the export of
effected, or the International Office for the control of narcotic substances shall communicate to the
The Ministry of health the natural or legal person who proposes to
export potassium permanganate or anhydride of acetic acid, and
The Ministry of industry and trade.
8B) Council Regulation (EEC) No 3677/90, as amended by Council Regulation (EC) No.
988/2002.
8 c) Article. 12 paragraph. 10 the United Nations Convention against
illicit traffic in narcotic drugs and psychotropic substances declared under
No 462/1991.
Resolution 20/4 of the 1998 special session of the General Assembly
The United Nations on drugs.
8 d) article 4 of Council Regulation (EEC) No 3677/90, as amended by Council regulation
(EC) no 988/2002.
8e) in Article 4a of Council Regulation (EEC) No 3677/90, as amended by Council regulation
(EC) no 988/2002.
8f) Article. 4A, paragraph. 3 Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EC) no 988/2002.
8 g) Article. 4A, paragraph. 9 of Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EC) no 988/2002.
Article 8 h). 4A, paragraph. 4 Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EC) no 988/2002.
Article 8i). 4A, paragraph. 8 of Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EC) no 988/2002.
8j) articles 2 and 3 of Commission Regulation (EEC) no 3769/92, as amended by regulation
Commission Regulation (EC) No 1232/2002.
8 k) articles 5 and 5a of Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EEC) no 900/92 and Council Regulation (EC) no 988/2002. ".
32. In section 21 of the title: "the importation of the substance and products with their
the content ".
33. In § 21. 1, the words ' substances, preparations and precursors "shall be replaced by
the words "substances and preparations".
34. In § 21. 3 the first and the second sentence deleted.
35. In section 22 to the end of paragraph 2 the following sentence "Changes the data referred
in the application for the issue of an export permit or import authorisation is
natural or legal person shall be obliged to inform, in writing, to the Ministry of
health care, not later than 5 days from the date when the changes occurred. ".
36. In section 22, paragraph. 3 at the end of the first sentence, the words "or on the
the request of the importer may be issued even for less "and the second is
shall be replaced by the phrase "the period of validity of the export licence provides the Ministry of
health care according to the period of validity of the import authorization state on whose
the territory has to be the export takes place, if the exporter requests for less. ".
37. In section 22, paragraph 4, the following paragraphs 5 and 6 shall be added:
"(5) when the export of the substance and of the Declaration on the
placing of goods under export procedure lodged with the Customs Office locally
the competent according to the place of residence or place of business of a natural person or
seat of the legal person. Furthermore, the export authorisation shall be presented in accordance with section 20,
the 20a and 20b of this law, if under this Act must be issued.
(6) in import of substance abuse and of the Declaration on the
release of goods for free circulation or with the economic
effects filed with the Office of the locally competent according to the place of residence or
the place of business of a natural person or a legal person headquarters. It is further
submit import permit pursuant to § 21 of this Act, if it must be
issued pursuant to this Act. ".
The present paragraph 5 shall become paragraph 7.
38. In section 22 paragraph 7 is added:
"(7) the Ministry of health shall decide on the refusal of requests for extradition
an export permit or import permit, of the suspension, withdrawal
or cancellation of an export permit or import authorization, if it is
about
and) illicit trade in accordance with international treaties, which the Czech
Republic is bound,
(b) the placing of false data or) nedoplnění incomplete data in the request
on the export permit or import authorisation within the prescribed period,
(c)) violation of the obligations arising from this Act or decision
issued on its basis, or
(d) the holder of the authorization to the treatment of) been convicted of an offence,
the merits of which is related to this activity, unless he
looking as if he has been convicted ".
39. In section 25 is at the end of paragraph 1, the following sentence "the request for extradition
an export permit or the import permit shall be made on form
issued by the Ministry of health. ".
40. In section 26, paragraph. 1, after the words "to transmit to the Ministry of health"
the words "on forms issued by the Ministry of health
in writing or in electronic form, signed by the advanced electronic
the signature under special legislation. ^ 10a) ".
Footnote. 10a) is inserted:
"10a) Act No 227/2000 Coll., on electronic signature and amending
certain other laws (the law on electronic signature), as amended by
amended.
Government Regulation No. 304/2001 Coll., implementing Act No 227/2000
Coll. on electronic signature and on amendments to certain other laws (law
on electronic signature) ".
Former footnote No. 10a to 10 c)) are renumbered as notes
footnote No. 10b) up to 10 d), including links to footnotes.
41. In section 26, paragraph. 1 at the end of the text of the letter b), the words "; the amount of the
given the estimates may be adapted ^ 10b) the International Office for the control of
Narcotics, ^ 2a) ".
Footnote. 10b):
"10b) Article. 19 paragraph. 2 and article. 21. 3 Decree No. 47/1965 Coll. ".
The existing footnote. 10b) up to 10 d) are renumbered as notes
footnote No. 10 c) to 10e), including links to footnotes.
42. In section 26 paragraph 2, the following paragraph 3 is added:
"(3) the persons who are entitled to be treated with drugs,
products and precursors on the basis of the authorization to the treatment, and persons
which for their operation does not require the issue of permits for the handling of
addictive substances, and precursors under section 5 (3). 7 and § 6
paragraph. 3, are obliged to report immediately to the Ministry of health
and of alienation substance abuse), and precursors,
(b)) of special circumstances, such as unusual orders and
transactions with these substances,
(c)) on the basis of his request for additional details relating to the
the activities, which are subject to authorisation for treatment. ".
The former paragraph 3 shall become paragraph 4.
43. In section 26, paragraph. 4, the words "1 month" shall be replaced by the words "30 days".
44. section 27, including title and footnote No. 10 c) is added:
the "section 27
Obligation of persons operating a pharmacy
(1) a person operating a pharmacy shall be obliged to forward to the regional authority
the end of February the annual report for the previous calendar year and of the status of the movement
stocks of addictive substances referred to in annex No. 1 or 5 of this Act,
as well as products containing them, with the exception of the products referred to in
Annex No. 8 of this Act. The annual report shall be filed on form
issued by the Ministry of health in writing or in electronic form
signed by an advanced electronic signature pursuant to specific legal
^ 10a) Regulation.
(2) upon termination of the activities of the pharmacy ^ 10 c) is a person that this activity
operated, be obliged to submit within 30 days from the termination of the activities of the
the Regional Office of the emergency information to the extent provided for in paragraph 1.
10 c) Law No. 160/1992 Coll., on health care in non-State
medical devices, as amended. ".
The existing footnote No. 10 c) to 10e) are renumbered as notes
footnote No. 10 d) to 10f), including links to footnotes.
45. In section 27a, paragraph. 1, the words "the district or municipal health management"
replaced by the words "the regional Veterinary Administration or Urban Health
Administration in Prague "and at the end of paragraph 1, the following sentence" message
served on a form issued by the Veterinary Administration in writing or
in electronic form signed by an advanced electronic signature pursuant to
special legislation. ^ 10a) ".
46. In section 27a, paragraph. 2 the words "County and city Veterinary Administration"
replaced by the words "the regional Veterinary Administration and city health
Administration in Prague ".
47. section 28 including title and footnote No 10f):
"section 28
The obligation of manufacturers, exporters, importers and persons offering to
marketing AIDS
(1) a person registered at the Ministry of health (section 16), with the
the exception of those on the market offering the ancillary substance are required to transmit
The Ministry of health
and for the end of February) the past calendar year, the annual reports on the manufacture,
the export and import of excipients listed in annex 10 of this law
and reports on export of auxiliary substances set out in annex 11 of this
the law,
(b)) the 15th day of the following month, monthly reports on exports
auxiliary substances referred to in annexes 10 and 11 of this law in
the cases, which requires export permits, 10e)
(c)) at its request for more detailed information on the production, export and import
auxiliary substances,
(d)) all information about stolen and other auxiliary substances
circumstances under special legislation. ^ 10f)
(2) When their activities, which requires a registration, a person is
which carries out this activity, required to pass within 30 days of their
the activities of the Ministry of health of the extraordinary in the extent of reporting
provided for in paragraph 1 (b). and).
(3) the Information referred to in paragraph 1 (b). and (b))) and submitted on forms
issued by the Ministry of health in writing or in electronic form
signed by an advanced electronic signature pursuant to specific legal
^ 10a) Regulation.
10F) article 3 of Council Regulation (EEC) No 3677/90, as amended by Council regulation
(EEC) no 900/92. ".
Footnote No. 10f) is referred to as a note under
line no. 10 g), including a link to a footnote.
48. section 29, including title and footnote No. 10 g) and 10 h) is added:
"§ 29
Obligation of persons producing opium poppy or cannabis
People growing opium poppy or cannabis on total area greater than 100 m2
they are obliged to pass the information to the locally competent customs authority referred to in
the place of cultivation, in writing or in electronic form, signed by the guaranteed
an electronic signature under special legislation ^ 10a)
and by the end of May)
1. assessment of the land, that were in the relevant calendar year sown with poppy seeds
setým or hemp, including the name of the registered varieties used, ^ g)
parcel number, name, and the numbers of cadastral territory, ^ 10 h)
2. an estimate of the acreage of the land on which it will be grown opium poppy or cannabis in
the next calendar year,
(b)) in the course of vegetation and harvest data on the area of land and how
destruction of opium poppy, poppy concentrate or hemp, including the name of the used
the registered variety, ^ 10 g) parcel number, name, and the numbers of the cadastral
territory, ^ 10) and not later than 5 days before their
disposal,
(c)) to the end of December of the calendar year
1. assessment of land that have been sown with poppy seeds or cannabis setým, assessment
the land from which it was harvested opium poppy or cannabis, including the name of the
used the registered variety, ^ g) parcel number, name, and numbers
cadastral territory, ^ 10 h)
2. the quantities harvested poppy concentrate, hemp, poppy seed and seed
hemp.
10 g) Act No. 92/1996 Coll., on plant varieties, seeds and seed potatoes grown
the plant, in the wording of later regulations.
10 h) Law No 344/1992 Coll., on the land register of the Czech Republic
(Land Registry Act), as amended. ".
Footnote No. 10 g) is referred to as a note under
footnote No. 10i), including a link to a footnote.
49. At the end of section 30, the following sentence "quarterly reports shall be submitted to the
form issued by the Ministry of health in writing or in
electronic form signed by an advanced electronic signature pursuant to
special legislation. ^ 10a) ".
50. section 31, including a title:
the "section 31
Form of reports
(1) Information shall be submitted on forms issued by the Ministry of
health, with the exception of reporting under section 27a, which serves to
Forms issued by the competent regional veterinary administrations or
Public health administration in Prague, and with the exception of reporting under section 29,
and that, in writing or in electronic form, signed by the guaranteed
an electronic signature under special legislation. ^ 10a)
(2) the Ministry of finance and the Ministry of agriculture shall lay down by Decree
model of form for the reporting of persons producing opium poppy or cannabis (section 29)
and the method of filling and handling with the form. ".
51. the heading of section 32 added: "Evidence and documentation".
52. In § 32 paragraph 1 the following new paragraphs 2 to 7, including
footnotes no 10j) to 10 l) are added:
"(2) a natural person or a legal person is required to document each
the placing on the market of precursors listed in annex No 9 this Act by
immediately binding regulation of the European communities. ^ 5f)
(3) concerning the export, import and transit of excipients is keeping controls
immediately binding regulation of the European communities. ^ 10j)
(4) on the manufacture and placing on the market of excipients listed in annex No. 10
This Act, with the exception of potassium permanganate, the evidence leads.
(5) a natural person or a legal person registered by the Ministry of
health care according to § 16 of this Act is to immediately
a binding regulation of the European Communities document production,
exports, imports, 10 k) ^ ^ ^ ^ 10 k 10 k) transit) and each of the placing on the market of assistive
substances referred to in annex 10 of this Act, with the exception of the manufacture and
the placing on the market of potassium permanganate.
(6) the obligation to keep a dossier including a customer Declaration ^ 5f) and
the register does not apply to persons placing on the market of substances listed
in annex 10 of this law, in the event that their total quantity
do not exceed the quantities set out in the calendar year of the Decree of the Ministry of
health care. Furthermore, the obligation to keep the documentation, including the Declaration of the
customer ^ 5f) does not apply to persons placing on the market of permanganate
potassium.
(7) a natural person or a legal person registered by the Ministry of
health care according to § 16 of this Act is to immediately
a binding regulation of the European Communities ^ 10) documenting each
the export of auxiliary substances set out in annex 11 of this Act.
10j) Article. 2 (2). 3 Council Regulation (EEC) No 3677/90.
10 k) article 2 of Council Regulation (EEC) No 3677/90, as amended by Council regulation
(EEC) no 900/92 and Council Regulation (EC) no 988/2002.
10 l) Article. 2 (2). 1 Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EEC) no 900/92. ".
The current paragraph 2 shall be deleted and paragraph 3 shall be renumbered as
paragraph 8.
53. In § 33 at the end of paragraph 1, the words "for a period of 5 years, and in
the case of precursors and auxiliary substances for at least 3 years ^ ^ 10 m) ".
Footnote 10 m) is added:
"10 m) Article. 2 (2). 4 Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EEC) no 900/92. ".
54. In § 34 paragraph 1 reads:
"(1) the checking of compliance with the obligations arising from this Act, and of the
decision issued on its basis shall be exercised by the credentials of the staff
and the Ministry of health),
(b)), the police of the Czech Republic,
(c)) the inclusion in the lands of the regional office,
d) Customs authorities only in matters relating to the cultivation of opium poppy and the
hemp,
(e)) of regional veterinary administrations and Municipal Health Administration in Prague
only in matters of health care
(hereinafter referred to as "inspectors"). ".
55. In article 34, the following paragraph 7 is added:
"(7) for the purposes of control of the cultivation of opium poppy or cannabis are
cadastral authorities customs authorities data from land register
free of charge ".
56. The head of the eighth including title and footnote No. 10n) up to 10 p):
"TITLE VIII
The PENALTIES
section 36
Administrative offences
(1) a legal person or a natural person who, in business or in
direct connection with him, committed misconduct by
and) exercises an activity which requires registration to treatment with
auxiliary substances (§ 3a paragraph 2), without this registration,
(b)) activity, which requires authorization to the treatment of
addictive substances, and precursors (section 4), without this permit, the
(c)) shall indicate false or incomplete information in the application for the authorization to the treatment
with addictive substances, and precursors (section 8)
(d) do not communicate in writing to the Ministry of health) changes to the data, which indicated
in the request for authorization to the treatment of addictive substances, preparations
and precursors, or cessation of the activity, to which it was issued
the authorization to the treatment of addictive substances, and precursors (section 8
paragraph. 9 and 11),
(e) the Ministry of health has notified in writing) the appointment of a representative
the responsible person or the person performing its function, or its function
(§ 9 paragraph 9)
(f)) does a new responsible person within 10 days from the date on which the
the existing responsible person no longer meets the prescribed conditions or
for other reasons, is permanently unable to carry out their function or gives up
the performance features and has requested the Ministry of health about the change of the responsible
the persons referred to in the authorization to the treatment (section 9, paragraph 10),
g) fails to comply with the storage of addictive substances, and precursors,
as well as the equipment for their production, the obligations under section 10,
h) transmit or sell the addictive substances, and precursors to persons
that are not entitled to treat them, or converts to these persons
rights associated with addictive substances, and precursors (section 12, paragraph.
1),
I) passes or sells auxiliary substances referred to in annex 10 of this law
persons who do not submit the transferring or seller questionnaire
statement by special legal regulation ^ 5f) (section 12 (2)),
j) manufactured, imported, exported or sold or precursors of auxiliary substances
referred to in annex 10 of this law and will not secure the designation of these
substances, before placing them on the market with a label indicating their name (§ 12
paragraph. 4),
to the disposal of unusable) does not addictive substances, preparations and
precursors, as well as the waste is tagged under section 14,
l) places the addictive substances and preparations in customs warehouses, free
zones and free skladech7) (para. 15 (b).)
m) be sent to the addictive substances, and precursors as ordinary
the consignment through the mailboxes or to persons who are not
entitled to be treated with drugs (section 15 (b) (c)),
n) prior fails to comply with the obligation of registration or application
for registration shall indicate false or incomplete data (article 16),
do not communicate in writing about) the Ministry of health information changes for
the granting of the registration (section 16 (4)) or the fact that it ceases to
to carry out the activity that was the subject of the registration (section 16 (5)),
p) takes the addictive substances or preparations containing precursors,
or auxiliary substances without an export permit (section 20, 20a and 20b),
q) indicate the false or incomplete information in the case of exports of permanganate
potassium or anhydride of acetic acid [section 20b paragraph 2 (a))],
r) takes the addictive substances or preparations with their content without import
authorization (section 21),
with) a false or incomplete information in the application for an export or import
authorization (section 22),
t) grown (§ 24) species and varieties of the cannabis plant (genus Cannabis), which
may contain not more than 0.3% of the substances from the Group of tetrahydrokanabinolů,
or cultivated plants of the genus Erythroxylon (shrub Kok),
u) takes or makovinu without the import or export without an export
authorisation (article 25),
in the reporting obligations or fails to) report indicating false or
incomplete information (section 26),
w) fails to comply with the obligation in the treatment of addictive substances,
products and precursors, which does not require authorisation for treatment (section
26 paragraph. 2)
x) does not pass the Ministry of health to the fifteenth day of the first month
the calendar quarter, the quarterly reports on the export or import of poppy concentrate
in the past quarter, or in a message stating the false or incomplete
data (section 30)
to fulfil the obligation to register y) and the documentation referred to in section 32 and 33 of this
the law,
from the obligation to fulfil or control) the notification obligation under section 35.
(2) the operator of a pharmacy has committed misconduct by
does not pass the regional authority) to the end of February, the annual reports for the past
the calendar year of the status and movement of stocks of addictive substances listed in
Annex No 1 or 5 of this Act, including products containing,
the exception of the products listed in annex 8 of this Act (section 27),
(b)) shall indicate in the annual reporting on the status and movement of stocks of addictive substances
listed in annex No. 1 or 5 of this Act, including the products
containing, with the exception of the products listed in annex 8 of this
the law, for the previous calendar year (§ 27) false or incomplete
data,
(c) upon termination of the activities of the pharmacy) does not pass the regional authority of the extraordinary
reports on the status and movement of stocks of addictive substances referred to in annex No.
1 or 5 of this Act, including products containing, with the exception of
the products listed in annex 8 of this Act, or in the report shall indicate the
false or incomplete information.
(3) the operator of a pharmacy or a distributor of pharmaceuticals by the administrative
tort by
fails to comply with the obligation to) (section 27a (1)) to report to the 10. January calendar
of the relevant regional Veterinary Administration or Urban Health
subscription management in Prague, preparations containing addictive substances listed in
Annexes 1 and 5 of this Act, with the exception of the products referred to in
Annex No. 8 of this law, veterinary doctors for the past calendar
year,
(b) indicate in the report) (section 27a (1)) of the sampling of products containing
addictive substances listed in the annexes 1 and 5 of this Act, with the exception of
the products listed in annex 8 of this Act, the veterinary surgeons
for the previous calendar year of false or incomplete information.
(4) a person registered for ^ 10n) Ministry of health (section 16), with the
the exception of the vendor of the excipients, committed misconduct by
and does not pass to the Ministry of health) of the end of February for the past
calendar year reporting on the production, export and import of excipients
referred to in annex 10 of this law and on the export of excipients
referred to in annex 11 of this Act [section 28 (1) (a).)]
(b)) does not pass the Ministry of health to the 15th day of the following
the month of monthly reports on exports of auxiliary substances listed in the annexes
No. 10 and 11 of this Act in the cases, which requires export
authorization [section 28 (1) (b))],
(c)) shall indicate in the report on the production, export and import of auxiliary substances referred to
in annex 10 of this Act during the preceding calendar year, and in the reports on the
export of auxiliary substances set out in annex 11 of this law
false or incomplete information [section 28 (1) (a).)]
(d)) shall be shown in the monthly reports on exports of excipients listed in
Annexes 10 and 11 of this Act in the cases, which requires
export permit [section 28 (1) (b))], false or incomplete
data,
(e)) does not pass the Ministry of health for information on stolen auxiliary
substances and other circumstances by prescription immediately binding
Of the European communities, in particular the ^ 10n) unusual orders or
transactions with the other ingredients, which may lead to the suspicion that these
substances intended for import, export or transit may be diverted for the
the illegal production of narcotic drugs or psychotropic substances [section 28 (1)
(a). (d))],
(f)) in their activities does not pass within 30 days from the termination of the activities of the
the extraordinary in the extent laid down in § 28 paragraph. 1 (a). and) or in
reports shall indicate false or incomplete information.
(5) a legal person or a natural person who, in business or in
direct connection with growing opium poppy or cannabis on the total
area greater than 100 m2, committed misconduct by
and fails to comply with the obligation referred to in) section 29,
(b)) shall indicate false or incomplete information in the reports referred to in section 29.
§ 37
The fine
(1) For administrative offences pursuant to § 36 odst. 1 is a legal person, or
a natural person who, in business or in direct connection with him,
saves a penalty to
and 500 000 CZK), with regard to the administrative offences referred to in points (d), (e))), f), (g)),
(h)), i), (j))) l), m), (n)),),),), t, v), w), x), y), and z),
(b)) 1 0000 0000 CZK in the case of administrative offences referred to in points (c)), q)),
(c)) 10 0000 0000 CZK in the case of administrative offences provided for in the letters and), b), p)
r).
(2) For administrative offences pursuant to § 36 odst. 2 the legal person, or
a natural person who, in business or in direct connection with him,
saves a penalty to
and 500 000 CZK), with regard to the administrative offences provided for in the letters) and (c)),
(b)) 1 0000 0000 CZK in the case of administrative offences referred to in subparagraph (b)).
(3) For administrative offences pursuant to § 36 odst. 3 the legal person, or
a natural person who, in business or in direct connection with him,
saves a penalty to
and 500 000 CZK), with regard to the administrative offences pursuant to subparagraph (a)),
(b)) 1 0000 0000 CZK in the case of administrative offences referred to in subparagraph (b)).
(4) For administrative offences pursuant to § 36 odst. 4 a legal person, or
a natural person who, in business or in direct connection with him,
saves a penalty to
and 500 000 CZK), with regard to the administrative offences pursuant to subparagraphs and (b))), e) and (f)),
(b)) 1 0000 0000 CZK in the case of administrative offences referred to in points (c) and (d)).)
(5) For administrative offences pursuant to § 36 odst. 5 is a legal person, or
a natural person who, in business or in direct connection with him,
saves a penalty to
and 500 000 CZK), with regard to the administrative offences pursuant to subparagraph (a)),
(b)) 1 0000 0000 CZK in the case of administrative offences referred to in subparagraph (b)).
section 38
Forfeiture of things
(1) for the administrative offence under section 36 may be a legal person, or the physical
the person in business or in direct connection with the store whether or not
forfeiture of addictive substances, preparations, precursors and auxiliary substances,
the equipment and materials needed for their manufacture, intended or used
for a criminal offence, if the legal person is a member.
(2) in the application of sanctions, confiscation of the things referred to in paragraph 1 shall take into account
in particular, the degree of the severity and extent of the consequences that the breach of the
the obligations caused or might cause, the circumstances in which it
occurred, and the period during which the infringement occurred.
(3) the owner of a forfeited things becomes a State.
section 39
(1) a natural person cultivating opium poppy or cannabis on a total area larger
than 100 m2 commits an offence by
and fails to comply with the notification obligations of) section 29,
(b)) shall indicate false or incomplete information in the reports referred to in section 29.
(2) for the offence referred to in paragraph 1 (b). and you can save into the fine) 100 000
And for the offence referred to in paragraph 1 (b). (b)) can be fine to 200
USD.
section 40
Common provisions on penalties
(1) a legal person under the administrative tort does not match, if he proves that
made every effort, that it was possible to require that the infringement of the
a legal obligation.
(2) in determining the amount of the fine, the legal person shall take into account the seriousness of the
the administrative tort, in particular to the way a criminal offence and its consequences, and
the circumstances under which it was committed.
(3) liability of legal persons for the administrative offence shall cease, if the
competent administrative authority about him has commenced proceedings in the 5 years from the date when the
aware of it, but not later than 10 years from the date when the administrative
the offence was committed.
(4) the administrative tort legal persons according to § 36 odst. 1, with the exception of
the administrative tort according to § 36 odst. 1 (a). (g))), y) and z) committed
in health care facilities, and administrative offence under § 36 odst. 4 in the first
degree discusses the Ministry of health.
(5) the administrative tort legal persons according to § 36 odst. 1 (a). (g)), y, k))
and out of the committed in the health care facility) and the administrative offence under section 36
paragraph. 2 (a). and (b))) and (c)) in the first instance hears regional office.
(6) the administrative tort legal persons according to § 36 odst. 5 (a). and (b)))
offences under section 39, paragraph. 1 (a). and (b))) and in the first instance hearing
the customs authority.
(7) the administrative tort legal persons according to § 36 odst. 3 (b). and (b)))
the first instance dealt with the relevant regional Veterinary Administration or
The city animal health management in Prague.
(8) responsibility for the negotiations, which occurred when the business physical
person ^ 10 °) or in direct connection with the applicable provisions of the
the law on liability of legal persons and sanctions.
(9) the Fines collected and enforced by the authority, which is saved. The decision on the imposition of
fines can be done within 5 years after the expiry of the period specified for their
payment.
(10) the income from fines imposed by the Ministry of health, the customs
authorities, the relevant regional veterinary administrations or Public
veterinary services in Prague is the income of the State budget. Income from
the fines imposed on the regional authority is the income of the region.
(11) in the collection and enforcement of fines imposed by the
special legislation. ^ 10 p)
10n) article 8 of Council Regulation (EEC) No 3677/90.
10o) § 2 of the commercial code.
10 p) Act No. 337/1992 Coll., on administration of taxes and fees, in the text of the
amended. ".
57. Section 41 new section 41a is inserted, including the footnote.
11A):
"section 41a
To natural persons and legal persons when dealing with precursors and
the other ingredients in customs warehouses and free trade
^ 11a) zones are not subject to the provisions of § 4, 16, 20a, 20b, 26 and 28 of this
the law.
11A) article 18 of the United Nations Convention against illicit
trafficking in narcotic drugs and psychotropic substances, the renowned No. 462/1991
SB. ".
58. section 42 including a footnote No. 11b) is added:
"§ 42
In all official documents, commercial documents and forms
must be used in the names of the drugs, precursors and auxiliary substances
According to the annexes of this law. ^ 5 g) in the case of proprietary medicinal products
^ 11b products) with their names indicate only the registered name.
11B) Act No. 79/1997 Coll., on pharmaceuticals and on changes and additions to the
some related laws, as amended. ".
59. In section 43 shall be inserted after paragraph 2 of the new paragraphs 3 to 6 shall be added:
"(3) the Customs authorities shall transmit to the police of the Czech Republic
individual reports of persons producing opium poppy or cannabis in accordance with section 29 of the
as follows:
and information according to § 29) (a). and) to 10. June of the calendar
of the year,
(b) the information referred to in section 29) (a). (b)).
(4) the Customs authorities shall transmit to the Directorate-General of customs duties
individual reports of persons producing opium poppy or cannabis in accordance with section 29 of the
as follows:
and information according to § 29) (a). and) to 10. June of the calendar
of the year,
(b) the information referred to in section 29) (a). (b)) shall, without delay,
(c) the report referred to in section 29) (a). (c)) until 31 December 2006. January for the previous calendar year.
(5) the Directorate-General of customs duties shall be communicated the Ministry of agriculture data
and according to section 29 (b)). and to 20.) June of the calendar year,
(b) under section 29 (b)). (b)) to 31. March for the previous calendar year,
(c) under section 29 (b)). (c)) until 31 December 2006. March for the previous calendar year
on forms issued by the Ministry of agriculture.
(6) the Directorate-General of customs duties, inform the Ministry of health data
and according to section 29 (b)). and to 20.) June of the calendar year,
(b) under section 29 (b)). (c)) until 31 December 2006. March for the previous calendar year
Forms issued by the Ministry of health. ".
The former paragraph 3 shall become paragraph 7.
60. In section 43, paragraph. 7 at the end of subparagraph (c)) shall be replaced by a comma and dot
the following point (d)), which read:
"(d)) shall inform the competent regional authority about the ongoing violations of the obligations
arising from this Act, and of the decisions taken on this
basis. ".
61. in section 43 shall be added to § 43a, including title and notes
line no. 11 c) to 11n) added:
"§ 43a
The scope of the public authorities
(1) the Ministry of health outside of the activities provided for in this law
Furthermore, in the field of addictive substances, preparations, precursors and auxiliary
substances
and monitors the movement of selected) auxiliary substances or precursors,
between the Czech Republic and other countries in the framework of the international
projects,
(b)) shall decide on appeals against the decisions of the Regional Office
in the cases referred to in § 40 paragraph. 5,
(c)) provides the International Narcotics Control Board
1. quarterly data relating to the import and export of narcotic drugs, ^ 11 c)
psychotropic substances ^ 11 d) Annex 5 of this law and of
containing these substances for the past 3 months,
2. once a year to 30. June figures relating to the production, manufacture,
consumption, stocks and seizures of narcotic substances and preparations the quantity
containing these substances for the previous calendar year, ^ 11e)
3. once a year to 30. June data on production, stocks,
imports and exports of psychotropic substances and of products containing these
substances for the previous calendar year, ^ 11f)
4. by 30 June. the June estimate of necessary drugs, ^ 11 g) psychotropic
^ 11) substances and preparations containing these substances on the following
calendar year and their Add-ons ^ 11i) during the calendar year,
(d)) provides the European Commission once a year, according to data immediately
a binding act of the European communities, ^ 11j)
e) performs responsibility in the field of precursors and auxiliary substances in accordance with
immediately to the mandatory provisions of the European communities, 11 k ^ ^)
f) cooperates with the competent authorities of the State of the importer and the exporter.
(2) the police of the Czech Republic
and inform the Ministry of health about) all the important
the facts necessary for the decision of Ministry of health
under this Act, in particular on the ^ 11j) attempts of alienation and estrangement
addictive substances, preparations, precursors and auxiliary substances,
(b)). April for the previous calendar year shall be sent to the Ministry of
health care overview of the quantities withdrawn, ^ 11l) precursors and auxiliary
substances, information on any other substance not included in annexes 9, 10 and 11
This law, which was found to have been used for the illicit manufacture of
narcotic drugs or psychotropic substances, forms, methods and
transport of illicit manufacturing narcotic drugs and psychotropic substances
the use of precursors and auxiliary substances in accordance with the immediately binding
Regulation of the European communities. ^ 11j)
(3) the Ministry of industry and trade
and) cooperates with the Ministry of health according to immediately
a binding regulation of the European communities 11 m ^ ^), 11n) prior to the issuance of
license of the Ministry of industry and trade to exports of permanganate
potassium and of acetic anhydride and general export permit
on the auxiliary substances set out in annex 11 of this Act,
(b)). April for the previous calendar year shall be sent to the Ministry of
Overview of the underlying health of imports and exports of excipients
referred to in annexes 10 and 11 of this Act.
(4) the Customs authorities
and shall inform the Ministry of health about) all the important
the facts necessary for its decision under this Act, ^ 11j)
in particular, on cases of ensure ^ 11o) addictive substances, preparations
precursors and auxiliary substances,
(b)). April for the previous calendar year shall be sent to the Ministry of
health care overview of secured ^ 11o) quantities of precursors and
excipients, details of any other substance not included in the annexes.
9, 10 and 11 of this law, of which it was found that was used to
the illicit manufacture of narcotic drugs or psychotropic substances, forms,
methods and means of the illicit manufacture of narcotic drugs and
with the use of psychotropic substances, precursors and auxiliary substances in accordance with
immediately binding regulation of the European communities, ^ 11j)
(c)) in accordance with European regulation immediately binding
^ twentieth century community) in the case of precursors and auxiliary substances data on
export authorisation,
(d)) shall check the exported quantities of auxiliary substances of annex 11 of this
the law, if they do not exceed the limits laid down by the Ministry of health
the Decree,
e) provide information about the importation or exportation of addictive substances,
products, precursors or auxiliary substances, the Ministry of health.
11 c) Article. 1, 2, 13, 20 and 25 of Decree No. 47/1965 Coll.
11 d) Article. 1 and 2 of the Convention on psychotropic substances declared under no 62/1989
SB.
11e) Article. 1, 2, 13, 20 and 27 of Decree No. 47/1965 Coll.
11F) Article. 1, 2, 3, 12 and 16 of the Convention on psychotropic substances declared under
No 62/1989 Coll.
11 g) Article. 1, 12 and 19 of Decree No. 47/1965 Coll.
11 h) resolutions of the economic and Social Council of the United Nations
No 1981/7.
The implementation of the Convention on psychotropic substances of 1971.
Resolutions of the economic and Social Council of the United Nations.
1991/44.
Prevention of leakage of psychotropic substances list III and IV of the Convention on the
psychotropic substances of 1971 into illicit channels in international
trading.
11i) Article. 12 paragraph. 4 (a). 5 and article. 19 paragraph. 3 Decree No. 47/1965 Coll.
11j) Article. 9 (2). 1 Council Regulation (EEC) No 3677/90.
11 k) Council Regulation (EEC) No 3677/90.
11l) section 79 of the criminal procedure code.
11 m) Article. 5A, paragraph. 3 Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EEC) no 900/92.
11n) article 5 of Commission Regulation (EEC) no 3769/92, as amended by Council regulation
(EEC) no 900/92 and Council Regulation (EC) no 988/2002.
11o) section 309 to 312 of the law No. 13/1993 Coll.
the twentieth century) Article. 4A, paragraph. 6 Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EC) no 988/2002. ".
62. In paragraph 44. 1, after the words "section 16", the words "paragraph. 1 to 5 ".
63. in annex No 5 is "Amphetamine" is added to column
"The international non-proprietary name (INN) in the Czech language" the word "Amineptin"
and in the column "chemical name" Word
"7-(10, 11-dihydro-5 h-dibenzo [a, d] cyklohepten-5-ylamino) heptanoic
the acid ".
64. Annex No 9 to 11 shall be added:
"Annex No 9 to the Act No. 167/1998 Coll.
Listed in table I PRECURSORS under the United Nations Convention against illicit
trafficking in narcotic drugs and psychotropic substances (communication No. 462/1991 Coll. and
According to the regulation of the European communities immediately binding ^ x))
------------------------------------------------------------------------------------------------------------------------
International non-proprietary name (INN) chemical name of Subheading customs
in the Czech language of the tariff
------------------------------------------------------------------------------------------------------------------------
Ephedrine and) (IR, 2S)-2-methylamino-1-phenyl-1-propanol, 2939 41 000
(b)) (IS, 2R)-2-methylamino-1-phenyl-1-propanol, and), (b))
(c)) of the racemic mixture of substances referred to in (a)
------------------------------------------------------------------------------------------------------------------------
Ergometrin N-[1-(hydroxymethyl) ethyl] D-amide acid diethylamide 2939 61 000
------------------------------------------------------------------------------------------------------------------------
Ergotamine 5 ' Alpha-benzyl-12 '-hydroxy-2 '-methyl-3 ', 6 ', 18-2939 62 000 ergotamantrion
------------------------------------------------------------------------------------------------------------------------
Fenylaceton 1-phenyl-2-propanone 2914 31 000
------------------------------------------------------------------------------------------------------------------------
Piperonal (cis + trans form) 1.2-(methylendioxy)-4-propenylbenzen (mixture of cis + trans form) 2932 91 000
------------------------------------------------------------------------------------------------------------------------
Acid lysergic acid (beta 8) 9-10-didehydro-6-methylergolin-8-carboxylic 2939 63 000
------------------------------------------------------------------------------------------------------------------------
3.4-methylendioxyfenyl-2-propanone 3.4-methylendioxyfenyl-2-propanone 2932 92 000
------------------------------------------------------------------------------------------------------------------------
N-acetylantranilová acid 2-acetamidobenzoic acid 2924 23 000
------------------------------------------------------------------------------------------------------------------------
Norefedrin (phenylpropanolamine) erythro-2-amino-1-phenyl-1-propanol 2939 49 000
------------------------------------------------------------------------------------------------------------------------
Used to synthesise MDA 1.3-benzodioxol-5-karbaldehyd 2932 93 000
------------------------------------------------------------------------------------------------------------------------
Pseudoephedrine and) (1R, 2R)-2-methylamino-1-phenyl-1-propanol, 2939 42 000
(b)) (1S, 2S)-2-methylamino-1-phenyl-1-propanol,
(c) the racemic mixture) substances listed under (a)), (b))
------------------------------------------------------------------------------------------------------------------------
Safrole 4-allyl-1.2-methylendioxybenzen 2932 94 000
------------------------------------------------------------------------------------------------------------------------
Including salt in all cases where the existence of such salts is possible.
Annex No 10 to the Act No. 167/1998 Coll.
AUXILIARY substances listed in table II of the UNITED NATIONS Convention against
illicit traffic in narcotic drugs and psychotropic substances (Notice No.
462/1991 Coll. and by immediately binding regulation of the European
Community ^ x))
------------------------------------------------------------------------------------------------------------------------
International non-proprietary name (INN) chemical name of Subheading customs
in the Czech language of the tariff
------------------------------------------------------------------------------------------------------------------------
Anhydride acetic acid, acetic anhydride 2915 24 000
------------------------------------------------------------------------------------------------------------------------
Anthranilic acid 2-aminobenzoic acid 2922 43 000
------------------------------------------------------------------------------------------------------------------------
Phenylacetic acid, phenylacetic acid 2916 34 000
------------------------------------------------------------------------------------------------------------------------
Potassium permanganate 2841 61 000 potassium permanganate
------------------------------------------------------------------------------------------------------------------------
Piperidin hexahydropyridin 2933 32 000
------------------------------------------------------------------------------------------------------------------------
Including the salts of the substances listed in all cases where the existence of such salts is possible.
Annex No 11 to the Act No. 167/1998 Coll.
AUXILIARY substances listed in table II of the UNITED NATIONS Convention against
illicit traffic in narcotic drugs and psychotropic substances (Notice No.
462/1991 Coll. and by immediately binding regulation of the European
Community ^ x))
------------------------------------------------------------------------------------------------------------------------
International non-proprietary name (INN) chemical name of Subheading customs
in the Czech language of the tariff
-----------------------------------------------------------------------------------------------------------------------
Acetone 2914 11 000 2-propanone
------------------------------------------------------------------------------------------------------------------------
Ether diethyl ether 2909 11 000
------------------------------------------------------------------------------------------------------------------------
Hydrochloric acid hydrochloric acid 2806 10 000
------------------------------------------------------------------------------------------------------------------------
Sulphuric acid sulphuric acid 2807 000 10
------------------------------------------------------------------------------------------------------------------------
Methyl ethyl ketone (MEK) butanone 2914 12 000-2
------------------------------------------------------------------------------------------------------------------------
Toluene 2902 30 000 methyl
------------------------------------------------------------------------------------------------------------------------
Including the salts of the substances listed in all cases where the existence of such salts is possible, with the exception of the acid salts
hydrochloric and sulphuric acid.
x) Article. 1 (1). 1 Council Regulation (EEC) No 3677/90, as amended by regulation
Commission Regulation (EC) No 1232/2002.
Article II
Transitional provisions
1. Initiated the procedure for the registration of which has not been completed to the
date of entry into force of this law shall be completed in accordance with existing
the legislation.
2. Initiated proceedings for penalties, which has not been completed at the date of
the entry into force of this law shall be completed in accordance with the existing laws,
regulations.
3. The obligation referred to in section 29 will meet the person for the first time in 2005.
4. The responsible person provided for prior to the date of entry into force of this Act
It is considered a responsible person under this Act.
Article. (III)
For the publication of the full text of the Act
The Prime Minister is hereby empowered to make in the collection of laws, promulgated the full text
Act No. 167/1998 Coll., on addictive substances and amending certain
other laws, as is apparent from subsequent laws.
PART THE SECOND
Amendment of the Act on the establishment of ministries and other central bodies of the State
administration of the Czech Republic
Article IV
Act No. 2/1969 Coll., on establishment of ministries and other central bodies
the State administration of the Czech Republic, as amended by law No 34/1970 Coll., Act
No 147/1970 Coll., Act No. 125/1973 Coll., Act No. 25/1976 Coll., Act
No 118/1983, Coll., Act No. 60/1988 Coll., Act No. 37/1989 Coll., Act
No 173/1989 Coll., legal measures of the Presidium of the Czech National Council No.
9/1990 Coll., Act No. 93/1990 Coll., Act No. 126/1990 Coll., Act No.
203/1990 Coll., Act No. 288/1990 Coll., legal measures of the Bureau
The Czech National Council No. 305/1990 Coll., Act No. 575/1990 Coll., Act No.
173/1991 Coll., Act No. 283/1991 Coll., Act No. 19/1992 Coll., Act No.
23/1992 Coll., Act No. 103/1992 Coll., Act No. 167/1992 Coll., Act No.
239/1992 Coll., legal measures of the Presidium of the Czech National Council No.
350/1992 Coll., Act No. 357/1992 Coll., Act No. 359/1992 Coll., Act No.
474/1992 Coll., Act No. 548/1992 Coll., Act No. 21/1993 Coll., Act No.
166/1993 Coll., Act No. 285/1993 Coll., Act No. 47/1994 Coll., Act No.
89/1995 Coll., Act No. 289/1995 Coll., Act No. 135/1996 Coll., Act No.
272/1996 Coll., the Act No. 152/1997 Coll., Act No. 15/1998 Coll., Act No.
148/1998 Coll., Act No. 63/2000 Coll., Act No. 130/2000 Coll., Act No.
154/2000 Coll., Act No. 204/2000 Coll., Act No. 239/2000 Coll., Act No.
257/2000 Coll., Act No. 258/2000 Coll., Act No. 365/2000 Coll., Act No.
458/2000 Coll., Act No. 257/2001 Coll., Act No. 13/2002 Coll., Act No.
47/2002 Coll., Act No. 219/2002 Coll., Act No. 517/2002 Coll., Act No.
62/2003 Coll., Act No. 162/2003 Coll. and Act No. 18/2004 Coll., amended
as follows:
1. In section 10, paragraph 1. 1, after the words "in direct managing competence"
the words ", the treatment of addictive substances, preparations, and precursors
the other ingredients ".
2. In section 10, the following paragraph 3 is added:
"(3) the organizational part of the Health Ministry's Inspectorate
narcotic drugs and psychotropic substances ".
PART THE THIRD
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 provisions of the article. I, points 48, 54, if
as for section 34 paragraph. 1 (a). (d)), 55, 56, as regards § 40 paragraph. 6, and 59,
which shall take effect on 1 January 2005. January 1, 2005.
Zaorálek in r.
Klaus r.
Spidla in r.
